VIBpharma

Pharmacovigilance and Risk ManagementOptimal PV and RM strategy and implementation to ensure regulatory compliance and maximise drug safety

and Risk Managementensure regulatory compliance and maximise drug safety

Benefit from a peer-to-peer interactive

roundtable morning to address key obstacles and find the solutions relevant to everyday procedures

Register online now at: www.vibpharma.com/pharmacovigilance

5th Annual

Tuesday 1 and Wednesday 2 December 2009, Brussels, Belgium

DISTINguISHED SPEAkERS INCLuDE:Dr Thomas Verstraeten, Vice President, Head, Biologicals Clinical Safety and Pharmacovigilance, gSk BIOLOgICALS

Dr Hans Joachim gamperl, Vice President, global Drug Safety and Pharmacovigilance QPPV, FRESENIuS BIOTECH

Craig Hartford, Executive Director, SRM/RMS Primary Care Business unit Leader, PFIZER

Prof Philippe Van der Auwera, global Head of Safety Risk Management (PDS) and Eu-QPPV, ROCHE

Dr Duc Vu, Director, Marketed Bilogics, Biotechnology and Natural Health Products, Marketed Health Products Directorate, HEALTH CANADA

Doris Stenver, Chief Medical Offi cer, Consumer Safety Division, DANISH MEDICINES AgENCy and Pharmacovigilance Working Party Delegate, EMEA

Monica Rusu, Director PharmacovigilanceEELA, global Pharmacovigilance and Risk Management, SOLVAy PHARMACEuTICALS gMBH

Phil Weatherill, Director, global Pharmacovigilance, IPSEN

Dr Maria grazia Zurlo, Vice President, Pharmacovigilance Strategy and Policy, PFIZER

Erica Velthuis, Senior Pharmacovigilance Scientist and Epidemiologist, gENZyME EuROPE

Dr Ennis Lee, Vice President and Qualifi ed Person for Pharmacovigilance, Pharma, Benefi t Risk Management, JANSSEN CILAg

Bert Van Leeuwen, Director of global Drug Safety, ORgANON (now part of the SCHERINg-PLOugH CORPORATION)

3 HIgHLIgHTS!Critical insights on the practical ●

implementation of PV on a global, regional and country specifi c scale

Take a global approach on PV and RM ●

issues: clarify requirements form the uSA, Eastern Europe, Canada, Norway and Denmark to ensure compliance in a global setting

Essential case studies on ensuring ●

legislative compliance and best practice

ADDED EXTRA BONuS:With 19 pharma and regulatory ●

representatives on the programme, this event off ers you invaluable insight into critical areas of PV and RM

with 19 pharma and regulatory representatives on the programme, this event will provide invaluable insight into key areas of Pv and rM

REgISTER NOW: ■ Email: book@vibevents.com■ Tel: +44 (0)20 7753 4268 ■ Fax: +44 (0) 20 7915 9773

Programme day one Tuesday 1 December 2009

11:40 Highlighting successful RM strategies in a post approval setting to maximise patient safetyCritical assessments of RM techniques and methodologies ●

Deciding on the best strategy for managing product risk ●

Highlighting successful techniques to monitor RM to ensure ●

minimal riskMeeting the regulators’ expectations with robust RM policies ●

Case study: the most effective methods for risk mitigation ●

Rudi Scheerlinck, Director, global Clinical Safety and Pharmacovigilance, uCB

Effective approaches to monitoring and reporting Adverse Drug Reactions (ADRs) 12:10 Exploiting the latest technologies and methodologies

for optimal ADR monitoring and reportingPositioning response to adverse events at the core of your ●

RM activityDevelopments from the cutting edge of the science and practice ●

of ADR signal detectionEvaluating the impact and effectiveness of electronic reporting ●

Speaker TBC

12:40 Lunch and networking

Essential case studies: detailing specific challenges and proposing solutions13:50 Determining a robust drug safety strategy for vaccines

to guarantee their excellence and therefore their acceptance for use in healthy peopleExploring the challenges to thoroughly analyse the benefit:risk ●

evaluation and mitigate hazardsGenerating guidelines to ensure that all adverse events are ●

recorded consistently and accuratelyMaximising adverse event information and data accuracy ●

through spontaneous reporting by minimising under-reporting Illuminating the importance of pharmacoepidemiology studies ●

to confirm the alerts identified by spontaneous reportingReviewing mechanisms for active surveillance to generate ●

best practiceDr Thomas Verstraeten, Vice President, Head, Biologicals Clinical Safety and Pharmacovigilance, gSk BIOLOgICALS

14:20 Case study: identifying the challenges of PV for orphan drugs in order to implement a strong risk management strategyTackling the internal challenges of a small company to make the ●

best use of limited resourcesBuilding a robust PV system with limited resources ●

Ensuring effective signal detection and RM during development ●

to fully assess drug safetyDeveloping signal detection and risk management strategies ●

post marketing for orphan drugs The way forward… ●

Dr giuseppe Alvaro, Director, Drug Safety and Pharmacovigilance, SANTHERA PHARMACEuTICALS

Ensuring globally effective PV strategies14:50 Highlighting the FDA’s Risk Evaluation and Mitigation

Strategies (REMS)Reviewing the legislation around REMS to clarify what ●

is necessaryDetermining practical insights into REMS to ensure they ●

are successfulClarifying the opportunities to integrate various global risk ●

management plans to create a global drug safety strategyCraig Hartford, Executive Director, SRM\RMS Primary Care Business unit Leader, PFIZER

08:30 Registration

09:00 Opening remarks from the ChairDr Monica Rusu, Director Pharmacovigilance EELA, global Pharmacovigilance and Risk Management, SOLVAy PHARMACEuTICALS

View from the regulators: clarifying their interpretation of key PV and RM legislation09:10 Case study: the Danish approach to PV and RM

Highlighting the Danish PV action plan: reviewing major ●

elements and objectives to ensure regulatory complianceClarifying the impact of significant societal trends, such as ●

the internationalisation and empowerment of the citizens, on work practices at national level to understand how this will affect your RM strategyEstablishing the interrelation between the Danish ●

Medicines Agency and the EU organisation ●

Evaluating the PSUR work share initiative and its effectiveness: ●

outlining the current status from a regulatory point of view RM and risk minimisation: case study examplesDoris Stenver, Chief Medical Officer, Consumer Safety Division, Danish Medicines Agency and Pharmacovigilance Working Party Delegate, EMEA

09:40 The Norwegian approach: implementing a PV plan and risk minimisation activities at a national levelEvaluating proposed RMPs: assessing how to increase their ●

quality and usefulness to maximise the efficiency of drug safety strategiesHighlighting lessons learned from the practical implementation ●

of activities proposed in RMPs to determine best practiceEnhancing PV activities ●

Reviewing educational materials to be used ●

Handling of DHPCs ●

Ingebjørg Buajordet, Head of Pharmacovigilance, NORWEgIAN MEDICINES AgENCy

10:10 Panel Session: Translating regulatory compliance into a practical, globally actionable PV strategyManaging across multiple regulatory frameworks to ensure ●

company-wide complianceDisseminating information and strategy effectively and creating ●

awareness throughout the organisationPractical guidance on implementation through and for affiliates ●

Doris Stenver, Chief Medical Officer, Consumer Safety Division, Danish Medicines Agency and Pharmacovigilance Working Party Delegate, EMEAIngebjørg Buajordet, Head of Pharmacovigilance, NORWEgIAN MEDICINES AgENCy

10:40 Morning refreshments and networking

Achieving successful, practical implementation of PV and RM processes11:10 Evaluating successful strategies for PV in marketed

products to maximise drug safetyHighlighting the key factors in PV in order to provide thorough ●

information on adverse reactions and overall drug safetyEnsuring you meet the regulators’ expectations through clear ●

results and increased transparencyDetermining best practice approaches for a successful ●

PV strategyLooking towards the future: the need for increasing transparency ●

in PV and its impact on pharmaceutical companiesDr Ennis Lee, Vice President and Qualified Person for Pharmacovigilance, Pharmaceuticals, Benefit Risk Management, JANSSEN CILAg

Programme day two Wednesday 2 December 2009

08:30 Registration

09:00 Opening remarks from the ChairPhil Weatherill, Director, global Pharmacovigilance, IPSEN

09:10 Roundtable morning sessionsDelegates will be able to attend three one-hour roundtable discussion groups from a selection of key topics. Each ses-sion will be chaired by an industry expert who will facilitate an exchange of opinions, essential experiences and learn-ing related to a current aspect of PV and RM Roundtable 1Exploring the most effective methods for the practical implementation of RMPsThis session will look at the most effective methods for implementing your RM strategies and the different tools you can use when gathering the data.Monica Rusu, Director PV EELA, global Pharmacovigilance and Risk Management, SOLVAy PHARMACEuTICALS gMBH

Roundtable 2Highlighting the role of the QPPVThis session will explore the role QPPV and their crucial role in the overall PV plan and how best to manage risks and the scope of their role.Dr Peter De Veene, Deputy European Qualified Person for Pharmacovigilance, ROCHE

Roundtable 3Reviewing global compliance in PV to maximise drug safety at a global levelThis session will explore global PV legislation and find solutions to the challenges to meet disparate regulations. You will also assess how to move forward to make this more viable in the future. Bert Van Leeuwen, Director of global Drug Safety, ORgANON (now part of the Schering Plough Corporation)

Roundtable 4Overcoming challenges when completing PSuRs to ensure all safety data is up to dateThis session will discuss the challenges surrounding PSURs to clarify their writing, submission and implementation. You will also analyse the work sharing initiative to assess current practices and the success of the scheme.Dr Agnieszka Majcher-Dann, Acting Qualified Person for Pharmacovigilance, Consumer Healthcare, JOHNSON & JOHNSON

Roundtable 5Pharmacoepidemiology in RM: clarifying its role in increasing drug safetyThis session will look at the significant links between pharmacoepidemiology and clinical development, post-marketing safety and RM to highlight how it can mitigate risk.Erica Velthuis, Senior Pharmacovigilance Scientist and Epidemiologist, gENZyME EuROPE

12:30 Lunch

15:20 Afternoon refreshments and networking

15:50 Focus on Eastern Europe: reviewing the PV structure and regulations to maximse drug safetyIdentifying the drug safety regulations in order to ●

enhance complianceEffectively following the new legislation to maximise your ●

PV strategies in Eastern EuropeReviewing methods of monitoring risk mitigation ●

strategies efficientlyAssessing the challenges of PV in Eastern Europe to better ●

understand where problems may occurCase study: highlighting examples of best practice to ●

develop a comprehensive benefit:risk assessmentDr Monica Rusu, Director Pharmacovigilance EELA, global Pharmacovigilance and Risk Management, SOLVAy PHARMACEuTICALS

Risk based inspections: passing audits with flying colours16:20 Preparing for risk based inspections to meet the

regulators’ expectationsReviewing the compliance report requested by the MHRA ●

(implemented in 2009) to fully understand what is requiredSuccessfully deploying assessment algorithms to accurately ●

interpret dataCompiling an inspection readiness plan for affiliates in order ●

for them to address all the necessary pointersFacilitating interaction between the central ●

pharmacovigilance team and the affiliates to create a successful company wide drug safety policyDr ute Hoeffner, European Qualified Person for Pharmacovigilance, NOVARTIS CONSuMER HEALTH

Enhancing safety monitoring processes through efficient epidemiology strategies16:50 Highlighting the importance of epidemiology in

PV and RM to increase safety monitoringEvaluating the advantages of epidemiology vs ●

pharmacoepidemiology to determine how best to maximise safety monitoringExploring the need for epidemiology in clinical ●

development to increase the safety data available before the drug goes to marketEstablishing the importance of epidemiology in post- ●

marketing safety to advance the level of scientific knowledge for a drugClarifying the use of epidemiology in RM to ensure safety ●

monitoring is maximisedErica Velthuis, Senior Pharmacovigilance Scientist and Epidemiologist, gENZyME EuROPE

Emphasising the role of the QPPV17:20 Assessing the growing importance of the QPPV in the

evolving PV environment to understand their key roleClarifying the scope of the QPPV’s role to fully realise the ●

pivotal part it playsHighlighting the challenges of the position and the legal ●

responsibility to ensure that all requirements are metDetermining how the role has evolved and where it will head ●

in the future to assess its likely impact on PVDr Maria grazia Zurlo, Vice President, Pharmacovigilance Strategy and Policy, Pfizer

17:50 Closing remarks from the Chair

18:00 End of day one

Programme day two Wednesday 2 December 2009

Focus on new regulatory initiatives13:40 Highlighting the Developmental Safety update

Report (DSuR) to assess the implications for future PV reportingEmphasising the implications of increasing public ●

expectation on drug safety to determine how to encourage users to discuss any perceived undesirable side effect with their doctor or pharmacistImproving communication with health professionals, ●

patients and the public to increase the accuracy of post marketing safety dataDeveloping different methods of raising awareness (types ●

of campaigns, leaflets and advertisements etc) to assess which is most affectiveEncouraging the public to report adverse reactions through ●

increased communication to minimise under-reportingAssessing PV reporting methods used by physicians and ●

patients to establish clear and concise approachesBert Van Leeuwen, Director of global Drug Safety, ORgANON (now part of the Schering Plough Corporation)

14:10 Reviewing the Periodic Safety update Report (PSuR) Work Sharing Initiative to evaluate its effectivenessExplaining the initiative introduced to minimise duplication ●

Exploring the authorities’ work processes and timeframes ●

to be able to work to their expectationsHighlighting how successful the initiative is through ●

feedback from the authoritiesAssessing the challenges which have arisen to evaluate ●

possible solutionsLooking forward: how to make the process more efficient ●

Dr Marina Belle, global Pharmacovigilance, unit Manager PSuR, SANDOZ INTERNATIONAL

14:40 Outlining the Canadian perspective in PV activitiesReviewing the Canadian regulatory system and Health ●

Canada activities related to the PSUR, Phamacovigilance and Risk Management Plan (PvP/RMP) in order to meet the requirementsHighlighting the PV "tool kit" to optimise quality and efficacy ●

while minimising the risks that may be associated with health products approved for sale in CanadaAssessing experiences and challenges encountered in the ●

review activities of PSUR, PvP/RMP in Canada to demonstrate trouble areas and best practiceEstablishing signal detection activities using “Canada ●

Vigilance database” and other international adverse drug reaction databases as well as information from PSURs to create a global drug safety outlookDr Duc Vu, Director, Marketed Biologics, Biotechnology and Natural Health Products, Marketed Health Products Directorate, HEALTH CANADA

15:20 Afternoon refreshments

key factors in today’s changing PV environment15:50 Increasing public awareness of risk to ensure that

patients fully understand the benefit:risk analysis of a drug hence can take an informed decision with their prescribing physicianEmphasizing the implications of increasing public ●

expectation on drug safety to determine how to encourage users to discuss any perceived undesirable side effect with their doctor or pharmacistImproving communication with health professionals, ●

patients and the public to increase the accuracy of post marketing safety data

Developing different methods of raising awareness (types of ●

campaigns, leaflets and advertisements etc) to assess which is most affectiveEncouraging the public to report adverse reactions through ●

increased communication to minimise under reportingAssessing PV reporting methods used by physicians and ●

patients to establish clear and concise approachesProf Philippe Van der Auwera, global Head of Safety Risk Management (PDS) and Eu-QPPV, ROCHE

RMPs: highlighting practical advice to ensure there are no gaps in your strategy 16:20 Writing an effective RMP to mitigate delays in

submission timelinesReviewing the key elements to be included to ensure you ●

meet the regulators’ requirementsEvaluating different approaches towards risk assessment in ●

order to include the most effective in your RMPDetermining the role of epidemiological studies in risk ●

management to use them to their full advantage in your RMPTroubleshooting: analysing areas where pitfalls are common ●

to minimise errors and timely delays in submissionWorking with different departments to generate all the ●

necessary informationHighlighting best practice examples demonstrating effective ●

implementation techniquesDr Agnieszka Majcher-Dann, Acting Qualified Person for Pharmacovigilance, Consumer Healthcare, JOHNSON & JOHNSON

16:50 Case study: best practice methods to monitor and evaluate RM to assess the effectiveness of your RMP Demonstrating different methodologies to monitor RM to ●

assess effective approachesReviewing the various tools available to determine best ●

practice in your monitoring approachEstablishing appropriate methods to measure the ●

effectiveness of your RM strategyHighlighting best practice methods and lessons learned ●

Phil Weatherill, Director, global Pharmacovigilance, IPSEN

17:20 Experiences of a small company: submitting a successful RMP supporting the Eu approval of a therapeutic antibody The company's drug safety and the antibody's properties as ●

necessary background information A safety strategy during clinical development as an essential ●

tool for risk evaluation The presentation of safety data in the dossier (CTD) impacts ●

the RMP The establishment of the RMP requires early planning and ●

multiple input Lessons learned ●

Dr Hans Joachim gamperl, Vice President, global Drug Safety and Pharmacovigilance QPPV, FRESENIuS BIOTECH gMBH

17:50 Closing remarks from the Chair and champagne prize draw

18:00 End of conference

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pauladams@arena-international.com, +44 (0) 20 7753 4259

About the eventFollowing the enormous success of our Pharmacovigilance and Risk Management event earlier this year, VIBpharma is proud to announce the dates for our fifth annual Pharmacovigilance and Risk Management conference this December. The role of drug safety both in drug development and postmarketingsurveillance has increased enormously over recent years, especially in an era where the public are much less tolerant to medical risk and have many more ways in which to express their opinions. With a continually changing regulatory environment it is imperative that you are kept up to date with the latest changes to develop a robust Pharmacovigilance strategy in which there are no gaps.

VIBpharma’s Pharmacovigilance and Risk Management conference will bring together major pharma and biotech manufacturers as well as the regulators to find solutions to this increasingly important issue. This event will cover topics such as effectively monitoring RMPs and best practice in their implementation; exploring global Pharmacovigilance approaches and creating global risk minimization strategies; increasing public awareness of the benefit:risk ratio of medicines and ensuring physicians fully comply to the Pharmacovigilance regulations; and ensuring the data exchange between companies.

This educational two-day conference, tailored to maximise thesharing of knowledge and expertise and to promote networkingfor professionals in this area, will ensure you effectivelymanage Risk Management with current medicines to mitigate any risks to patients.

TESTIMONIALS – Here is what previous delegates have said about previous PV conferences

“Very useful with a lot of hot topics”Patient Safety Manager, ASTRAZENECA“Very good to meet people; fruitful discussions”CQA PV Specialist, NOVARTIS“It was very useful and lively meeting and I have the opportunity to interact with many other colleagues not only from the pharma industry but also the regulators. We shared a lot of experience and I learned a lot!”Director of PV, SOLVAy PHARMA“A good choice of speakers and enough time devoted to discussion”Head of Drug Safety, BOEHRINgER INgELHEIM“Globally a good overview with current practices and issues in PV. A good opportunity to exchange experiences with colleagues”Senior Director, Safety and Compliance, IPSEN INNOVATIONS“Good interaction and variety of speakers. Overall I enjoyed the experience and exchanged best practice with others”PV Manager, SCHERINg PLOugH“Very high quality speakers and the roundtable discussion groups allowed a good exchange of experiences”Drug Safety Specialist, MERCk SERONO“Very good, well organised conference”Director, Marketed Biologicals, HEALTH CANADA“Highly professional speakers and audience, very knowledgeable and open. Pleasant overall”Drug Safety Solution Manager, QuINTILES

Who should attend:Heads, Directors and Managers from pharma and biotech manufacturers working in the following areas:

● Pharmacovigilance ● Qualified Person (QP) for PV● Drug Safety● Benefit-Risk Management● Medical● Risk Management● Clinical Operations● Clinical Safety● Epidemiology● Product Safety and Quality Management● Regulatory Affairs

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Pharmacovigilance and Risk Management, Tuesday 1 and Wednesday 2 December 2009, Brussels, Belgium

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