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Pharmacovigilance and Risk Management
 

Pharmacovigilance and Risk Management

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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 ...

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 the sharing of knowledge and expertise and to promote networking for professionals in this area, will ensure you effectively manage risk management with current medicines to mitigate any risks to patients.

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    Pharmacovigilance and Risk Management Pharmacovigilance and Risk Management Document Transcript

    • 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: with 19 pharma and regulatory Dr Thomas Verstraeten, Vice President, Head, Biologicals Clinical representatives on the programme, Safety and Pharmacovigilance, gSk BIOLOgICALS this event will provide invaluable Dr Hans Joachim gamperl, Vice President, global Drug Safety and insight into key areas of Pv and rM Pharmacovigilance QPPV, FRESENIuS BIOTECH Craig Hartford, Executive Director, SRM/RMS Primary Care Business unit Leader, PFIZER 3 HIgHLIgHTS! Prof Philippe Van der Auwera, global Head of Safety Risk Management (PDS) and Eu-QPPV, ROCHE ● Critical insights on the practical Dr Duc Vu, Director, Marketed Bilogics, Biotechnology and Natural implementation of PV on a global, Health Products, Marketed Health Products Directorate, HEALTH regional and country specific scale CANADA Doris Stenver, Chief Medical Officer, Consumer Safety Division, ● Take a global approach on PV and RM DANISH MEDICINES AgENCy and Pharmacovigilance Working Party issues: clarify requirements form the Delegate, EMEA uSA, Eastern Europe, Canada, Norway Monica Rusu, Director PharmacovigilanceEELA, global and Denmark to ensure compliance in Pharmacovigilance and Risk Management, SOLVAy PHARMACEuTICALS gMBH a global setting Phil Weatherill, Director, global Pharmacovigilance, IPSEN ● Essential case studies on ensuring Dr Maria grazia Zurlo, Vice President, Pharmacovigilance Strategy legislative compliance and best practice and Policy, PFIZER Erica Velthuis, Senior Pharmacovigilance Scientist and Epidemiologist, gENZyME EuROPE ADDED EXTRA BONuS: Dr Ennis Lee, Vice President and Qualified Person for Pharmacovigilance, Pharma, Benefit Risk Management, ● With 19 pharma and regulatory JANSSEN CILAg representatives on the programme, this Bert Van Leeuwen, Director of global Drug Safety, ORgANON (now event offers you invaluable insight into part of the SCHERINg-PLOugH CORPORATION) critical areas of PV and RM 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
    • 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 RM activity ● Medicines 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 Case study: identifying the challenges of PV for ● Practical guidance on implementation through and for affiliates orphan drugs in order to implement a strong risk Doris Stenver, Chief Medical Officer, Consumer Safety Division, management strategy Danish Medicines Agency and Pharmacovigilance Working ● Tackling the internal challenges of a small company to make the Party Delegate, EMEA best use of limited resources Ingebjørg Buajordet, Head of Pharmacovigilance, ● Building a robust PV system with limited resources NORWEgIAN MEDICINES AgENCy ● Ensuring effective signal detection and RM during development to fully assess drug safety 10:40 Morning refreshments and networking ● Developing signal detection and risk management strategies post marketing for orphan drugs Achieving successful, practical implementation ● The way forward… of PV and RM processes Dr giuseppe Alvaro, Director, Drug Safety and 11:10 Evaluating successful strategies for PV in marketed Pharmacovigilance, SANTHERA PHARMACEuTICALS products to maximise drug safety ● Highlighting the key factors in PV in order to provide thorough Ensuring globally effective PV strategies information on adverse reactions and overall drug safety 14:50 Highlighting the FDA’s Risk Evaluation and Mitigation ● Ensuring you meet the regulators’ expectations through clear Strategies (REMS) results and increased transparency ● Reviewing the legislation around REMS to clarify what ● Determining best practice approaches for a successful is necessary PV strategy ● Determining practical insights into REMS to ensure they ● Looking towards the future: the need for increasing transparency are successful in PV and its impact on pharmaceutical companies ● Clarifying the opportunities to integrate various global risk Dr Ennis Lee, Vice President and Qualified Person for management plans to create a global drug safety strategy Pharmacovigilance, Pharmaceuticals, Benefit Risk Craig Hartford, Executive Director, SRMRMS Primary Care Management, JANSSEN CILAg Business unit Leader, PFIZER
    • Programme day two 15:20 Afternoon refreshments and networking 08:30 Registration 15:50 Focus on Eastern Europe: reviewing the PV structure 09:00 Opening remarks from the Chair and regulations to maximse drug safety Phil Weatherill, Director, global Pharmacovigilance, IPSEN ● Identifying the drug safety regulations in order to enhance compliance 09:10 Roundtable morning sessions ● Effectively following the new legislation to maximise your Delegates will be able to attend three one-hour roundtable PV strategies in Eastern Europe discussion groups from a selection of key topics. Each ses- ● Reviewing methods of monitoring risk mitigation sion will be chaired by an industry expert who will facilitate strategies efficiently an exchange of opinions, essential experiences and learn- ● Assessing the challenges of PV in Eastern Europe to better ing related to a current aspect of PV and RM understand where problems may occur ● Case study: highlighting examples of best practice to Roundtable 1 develop a comprehensive benefit:risk assessment Exploring the most effective methods for the practical Dr Monica Rusu, Director Pharmacovigilance EELA, implementation of RMPs global Pharmacovigilance and Risk Management, SOLVAy PHARMACEuTICALS This session will look at the most effective methods for implementing your RM strategies and the different Risk based inspections: passing audits with tools you can use when gathering the data. flying colours Monica Rusu, Director PV EELA, global Pharmacovigilance 16:20 Preparing for risk based inspections to meet the and Risk Management, SOLVAy PHARMACEuTICALS gMBH regulators’ expectations Roundtable 2 ● Reviewing the compliance report requested by the MHRA (implemented in 2009) to fully understand what is required Highlighting the role of the QPPV ● Successfully deploying assessment algorithms to accurately This session will explore the role QPPV and their interpret data crucial role in the overall PV plan and how best to ● Compiling an inspection readiness plan for affiliates in order manage risks and the scope of their role. for them to address all the necessary pointers Dr Peter De Veene, Deputy European Qualified Person for ● Facilitating interaction between the central Pharmacovigilance, ROCHE pharmacovigilance team and the affiliates to create a successful company wide drug safety policy Roundtable 3 Dr ute Hoeffner, European Qualified Person for Reviewing global compliance in PV to maximise drug Pharmacovigilance, NOVARTIS CONSuMER HEALTH safety at a global level Enhancing safety monitoring processes This session will explore global PV legislation and through efficient epidemiology strategies find solutions to the challenges to meet disparate 16:50 Highlighting the importance of epidemiology in regulations. You will also assess how to move forward PV and RM to increase safety monitoring to make this more viable in the future. ● Evaluating the advantages of epidemiology vs Bert Van Leeuwen, Director of global Drug Safety, pharmacoepidemiology to determine how best to maximise ORgANON (now part of the Schering Plough Corporation) safety monitoring Exploring the need for epidemiology in clinical Roundtable 4 ● development to increase the safety data available before Overcoming challenges when completing PSuRs to the drug goes to market ensure all safety data is up to date ● Establishing the importance of epidemiology in post- This session will discuss the challenges surrounding marketing safety to advance the level of scientific PSURs to clarify their writing, submission and knowledge for a drug implementation. You will also analyse the work ● Clarifying the use of epidemiology in RM to ensure safety sharing initiative to assess current practices and the monitoring is maximised Erica Velthuis, Senior Pharmacovigilance Scientist and success of the scheme. Epidemiologist, gENZyME EuROPE Dr Agnieszka Majcher-Dann, Acting Qualified Person for Pharmacovigilance, Consumer Healthcare, Emphasising the role of the QPPV JOHNSON & JOHNSON 17:20 Assessing the growing importance of the QPPV in the Roundtable 5 evolving PV environment to understand their key role Pharmacoepidemiology in RM: clarifying its role in ● Clarifying the scope of the QPPV’s role to fully realise the increasing drug safety pivotal part it plays ● Highlighting the challenges of the position and the legal This session will look at the significant links responsibility to ensure that all requirements are met between pharmacoepidemiology and clinical ● Determining how the role has evolved and where it will head development, post-marketing safety and RM to in the future to assess its likely impact on PV highlight how it can mitigate risk. Dr Maria grazia Zurlo, Vice President, Pharmacovigilance Erica Velthuis, Senior Pharmacovigilance Scientist and Strategy and Policy, Pfizer Epidemiologist, gENZyME EuROPE 17:50 Closing remarks from the Chair 12:30 Lunch 18:00 End of day one
    • 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
    • Media partners About the event Pharmaceutical Technology is Following the enormous success of our Pharmacovigilance and used daily as a means of creating Risk Management event earlier this year, VIBpharma is proud to partnerships and as a point of announce the dates for our fifth annual Pharmacovigilance and reference by professionals within the pharmaceutical industry. Risk Management conference this December. The role of drug This comprehensive resource supplies the latest news releases, safety both in drug development and postmarketingsurveillance detailed information on industry projects, white papers, has increased enormously over recent years, especially in an event information and a thorough breakdown of products and era where the public are much less tolerant to medical risk and services. www.pharmaceutical-technology.com have many more ways in which to express their opinions. With a continually changing regulatory environment it is imperative Drug Development Technology that you are kept up to date with the latest changes to develop a is a procurement and reference robust Pharmacovigilance strategy in which there are no gaps. resource providing a one-stop- shop for professionals and decision makers within the VIBpharma’s Pharmacovigilance and Risk Management drug development and medicines industry. We provide a conference will bring together major pharma and biotech comprehensive breakdown of drug development contractors manufacturers as well as the regulators to find solutions to and suppliers, up-to-date news and press releases, white this increasingly important issue. This event will cover topics papers and detailed information on current industry projects such as effectively monitoring RMPs and best practice in and trends. Our recruitment area provides career information their implementation; exploring global Pharmacovigilance and the latest job vacancies in the field. approaches and creating global risk minimization strategies; www.drugdevelopment-technology.com increasing public awareness of the benefit:risk ratio of medicines and ensuring physicians fully comply to the The Business Review websites are Pharmacovigilance regulations; and ensuring the data exchange your number one stop for all the between companies. latest news, comment and industry information. Each Business Review website offers content that is produced by a dedicated This educational two-day conference, tailored to maximise the team of journalists and global industry experts. In addition to sharing of knowledge and expertise and to promote networking the free content made available on the sites an intelligence for professionals in this area, will ensure you effectively store will provide you with premium market analysis reports manage Risk Management with current medicines to mitigate from the leading global suppliers of market research and any risks to patients. industry analysis. Pharmaceutical Business Review is the world's leading pharma website, being used by over 100,000 visitors TESTIMONIALS – Here is what previous delegates every month. For further information have said about previous PV conferences contact jsharp@industryreview.com “Very useful with a lot of hot topics” World Pharmaceutical Frontiers Patient Safety Manager, ASTRAZENECA The pharmaceutical industry is World Pharmaceutical Frontiers www.worldpharmaceuticals.net “Very good to meet people; fruitful discussions” changing fast. There are more regulations, technologies, CQA PV Specialist, NOVARTIS faster product launches and shorter product life cycles than ever before. World Pharmaceuticals frontiers is, and will “It was very useful and lively meeting and I have the continue to be, at the forefront of these changes, so visit us opportunity to interact with many other colleagues at www.worldpharmaceuticals.net and stay up to date with not only from the pharma industry but also the all latest developments regulators. We shared a lot of experience and I learned a lot!” Director of PV, SOLVAy PHARMA Who should attend: “A good choice of speakers and enough time devoted Heads, Directors and Managers from pharma and biotech to discussion” manufacturers working in the following areas: Head of Drug Safety, BOEHRINgER INgELHEIM ● Pharmacovigilance “Globally a good overview with current practices ● Qualified Person (QP) for PV and issues in PV. A good opportunity to exchange ● Drug Safety experiences with colleagues” ● Benefit-Risk Management Senior Director, Safety and Compliance, IPSEN ● Medical INNOVATIONS ● Risk Management “Good interaction and variety of speakers. Overall I ● Clinical Operations enjoyed the experience and exchanged best practice ● Clinical Safety with others” ● Epidemiology PV Manager, SCHERINg PLOugH ● Product Safety and Quality Management ● Regulatory Affairs “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” 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
    • 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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