eur opean IN DUSTR IA L PHA RMACY - … companies engage with their customers. The first is a switch...

europeanINDUSTRIALPHARMACY

ISSUE 18 • OCTOBER 2013www.industrialpharmacy.eu

www.eipg.eu

features4 FROM PUSH TO PULL MARKETING IN

HEALTHCAREThis article describes how new technology enablescustomer communication to be tailored to eachhealthcare professional – creating personalisedchannels of highly relevant information.by Morten Hjelmsoe

7 PRINTING MEDICINES3D printers have many potential biomedicalapplications and have recently been used to printunit dosage forms. This article illustrates how printingtechnology could revolutionise the manufacture ofmedicines.by Simon Gaisford

9 PHARMACY IN NORWAYThe author summarises the evolution of pharmacy inNorway and how regulations and economics havecontributed to the climate today.by Wenche Gordon

12 THE NEW GDP GUIDELINESThe author summarises and comments on the newguidelines on Good Distribution Practice ofMedicinal Products for Human Use, which came intoforce on 8 September 2013. These guidelines applynot only to the wholesalers and manufacturers ofpharmaceuticals, but also to brokers.by Siegfried Schmitt

14 COMPETENCES FOR INDUSTRIAL PHARMACYPRACTICE IN BIOTECHNOLOGY – THE PHAR-IN PROJECTThis article informs on the PHAR-IN PROJECT, which isfunded by the European Commission and aims torecruit pharmacy industrialists and educationalistswho will propose a list of competences andoutcomes required for education in biotechnologyin the pharmaceutical industry.by Jeffery Atkinson, Jane Nicholson, Bart Rombaut

regulars3 EDITORIAL COMMENT18 REGULATORY REVIEW19 NEWS FROM THE EIPG20 EVENTS

2 european INDUSTRIAL PHARMACY October 2013 • Issue 18

europeanINDUSTRIALPHARMACYIssue 18 October 2013

ISSN 1759-202X

MANAGING EDITORSue Briggs

PRODUCTIONDave Johnson

SUBSCRIPTIONSJill Monk

EDITORIAL BOARDMichael AnisfeldClaude FarrugiaMichael GamlenLinda HakesJohn Jolley

European Industrial Pharmacyis published four times a year by: Euromed CommunicationsPassfield Business Centre,

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Views expressed in European IndustrialPharmacy are those of the contributorsand not necessarily endorsed by thePublisher, Editor, Editorial Board, or byour corporate sponsors who accept noliability for the consequences of anyinaccurate or misleading information

©2013 Euromed Communications

europeanINDUSTRIALPHARMACYdiscussion group:

www.pharmweb.net/gmp.html

european INDUSTRIAL PHARMACYis the official publication of the European IndustrialPharmacists Group (Groupement des Pharmaciensde l’Industrie en Europe) www.eipg.eu

Editor’s noteThe article referred to in the descriptionof the last issue’s cover photo has notbeen included.Cover photo: Printing medicines (seearticle on page 7)

associate editors

Belgium: Philippe Bollen

Bulgaria: Valentina Belcheva

Czech Republic: Ales Franc

Denmark: Marie Fog

Finland: Anni Svala

France: Jean-Pierre Paccioni

Germany: Armin Hoffmann

Great Britain: Shilpa Gohil, Janet Halliday

Greece: Ioannis Nikolakakis

Hungary: Sylvia Marton

Ireland: Anna O’Mahony

Italy: Piero Iamartino

Latvia: Inta Saprovska, Anita Senberga

Malta: Claude Farrugia

Netherlands: Amon Wafelman

Norway: Wenche Gordon

Portugal: Nuno Moreira

Spain: Beatriz Artalejo

Sweden: Marianne Andersson

Switzerland: Valter Gianesello

european INDUSTRIAL PHARMACY October 2013 • Issue 18 3

Since 21st April when I was elected as the newPresident of the European Industrial PharmacistsGroup (EIPG), I have realised that followingProfessor Gino Martini is a real challenge.Throughout his presidency, Gino succeeded indeveloping EIPG as an Association that is, andcan be seen to be, a key player in industrialpharmacy and a point of reference for industrialpharmacists. EIPG has a very professionalBureau, a new financial process, a firmfoundation, growing influence and membershipand a common vision of the importance andimpact of industrial pharmacists on thepharmaceutical environment.I am pleased to take over the presidency of

EIPG to give a new impetus to the Associationand to benefit from the pharmaceuticalexpertise of the different member countries.Industrial pharmacists in Europe should get toknow each other better and raise their profile tobe recognised by the European institutions.Taking into account the current and future

challenges facing the pharmaceutical industry,some of the strategic orientations of my2013/2016 mandate are as follows.• To reinforce the partnerships with keystakeholders, such as the EuropeanCommission, the European MedicinesAgency, the European groups of communityand hospital pharmacists, the Europeantrade associations, universities and non-European Union (EU) representatives, such

as the International Conference onHarmonisation and the United StatesPharmacopeia.

• To develop and support working groups,with leadership given to each countrydelegation, and a mixture of both generaltopics, such as ethics, pharmacist’s roles andtraining promotion, public health concerns,and European regulations, and moretechnical aspects, such as recommendationson cold chain transport, ambient transport,medicine shortage services, internationalgood distribution practice, good practice forover-the-counter products, generics andbiosimilars, and raw material sampling.

• To widen the visibility of EIPG and itsworking practices through a strengthenedwebsite.

• To continue to develop the influence andwork of EIPG by increasing members’participation across the EU and to encouragethe presence of observers from non-EUcountries.

• To implement new EIPG internal rules andestablish a new finance commission.

I am confident in the success of EIPG, thanksto the active participation of its members, theirpersonal involvement and backgroundexperience, all of which will contribute to therecognition of industrial pharmacists withinEurope and globally.

Best wishesJean-Pierre Paccioni

editorialMessage from the new President, Mr Jean-Pierre Paccioni

Joe Ridge, pharmacist, publisher and CEO of Euromed Publications died ofpancreatic cancer on 8th August. As well as a number of other scientific publications,

Joe was Editor of “European Industrial Pharmacy”, our EIPG Journal. An inveteratetraveller and fluent in French, Joe enjoyed attending the General Assemblies of theEIPG. Joe was a clever, articulate and fine gentleman. He will be sadly missed by allour delegations. Our condolences go to his wife Shirley, their two sons and families

and all staff at Euromed.

Joe Ridge 1937–2013

european INDUSTRIAL PHARMACY October 2013 • Issue 184

Trends driving change inhealthcare communicationThere are a number of trends, bothin society at large and specific tothe life science industry, thattogether pose a major challenge tohow companies engage with theircustomers.The first is a switch from products

to services. This ‘beyond the pill’world is rapidly coming into being,driven partly by the increased focuson patient outcomes. Consequently,companies have to now considertotal treatment – ensuring not onlyeffective medication but alsocompliance and lifestyle changesamong many other factors. Thismove to services means thatcompanies have to work ever moreclosely with healthcare professionals,seeking increased partnership andco-operation. There is, unfortunately, a parallel

trend that is the decreasingeffectiveness of traditional customerengagement. Counter-intuitively,increasing advertising spends andscaling up sales forces appear toresult in less time to communicateand less engaged customers. Sowhile companies need to engagemore closely with their customers,they are finding that the more thatthey try to reach out, the fartheraway customers seem to get! This brings us to the next trend,

one that I call the rising price ofbrain real estate. We all see

thousands of marketing messagesand have media streaming, beamingand blasting information at us 24/7.As our minds fill up, we’reincreasingly choosy about what wedecide to put in there. Forhealthcare professionals, thesituation is no different – perhapseven more extreme. Increasingdemands on their time, challengesto their authority and a feeling thatthey are already over-marketed to,means that they are actively closingthemselves off from the industry.At the same time, medical

professionals also have to deal withincreasingly complex treatments.They have to know more than ever –especially now that we see thebeginnings of another major trendthat is individualised medicine.It all adds up to an interesting

dilemma: physicians do needinformation but are increasinglyresistant to traditional approaches,while life science companies needto be more involved in patienttreatment but are finding it everharder to connect. What to do?

A question of relevanceTo respond to these trends, Ibelieve that we need to rethink ourapproach to communication. Withtraditional marketing, there is anunderlying problem: relevance.Because industry communicationdoesn’t address healthcareprofessional’s specific circumstances

and needs, it doesn’t receive muchattention. Why would it? Time isscarce, there are lots of things onthe physician’s mind, and thecommunication is seen as notparticularly important. So it getsignored. Consequently companiesfeel that they now have tocommunicate more and shoutlouder. This increases the frustrationfrom customers who,understandably, make themselvesharder to reach. And so itcontinues, resulting in the industryand its customers drawing everfurther apart.To reconnect with our customers,

I believe that we need to changeour understanding of whatpharmaceutical marketing is for.Rather than see the problem as oneof getting attention (more reps,more advertisements, biggerconferences), we should, instead,see that it’s really about transferringknowledge. If we look at it like this,we shouldn’t really be ‘attentionseekers’ but rather ‘informationtransporters’. So the question thenbecomes: how do you best transferknowledge?

From push to pullcommunicationThe introduction of newtechnologies enables us to thinkdifferently about communication.While we often talk about ClosedLoop Marketing here, I actuallyprefer the term ‘pull marketing’ or‘pull communication’. It’s not a bigdeal, but it more clearlydemonstrates the difference fromtraditional ‘push’ forms of customercommunication. Put bluntly thedifference is:• a push communication is what Iwant you to know;

• a pull communication is under-standing what you need to know.

‘Push’ is what we’ve been doing foryears. It’s the mass communication ofmessages. It’s fundamentally aboutdealing with people as groups ratherthan individuals. In effect, that meansproviding the same message foreveryone and delivering it in thesame way and at roughly the sametime.I like to think of this as acting like

bus drivers. We have a destination in

FROM PUSH TO PULLMARKETING IN HEALTHCAREby Morten Hjelmsoe

• Major industry and societal trends pose a challenge totraditional customer engagement.

• New technology offers the opportunity to thinkdifferently about communication.

• Digital sales tools enable us to switch from low-valuemessage delivery to high-value individualisedcommunication.

Morten Hjelmsoe is CEO and founder of Agnitio, based in Copenhagen, Denmark.He explores the opportunities that the life science industry is now enjoying from aform of communication that’s always just for you.


FROM PUSH TO PULL MARKETING IN HEALTHCARE continued

mind for healthcareprofessionals; we plan outa route to get them there– all according to a stricttimetable, with everyonetravelling together and atthe same speed (Figure 1). The problem with this

is that customers are allindividuals. They eachhave their own particularset of knowledge,interests and needs.Sometimes, they’ll know a lot abouta topic, so don’t need a lot ofinformation to understand it.Sometimes, they have a low level ofknowledge and will need to stay onthis topic for longer. Andsometimes, they’ll want informationthat simply isn’t on the route. Pushmarketing can’t easily account forsuch personal needs. The result?We’re pushing our customers to goplaces they have no interest inbeing.By contrast, pull communication

requires that we act more like taxidrivers (Figure 2). This is a muchmore empowered position. Here,our job is to react to people’sindividual needs and work out thebest route for them. Asking “wheredo you need to go?” isfundamentally different from asking“do you want to go here?” It’s alsomuch more likely to get a positiveresponse!

A virtuous circleIt’s technology that has enabled thisswitch from acting like bus driversto being customer-responsivechauffeurs. We can now putphysicians in charge of theconversation. For example, digitalsales tools not only make thingslook engaging, they actively engage– allowing healthcare professionalsto choose the topics that they areinterested in. So, during adiscussion with a companyrepresentative, for example,medical professionals can activelypull the information they want.This is just the starting point.

Smart digital sales tools allow us totake note of each medicalprofessional’s particular interests as

they interact with the systems. Thatway we can return later to providemore relevant information on a topicthat they’ve already expressedinterest in. And it continues this way– continually developing a bettercustomer understanding that furtherpowers the provision of high valueand very relevant information.Importantly, such rich data isn’t

possible with traditional pushmarketing. If you’re only pushinginformation, you can only learn how‘pushy’ you are being. It’s likemeasuring the bus driver – you cantrack the route, time, stops, delays,etc., but you’ll know little or nothingabout the passengers or where theyactually want to go.To get to a virtuous circle of

continually improving customerunderstanding (and, therefore,better communication), you need tobe capturing rich data and that’sonly possible if you’re having a richdata conversation. In other words:

you have to be doing pullmarketing.Applying technology in

this way not onlyempowers the physicianbut us too. Good digitalsales tools aren’t aboutautomation but ratherempowerment. With theright tools, we andespecially our sales forcesget ‘upgraded’ fromdeliverers of messages to

responsive consultants who ensurethat each of their customer’s needsare met. In other words, our repscan make individual strategies torespond to the greaterunderstanding that they now haveof their customers. This is somethingthat our sales executives have beendreaming of for many years.

Personalised channelsIn addition to empowering us tomeet individual customer’sinformation requirements, we cannow also pay attention to how theywant it delivered. After all, what’sthe point of talking at exactly theright knowledge level, if theinformation isn’t available when andwhere it is needed? What we mustdo is get the right information inthe right channel at the right time(Figure 3). We live in an age when digital

information should flow to whereverwe need it. Mobile communications

Figure 1: Traditional push communication.

Figure 2: Individualised pull communication.


aren’t mobile because we carrythem around in our pockets. It’struly mobile when it’s always there –delivered in a form that’s right forthe context that you’re in. Everyoneincreasingly expects this from his orher media and it’s what healthcareprofessionals are expecting too.This is actually a major opportunity

to make our communications morerelevant. We can now not only

personalise the information toindividual requirements, but thedelivery mechanism too. Whetherthe physician wants the knowledgeon a mobile device, througheMagazines, eTraining or a face-to-face meeting with a sales rep, theycan get what’s most relevant forthem. In fact, we can personalise further

with the perfect match of desired

content and delivery mechanism.What this means is that the movefrom push marketing to pullcommunication is a switch fromsaying “here’s what we want you toknow in the form that we think isbest” to saying “here’s the preciseknowledge you’re seeking –presented in a way that’s just foryou.”

Future trendsThe good news is that, while thereare major communicationchallenges, our industry isresponding. There is now anawareness of the issues and a desireto make changes. New ideas areemerging and opportunitiespreviously under-exploited – notleast the application of new digitaltechnologies – are now being widelyintroduced. We are moving towardsmore responsive and personalisedforms of communication. We reallyare shifting from a push to a pull.This not only dramatically improvesthe quality of service that weprovide our customers but alsomeans a better perception of theindustry as a whole. If we stay onthis track, the future trend for theindustry looks very positive.

FROM PUSH TO PULL MARKETING IN HEALTHCARE continued

Figure 3: Mobile and multichannel communication.

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2D printing of drug solutions is themost straightforward application ofink-jet technology, since this isanalogous to printing an image (it isalso possible to print suspensions, ifthe particle size of the dispersephase is suitably small that the printhead nozzle does not becomeblocked). The solution is printedonto a substrate to create the finaldosage form. The substrate can bea tablet, powder or polymer film.One immediate benefit of printingthe drug onto a substrate is that it ispossible to manufacture a widerange of unit doses (by varyingeither the concentration of the drugsolution or the area being printed),which brings the paradigm ofpersonalised-dose medicines closerto reality. It would, in principle, bepossible to manufacture, at thepoint of dispensing, medicines witha dose specific to individualpatients. The advent of multi-colour

cartridges also means it is possibleto print combination products(containing more than one drug).

One consideration with ink-jetprinting is that the volume of liquidprinted is usually small, which meansthat the dose range achievable isusually narrow. In my experience, asingle print pass can achieve dosesof up to 50�µg/cm2 (the value isdependent on the solubility of theactive pharmaceutical ingredient).As such, ink-jet printing lends itselfto formulation of highly potent, low-dose actives. The fact that it is likelythat a potent drug will also have anarrow therapeutic index (meaningthe dose will vary from person toperson) further highlights thepotential of the technology formanufacturing personalised-dosemedicines.A dosage form becoming

increasingly popular is the oral-dispersible film (ODF). These arepolymer films designed to dissolveon the tongue. Popular forconsumer healthcare products (suchas breath fresheners), they areincreasingly being used for deliveryof drugs (for instance, benzocainefor relief of flu symptoms andsimeticone for relief of bloating).ODFs are usually cast from asolution of drug and polymer andso the drug is homogeneouslydispersed throughout the film. Ink-jet printing can be used to print thedrug onto a substrate film. As notedabove, this increases the range ofdoses that can be manufactured. Italso means that the drug is located

PRINTING MEDICINESby Simon Gaisford

Printing technologies have advanced significantly overthe past 20 years and many 2D (liquid) and 3D (solid)

printers are commercially available. Modern 2D (ink-jet)printers are capable of producing upwards of 20,0005–15pL droplets of solution per second. While they aretypically designed for producing images on a flatsubstrate, the capacity to jet small volumes with suchexquisite control has led to the use of ink-jet printing inmany diverse fields, including the pharmaceutical sector,usually for controlled deposition of actives onto asubstrate. The latest design of 3D printers use a heatednozzle to melt an extruded polymer – the moltenpolymer solidifies on a build plate and the printerconstructs an object in 3D layer by layer. 3D printershave many potential biomedical applications (such asprinting bone or tissue scaffolds) and have recently beenused to print unit dosage forms. In either case, printingtechnology has the potential to revolutionise themanufacture of medicines over the next decade.

Dr Gaisford is a Reader in Pharmaceutics at University College London and runs aresearch group looking at the effect of physical form on pharmaceutical productperformance. He uses thermal ink-jet printing to prepare oral dispersible films andinhalable particles and to isolate polymorphic forms. He has published more than 60papers, 5 book chapters and 2 books. Email: [email protected]; Web:http://iris.ucl.ac.uk/iris/browse/profile?upi=SGAIS88

Figure 1: Individual ODFs printed with a 2D ink-jet printer.


PRINTING MEDICINES continued

on the surface of the film, ratherthan throughout the polymericmatrix. In the case of cast films, ifthe drug concentration is above itssolubility, there is the possibility thatcrystallisation might occur duringstorage. There is also the possibilitythat the drug itself may act as aplasticiser for the polymer in a castfilm, altering its mechanicalproperties. Both these issues areavoided with printed films. Anadditional formulation advantage ofprinting the drug is that it can belocated on one surface of the film,so if the film is designed for buccaldelivery, it can be ensured that thedrug is in direct contact with thesite of absorption.Ink-jet printing may also be used

to manufacture an ODF directly, byadding a polymer to the solution tobe printed (Figure 1 shows a filmthat was printed onto an acetatebacking sheet). This means that thedrug could be co-printed with thepolymer to produce a filmanalogous to those made viaconventional casting. Oneimmediate benefit of this approachis that it is possible to ensure drug-loaded film does not come intocontact with a cutter duringpunching (a process that oftencreates nucleation points and socan potentially lead to crystallisationof the active upon storage).2D printing can also be used in

the production of 3D dosage formsand devices. For instance, if theprint head is mounted above aliquid reservoir, then it is possible toproduce colloidal suspensions (byprinting a drug solution into anantisolvent), liposomes (andliposomes incorporating drugs),reservoir-type microparticles,polymer microparticles for sustaineddrug release and inhalable particles(Figure 2, the latter by printing intoliquid nitrogen and freeze-dryingthe resulting frozen solid). It is alsopossible to coat pre-manufacturedmedical devices with drug or tissuecells. For instance, ink-jet printinghas been used as the finalmanufacturing step in theproduction of drug-eluting stents.Recently, a bio-ink has been

developed that maintains theviability of living cells while in theprinter cartridge and that preventsblockage of the nozzle duringprinting.3D printing permits the

manufacture of larger structuresand/or solid unit dosage forms,usually by controlled layer-by-layerhot-melt deposition of an extrudedpolymer or drug-polymer blend. It ispossible to print modified releasetablets with layers comprisingdifferent polymers and/or drugs andso control the drug release profile.It is also possible to print tablets ofvarying size, and so, again, there isapplication to production ofpersonalised dose medicines.Increasing in complexity, it is alsopossible to print a polymeric orcellulosic scaffold upon which tissuecells can be printed, withapplication to replacement skin,cartilage and organ regeneration.In summary, printing technology

has the potential to revolutionisethe manufacture of pharmaceuticals,especially in the context ofpersonalised dose medicines and in

the construction of 3D matrixdevices.

Further reading1. Buanz, ABM et al. Preparation ofpersonalised-dose salbutamol sulphateoral films with thermal ink-jet printing.Pharm Res 2011; 28:2386–2392.2. Deng-Guang, Y et al. Novel oral fast-dissolving drug delivery devices with pre-defined inner structure fabricated bythree-dimensional printing. J PharmPharmacol 2009; 61:323–329.3. Ferris, CJ et al. Bio-ink for on-demandprinting of living cells. Biomater Sci 2013;1:224–230.4. Katstra, WE et al. Oral dosage formsfabricated by three dimensional printing.J Cont Rel 2000; 66:1–9.5. Mueannoom, W et al. Thermal ink-jetspray freeze-drying for preparation ofexcipient-free salbutamol sulphate forinhalation. Eur J Pharm Biopharm 2012;80:149–155.6. Sandler, N et al. Inkjet printing of drugsubstances and use of porous substratestowards individualized dosing. J PharmSci 2011; 100:3386–3395.7. Scoutaris, N et al, Inkjet printing as anovel medicine formulation technique. JCont Rel 2011; 156:179–185.

Figure 2: Inhalable particles of salbutamol sulfate, prepared by printing anaqueous drug solution into liquid nitrogen.


Historical backgroundThe regulations of the pharmacyprofession in Norway wereintroduced with the RoyalDecree/Medicinal Act of 4December 1672, at a time when thecountry was still under Danish rule.This law served as a guarantee forsupply of high quality medicines tothe population and as a contractbetween the pharmacy owner onthe one side and the King andsociety on the other by leaving thepharmacists a generous enougheconomy to purchase materials ofthe best quality for the productsthey compounded. This law was, inprinciple, in force until 2001 when amajor deregulation took place,allowing “anybody” to actually owna pharmacy as long as a qualifiedpharmacist was employed to takecare of the actual dispensing. Amore than 400-year-old traditionwas thus abandoned.Historically, the training of

pharmacists took place in thepharmacies with the final examsbeing made under the auspices ofcertain pharmacy proprietors andthe Medical Faculty of theUniversity. After the responsibility ofeducation of pharmacists was takenover by the University of Oslo in theearly 1900s, the great discoverieswithin medicine and biology of thelate 19th century had a large impact

on the teaching programmes1. Thebroad scope of the education ofpharmacists in Norway thus gavethe profession a good basis forpositions in the pharmaceuticalindustry from the time this industryemerged, and this tradition hasbeen sustained to the present time.Since the number of studentsadmitted to the Institute ofPharmacy was very limited untilrecent years when pharmacytraining was also established atother universities, the meticulousselection of students alsocontributed to give the professionan additional high quality. Thisprovided a good foundation forpharmacists to succeed in thepharmaceutical industry.However, in most positions in the

pharmaceutical industry, pharmacistsdo not have a professionalmonopoly like in the pharmacies,but have to compete with otheracademically trained professionals.The majority of pharmacists havenevertheless chosen community orhospital pharmacy as their place ofwork, for which the training isdirectly adapted.

Pharmaceutical industry inNorwayManufacture of pharmaceuticalproducts was gradually separatedfrom pharmacy shops, whose

premises, until the 1980s, were alsoequipped as small manufacturingplants, and shifted to thepharmaceutical industry where onlylarge-scale manufacturing notdispensing of medicines took place.The latter was restricted to becarried out in pharmacies only. Thefirst pharmaceutical companieswere established in the latter half ofthe 19th century. In 1913, there were24 manufacturers of “pharmacyproducts and poisons that had notbeen produced by pharmacies”,and, in 1914, a law concerning theprocessing of toxic substances andother pharmacy products waspassed in parliament. This lawspecifically required that thetechnical director of a companyshould have a degree in pharmacyas well as pharmaceuticalexperience, which caused a certainresentment among pharmacyproprietors and their employeepharmacists, and an attack on the“speculators in patent medicines”was published in the, at that time,existing pharmaceutical journal.Above all, the most offensive issuewas the fact that the venues for themanufacturing of medicinalproducts were outside of thetraditional pharmacies2. However, the principle that a

qualified pharmacist should beresponsible for the manufacturingwas maintained in the industry, inthe sense that the law required suchqualified staff to approve finalproduction batches. Since Norwayis a member of the EuropeanEconomic Area and has fullyimplemented EU regulations withregards to the manufacture ofmedicinal products, and, in thisrespect, is accepted by the EU atthe level of other members, thisposition is carried out by theQualified Person function, for whicha pharmacy degree is more or lessmandatory. Pharmacists have,therefore, had an importantposition in industry from the verystart, and this has been continuedthroughout the years. The first pharmaceutical

companies in Norway wereestablished and owned both bypharmacists and those with otherbackgrounds. As they grew in size

PHARMACY IN NORWAYby Wenche Gordon

Throughout history, pharmacists have had theresponsibility to provide high-quality medicinal

products to the population, and contribute to thewellbeing of the people they serve. This may also be oneof the reasons why the manufacture of medicinal productshas long been heavily regulated and carried out bymembers of a profession with the particular qualificationsenabling them to succeed in this intricate work.

Wenche Gordon obtained an MSc Pharm degree from the University of Oslo in 1971.She has been employed in community and hospital pharmacy in Norway and Englandfor 10 years, and worked for a brief period at the Norwegian Medicines Agency. Shehas more than 30 years’ experience in the pharmaceutical industry in various positionsand with several companies, but with regulatory affairs as her main field ofoccupation. She is currently employed at Pronova BioPharma in Oslo as RegulatoryProject Director.


and expanded their activities, theywere gradually taken over bymultiple owners, and some werestructured as share companies fromthe start. In the beginning, themanufacture was intended forsupplying the domestic market.Later, several of the companiessucceeded in considerable exportof their products. In addition totheir own products, they could alsobe representatives and partners forforeign pharmaceutical companies,and could have a wide portfolio ofimported product for sale inNorway. This part of the businessgradually changed as the foreigncompanies established their ownsales offices in Norway. We,therefore, saw two categories ofindustry being established,manufacturing-based companiesand office-based affiliates of foreigncompanies. The latter often hadpharmacists as their leaders whenthey were set up, but this hasgradually changed over the years toinclude other professions.

Health policy and thepharmaceutical industryFrom a political viewpoint, thepharmaceutical industry hastraditionally been seen as asupplier/vendor of pharmaceuticalsto the health sector and anexpenditure on the national healthbudget, not as a contributor to thedomestic product and an importantemployer of highly qualifiedworkers. The domestic industry has,therefore, had little governmentalsupport, and several of thepreviously Norwegian ownedcompanies have ended up withforeign ownership through mergersand acquisitions. This has invariablyled to reduction of activities and aconsiderable downsizing. Only oneforeign company has built up a newmanufacturing site in Norway. Thistook place nearly 40 years ago, butthe plant, now owned by FreseniusKabi, is still operating verysuccessfully.The current policy with regards to

medicinal products is partially basedupon the 2004–2005 White Paper(Stortingsmelding Nr. 18) approved

on 11 March 2005. There are threeprincipal goals recommended in thepaper.– Medicinal products should beused correctly, both from amedical and economic viewpoint.

– The patients shall be guaranteedaccess to effective medicinalproducts, independently of theirability to pay.

– Medicinal products should havethe lowest possible price.Thus, economical considerations

have a dominating role in themaking of political decisions.Naturally, this has led to a very highrate of use of generic products. TheWhite Paper does not mentionmuch about pharmaceuticalindustry, but what is written showslittle confidence that there will everbe a development of this industry ofany sizeable proportion in thefuture.However, in recent years, there

have been signals from thegovernment side that biotechresearch and innovation should beappointed as an area of priority, andthere are now possibilities forrelatively generous government

funding for research-basedcompanies. Thus, several smallstart-up research-based companiesare now emerging, some withpromising results from theirresearch. So far, only one of them(Photocure) has reached the marketwith their own cancer treatmentproducts, of which they now have aconsiderable export. This companywas established in 1997 and carriedout the development of theirproduct based on researchconducted at the NorwegianRadium Hospital. The pharmaceutical market in

Norway is dominated by importedproducts, as shown in Figure 1. Thishas, in recent times, been an issueof discussion, since both thenumber of manufacturing facilitieswith equipment and the number ofpersonnel with the competence tooperate it, is now considered to beapproaching a critical low limitshould an emergency occur, such asa pandemic.The most successful Norwegian

manufacturing companies havespecialised in niche products, andtheir export figure is high compared

PHARMACY IN NORWAY continued

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PHARMACY IN NORWAY continued

to the sales on the domesticmarket. In addition to the previouslymentioned company Photocure, wehave one of the world’s biggestdeveloper and manufacturer of X-ray contrast media and otherimaging agents (formerly Nyegaard& Co., now GE Healthcare), theworld’s largest manufacturer ofomega-3 fatty acids for medicinaluse (Pronova BioPharma) and adeveloper and manufacturer of fishvaccines of considerableimportance on the world market(Pharmaq). Today there are 11 companies

with manufacturing licences inNorway. They are mainly situated inthe Oslo area, but a few havemanufacturing plants in the areasurrounding the southern part ofthe Oslo fjord. GE Healthcare havetheir large active pharmaceuticalingredient manufacturing plant onthe south coast, and Pharmaq haveestablished their plantmanufacturing fish vaccines in thearea north of Trondheim. Themanufacturing companies hadapproximately 2500 employees in

2010, and there were approximately1500 employees in the importingcompanies.During the last two decades,

several Norwegian consultancycompanies have been established,and they have been steadilyincreasing their number of staffand offered attractive positions toacademics with suitablebackground, among thempharmacists. The positions inquestion are office-based likeregulatory affairs, or related toclinical trials. Also, a fewpharmacists have been attached toforeign consultancy companies forsimilar assignments in Norway. Thedevelopment with regards toemployees can be seen in Figure 2.Unfortunately, there are no good

recent statistics for the proportionof pharmacists among the totalnumber of employees. The lastreliable and accurate figures arefrom 19983. In this survey, the totalnumber of pharmacists employedin industry was 322 and 5 employedwith clinical research organisations.Approximately 200 of those were

employed in companies withNorwegian ownership andmanufacturing in Norway at thattime.Although several employers have

carried out considerable downsizingwith consequent loss of workplaces, the emergence of the newresearch-based start-up companieshave been able to absorb the mostcompetent and experiencedprofessionals, to the mutual benefitof both.Pharmacists occupy a wide range

of positions within the industry inNorway. The educationalbackground, in many cases withfurther specialisation, openspractically any position withinresearch and development,manufacturing, quality control,regulatory affairs, medical affairs,pharmacovigilance, businessdevelopment and sales. There are,therefore, also many pharmacists atvarious management levels right upto top management.The industry thus has a long

tradition for being a popular placeof work for pharmacists, offeringgood career possibilities andopportunities for specialisation, inaddition to an inspiring cross-professional environment. Those ofus who work in the industry hopethat a further expansion of thiswork market will still be seen, atleast of a sufficient size to catch upwith the number of recently lostpositions.

References1 Hamran O. Farmasøytenes historie iNorge 1858–2008. Oslo: Forlaget Press;2008.

2 Amdam RP and Sogner K. Wealth ofContrasts. Nyegaard & Co. – ANorwegian Pharmaceutical Company1874–1985. Oslo: Ad Notam Gyldendal;1994.

3 Norsk Farmaceutisk Etat. NorskFarmaceutisk Forening. Oslo: NorgesApotekerforening; 1998.

4 Legemiddelindustrien. Tall og fakta 2012.Oslo: Legemiddelindustrien; 2012.

Kilde: LMI

Ansa

tte

År

44004450

45704600

4570 4560

4370

46704630

3947

3500

3700

3900

4100

4300

4500

4700

4900

201120102009200820072006200520042003200220012000

4690

4223

Figure 2: Total numbers of employees in the pharmaceutical industry inNorway during the period 2000–20014.

Source: LMIYear

Employees


The role of the ResponsiblePersonWith this new regulation comes keychanges for wholesalers. Inparticular, the role of theResponsible Person has beendefined in much more detail. This isa role comparable to the head of thequality unit. The regulation specifiesthat the Responsible Person shouldfulfil their responsibilities personallyand should be continuouslycontactable. The Responsible Personis only allowed to delegate duties,but not responsibilities. Dependingon the scale of the wholesaleoperation, including warehouses anddistribution, this may require severalResponsible Persons in support ofbeing continuously contactable.Though it is not detailed further inwhat timeframe and by what meansthe Responsible Person should becontactable, it is reasonable toassume that this should at the mostbe within a few hours, e.g. in thecase of a recall.As expected, the Responsible

Person should have appropriatecompetence and experience as wellas knowledge of and training ingood distribution practice (GDP). Inaddition, the guideline states that “A degree in pharmacy is desirable”.No explanation is given for thispeculiar expectation, nor is it madeclear what acceptable alternativesmay be. There is no obvious reasonwhy a person with a differentprofessional background should not

be capable of performing the dutiesof a Responsible Person. Personshaving wholesale expertise and anunderstanding of GDP can, in fact,come from any walk of life.Furthermore, few companies employa pharmacist in the role of theResponsible Person, as wholesaleand distribution is not a classicalfield of expertise for pharmacists.The danger is that we may see asimilar diversity in requirementswithin the European Union (EU)Member States for the professionalbackground of Responsible Personsas is already the case for QualifiedPersons.

Wholesalers and brokersWhereas the 1994 guideline onlyreferred to wholesalers, the newguideline affects both wholesalersand brokers. The difference is thatwholesalers must be licenced andbrokers must be registered in aMember State of the EU. Theregulations go even further, requiringthat brokers must have a permanentaddress and contact details in theMember State where they areregistered. It is not clear if statisticsare available that would show howwidely broker services are used formedicinal products. Thus, the impactof this regulation is not immediatelyobvious. Nor is it known whether thelimitations put on brokers, such asEU residency, will have an impact ondrug supplies for the EU. What is,however, clear is that many EU

regulatory agencies are not yetprepared for this change in theregulations. The author’s attempts atfinding out via the internet how toregister as a broker in various EUcountries failed miserably. It isquestionable whether all agencieshave a system for broker registrationin place.

The Quality SystemThe directive requires bothwholesalers and brokers to operatea Quality Management System(QMS), which is something new forbrokers. As this requirementapplies, irrespective of size of theorganisation, it will be interesting tosee regulatory expectations on howan individual, who operates as abroker, will have to self-audit him-or herself, or how detailed thestandard operating procedures willhave to be written for the person tounderstand what they are doing.This is not to say that a QMS is nota necessity, merely that the actualintention of the guideline is notalways entirely clear. Quality Risk Management (QRM) is

now a must have element of theQMS. This is certainly a sensiblerequirement, given the manybenefits of QRM, particularly as ithelps document rationales andreasons for operational andorganisational set-ups. However, itcannot be expected that wholesalersand brokers will have a soundunderstanding of this requirement,and thus be able to comply withease. Even the drug substance anddrug product manufacturers strugglewith the implementation of QRM. Alltoo often, performing a few riskassessments is considered sufficientfor achieving compliance. This is, ofcourse, far from adequate.The directive also brought about

some significant changes affectingwarehouses, in particular, withregards to storage and segregation,and computerised systems. Thestandard requirements for restrictedaccess and segregated areas formedicinal products can still becomplied with either throughphysical segregation or by means ofa validated computerised system.This is aligned with the goodmanufacturing practice (GMP)

THE NEW GDP GUIDELINESby Siegfried Schmitt

On 7 March 2013, the European Commissionpublished the Guidelines on “Good Distribution

Practice of Medicinal Products for Human Use” (2013/C68/01). This new GDP Guideline is a 14-page documentthat replaces the previous version from 1994. It appliesnot only to the wholesalers and manufacturers ofpharmaceuticals, but also to brokers. The guideline cameinto force on 8 September 2013.

Siegfried Schmitt is a Principal Consultant in PAREXEL's Strategic Consulting team.His key areas of interest are agile quality systems, competitive compliance and QbD.He has over 20 years' experience in the pharma and medical device industry. Hejoined PAREXEL in 2007.


requirements. In deviation from theGMPs, medicinal products receivedfrom a third country, but notintended for the EU market, have tobe physically segregated. The samerequirement for physical segregationnow also applies to expired product.Especially in fully automatedwarehouses, where product locationis randomly assigned by theautomated system, and currentstatus (e.g. released) traceability isassured through the validatedcomputerised system, this willpotentially require either changes tothe program logic plus theassociated revalidation activities, orcreating a physically segregatedsolution outside the automatedwarehouse. In either case,warehouse operators will incur extracost. This effectively applies dualstandards to the acceptability ofcomputerised standards under GMPand GDP.The directive also addresses

Computerised Systems Validation.Computerised systems need to bevalidated or its fitness for purposedemonstrated through verificationstudies. What constitutes“appropriate verification studies”though remains a total mystery. It isaccepted practice that qualityrelevant records need to be retained

for certain periods of time. Why theauthors of this guideline decided tocodify that back-up data (not therecords!) are to be retained for aminimum of 5 years at a separateand secure location is anotherunexplained mystery. Back-ups aregenerally kept for a week, by whichtime they have become obsolete.Not even Annex 11 of EudraLex Vol4 details such requirements. Again,the GDP guideline is not alignedwith those for GMP.

SummaryDespite these issues, the guidelinecertainly strengthens complianceand strengthens supply chainsecurity. For most wholesalers, andpossibly the vast majority of brokers,this directive will require them toamend, change or even build from

scratch Quality Systems that meetthese requirements. For thepharmaceutical industry’s auditors, itmeans being acutely aware of thesubtle, but important, differencesbetween GMP and GDP, and for theregulatory authorities, it meansputting in place processes andprocedures for the registration ofbrokers and the inspection ofwholesalers and brokers against theirlicence or registration. Forconsumers, these tightenedregulations may potentially lead tocertain drug shortages. Wholesalersand brokers, and ultimately thepharmaceutical industry, will offloadthe increased cost this directivebrings with it onto the consumers,i.e. the patients. Strengtheningsupply chain security and patientsafety comes at a cost.

THE NEW GDP GUIDELINES continued

Editor’s comment: “EIPG, in its responses to consultation documents on the FalsifiedMedicines Directive and the Commission’s GDP Guidelines, has expressedits opinion that failure to establish minimum qualification requirements,responsibilities and professional accountability for the ResponsiblePerson in a manner concordant to those of the Qualified Person, is amajor shortcoming of the Directive. In the absence of such provisions,EIPG believes that a pharmacist represents the class of professionalwhose undergraduate training best encompasses knowledge of thenecessary legislation, quality assurance and quality managementprinciples, and an understanding of medicinal products at such a level asto be able to implement the conditions necessary for their safe transportand storage.”

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The aim of the project is to recruit apanel of industrialists andeducationalists that will propose alist of competences and outcomesrequired for education inbiotechnology for future and currentemployees in the pharmaceuticalindustry. These will then be rankedusing Delphi methodology inimportance by a wider panel ofindustrialists and academics (drawnin a first stage from EIPG and EAFPmembership with a snowballingeffect for recruitment of others).Using several rounds of the Delphiprocess, a consensual, hierarchal listof competences and outcomes willbe produced and possible factoidcompetences removed. The list willthen be used to adapt theeducation and training inbiotechnology given at highereducation institutions (HEIs). All information will be freely

available, with no copyright orownership issues involved, to otherEuropean organisations, professionalassociations, HEIs, big pharma, etc.wishing to produce similar courses.Through its European network ofMember Associations, the EIPG willadvertise the results of the project toemployees of the pharmaceuticalindustry. The EAFP and thePHARMINE network will ensuredissemination to academics. In allcases, dissemination will be throughclassical channels: websites,conference presentations, emailnewsletters and journal articles.This project will have a substantial

impact on employees of the drugindustry, providing them with theskills they need in a fast-changingworld. It will also improve the abilityof the European industry tocompete in the globalpharmaceutical world. Ultimately,

the project will impact on the well-being of the European populationthrough research and development(R&D) and production of safer, moreeffective, modern-day medicines.

The work programmes (WPs)PHAR-IN is divided into five WPs.WP1 management (MNGT) will berun jointly by P1/VUB (VrijeUniversiteit Brussels;www.vub.ac.be/en/?via=accept-language) and P2/PCN (PharmacolorConsultants Nancy (pcn-consultants);http://pcn-consultants.com/).Basecamp (https://basecamp.com/)software will be used. This is a web-based project management andcollaboration tool with to-dos, files,messages, schedules andmilestones.WP2 implementation (IMP) will be

run by P2/PCN. This will constitutethe core of the project and willconsist of the following.• Production of a list of topics for acurriculum in present daypharmaceutical biotechnologyusing a Delphi process. TheDelphi method is a structuredcommunication technique whichrelies on a panel of experts(members of EIPG and EAFP, andindustrial pharmacists). The latteranswer questionnaires – in thiscase, the ranking of topics for apharmaceutical biotechnologycourse (PBC) – in two or morerounds. After each round, afacilitator (P2/PCN) provides ananonymous summary of theexperts’ forecasts from theprevious and experts areencouraged to revise their earlieranswers in the light of the repliesof other members of their panel. Itis believed that, during thisprocess, the range of answers willdecrease and the group willconverge towards the "correct"answer. Ranking will be doneusing Likert scales that are used inquestionnaires to obtainparticipant’s preferences ordegree of agreement with astatement or set of statements.

• Production, running andevaluation of the course at King’sCollege, London (KCL) and theUniversity of Catania (UniCt;www.unict.it/en/rectors-welcome).

COMPETENCES FORINDUSTRIAL PHARMACYPRACTICE INBIOTECHNOLOGY – THE PHAR-IN PROJECTby Jeffery Atkinson, Jane Nicholson, Bart Rombaut

The PHAR-IN consortium (538252-LLP-1-2013-1-BE-ERASMUS-EKA) consists of pharmacy faculties and

industrial partners from countries of the EuropeanHigher Education Area (EHEA), members of theEuropean Association of Faculties of Pharmacy (EAFP;www.eafponline.eu/), together with a professionalorganisation representing industrial pharmacists, theEuropean Industrial Pharmacists’ Group (EIPG;www.eipg.eu/). PHAR-IN is funded by the EuropeanCommission (EC) via its Education, Audio-visual andCulture Agency (EACEA;http://eacea.ec.europa.eu/index_en.php).

Jeffrey Atkinson is Emeritus Professor at Lorraine University and Executive Director,Pharmacolor Consultants Nancy (pcn-consultants), Villers, France.Jane Nicholson is Executive Director of the EIPG, Paris, France.Bart Rombaut is President of the EAFP and Head of the Department ofPharmaceutical Biotechnology and Molecular Biology, Faculty of Medicine andPharmacy, Vrije Universiteit Brussels, Brussels, Belgium.


WP3 quality plan (QPLN) will becentred on the evaluation of thework of the consortium. It will be runby P2/PCN. WP4 dissemination(DISS) will be run by P2/PCN and willconcern the dissemination of theconsortium’s work and results to allpotential stakeholders starting withmembers of EIPG and EAFP. WP5exploitation (EXP), run by P2/PCN,will promote the survival of theproject once the 2-year period ofEC/EACEA funding is over.

The partnersP1, the VUB will act as administratorof the PHAR-IN project. VUB is anoffshoot of the French-speakingUniversité Libre de Bruxelles thatwas founded in 1834. In 1970, thetwo universities became separatelegal, administrative and scientificentities. VUB has a medical andpharmacy faculty. The latter is at theforefront of modern developmentsin pharmacy education and training

in community, hospital and industrialpharmacy practice. VUB has runmany EU-funded and other types ofprojects in the fields of pharmacyeducation, training and research –mostly recently the PHARMINE(“PHARMacy education IN Europe”)project (www.pharmine.org) thatdealt with pharmacy education andtraining in the EU, and the on-goingEACEA-funded programme PHAR-QA that deals with QualityAssurance in European PharmacyEducation and Training (www.phar-qa.eu/). The key activities of P1/VUB

include pharmacy education andtraining (PET) for community,hospital and industrial pharmacypractice, scientific research in fourareas (molecular virology, analyticalchemistry, neurosciences, moleculartoxicology), and research in PET:“gaming”, problem-based learning,project learning and line projects.The managerial tasks at VUB will

be assumed by Bart Rombaut. BartRombaut has a Pharmacy and PhDdegrees from VUB and has beenprofessor there since 1991 andDean of the School of Pharmacysince 2005. He was also guestprofessor at the University ofNijmegen (Netherlands), receivedthe International Prize PrincessJosephine-Charlotte foroutstanding work in the field ofNeuro-virology, and is a member ofthe Real Academia National deFarmacia (Spain). He is on the boardof the important pharmaceuticaland biomedical organisations inEurope and the world. He wasproject leader of “PHARMINE”,2008. His wide-ranging researchinterests include molecular virology,vaccines and antiviral products; hehas an “h” index of 14(http://thomsonreuters.com/web-of-science/). P2, PCN, will act as executive

director. pcn-consultants offersconsultancy for projects in thebiomedical/pharmaceutical sciencesat the European level frompreparation through coordination toreport writing and dissemination.Documents can be prepared inEnglish or French according to EUor other guidelines. pcn-consultants evolved from"Pharmacolor", an SME that wasstarted in 1986. Pharmacolor, basedin the Pharmacological Laboratoryof the Pharmacy Faculty in Nancy,was involved in the preclinicaldevelopment of many anti-hypertensive agents such as thecalcium entry blockers darodipine,nifedipine and isradipine, the ACEinhibitors captopril, perindopril andramipril, and the AT1 antagonisttelmisartan. Pharmacolor was alsoinvolved in the preclinical evaluationof melatonin derivatives.Pharmacolor also developed severaldegree courses, such as a mastersin preclinical drug evaluation, aswell as the "European SummerSchool in Pharmacology".The managerial tasks at pcn-

consultants will be assumed byJeffrey Atkinson. Jeffrey Atkinsonwas educated at CambridgeUniversity, England and taught

COMPETENCES FOR INDUSTRIAL PHARMACY PRACTICE IN BIOTECHNOLOGY continued

WP Milestone Measurable indicators of progress

MNGT Setting-up of Basecamp website. Basecamp website exists and is Posting of information and its functional.discussion.

MNGT Three consortium meetings at VUB in Meetings are held, well-attended Brussels: kick-off, intermediate and and all relevant matters are dealt final. with.

MNGT Production of intermediate and final Reports and financial tables are reports, and financial tables by VUB accepted by EACEA.and PCN, approved by consortium.

IMP Drawing up of first list of Lists are produced; consensus competences and modalities for PBC, Delphi process is performed; Delphi through committee, drawing a final consensus framework of up of second and future lists, Delphi topics for the PBC is produced.through EIPG, EAFP and industrialists.

IMP Establish PBC and advertise. PBC is produced. Advertising is carried out satisfactorily: all target groups are contacted.

IMP Run and evaluate PBC. PBC successfully carried out and evaluated.

QPLN Ensure quality assurance (QA) and QA is successfully ensured and the monitoring of the project. project successfully monitored.

DISS Ensure production and dissemination All stakeholders are successfully of information on the project to contacted.potential stakeholders.

EXP Post-funding period: maintenance of Post funding exploitation is Delphi tool, track changes in successfully carried out.competences, develop PBC according to changes in competences. Adapt to areas other than biotechnology.

A summary of the project


cardiovascular pharmacology andtherapeutics at the University ofCalifornia, Davis, California, USA,the "Mario Negri" PharmacologyInstitute, Milan, Italy, the MedicalFaculty of Lausanne University,Switzerland, and the PharmacyFaculty of Nancy University, France.Twenty years ago he created amasters degree course in preclinicaldrug evaluation/safetypharmacology in collaboration withthe European pharmaceuticalindustry; many of the graduates ofthis course now work in thepharmaceutical and relatedindustries. He also directedpreclinical research at the NestléResearch Laboratories, Lausanne,Switzerland and Rhône-PoulencSanté, Paris, France. Whilst workingat Nancy University, he collaboratedextensively with European andAmerican drug companies on thedevelopment of severalantihypertensive drugs. He sat onthe board of many industrial andgovernment research committees inEurope, US and Asia. His seminalwork includes over 200 publicationswith a global "h" index of 24. JeffreyAtkinson has been working as anexpert and evaluator for the EU forover 15 years. He is EmeritusProfessor of Pharmacology atLorraine University, France.P3, the EIPG, will be an essential

element of implementation WP andtogether with EAFP will lead WP5exploitation. EIPG will also provideinvaluable advice on the regulatoryaspects of any recommendationsand other issues coming out ofPHAR-IN. EIPG is a Europeanassociation representing thenational, professional organisationsof pharmacists employed in thepharmaceutical and allied industriesof the Member States of the EU. Itsfoundation dates back to 1966 and,over the years, it has progressed itsactivities in line with the evolutionof the EU. As a Europeanassociation having its official sealwith the French Order ofPharmacists, EIPG is registered atthe Prefecture of Police in Paris.Today, EIPG represents about12,000 pharmacists working in the

European industry.The managerial tasks at P3 will be

assumed by Luigi Martini who isProfessor of PharmaceuticalInnovation at KCL and Director ofRainbow Medical Engineering; KCLis Europe’s largest centre of healtheducation, with world renownedclinical services and research inphysical and mental health.Professor Martini has occupiedmany roles in industry from SeniorDirector of Preclinical andPharmaceutical Development forEmerging Markets and Asia Pacificat GlaxoSmithKline to thedevelopment of dosage forms andthe design and successfulimplementation of technologicalplatforms, e.g. the DiffCORE andMyDOSE technologies. ProfessorMartini was made visiting Professorat John Moores University ofLiverpool in 2006 and designated aFellow of the Royal PharmaceuticalSociety in 2008. He was appointed amember of the REF2014 sub-panelfor Pharmacy, Dentistry, Nursing andAllied Healthcare Professionals in2011. His research interests includethe use of ultrasonic processingtechnology to fabricate medicaldevices and pharmaceutical dosageforms, the design of dosage formconcepts for delivering personalisedmedicines and the development ofbiopharmaceuticals.EIPG/KCL will also be represented

by Brian Gennery who will develop adistance learning course based onthe results of the PHAR-IN Delphisurvey.P4, UniCt, will play a major role in

WP2 implementation. UniCt hasbeen a focal point in culture andlearning since its founding in 1434.Today, it offers an attractive portfolioof academic titles and is engaged increating a "laboratory" in which theancient knowledge of theMediterranean culture meets thenew technologies in order to offeran original and advanced trainingexperience. UniCt is also a veryattractive proposition for companieswith an interest in the transfer oftechnology from the universitydepartments, institutes and researchcentres. The Faculty of Pharmacy

has updated its formative offerfitting in line with the strategy of theEHEA and the EU Directive for theprofession of pharmacist. UniCt alsohas specialist courses ofPharmaceutical Chemistry andTechnology and Pharmacy.The managerial tasks at UniCt will

be assumed by GiuseppeRonsisvalle who is Vice-President ofthe Organisation for Economic Co-operation and Development (OECD)Programme on InstitutionalManagement in Higher Education(IMHE, www.oecd.org/edu/imhe/).He recently participated as amember of the evaluation team inthe analysis of the Lombardy withinthe OECD reviews of highereducation in regional and citydevelopment. Professor Ronsisvalleis coordinator of the Internal QualityOffice (Presidio della Qualità) of theUniCt. He is also former president ofthe Italian Conference of Deans ofPharmacy, and Vice-President of theEAFP. He is the Italian representativein the Steering Committee forEducation Policy and Practice(CDPPE) of the Council of Europe.He was a member of UniCt team forthe EUA-CRE evaluation andcollaboration with OECD in theprogramme on higher education inregional and city development. Heis a member of the Italian ChemicalSociety and the Accademia Gioeniaof Natural Sciences. GiuseppeRonsisvalle’s main interests are R&Dof neuro-protection drugs and newcentral analgesics, as well as thestudy of mechanisms ofneurodegenerative disease.P5, Genzyme (www.genzyme.be/

default.asp), will play a key role inWP2 implementation. Genzyme is aparticularly interested party in thiseducation project, as educationresources are hard to find. To date,Genzyme has invested substantialtime and resources to educate andtrain their personnel. This projectwill enable Genzyme to have readilyeducated industrial pharmacistsavailable to support their currentoperations and the expansionproject.In October 2001, Genzyme

Corporation acquired the Belgian



part of Pharming N.V. in Geel,Belgium to develop Genzyme’s firstbio-therapeutics manufacturingfacility in Europe. The manufacturingfacility comprises a continuousproduction line for themanufacturing of enzymes forenzyme replacement therapies anda fed-batch production line for themanufacturing of therapeuticmonoclonal antibodies. The firstproduct is enzyme replacementtherapy for Pompe disease, a rare,often fatal, genetic disease of themuscle. Regulatory approval forcommercial production of thisenzyme was received in 2009–2010for the EU, Japan, Canada, US andBrazil. The monoclonal antibodyproduced in Geel was for thetreatment of B-CLL leukaemia, andapproval of its manufacturing for theEU and US was received in 2009 and2010. This monoclonal antibody isalso being evaluated in a number ofclinical trials for treatment of othercancers and multiple sclerosis.The managerial tasks at Genzyme

will be assumed by Gunther Pauwelswho currently holds the position ofSenior Director of Quality Affairs atGenzyme, Geel, Belgium. GuntherPauwels has worldwide experienceand expertise (>15 years) in thedesign, start-up, qualification andvalidation of multiple Pharma andBiotech production units. Hisspecialised education as anIndustrial Pharmacist has enabledhim to absorb solid and pragmaticexpertise in the various elementswithin the Pharmaceutical Qualityarena. Gunther Pauwels believes insystems, organisation andgovernance; ‘Quality is not a sillycoincidence, but a result of carefulplanning and meticulous execution’.

Gunther Pauwels is an activemember and speaker withinrecognised industry associations,such as VAPI, ISPE, PDA and ASQ;and is a certified (ASQ) QualityAuditor.P6, Areta International

(www.aretaint.com/), will play a keyrole in WP2 implementation. AretaInternational is a biotech companydedicated to the contractdevelopment and manufacturing ofbiotechnology products and cell-based medicines. The company wasfounded in 1999 and is located inthe Insubrias Biopark, 30kmnorthwest of Milan. Areta isorganised in two divisions: Aretaservices (GMP and R&D) and Aretaresearch (research and co-development of bio-drugs). TheGMP unit is focused onmanufacturing of bio-drugs foradvanced therapies. Stem cells fortissue regeneration, tumourtreatment using cells or recombinantproteins, antibodies for therapy orfor therapeutic cells selection andDNA as vaccines are examples ofprojects being performed by Areta.In the R&D field, Areta hasdeveloped more than 300 projectsof customised monoclonalantibodies specific to differentantigens. The company also has aunique skill in setting upimmunological and cell-based testsfor characterisation and qualitycontrol of different products.The managerial tasks at Areta will

be assumed by Maria Luisa Nolli,the founder and Chief ExecutiveOfficer of Areta International. Sheholds a degree in BiologicalSciences from the University of Paviaand a PhD from the Université Librede Bruxelles. Dr. Nolli has more than

20 years’ industrial experience as ascientist and group leader in cellbiology and immunology working atthe Lepetit Research Center, part ofthe multinational group of DowPharma (Merrell Dow, MarionMerrell Dow and Hoechst MarionRoussel). Since 2007, she has beenChief Executive Officer of HO.p.e.s.r.l, a spin-off of the State Universityof Milan, with Areta International, forthe development of an innovativeuniversal kit to ascertain growthhormone abuse for anti-dopingpurposes as well as biomedicalapplications. She is a member of theExecutive Committee of Assobiotec(the Italian biotechnology industryassociation), Board Member atEuropaBio (the EuropeanAssociation for Bio-industries) andMember of the EuropeanFederation of Biotechnology. She isauthor and coauthor of more than30 papers and 11 patents and sheobtained “The Piazza MercantiAward” 5th edition (2007) given bythe Chamber of Commerce ofMilan, and the “Rosa Camuna Prize”from Regione Lombardia (2012). Sheis also one of the 100 profiles of thevolume dedicated to the city ofMilan of the series entitled “Thewomen protagonist” (2010).

ConclusionThe PHAR-IN consortium thatinvolves academia and industry willproduce a Delphi-based, rapidanalysis tool for the identification ofthe most up-to-date requirementsfor pre- and post-graduateeducation in competences forindustrial pharmacy practice inbiotechnology. It will then go on todevelop the courses required forsuch education.


ErratumIndustrial Pharmacy advises that within the content of the article titled “Generics uptake in Europe – the impact ofpricing and reimbursement policies”, published in Industrial Pharmacy, March 2013, Issue 37, the phrase 'pricereferencing' should be replaced with 'pricing and reimbursement' throughout the article. Furthermore, this article wasabstracted based on the original paper published in GaBI Journal: Vogler S. The impact of pharmaceutical pricing andreimbursement policies on generics uptake: implementation of policy options on generics in 29 Europeancountries–an overview. Generics and Biosimilars Initiative Journal (GaBI Journal) 2012;1(2):93–100.doi:10.5639/gabij.2012.0102.020.Reprint was granted with permission from Pro Pharma Communications International: Generics and BiosimilarsInitiative Journal (GaBI Journal). Copyright © 2012 Pro Pharma Communications International. All rights reserved.

regulatory reviewThe current review period hasseen a number of changes inthe regulation of medicinesand regulatory guidance inthe EU, International marketsand the USA.

United States ofAmericaPre-launch activitiesimportation requestsThis draft guidance describes the USFood and Drug Administration’s(FDA's) policy regarding requests forthe importation of unapprovedfinished dosage form drug productsby applicants preparing products formarket launch based on anticipatedapproval of a pending new drugapplication, an abbreviated newdrug application or a biologicslicensing application.

Monitoring crude heparin forqualityThis final Guidance for Industryclarifies FDA's expectations andrecommendations and includesreferences to a recently-developedassay for detecting ruminantcontamination of crude heparin.

Draft guidance documentsissued before 2010; withdrawalof guidancesFDA is withdrawing draft guidancesthat are no longer up-to-date. and isalso actively reviewing the draftguidances to determine which onesto either revise or finalise.

EuropeFirst conclusions of parallelassessment of quality-by-design applications The European Medicines Agencyand US FDA have published a jointQ&A that outlines the conclusions oftheir first parallel assessment ofquality-by-design elements ofmarketing authorisation (MA)applications.

Concept paper revision of thenote for guidance onmanufacture of the finisheddosage formThe objective of the guidelinewhich is open for comment until

31 December 2013, is to underlineall aspects of manufacture that areimportant both for applicant andregulator. Information which fallsunder GMP should not be part ofthe MA file and only product-specific issues need to bedescribed. A need to incorporateholding times and conditions aswell as shipping/transportationconditions will be discussed.

Concept paper on developmentof product-specific guidance ondemonstration ofbioequivalenceThis draft concept paper has beenreleased for a 2-month publicconsultation.

Importation of activesubstances (Heads ofMedicines agencies)Active substances (ASs) intendedfor the manufacture of medicinalproducts may arrive at theEuropean Economic Area (EEA)from countries that are not listed asbeing GMP equivalent to EU andwithout the required writtenconfirmation. The process map inthis document describes the actionsthat, if taken by an importer underthese circumstances, may facilitatethe avoidance of problems at thepoint of importation, or later in thesupply chain.

EU GMP Guide Chapter 2:personnelChanges have been made in orderto integrate the principles of“Pharmaceutical Quality System asdescribed in the ICH Q10. A sectionhas been added on consultants. Theexistence in certain circumstances ofa Head of Quality Assurance orhead of the Quality Unit isintroduced. The revision comes intooperation on 16 February 2014.

MHRAASs imported into the EEAThe MHRA will not control ASimport at the border and will insteadcontrol at inspection ofmanufacturers and, where there is arisk trigger, at inspection of ASimporters and distributors.

Requirements for Change ofOwnership submissionsApplicants will now be required todeclare the Marketing Status of theproduct when the transfer of licencehas been applied for.

InternationalICH Q3D Guideline forElemental Impurities This new guideline has reachedStep 2b of the ICH Process andnow enters the consultation period(Step 3). It is open for commentuntil 31 December 2013.

WHOTwo documents marked asrestricted in terms of the readershipto which they have been issued forcomment are summarised below.

General guidance forinspectors on “hold-time”studies Indicates that maximum allowablehold-time should be established toensure that in-process and bulkproduct can be held, pending thenext processing step, without anyadverse effect to the quality of thematerial. These time periods mustbe supported by adequate data.

Proposed updated text forGMP for pharmaceuticalproducts: main principles The paragraphs that need to beupdated have been identified asbeing in the following sections:• Section 1 – QualityAssurance/Quality System

• Section 2 – GMP forpharmaceutical products

• Section 7 – Contract productionand analysis

• Section 17 – Good practices inquality control

For further information on theseand other topics we suggest yourefer to the websites of relevantregulatory bodies and to currentand past editions of “GMP ReviewNews” published by EuromedCommunications. To subscribe tothis monthly news service [email protected]

18 european INDUSTRIAL PHARMACY October 2013 • Issue 18

EducationIn June, after some last minuteproposals for amendments to therevision of Directive 36/2005/EC,agreement was reached betweenthe Irish Presidency of the Counciland the European Parliamentrepresentatives on the text of theProfessional Qualifications Directive.The text has been circulated to ournational delegates.The application to review and

update the competencies neededfor the biotechnology component ofthe pharmacy course (PHAR-IND)has been approved for funding bythe European Commission underthe Erasmus programme. Industrialpartners involved are EIPG,Genzyme (Belgium) and AretaInternational (Italy), along with theVrije University, Brussels, theUniversity of Nancy (Pharmacolor

Consultancy) and the University ofCatania.

Good Manufacturing PracticeEIPG comments on the EuropeanUnion Commission’s revised chapters3 (Premises and Equipment), 5(Production) and 6 (Quality Control)and Exposure Limits in SharedFacilities were submitted to theEuropean Medicines Agency (EMA)and Directorate-General for Healthand Consumers (SANCO). As aresult, we have been invited to senda representative to a workshop atthe EMA next month on dedicatedfacilities.

US PharmacopeialConventionA representative of the USPharmacopeia (USP) office in Baseland a member of the Headquarters

staff from Rockville met with ourPresident and Treasurer at the Ordrede Pharmacien to discuss areas ofpotential collaboration. The USP islooking for experts to join theirpanels on drug classification, drugshortages and diagnostics.

European PharmacyStudents’ AssociationThe new President of the EuropeanPharmacy Students’ Association(EPSA) is Tiia Metiäinen (Finland) andthe EPSA Vice-President of ExternalAffairs is Gabriela Valentova (CzechRepublic). They can be contacted viatheir executive [email protected] [email protected]

Jane Nicholson, Executive DirectorEIPG, [email protected]

I am currently finalising mypharmacy studies at the Universityof Helsinki. I became involved instudent association work right fromthe beginning – and got hooked.After being active locally, it feltnatural to move to national leveland I got involved in the EuropeanPharmaceutical Students’Association (EPSA), first as arepresentative of Finnish pharmacystudents and later as a member ofthe EPSA Team as TrainingCoordinator, Vice President ofEducation and now President.What attracted me to EPSA was

the open and constructiveatmosphere, as well as theinternational environment. Beingactive in a student organisation on aEuropean level offers so manyopportunities to learn about yourprofession, different cultures andEuropean health policy making. Asstudents, we represent potential forall the sectors of pharmacy and,therefore, an organisation like EPSAprovides a completely uniquepanoramic view of European

pharmacy as a whole.As President, my tasks divide

between internal and externalfunctions, such as leading a team ofover 20 students from aroundEurope, chairing our GeneralAssembly and representing EPSA toour members as well as externalpeople. My goals for this mandateinclude finding the right balancebetween these two aspects of myposition. I would like to bring atouch of Nordic efficiency to thefunctioning of the association,encouraging an outcome-orientedapproach in our work as well asaiming to boost EPSA’s visibility topharmacy students and professionalbodies alike. Advocacy is one of our key areas

of work and we are currentlyrefining our processes, makingthem more transparent andrepresentative through an advocacyplatform for European pharmacystudents created last mandate.Tightly linked to this is supportingour member associations inpromoting collaboration between

pharmacy students locally as well asencouraging student advocacy on anational level. It is important thatstudents get engaged andinterested in the future of theirprofession if we want to improveEuropean pharmacy in the future.Collaboration with professional

organisations forms a cornerstonefor EPSA, as maintaining a dialoguebetween the student andprofessional worlds is important sostudents are aware of hot topics inpharmacy, and can voice theiropinions on issues that they mightbe required to find solutions to inthe near future. A good example ofEPSA’s professional collaboration isour work with EIPG on theupcoming EPSA careers websitethat provides information ondifferent opportunities for Europeanpharmacy students in thepharmaceutical industry.

Tiia MetiäinenEPSA

news from the EIPG

19european INDUSTRIAL PHARMACY October 2013 • Issue 18

Message from Tiia Metiäinen, President of the European PharmaceuticalStudents’ Association


eventsNOVEMBER4–8 November 2013 – Basel,SwitzerlandThe Universe of Pre-filledSyringes and Injection Deviceswww.pda.org

6–7 November 2013 – Istanbul, TurkeyBiological Production Strategiesin Turkey and MENAwww.informa-ls.com/biotechmena

20–21 November 2013 – Oxford, UK21st Annual MicrobiologyConferencewww.pharmig.org.uk

25–27 November 2013 – London, UKTableting Technology for thePharmaceutical Industrywww.jpag.org

25–27 November 2013 – Budapest,HungaryPharma Packaging 2013www.gmp-compliance.org

27–29 November 2013 – Lisbon,Portugal8th QP Association Forumwww.gmp-compliance.org

DECEMBER2–4 December 2013 – London, UKGMP and GDP Symposiumwww.mhra.gov.uk

10–11 December 2013 – Barcelona,SpainRapid Microbiological MethodsConferencewww.gmp-compliance.org

11 December 2013 – Edinburgh, UKHalf-day Symposium“Dissolution of inhaled products:in vitro developments, in vivorelevance and the potentialimpact on regulatory thinking”www.jpag.org

12–13 December 2013 – Heidelberg,GermanyThe Responsible Person forGood Distribution Practiceswww.gmp-compliance.org

JANUARY21–23 January 2014 – Frankfurt,GermanyClinical Supply Chainwww.pharma-iq.com

28–29 January 2014 – Berlin, GermanyProtective Packaging Solutionsfor Pharmaceutical ProductStabilitywww.gmp-compliance.org

28–29 January 2014 – London, UKJoint Regulators/Industry QbDWorkshopwww.pda.org

FEBRUARY6th February 2014 – London, UKDevelopments in Analysis ofOrally Inhaled and Nasal DrugProductswww.jpag.org

11 February 2014 – Manchester, UKGood Clinical PracticeSymposiumwww.mhra.gov.uk

18–19 February 2014 – Brussels,Belgium6th Annual Disposable Solutionsfor Biomanufacturingwww.pharma-iq.com

18–19 February 2014 – Berlin, GermanyPharmaceutical Microbiologywww.pda.org

18–20 February 2014 – Munich,Germany6th Disposable Solutions forBiomanufacturing Summitwww.disposablebiomanufacturing.com

24–25 February 2014 – WashingtonDC, USA2014 Aseptic Annual Conferencewww.ispe.org

24–27 February 2014 – Montreal,Canada12th Annual Cold Chain GDP &Temperature ManagementLogistics Summitwww.coldchainpharm.com

25–26 February 2014 – BarnardCastle, UKCleaning Validationwww.honeyman.co.uk

MARCH4–5 March 2014 – London, UKClinical Outsourcing &Partnership World 2014www.healthnetworkcommunications.com

11–12 March – Brussels, BelgiumParenteral Packagingwww.pda.org

13 March 2014 – London, UKThe Pharma Summit 2014Reinventing Business Modelsand Marketswww.economistconferences.co.uk

14 March 2014 – London, UKGood Clinical PracticeSymposium 2014www.mhra.gov.uk

24–26 March 2014 – Heidelberg,GermanyICH Q7 Compliance for APIsManufactured by ChemicalSynthesiswww.gmp-compliance.org

25–26 March 2014 – Lyon, FranceModern BiopharmaceuticalManufacturingwww.pda.org

26–28 March 2014 – Barcelona, Spain19th Congress of the EAHP: TheInnovative Hospital Pharmacist –Imagination, Skills andOrganisation www.eahp.eu/congresses

31 March–3 April 2014 – Lisbon,Portugal9th Pharmaceuticals,Biopharmaceutics andPharmaceutical TechnologyWorld Meeting www.apv-mainz.de

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