Pharmacovigilance and Risk Management

VIBpharmaBenefit frtoom-p ae epre rienrout-e5th Annualnrdatcatbivle Pharmacovigilance e tmo oardndinreg sosb ksetay cfliensd a tnhd er esloelvuatand Risk Management n iot nts o evperroycdeady uresOptimal PV and RM strategy and implementation to ensure regulatory compliance and maximise drug safetyTuesday 1 and Wednesday 2 December 2009, Brussels, BelgiumDISTINguISHED SPEAkERS INCLuDE:Dr Thomas Verstraeten, Vice President, Head, Biologicalswith 19 pharma and regulatory Clinical Safety and Pharmacovigilance, gSk BIOLOgICALS representatives on the programme, Dr Hans Joachim gamperl, Vice President, global DrugSafety and Pharmacovigilance QPPV, FRESENIuS BIOTECHthis event will provide invaluable insight into key areas of Pv and rMCraig 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, ROCHE3 HIgHLIgHTS!Dr Duc Vu, Director, Marketed Bilogics, Biotechnology ●Critical insights on the practical and Natural Health Products, Marketed Health Products Directorate, HEALTH CANADAimplementation of PV on a global, regional and country specifi c scaleDoris Stenver, Chief Medical Offi cer, Consumer Safety Division, DANISH MEDICINES AgENCy and Pharmacovigilance Working ●Take a global approach on PV and RM Party Delegate, EMEAissues: clarify requirements form the Monica Rusu, Director PharmacovigilanceEELA,global Pharmacovigilance and Risk Management,uSA, Eastern Europe, Canada, Norway SOLVAy PHARMACEuTICALS gMBHand Denmark to ensure compliance in Phil Weatherill, Director, global Pharmacovigilance, IPSENa global settingDr Maria grazia Zurlo, Vice President, Pharmacovigilance ●Essential case studies on ensuring Strategy and Policy, PFIZERlegislative compliance and best practiceErica Velthuis, Senior Pharmacovigilance Scientist and Epidemiologist, gENZyME EuROPEDr Ennis Lee, Vice President and Qualifi ed Person for Co-sponsorPharmacovigilance, Pharma, Benefi t Risk Management, JANSSEN CILAgBert Van Leeuwen, Director of global Drug Safety, ORgANON(now part of the SCHERINg-PLOugH CORPORATION) REgISTER NOW: ■ Email: book@vibevents.com■ Tel: +44 (0)20 7753 4268 ■ Fax: +44 (0) 20 7915 9773 Register online now at: www.vibpharma.com/pharmacovigilanceProgramme day one Tuesday 1 December 200908:30 Registration11:40 Highlighting successful RM strategies in a post approval setting to maximise patient safety09:00 Opening remarks from the Chair ●Critical assessments of RM techniques and methodologies Dr Monica Rusu, Director Pharmacovigilance EELA, ●Deciding on the best strategy for managing product riskglobal Pharmacovigilance and Risk Management, ●Highlighting successful techniques to monitor RM to ensure SOLVAy PHARMACEuTICALSminimal risk ●Meeting the regulators’ expectations with robust RM policiesView from the regulators: clarifying their ●Case study: the most effective methods for risk mitigation interpretation of key PV and RM legislationRudi Scheerlinck, Director, global Clinical Safety and 09:10 Case study: the Danish approach to PV and RMPharmacovigilance, uCB ●Highlighting the Danish PV action plan: reviewing major elements and objectives to ensure regulatory complianceEffective approaches to monitoring and reporting ●Clarifying the impact of significant societal trends, such as Adverse Drug Reactions (ADRs) the internationalisation and empowerment of the citizens, 12:10 Exploiting the latest technologies and methodologies on work practices at national level to understand how this for optimal ADR monitoring and reportingwill affect your RM strategy ●Positioning response to adverse events at the core of your ●Establishing the interrelation between the Danish Medicines RM activityAgency and the EU organisation ●Developments from the cutting edge of the science and practice ●Evaluating the PSUR work share initiative and its effectiveness: of ADR signal detectionoutlining the current status from a regulatory point of view RM ●Evaluating the impact and effectiveness of electronic reportingand risk minimisation: case study examplesSpeaker TBCDoris Stenver, Chief Medical Officer, Consumer Safety Division, Danish Medicines Agency and Pharmacovigilance Working 12:40 Lunch and networking Party Delegate, EMEAEssential case studies: detailing specific 09:40 The Norwegian approach: implementing a PV plan challenges and proposing solutionsand risk minimisation activities at a national level ●Evaluating proposed RMPs: assessing how to increase their 13:50 Determining a robust drug safety strategy for vaccines quality and usefulness to maximise the efficiency of drug to guarantee their excellence and therefore their safety strategiesacceptance for use in healthy people ●Highlighting lessons learned from the practical implementation ●Exploring the challenges to thoroughly analyse the benefit:risk of activities proposed in RMPs to determine best practiceevaluation and mitigate hazards ● Enhancing PV activities ●Generating guidelines to ensure that al adverse events are ● Reviewing educational materials to be used recorded consistently and accurately ● Handling of DHPCs ●Maximising adverse event information and data accuracy Ingebjørg Buajordet, Head of Pharmacovigilance, through spontaneous reporting by minimising under-reporting NORWEgIAN MEDICINES AgENCy ●Illuminating the importance of pharmacoepidemiology studies to confirm the alerts identified by spontaneous reporting10:10 Panel Session: Translating regulatory compliance into ●Reviewing mechanisms for active surveil ance to generate a practical, globally actionable PV strategybest practice ●Managing across multiple regulatory frameworks to ensure Dr Thomas Verstraeten, Vice President, Head, Biologicals Clinical company-wide complianceSafety and Pharmacovigilance, gSk BIOLOgICALS ●Disseminating information and strategy effectively and creating awareness throughout the organisation14:20 Ensuring the safety of Orphan Drugs: ●Practical guidance on implementation through and for affiliatesa company perspectiveDoris Stenver, Chief Medical Officer, Consumer Safety Division, ●Tackling the internal PV chal enges of a smal organisation Danish Medicines Agency and Pharmacovigilance Working ●Building a robust PV system with limited resources Party Delegate, EMEA ●Ensuring signal detection and risk management during development Ingebjørg Buajordet, Head of Pharmacovigilance, ●Developing signal detection and risk management NORWEgIAN MEDICINES AgENCy post-marketing for Orphan Drugs 10:40 Morning refreshments and networking ●The way forward… Dr giuseppe Alvaro, Director, Drug Safety and Achieving successful, practical implementation Pharmacovigilance, SANTHERA PHARMACEuTICALSof PV and RM processesEnsuring globally effective PV strategies11:10 Evaluating successful strategies for PV in marketed products to maximise drug safety14:50 Highlighting the FDA’s Risk Evaluation and Mitigation ●Highlighting the key factors in PV in order to provide thorough Strategies (REMS)information on adverse reactions and overall drug safety ●Reviewing the legislation around REMS to clarify what ●Ensuring you meet the regulators’ expectations through clear is necessaryresults and increased transparency ●Determining practical insights into REMS to ensure they ●Determining best practice approaches for a successful are successfulPV strategy ●Clarifying the opportunities to integrate various global risk ●Looking towards the future: the need for increasing transparency management plans to create a global drug safety strategyin PV and its impact on pharmaceutical companiesCraig Hartford, Executive Director, SRM\RMS Primary Care Dr Ennis Lee, Vice President and Qualified Person for Business unit Leader, PFIZERPharmacovigilance, Pharmaceuticals, Benefit Risk 15:20 Afternoon refreshments and networkingManagement, JANSSEN CILAgProgramme day two Wednesday 2 December 200915:50 Focus on Eastern Europe: reviewing the PV structure 08:30 Registrationand regulations to maximse drug safety09:00 Opening remarks from the Chair ●Identifying the drug safety regulations in order to Phil Weatherill, Director, global Pharmacovigilance, IPSENenhance compliance ●Effectively fol owing the new legislation to maximise your 09:10 Roundtable morning sessionsPV strategies in Eastern EuropeDelegates will be able to attend three one-hour roundtable ●Reviewing methods of monitoring risk mitigation discussion groups from a selection of key topics. Each ses-strategies efficientlysion will be chaired by an industry expert who will facilitate ●Assessing the challenges of PV in Eastern Europe to better an exchange of opinions, essential experiences and learn-understand where problems may occuring related to a current aspect of PV and RM ●Case study: highlighting examples of best practice to develop a comprehensive benefit:risk assessmentRoundtable 1Dr Monica Rusu, Director Pharmacovigilance EELA, global Pharmacovigilance and Risk Management, Exploring the most effective methods for the practical SOLVAy PHARMACEuTICALSimplementation of RMPsThis session will look at the most effective methods Risk based inspections: passing audits with for implementing your RM strategies and the different flying colourstools you can use when gathering the data.16:20 Preparing for risk based inspections to meet the Monica Rusu, Director PV EELA, global Pharmacovigilance regulators’ expectationsand Risk Management, SOLVAy PHARMACEuTICALS gMBH ●Reviewing the compliance report requested by the MHRA (implemented in 2009) to fully understand what is requiredRoundtable 2 ●Successfully deploying assessment algorithms to accurately Highlighting the role of the QPPVinterpret dataThis session will explore the role QPPV and their ●Compiling an inspection readiness plan for affiliates in order crucial role in the overall PV plan and how best to for them to address all the necessary pointers ●Facilitating interaction between the central manage risks and the scope of their role.pharmacovigilance team and the affiliates to create a Dr Peter De Veene, Deputy European Qualified Person for successful company wide drug safety policyPharmacovigilance, ROCHEDr ute Hoeffner, European Qualified Person for Roundtable 3Pharmacovigilance, NOVARTIS CONSuMER HEALTHReviewing global compliance in PV to maximise drug Enhancing safety monitoring processes safety at a global levelthrough efficient epidemiology strategiesThis session will explore global PV legislation and 16:50 Highlighting the importance of epidemiology in find solutions to the challenges to meet disparate PV and RM to increase safety monitoringregulations. You will also assess how to move forward ●Evaluating the advantages of epidemiology vs to make this more viable in the future. pharmacoepidemiology to determine how best to maximise Bert Van Leeuwen, Director of global Drug Safety, safety monitoringORgANON (now part of the Schering Plough Corporation) ●Exploring the need for epidemiology in clinical development to increase the safety data available before Roundtable 4the drug goes to marketOvercoming challenges when completing PSuRs to ●Establishing the importance of epidemiology in post-ensure all safety data is up to datemarketing safety to advance the level of scientific This session will discuss the challenges surrounding knowledge for a drugPSURs to clarify their writing, submission and ●Clarifying the use of epidemiology in RM to ensure safety monitoring is maximisedimplementation. You will also analyse the work Erica Velthuis, Senior Pharmacovigilance Scientist and sharing initiative to assess current practices and the Epidemiologist, gENZyME EuROPEsuccess of the scheme.Dr Agnieszka Majcher-Dann, Acting Qualified Person Emphasising the role of the QPPVfor Pharmacovigilance, Consumer Healthcare, 17:20 Assessing the growing importance of the QPPV in the JOHNSON & JOHNSONevolving PV environment to understand their key role ●Clarifying the scope of the QPPV’s role to fully realise the Roundtable 5pivotal part it playsPharmacoepidemiology in RM: clarifying its role in ●Highlighting the challenges of the position and the legal increasing drug safetyresponsibility to ensure that all requirements are metThis session will look at the significant links ●Determining how the role has evolved and where it wil head between pharmacoepidemiology and clinical in the future to assess its likely impact on PVdevelopment, post-marketing safety and RM to Dr Maria grazia Zurlo, Vice President, Pharmacovigilance Strategy and Policy, Pfizerhighlight how it can mitigate risk.Erica Velthuis, Senior Pharmacovigilance Scientist and 17:50 Closing remarks from the ChairEpidemiologist, gENZyME EuROPE 18:00 End of day one12:30 LunchProgramme day two Wednesday 2 December 2009Focus on new regulatory initiatives ●Developing different methods of raising awareness (types of campaigns, leaflets and advertisements etc) to assess which 13:40 Highlighting the Developmental Safety update is most affectiveReport (DSuR) to assess the implications for ●Encouraging the public to report adverse reactions through future PV reportingincreased communication to minimise under reporting ●Emphasising the implications of increasing public ●Assessing PV reporting methods used by physicians and expectation on drug safety to determine how to encourage patients to establish clear and concise approachesusers to discuss any perceived undesirable side effect with Prof Philippe Van der Auwera, global Head of Safety Risk their doctor or pharmacistManagement (PDS) and Eu-QPPV, ROCHE ●Improving communication with health professionals, patients and the public to increase the accuracy of post RMPs: highlighting practical advice to ensure marketing safety datathere are no gaps in your strategy ●Developing different methods of raising awareness (types 16:20 Writing an effective RMP to mitigate delays in of campaigns, leaflets and advertisements etc) to assess which is most affectivesubmission timelines ●Reviewing the key elements to be included to ensure you ●Encouraging the public to report adverse reactions through increased communication to minimise under-reportingmeet the regulators’ requirements ●Evaluating different approaches towards risk assessment in ●Assessing PV reporting methods used by physicians and patients to establish clear and concise approachesorder to include the most effective in your RMPBert Van Leeuwen, Director of global Drug Safety, ●Determining the role of epidemiological studies in risk ORgANON (now part of the Schering Plough Corporation)management to use them to their ful advantage in your RMP ●Troubleshooting: analysing areas where pitfalls are common 14:10 Reviewing the Periodic Safety update Report (PSuR) to minimise errors and timely delays in submissionWork Sharing Initiative to evaluate its effectiveness ●Working with different departments to generate al the ●Explaining the initiative introduced to minimise duplicationnecessary information ●Exploring the authorities’ work processes and timeframes ●Highlighting best practice examples demonstrating effective to be able to work to their expectationsimplementation techniques ●Highlighting how successful the initiative is through Dr Agnieszka Majcher-Dann, Acting Qualified Person feedback from the authoritiesfor Pharmacovigilance, Consumer Healthcare, ●Assessing the challenges which have arisen to evaluate JOHNSON & JOHNSONpossible solutions16:50 Case study: best practice methods to monitor and ●Looking forward: how to make the process more efficientDr Marina Belle, global Pharmacovigilance, unit Manager evaluate RM to assess the effectiveness of your RMP PSuR, SANDOZ INTERNATIONAL ●Demonstrating different methodologies to monitor RM to assess effective approaches14:40 Outlining the Canadian perspective in PV activities ●Reviewing the various tools available to determine best ●Reviewing the Canadian regulatory system and Health practice in your monitoring approachCanada activities related to the PSUR, Phamacovigilance ●Establishing appropriate methods to measure the and Risk Management Plan (PvP/RMP) in order to meet the effectiveness of your RM strategyrequirements ●Highlighting best practice methods and lessons learned ●Highlighting the PV "tool kit" to optimise quality and efficacy Phil Weatherill, Director, global Pharmacovigilance, IPSENwhile minimising the risks that may be associated with 17:20 health products approved for sale in CanadaExperiences of a small company: submitting a successful RMP supporting the Eu approval of ●Assessing experiences and chal enges encountered in the review activities of PSUR, PvP/RMP in Canada to demonstrate a therapeutic antibody trouble areas and best practice ●The company's drug safety and the antibody's properties as necessary background information ●Establishing signal detection activities using “Canada Vigilance database” and other international adverse drug ●A safety strategy during clinical development as an essential reaction databases as wel as information from PSURs to tool for risk evaluation create a global drug safety outlook ●The presentation of safety data in the dossier (CTD) impacts Dr Duc Vu, Director, Marketed Biologics, Biotechnology the RMP and Natural Health Products, Marketed Health Products ●The establishment of the RMP requires early planning and Directorate, HEALTH CANADAmultiple input ●Lessons learned15:20 Afternoon refreshmentsDr Hans Joachim gamperl, Vice President, global Drug Safety key factors in today’s changing PV environmentand Pharmacovigilance QPPV, FRESENIuS BIOTECH gMBH15:50 Increasing public awareness of risk to ensure that 17:50 Closing remarks from the Chair and champagne patients fully understand the benefit:risk analysis prize drawof a drug hence can take an informed decision with their prescribing physician18:00 End of conference ●Emphasizing 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 pharmacist ●Improving communication with health professionals, patients and the public to increase the accuracy of post marketing safety dataCo-sponsorAbout 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 Media partnersera where the public are much less tolerant to medical risk and Pharmaceutical Technologyhave many more ways in which to express their opinions. With is used daily as a means of creating a continually changing regulatory environment it is imperative partnerships and as a point of that you are kept up to date with the latest changes to develop a reference by professionals within the pharmaceutical industry. robust Pharmacovigilance strategy in which there are no gaps.This comprehensive resource supplies the latest news releases, detailed information on industry projects, white papers, VIBpharma’s Pharmacovigilance and Risk Management event information and a thorough breakdown of products and conference will bring together major pharma and biotech services. www.pharmaceutical-technology.commanufacturers as well as the regulators to find solutions to this increasingly important issue. This event will cover topics Drug Development Technology is a such as effectively monitoring RMPs and best practice in procurement and reference resource their implementation; exploring global Pharmacovigilance providing a one-stop-shop for approaches and creating global risk minimization strategies; professionals and decision makers within the drug development increasing public awareness of the benefit:risk ratio of and medicines industry. We provide a comprehensive medicines and ensuring physicians fully comply to the breakdown of drug development contractors and suppliers, Pharmacovigilance regulations; and ensuring the data exchange up-to-date news and press releases, white papers and detailed between companies.information on current industry projects and trends. Our recruitment area provides career information and the latest job This educational two-day conference, tailored to maximise thevacancies in the field. www.drugdevelopment-technology.comsharing of knowledge and expertise and to promote networkingfor professionals in this area, will ensure you effectivelyThe Business Review websites are manage Risk Management with current medicines to mitigate your number one stop for al the any risks to patients.latest news, comment and industry information. Each Business Review website offers content that is produced by a dedicated team of journalists and global industry experts. In addition to the free content made available on the sites an intel igence store TESTIMONIALS – Here is what previous delegates wil provide you with premium market analysis reports from the have said about previous PV conferences leading global suppliers of market research and industry analysis. “Very useful with a lot of hot topics”Pharmaceutical Business Review is Patient Safety Manager, ASTRAZENECAthe world's leading pharma website, being used by over 100,000 visitors “Very good to meet people; fruitful discussions”every month. For further information CQA PV Specialist, NOVARTIScontact jsharp@industryreview.com“It was very useful and lively meeting and I have the opportunity to interact with many other colleagues World Pharmaceutical Frontiersnot only from the pharma industry but also the World Pharmaceutical Frontierswww.worldpharmaceuticals.netThe pharmaceutical industry is regulators. We shared a lot of experience and I changing fast. There are more regulations, technologies, learned a lot!”faster product launches and shorter product life cycles than Director of PV, SOLVAy PHARMAever before. World Pharmaceuticals frontiers is, and will continue to be, at the forefront of these changes, so visit us “A good choice of speakers and enough time devoted at www.worldpharmaceuticals.net and stay up to date with all to discussion”latest developmentsHead of Drug Safety, BOEHRINgER INgELHEIM“Globally a good overview with current practices and issues in PV. A good opportunity to exchange Who should attend:experiences with colleagues”Heads, Directors and Managers from pharma and biotech Senior Director, Safety and Compliance, IPSEN manufacturers working in the following areas:INNOVATIONS● Pharmacovigilance ● Clinical Operations“Good interaction and variety of speakers. Overall I ● Qualified Person ● Clinical Safetyenjoyed the experience and exchanged best practice (QP) for PV● Epidemiologywith others”● Drug Safety● Product Safety and PV Manager, SCHERINg PLOugH● Benefit-Risk Management Quality Management“Very high quality speakers and the roundtable ● Medical● Regulatory Affairsdiscussion groups allowed a good exchange of ● Risk Managementexperiences”Drug Safety Specialist, MERCk SERONO“Very good, well organised conference”Do you wish to exhibit your products Director, Marketed Biologicals, HEALTH CANADAand services at this exclusive event?“Highly professional speakers and audience, very knowledgeable and open. Pleasant overall”Contact details: Paul Adams, Drug Safety Solution Manager, QuINTILESpauladams@arena-international.com, +44 (0) 20 7753 4259Booking Form Pharmacovigilance and Risk Management, Tuesday 1 and Wednesday 2 December 2009, Brussels, BelgiumYes, i would like to register for the event:BeforeBeforeAfter■ Register online at 6.10.20093.11.20093.11.2009 www.vibpharma.com/pharmacovigilancei am a Pharma Manufacturer/biotech representative and i would like to register for the event:■ Email us at I would like to attend the 2-day conference + the interactive €2590€2730€2940CD-ROM (saving €70) † events@arena-international.com I would like to attend the two day conference only €1960 + VAT @ €2100 + VAT @ €2310 + VAT @ ■ Tel +44 (0)20 7753 426821% = €2371.6021% = €254121% = €2795.10■ Fax +44 (0)20 7915 9773i am an Academic representative and i would like to register for the event: I would like to attend the 2-day conference + the interactive €1680€1820€2030Venue DetailsCD-ROM (saving €70) †The two day conference will take place on Tuesday €1050 + VAT @ €1190 + VAT @ €1400 + VAT @ 1 and Wednesday 2 Dec 2009, in Brussels, Belgium I would like to attend the two day conference only 21% = €1270.5021% = €1439.9021% = €1694at the Sheraton Brussels Airport Hotel For further fees for all other attendeesinformation contact our Operations department on +44 (o) 207 753 4201. 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