Pharmacovigilance and Risk Management

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Developing an effective yet transparent pharmacovigilance strategy and keeping ahead of regulatory changes can be challenging, yet the EU’s complex safety regulations and ever-increasing media attention make both functions vital.

At VIBpharma’s 5th annual Pharmacovigilance and Risk Management conference you will gain solutions to the issues you are currently facing; from the difficulties with RMP’s and how to effectively manage risk management with current medicines to mitigate any risks to patients.

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Pharmacovigilance and Risk Management

  1. 1. VIBpharma Benef it to-pee from a pee round r interacti r- 5th Annual tab ve to add le morning Pharmacovigilance obsta ress key find th cles and releva e solutio nt to ns and Risk Management proce everyday dures Optimal PV and RM strategy and implementation to ensure regulatory compliance and maximise drug safety 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 with 19 pharma and regulatory representatives on the programme, Dr Hans Joachim gamperl, Vice President, global Drug Safety and Pharmacovigilance QPPV, FRESENIuS BIOTECH this event will provide invaluable Craig Hartford, Executive Director, SRM/RMS Primary Care insight into key areas of Pv and rM Business unit Leader, PFIZER Prof Philippe Van der Auwera, global Head of Safety Risk Management (PDS) and Eu-QPPV, ROCHE 3 HIgHLIgHTS! Dr Duc Vu, Director, Marketed Bilogics, Biotechnology ● Critical insights on the practical and Natural Health Products, Marketed Health Products Directorate, HEALTH CANADA implementation of PV on a global, regional and country specific scale Doris Stenver, Chief Medical Officer, Consumer Safety Division, DANISH MEDICINES AgENCy and Pharmacovigilance Working Party Delegate, EMEA ● Take a global approach on PV and RM issues: clarify requirements form the Monica Rusu, Director PharmacovigilanceEELA, global Pharmacovigilance and Risk Management, uSA, Eastern Europe, Canada, Norway SOLVAy PHARMACEuTICALS gMBH and Denmark to ensure compliance in Phil Weatherill, Director, global Pharmacovigilance, IPSEN a global setting Dr Maria grazia Zurlo, Vice President, Pharmacovigilance ● Essential case studies on ensuring Strategy and Policy, PFIZER legislative compliance and best practice Erica Velthuis, Senior Pharmacovigilance Scientist and Epidemiologist, gENZyME EuROPE Dr Ennis Lee, Vice President and Qualified Person for Co-sponsor Pharmacovigilance, Pharma, Benefit Risk Management, JANSSEN CILAg Bert 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/pharmacovigilance
  2. 2. Programme day one Tuesday 1 December 2009 08:30 Registration 11:40 Highlighting successful RM strategies in a post approval setting to maximise patient safety 09:00 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 risk global Pharmacovigilance and Risk Management, ● Highlighting successful techniques to monitor RM to ensure SOLVAy PHARMACEuTICALS minimal risk View from the regulators: clarifying their ● Meeting the regulators’ expectations with robust RM policies interpretation of key PV and RM legislation ● Case study: the most effective methods for risk mitigation Rudi Scheerlinck, Director, global Clinical Safety and 09:10 Case study: the Danish approach to PV and RM Pharmacovigilance, uCB ● Highlighting the Danish PV action plan: reviewing major elements and objectives to ensure regulatory compliance Effective 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 will affect your RM strategy for optimal ADR monitoring and reporting ● Positioning response to adverse events at the core of your ● Establishing the interrelation between the Danish Medicines RM activity Agency 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 detection outlining the current status from a regulatory point of view RM ● Evaluating the impact and effectiveness of electronic reporting and risk minimisation: case study examples Speaker TBC Doris Stenver, Chief Medical Officer, Consumer Safety Division, Danish Medicines Agency and Pharmacovigilance Working 12:40 Lunch and networking Party Delegate, EMEA Essential case studies: detailing specific 09:40 The Norwegian approach: implementing a PV plan challenges and proposing solutions and 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 strategies acceptance 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 practice evaluation and mitigate hazards ● Enhancing PV activities ● Generating guidelines to ensure that all 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 reporting 10:10 Panel Session: Translating regulatory compliance into ● Reviewing mechanisms for active surveillance to generate a practical, globally actionable PV strategy best practice ● Managing across multiple regulatory frameworks to ensure Dr Thomas Verstraeten, Vice President, Head, Biologicals Clinical company-wide compliance Safety and Pharmacovigilance, gSk BIOLOgICALS ● Disseminating information and strategy effectively and creating awareness throughout the organisation 14:20 Ensuring the safety of Orphan Drugs: ● Practical guidance on implementation through and for affiliates a company perspective Doris Stenver, Chief Medical Officer, Consumer Safety Division, ● Tackling the internal PV challenges of a small organisation Danish Medicines Agency and Pharmacovigilance Working ● Building a robust PV system with limited resources Party Delegate, EMEA ● Ensuring signal detection and risk management Ingebjørg Buajordet, Head of Pharmacovigilance, during development NORWEgIAN MEDICINES AgENCy ● Developing signal detection and risk management 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 PHARMACEuTICALS of PV and RM processes 11:10 Evaluating successful strategies for PV in marketed Ensuring globally effective PV strategies products to maximise drug safety 14:50 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 necessary results and increased transparency ● Determining practical insights into REMS to ensure they ● Determining best practice approaches for a successful are successful PV 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 strategy in PV and its impact on pharmaceutical companies Craig Hartford, Executive Director, SRMRMS Primary Care Dr Ennis Lee, Vice President and Qualified Person for Business unit Leader, PFIZER Pharmacovigilance, Pharmaceuticals, Benefit Risk Management, JANSSEN CILAg 15:20 Afternoon refreshments and networking
  3. 3. Programme day two 15:50 Focus on Eastern Europe: reviewing the PV structure 08:30 Registration and regulations to maximse drug safety ● Identifying the drug safety regulations in order to 09:00 Opening remarks from the Chair Phil Weatherill, Director, global Pharmacovigilance, IPSEN enhance compliance ● Effectively following the new legislation to maximise your PV strategies in Eastern Europe 09:10 Roundtable morning sessions ● Reviewing methods of monitoring risk mitigation Delegates will be able to attend three one-hour roundtable strategies efficiently discussion groups from a selection of key topics. Each ses- ● Assessing the challenges of PV in Eastern Europe to better sion will be chaired by an industry expert who will facilitate understand where problems may occur an exchange of opinions, essential experiences and learn- ● Case study: highlighting examples of best practice to ing related to a current aspect of PV and RM develop a comprehensive benefit:risk assessment Dr Monica Rusu, Director Pharmacovigilance EELA, Roundtable 1 global Pharmacovigilance and Risk Management, Exploring the most effective methods for the practical SOLVAy PHARMACEuTICALS implementation of RMPs Risk based inspections: passing audits with This session will look at the most effective methods flying colours for implementing your RM strategies and the different tools 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’ expectations and Risk Management, SOLVAy PHARMACEuTICALS gMBH ● Reviewing the compliance report requested by the MHRA (implemented in 2009) to fully understand what is required Roundtable 2 ● Successfully deploying assessment algorithms to accurately Highlighting the role of the QPPV interpret data This session will explore the role QPPV and their ● Compiling an inspection readiness plan for affiliates in order for them to address all the necessary pointers crucial role in the overall PV plan and how best to ● 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 policy Pharmacovigilance, ROCHE Dr ute Hoeffner, European Qualified Person for Pharmacovigilance, NOVARTIS CONSuMER HEALTH Roundtable 3 Reviewing global compliance in PV to maximise drug Enhancing safety monitoring processes safety at a global level through efficient epidemiology strategies This 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 monitoring regulations. 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 monitoring ORgANON (now part of the Schering Plough Corporation) ● Exploring the need for epidemiology in clinical development to increase the safety data available before Roundtable 4 the drug goes to market Overcoming challenges when completing PSuRs to ● Establishing the importance of epidemiology in post- ensure all safety data is up to date marketing safety to advance the level of scientific knowledge for a drug This session will discuss the challenges surrounding ● Clarifying the use of epidemiology in RM to ensure safety PSURs to clarify their writing, submission and monitoring is maximised implementation. You will also analyse the work Erica Velthuis, Senior Pharmacovigilance Scientist and sharing initiative to assess current practices and the Epidemiologist, gENZyME EuROPE success of the scheme. Emphasising the role of the QPPV Dr Agnieszka Majcher-Dann, Acting Qualified Person for Pharmacovigilance, Consumer Healthcare, 17:20 Assessing the growing importance of the QPPV in the JOHNSON & JOHNSON evolving PV environment to understand their key role ● Clarifying the scope of the QPPV’s role to fully realise the Roundtable 5 pivotal part it plays Pharmacoepidemiology in RM: clarifying its role in ● Highlighting the challenges of the position and the legal increasing drug safety responsibility to ensure that all requirements are met This session will look at the significant links ● Determining how the role has evolved and where it will head between pharmacoepidemiology and clinical in the future to assess its likely impact on PV Dr Maria grazia Zurlo, Vice President, Pharmacovigilance development, post-marketing safety and RM to Strategy and Policy, Pfizer highlight how it can mitigate risk. Erica Velthuis, Senior Pharmacovigilance Scientist and 17:50 Closing remarks from the Chair Epidemiologist, gENZyME EuROPE 18:00 End of day one 12:30 Lunch
  4. 4. Wednesday 2 December 2009 Focus 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 affective Report (DSuR) to assess the implications for ● Encouraging the public to report adverse reactions through future PV reporting increased 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 approaches users to discuss any perceived undesirable side effect with Prof Philippe Van der Auwera, global Head of Safety Risk their doctor or pharmacist Management (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 data there 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 affective submission timelines ● Reviewing the key elements to be included to ensure you ● Encouraging the public to report adverse reactions through meet the regulators’ requirements increased communication to minimise under-reporting ● Evaluating different approaches towards risk assessment in ● Assessing PV reporting methods used by physicians and order to include the most effective in your RMP patients to establish clear and concise approaches ● Determining the role of epidemiological studies in risk Bert Van Leeuwen, Director of global Drug Safety, management to use them to their full advantage in your RMP ORgANON (now part of the Schering Plough Corporation) ● Troubleshooting: analysing areas where pitfalls are common 14:10 Reviewing the Periodic Safety update Report (PSuR) to minimise errors and timely delays in submission Work Sharing Initiative to evaluate its effectiveness ● Working with different departments to generate all the ● Explaining the initiative introduced to minimise duplication necessary information ● Exploring the authorities’ work processes and timeframes ● Highlighting best practice examples demonstrating effective to be able to work to their expectations implementation techniques ● Highlighting how successful the initiative is through Dr Agnieszka Majcher-Dann, Acting Qualified Person feedback from the authorities for Pharmacovigilance, Consumer Healthcare, ● Assessing the challenges which have arisen to evaluate JOHNSON & JOHNSON possible solutions 16:50 Case study: best practice methods to monitor and ● Looking forward: how to make the process more efficient Dr Marina Belle, global Pharmacovigilance, unit Manager evaluate RM to assess the effectiveness of your RMP ● Demonstrating different methodologies to monitor RM to PSuR, SANDOZ INTERNATIONAL assess effective approaches 14:40 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 approach Canada 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 strategy requirements ● Highlighting best practice methods and lessons learned ● Highlighting the PV "tool kit" to optimise quality and efficacy Phil Weatherill, Director, global Pharmacovigilance, IPSEN while minimising the risks that may be associated with health products approved for sale in Canada 17:20 Experiences of a small company: submitting ● Assessing experiences and challenges encountered in the a successful RMP supporting the Eu approval of 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 ● Establishing signal detection activities using “Canada necessary background information Vigilance database” and other international adverse drug ● A safety strategy during clinical development as an essential reaction databases as well 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 CANADA multiple input ● Lessons learned 15:20 Afternoon refreshments Dr Hans Joachim gamperl, Vice President, global Drug Safety and Pharmacovigilance QPPV, FRESENIuS BIOTECH gMBH key factors in today’s changing PV environment 15:50 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 draw of a drug hence can take an informed decision with their prescribing physician 18:00 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 data
  5. 5. Co-sponsor About the event Following 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 partners era where the public are much less tolerant to medical risk and have many more ways in which to express their opinions. With Pharmaceutical Technology is a continually changing regulatory environment it is imperative used daily as a means of creating that you are kept up to date with the latest changes to develop a partnerships and as a point of robust Pharmacovigilance strategy in which there are no gaps. reference by professionals within the pharmaceutical industry. This comprehensive resource supplies the latest news releases, VIBpharma’s Pharmacovigilance and Risk Management detailed information on industry projects, white papers, conference will bring together major pharma and biotech event information and a thorough breakdown of products and manufacturers as well as the regulators to find solutions to services. www.pharmaceutical-technology.com 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 the vacancies in the field. www.drugdevelopment-technology.com sharing of knowledge and expertise and to promote networking for professionals in this area, will ensure you effectively The Business Review websites are manage Risk Management with current medicines to mitigate your number one stop for all 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 intelligence store TESTIMONIALS – Here is what previous delegates will 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, ASTRAZENECA the 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, NOVARTIS contact jsharp@industryreview.com “It was very useful and lively meeting and I have the opportunity to interact with many other colleagues World Pharmaceutical Frontiers not only from the pharma industry but also the The pharmaceutical industry is World Pharmaceutical Frontiers www.worldpharmaceuticals.net 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 PHARMA ever 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 developments Head 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 Safety enjoyed the experience and exchanged best practice (QP) for PV ● Epidemiology with others” ● Drug Safety ● Product Safety and PV Manager, SCHERINg PLOugH ● Benefit-Risk Management Quality Management “Very high quality speakers and the roundtable ● Medical ● Regulatory Affairs discussion groups allowed a good exchange of ● Risk Management experiences” Drug Safety Specialist, MERCk SERONO “Very good, well organised conference” Do you wish to exhibit your products Director, Marketed Biologicals, HEALTH CANADA and services at this exclusive event? “Highly professional speakers and audience, very knowledgeable and open. Pleasant overall” Contact details: Paul Adams, Drug Safety Solution Manager, QuINTILES pauladams@arena-international.com, +44 (0) 20 7753 4259
  6. 6. Booking Form Pharmacovigilance and Risk Management, Tuesday 1 and Wednesday 2 December 2009, Brussels, Belgium Yes, i would like to register for the event: Before Before After ■ Register online at 6.10.2009 3.11.2009 3.11.2009 www.vibpharma.com/pharmacovigilance i am a Pharma Manufacturer/biotech representative and i would like to register for the event: I would like to attend the 2-day conference + the interactive €2590 €2730 €2940 ■ Email us at CD-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 4268 21% = €2371.60 21% = €2541 21% = €2795.10 ■ Fax +44 (0)20 7915 9773 i 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 €2030 Venue Details CD-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% = €1270.50 21% = €1439.90 21% = €1694 at the Sheraton Brussels Airport Hotel For further fees for all other attendees information contact our Operations department on +44 (o) 207 753 4201. 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