Introduction to IFPMA
Transcript of Introduction to IFPMA
Introduction to IFPMA | Committed to a healthier future
Rapid PV landscape change in Africa & Middle East
Drugs Regulatory Unit Ministry of Health
• External influence e.g.
European Good Vigilance
Practice Guidelines (GVP)
• Strategic focus of WHO in
Low/ Middle Income
Countries (LMICs)
• Access to technology
Introduction to IFPMA | Committed to a healthier future
WHO International Drug Monitoring Program
131 countries are full members of WHO International Drug Monitoring Program
Introduction to IFPMA | Committed to a healthier future
Technology is a driver • Regulators developing and adopting new technology to optimise
Adverse Event (AE) reporting; • Use of social media may accelerate change
Introduction to IFPMA | Committed to a healthier future
Middle East - snapshot
• Regional legislation , pan-Arab GVPs launched in July 20015, by League of Arab States. Heavily influenced by EU GVPs
• No regional regulatory authority to coordinate assessment etc. Gulf Cooperation Council (GCC) plays role in other activities.
• Arab countries have implemented to varying degrees; Egypt and Saudi Arabia taking the lead.
• Jordan/ Saudi Arabia have begun inspection programmes
Introduction to IFPMA | Committed to a healthier future
African Medicines Agency (AMA) AMA treaty signed in May 2018, includes safety monitoring/ market surveillance as some of the AMA roles
* Select Medicinal Products
Coordination
Regulatory Oversight
Pooling Resources
Objectives
Marketing Authorization*
Inspection
Market Surveillance
Safety Monitoring
Oversight of Clinical Trials
Quality Control
*
Introduction to IFPMA | Committed to a healthier future
African Medicines Regulatory Harmonisation (AMRH) Launched in March 2018, representing Africa Charter of the WHO led CIP. Platform establishes a PV JAG and TWG.
Introduction to IFPMA | Committed to a healthier future
Implementation Challenges Despite similarity in some national PV legislations, we are seeing an increase in divergence in PV requirements in key areas: Mismatch between legislation and capacity to implement • ICSR reporting : Local versus Global, and timelines • PV System Master File (PSMFs) • Qualified Person for PV (QPPV) • Additional Monitoring requirements • PSUR & RMP: formats and regional annexes • Inspections
Introduction to IFPMA | Committed to a healthier future
“Right Size” PV systems
Right-size PV systems fulfil core PV requirements to protect national patient safety and:
– align to international PV standards where possible to assess local data in global context
– right-size alternatives may be incorporated where there are other means to protect patient safety.
– Trust building, data sharing and work-sharing between regulators is encouraged
Introduction to IFPMA | Committed to a healthier future
Conclusions
• Africa & Middle East countries are rapidly building PV capacity
• Digital technology is a key accelerator
• We encourage global PV convergence and “Right-size” PV systems
• We are driving a unified industry voice
• Industry, like all stakeholders in safety, need a seat at the table to play our part when the need for robust PV systems is being discussed
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Bruce+Donzan3+
The!author!is!employed!by!Genentech!Inc.,!A!Member!of!the!Roche!Group!and!is!a!stock!
holder!in!Roche!Holding!AG,!Pharmaceu@cal!Company.!
Gillian+Winstanley+
The!author!is!employed!by!Amgen!Canada!Inc.!and!is!a!stock!holder!in!Amgen.!
The!views!expressed!in!this!presenta@on!reflect!the!personal!views!of!the!author.!They!
should!not!be!aFributed!to!the!Interna@onal!Society!of!Pharmacovigilance!and!do!not!
necessarily!reflect!the!views!of!the!authors’!employers!or!any!ins@tu@ons!the!authors!
are!otherwise!affiliated!to.!
Disclaimer+
17!
Agenda+
• Key!Drivers!and!challenges!• EFPIA!IPVG!LatAm!team!priori@es!
• How!can!Private!sector!collabora@on!support!na@onal!regulatory!systems!for!PV?!!
• Overview!of!Vigilan@a!
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!Rapid!development!of!PV!legisla@on!in!LATAM!in!last!few!years!
!Divergence!in!countryRspecific!PV!requirements!!
!Appe@te!for!global!harmonisa@on!(ICH)!but!limited!experience!to!
support!implementa@on!
!Infrastructure!and!capacity!at!Health!Authori@es!needs!to!
con@nue!to!evolve!to!support!robust!PV!systems!aligned!with!
interna@onal!standards!e.g.!E2B!
!
Key+drivers+and+challenges+
PV!in!LATAM!is!challenging!with!!
impact!to!meet!compliance!and!resource!needs!
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PV+environment+is+rapidly+evolving+
!
2017!R!
NOMR220!
&!
guidelines!
2017!R!ICH!
membership!
2018!R!GPvP!public!
consulta@on,!XML!
transmission!
!
2014!–!
Decree!1782!
20!www.efpia.eu+
Review+LATAM+PV+environment+to+promote:+
Iden@fy!key!na@onal!requirements!in!need!of!convergence!&!harmonisa@on!
Adop@on!of!ICH!requirements!as!base!approach,!where!possible!!
Reduce!complex!&!countryRspecific!requirements!that!do!not!impact!public!safety!
Industry!and!Regulators!to!use!resources!more!effec@vely!and!increase!compliance!
A!scienceRbased!approach!to!pharmacovigilance!
Ensure+industry+groups+endorse+approach,+align+and+speak+with+one+voice+at:++
Regional!level:!e.g.!EFPIA!IPVG!LATAM,!FIFARMA,!IFPMA!
Na@onal!level:!!ensuring!engagement,!endorsement!and!support!from!na@onal!trade!
associa@ons!before!progressing.!!
Support+IPVG+objec3ve+of+‘rightUsize’+PV+systems+and+interna3onal+coopera3on+
+
EFPIA+IPVG+LatAm+team+priori3es++
We!will!work!in!PARTNERSHIP!and!!
TRANSPARENTLY!with!local!industry!associa@ons!!
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Technical!knowledge!
• Network!of!experienced!pharmacovigilance!professionals!
• Provide!support!for!implementa@on!of!new!technologies!e.g.!electronic!exchange!
Educa@on!and!awareness!
• Sponsorship!or!provision!of!speakers!to!allow!informa@on!to!be!shared!with!stakeholders!in!LatAm!
• Promote!culture!of!adverse!event!repor@ng!
Global!PV!knowledge!
• Provide!feedback!to!support!development!of!‘rightRsized’!PV!systems!and!regula@ons!
• BestRprac@ce!sharing!of!PV!developments!in!other!countries!
How+can+Private+sector+collabora3on+support+na3onal+regulatory+systems+for+PV?+
+
22!VIGILANTIA!is!a!mul@stakeholder!project!sponsored!by!FIFARMA!and!funded!by!AbbVie!
PV+Training+in+a+box+is!an!effec@ve!training!combo!
on!Pharmacovigilance.basic.aspects.modularly!assembled!
as!a!OneRFitsRAll!project!to!
sa@sfy!different!audiences!
(HCPs,!Pharmacists,!Payers,!
Journalists,!PAGs)!with!a!1R
DAY!AGENDA!session.!
A!CoRsponsored!Annual+ISoP+Symposium+offers!a!unique!chance!to!discuss!
drug!safety!and!signal!
detec@on!from!different!
points!of!view!and!to!share!
ideas!on!how!pa@ents'!safety!
could!be!further!improved!
among!mul@Rstakeholders.!
Peers+and+voice+is!a!Scien@fic!Network!with!
the!objec@ve!to!address!
and!amplify!the!maFers!that!has!become!
more!of!a!challenge!for!
HCPs,!Drug!Agencies,!
Scien@fic!!!organiza@ons,!
Universi@es,!State!
Authori@es,!and!
Pharmaceu@cal!Industry.!!
Demonstrate!how!
FIFARMA!is!
pioneering!on!the!
pharmacovigilance!
educa@on!arena!and!
help!to!address!the!
subRop@mal!postR
marke@ng!surveillance!
(Agencies)!in!La@n!
America!before!the!
arrival!of!new!
biosimilars.!
MEDICAL!EDUCATION! ISOP!EXTERNAL!COLLABORATION! PEERS!AND!VOICE! FIFARMA!
23!VIGILANTIA!is!a!mul@stakeholder!project!sponsored!by!FIFARMA!and!funded!by!AbbVie!
PV+Training+in+a+box!
MEDICAL!EDUCATION! ISOP!EXTERNAL!COLLABORATION! PEERS!AND!VOICE! FIFARMA!
24!VIGILANTIA!is!a!mul@stakeholder!project!sponsored!by!FIFARMA!and!funded!by!AbbVie!
A!CoRsponsored!Annual+ISoP+Symposium+with!the!La@n!American!Chapter!
MEDICAL!EDUCATION! ISOP!EXTERNAL!COLLABORATION! PEERS!AND!VOICE! FIFARMA!
RSVP!Data!from!5th!Symposium!ISoP!La@n!American!Chapter!over!118!preRregistered!aFendees!
27!
Leader:!Clara!Sanchez!Luna!
Academic!Expert:!Carlos!Maldonado!Leader:!Eduardo!Tinao!
Academic!Expert:!María!Rosa!Papale!
Leader:!Fernando!Fon!
!
Leader:!Jean!Jaques!Duhart!
Leader:!Rosa!Luz!Guerrero!Terán!
Leader:!Rosana!Mastellaro!
!
MEDICAL!EDUCATION! PEERS!AND!VOICE!ISOP!EXTERNAL!COLLABORATION! FIFARMA!
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Annual!ISoP!Mee@ng!2018!|!Geneva!2018.11.12!
!
Private!Sector!Collabora@on!
with!Na@onal!Regulatory!Systems!
!AsiaRPacific!&!China!
Eurasian!Economic!Union!
Simplifying!and!Improving!Global!ICSR!Submission!!
!
J.!Christophe!Delumeau!
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J.!Christophe!Delumeau,!MD,!PhD!
• FullR@me!employee!of!Bayer!South!East!Asia!(Singapore)!as!head!of!pharmacovigilance!policy!strategy.!
• Not!holding!any!stock!op@on.!
• Not!holding!any!share!of!any!pharma!nor!health!care!company.!
• Not!receiving!any!consul@ng!fees!or!grants.!
• Receiving!no!compensa@on!for!serving!as!Board!and!Execu@ve!CommiFee!member!of!the!Interna@onal!Society!of!
Pharmacovigilance!(ISoP).!
• Receiving!no!compensa@on!for!serving!the!chair!or!coRchair!of!working!groups!or!ini@a@ves!of!the!Interna@onal!of!
the!European!Federa@on!of!Pharmaceu@cal!Industries!and!Associa@ons!(EFPIA).!
• Receiving!no!compensa@on!for!serving!as!Visi@ng!Expert!at!DukeRNUS!university,!Singapore.!
• The!views!expressed!in!this!presenta@on!reflect!the!personal!views!of!the!author!and!do!not!necessarily!reflect!the!
views!of!the!authors’!employers!(Bayer)!nor!ISoP,!nor!EFPIA,!nor!any!other!ins@tu@ons!the!author!may!otherwise!
be!collabora@ng!with.!
Disclaimer!and!declara@on!of!conflicts!of!interest!
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• EAEU:!Eurasian!Economic!Union!
• EFPIA:!European!Federa@on!of!Pharmaceu@cal!Industries!and!Associa@ons!
• EFPIARIPVG:!EFPIA!Interna@onal!PV!Global!Team!
• EFPIARIPVRWS:!EFPIA!Interna@onal!PV!(regional)!WorkRStream!
• HCP:!Health!Care!Professionals!
• HCS:!Health!Care!System!
• ICH:!Interna@onal!Council!for!Harmonisa@on!of!Technical!Requirements!for!Pharmaceu@cals!for!Human!
Use!
• ICHRE2B!(ICH!standard!for!ICSR!data!transmission!!
• ICSR:!Individual!Case!Safety!Reports!
• NRA:!Na@onal!Regulatory!Authority!
• NRS:!Na@onal!Regulatory!System!
• MAH:!Market!Authorisa@on!Holder!
• PV:!Pharmacovigilance!
• SiGiR:!Simplify!and!improve!Global!ICSR!Repor@ng!(one!of!EFPIARIPVG!strategic!ini@a@ve)!
• WHORIPDM:!WHO!Interna@onal!Program!for!Drug!Monitoring!
• WHORUMC:!Uppsala!Monitoring!Centre!(WHO!collabora@ng!centre!
Abbrevia@ons!used!in!this!presenta@on!
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Ini3a3ves+aimed+to+improve+pharmacovigilance+systems+e.g.+
• Contribute!to!the!development/improvement!of!country!PV!legisla@ons!and!guidance!
• Improve!ICSR!repor@ng!from!HCPs!and/or!Pa@ents!
• Improve!ICSR!submission!methods!and!infrastructure!(E2B)!
• Educate!and!Train!PV!professionals!and!other!HCPs!
• Improve!the!methods!applied!in!PV!and!Pharmacoepidemiology!
• Create/develop/improve!risk!minimisa@on!solu@ons!suitable!for!diverse!HCSs!
• Contribute!to!the!PV!component!of!Public!Health!programs!
Examples!of!Private!Sector!–!NRA!Partnership!in!Pharmacovigilance!
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Possible+se^ngs+
• LargeRscale!collabora@ve!ini@a@ves!e.g.!partnering!between!the!European!Union!and!the!
EFPIA!for!the!components!of!the!IMI!project.!
• Country!pharma!associa@on!or!specific!companies!approaching!a!NRA!proposing!a!
collabora@ve!ini@a@ve,!program!or!event.!
• NRA!appoin@ng!a!country!pharma!associa@on!or!selected!companies!Specific!companies!to!
contribute!to!an!event,!pilot!a!procedure!or!tool,!or!for!providing!training!or!knowRhow.!
• The!collabora@ve!serng!may!involve!other!stakeholders!such!as!a!university!or!ISoP.!
• Other!types!of!collabora@ve!serngs!
A!diversity!of!collabora@ve!serngs!
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Who+are+the+people+from+the+Private+Sector+engaging+into+partnering+with+NRA+
• Employees!of!pharma!companies!engaging!into!ini@a@ves!involving!their!respec@ve!
companies!
• Private!sector!employees!engaging!into!collabora@ons!with!NRA!as!members!of!an!
organisa@on!different!from!their!company!!
o The!Interna@onal!Society!of!Pharmacovigilance!(ISoP).!
o The!European!Federa@on!of!Pharmaceu@cal!Industries!and!Associa@ons!(EFPIA).!
o IFPMARaffiliated!country!pharma!associa@on.!
o In!the!context!of!an!academic!serng!e.g.!a!UniversityRdriven!ini@a@ve.!
A!diversity!of!collabora@ve!serngs!
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IPV+Regional+WorkUStream
IPVG+Ini3a3ve+
IFPMARaffiliated!Country!pharma!
associa@ons!!
People!from!
specific!!pharma!
companies!!
NRA
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Training+and+provision+of+know+how+
Involvement!of!staff!from!Indonesian!affiliates!of!mul@na@onal!pharma!companies!into!the!
ISoP!Indonesia!Chapter!to!provide!interna@onal!knowRhow!to!Indonesian!stakeholders!from!
the!Public!sector!or!domes@c!pharma!companies.!
Appointment!of!experts!from!pharma!companies!to!provide!lectures!e.g.!!
• Annual!APECRCoE!PV!training!organised!by!the!Korean!Health!Authority!(Seoul)!
• DukeRNUS!CoRE!Graduate!Cer@ficate!on!Fundamentals!in!Pharmaceu@cal!Regula@on!
(Singapore)!
• ISoP!Training!organised!in!coopera@on!with!NRAs!(e.g.!Thailand,!China,!Australia,!
Indonesia)!!
• PV!training!organised!by!NRA!of!mul@ple!Asian!countries!possibly!in!coopera@on!with!
Country!pharma!associa@on.!
Collabora@ve!ini@a@ves!in!the!AsiaUPacific+Region+
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Other+types+of+collabora3ve+ac3vi3es+
• Involvement!of!EFPIARIPV!India!WorkRStream!and!Indian!pharma!associa@ons!into!the!
making!or!!revision!of!the!Indian!PV!legisla@on!framework!(e.g.!PvGI)!
• Collabora@on!between!NMPA’s!CDE!or!CDR!and!RDPAC!for!reviewing!the!new!Chinese!
safety!regulatory!framework!aimed!at!mee@ng!ICH!requirements.!!
• Involvement!of!RDPAC!in!the!defini@on!of!E2B(R3)!specifica@ons!applicable!to!China!
• Involvement!of!selected!companies!in!tes@ng!concepts!to!be!implemented!in!the!future!PV!
regula@on!of!Malaysia.!
• Review!by!the!EFPIARIPV!WorkRStream!of!drats!of!new!regula@on!from!AsiaRPacific!
countries.!Provision!of!a!consensus!feedRback!
• ISoP!Special!Interest!Group!on!Risk!Minimisa@on!methods!for!Asian!Countries!involving!
NRA!representa@ves,!Academic!experts!and!PV!professionals!from!pharma!companies!
Collabora@ve!ini@a@ves!in!the!AsiaUPacific+Region+
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• Involvement!of!PV!representa@ves!of!the!AIPM!(Russian!pharma!associa@on)!into!the!
Working!Group!on!Na@onal!PV!Legisla@on!Update!in!!charge!of!revising!the!PV!regula@on!
and!Good!Vigilance!Prac@ce!framework!applicable!to!Russia.!This!includes:!
o Par@cipate!into!regular!official!mee@ngs!at!the!Roszdravnadzor!
o Provide!consultancy!input!
o Drat!norma@ve!documenta@on.!
• Pharma!industry!representa@ves!are!appointed!to!contribute!to!training!and!conference!
organised!by!the!Roszdravnadzor!intended!to!PV!professionals!of!public!and!private!sectors!
• Interna@onal!Pharmacovigilance!conference,!organised!jointly!by!the!Roszdravnadzor!and!
the!AIPM!in!Moscow!on!October!10th!2018.!Involvement!of!local!and!global!speakers!from!
pharmaceu@cal!industries.!
Collabora@ve!ini@a@ves!in!the!Russian+Federa3on+
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• Involvement!of!pharma!representa@ves!into!the!working!groups!in!charge!of!elabora@ng!
the!supraRna@onal!GxP!regula@ons!applicable!to!the!Eurasia!Economic!union!i.e.!Russia,!
Belarus,!Kazakhstan,!Armenia,!Kyrgyzstan.!This!includes:!
o Good!Pharmacovigilance!Prac@ce!
o Good!Clinical!Prac@ce!o Eurasian!Registra@on!Rules!o Requirements!to!CCDS!
o List!of!Terms!used!in!Eurasian!GxP!Documents.!
• Contribute!to!PV!training!sessions!and!conference!organised!by!the!Health!Authori@es!of!
EAEU!countries.!
Collabora@ve!ini@a@ves!in!other!Eurasian+Economic+Union+countries+(EAEU)!
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• Some!NRAs!are!s@ll!reques@ng!MAHs!to!
submit!ICSRs!on!CIOMS!forms!on!PDFs!
• Those!CIOMS!forms!are!entered!manually!by!
NRA!staff!into!the!VigiFlow!container!of!the!
country!whereas!those!ICSRs!are!available!in!
E2B!format!in!the!safety!database!of!the!MAH!
! SubUop3mal+se^ng+that+can+be+fixed+if+NRAs+accept+receiving+ICSRs+as+XMLUE2B+files.+
!
Non-E2B National PV database
MAH Database E2B
VigiBase
ICSR submitted on paper
ICSRs in E2B format available but missed by VigiBase®
PublicRPrivate!Partnering!for!implemen3ng+eUsubmission+
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E2B VigiFlow National PV database
MAH Database E2B
VigiBase
ICSRs submitted via XML
ICSRs in E2B format available
• In!2015,!Bayer!PV!AsiaRPacific!collaborated!with!the!UMC!to!deploy!ICSRs!submission!in!the!
format!of!E2BRXML!files!in!all!AsiaRPacific!
countries!equipped!using!VigiFlow!as!na@onal!
pharmacovigilance!database!
! To+address+a+broader+array+of+ICSR+submission+issues+with+a+global+scope,+EFPIA+Interna3onal+PV+has+set+the+SiGiR+ini3a3ve+to+Simplify+and+Improve+Global+ICSR+Repor3ng.+
!
PublicRPrivate!Partnering!for!implemen3ng+eUsubmission+
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✱ Monitor!the!ICSR!repor@ng!environment!interna@onally!
✱ Enter!into!a!dialogues!with!NRAs!looking!for!solu@ons!to!upgrade!their!na@onal!PV!database!to!the!ICHRE2B!standard!for!transmission!of!ICSR!data!
✱ Analyse!the!issues!faced!by!those!NRAs!for!upgrading!their!systems!to!E2B!in!the!context!of!
upcoming!obsolescence!of!E2B(R2)!and!proposed!solu@ons.!
✱ Advocate!for!most!harmonised!E2B(R3)!solu@ons,!especially!those!to!address!Na@ve!language.!
✱ Collaborate!with!the!UMC!and!IT!system!vendors!for!op@mizing!solu@ons!
✱ Review!Apps!&!online!portals!for!direct!ICSR!collec@on!and!transmission!from!reporters!to!
NRAs,!providing!an!industry!view!on!their!use!when!needed.!!
! The!SiGiR!ini@a@ve!is!aiming!at!collabora@ng!with!IFPMARaffiliated!pharma!associa@ons!of!the!
specific!countries!as!well!as!interna@onal!organisa@ons!engaged!in!global!harmonisa@on.!
Simplify+and+Improve+Global+ICSR+Repor3ng+|+Goals!of!the!SiGiR!ini@a@ve!
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✱ As!a!first!step,!the!SiGiR!ini@a@ve!is!focusing!on!taking!advantage!from!the!new!language!
facili@es!added!to!E2B(R3)!for!hos@ng!contents!in!Na@ve!languages.!
✱ The!purpose!of!this!approach!is!to!maintain!the!harmonisa@on!of!the!E2B!framework!in!a!
context!where!an!increasing!number!of!countries!reques@ng!to!receive!contents!in!Na@onal!
languages!are!aiming!at!moving!to!E2B.!
!
! The+overarching+goal+of+the+SiGiR+ini3a3ve+is+to+facilitate+the+implementa3on+of+harmonised+solu3ons+which+will+op3mise+the+use+of+resources+on+both+NRA+and+MAH+sides.+
Purposes+and+goals+of+the+EFPIA’s+SiGiR+ini3a3ve+
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✱ Thank!you!for!your!aFen@on+
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European Federation of Pharmaceutical Industries and Associations
www.efpia.eu