5th Annual
          Implementing best practices in drug safety and surveillance

   17th - 19th March 2...
Conference Introduction
                                                                                        5th Annual...
Pre-Conference Interactive Workshop
                                                           5th Annual Pharmacovigilanc...
Day 1
                                                                           5th Annual Pharmacovigilance Conference
Day 2
                                                                       5th Annual Pharmacovigilance Conference
Registration Form
                                                                                        5th Annual Pharm...
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5th Annual Pharmacovigilance (2010) Ts

  1. 1. 5th Annual Pharmacovigilance Implementing best practices in drug safety and surveillance 17th - 19th March 2010, BSG Conference Centre, London, UK BOOK NOW! Key Speakers Dr Rachel Sobel, Senior Director, Epidemiology - Specialty Care BU Group Head, Pfizer Seema Jaitly, VP Global Medical & Scientific Affairs, Stiefel Laboratories, GSK Dr John Parkinson, Director, General Practice Research Database (GPRD), MHRA Dr John Talbot, Director - Patient Safety, Processes & Standards, AstraZeneca R&D Professor Saad Shakir, Director, Drug Safety Research Unit Dr Jacques Wodelet, Head of Quality Intelligence & Consultation, Merck-Serono, Geneva Dr Irene Michas, Director, Pharmacovigilance Education and Process Documentation (PEPD), Pfizer Paolo Biffignandi, Chief Medical Officer, EU Vigilance & President, TOPRA Jim Weatherall, Global Lead, Biomedical Informatics, AstraZeneca Dr K N Woodward, Head - Global Pharmacovigilance, Intervet - Schering-Plough Animal Health Pre Conference workshop Wednesday 17th March 2010 Safety Data Exchange Agreements (SDEA) for licensed and unlicensed products Led by: Emma Boulton, Global Head of Pharmacovigilance and Medical Information,EUSA Pharma, and Lesley Deane, PhV Consultancy Associate Sponsors Driving the Industry Forward | www.futurepharmaus.com Organised By Media Partners To Book Call: +44 (0) 20 7336 6100 | http://www.visiongain.com/pv
  2. 2. Conference Introduction 5th Annual Pharmacovigilance Conference 17th -19th March 2010, London UK Implementing best practices in drug safety and surveillance Associate Sponsors: Pharmaceutical and biotechnology companies can now draw on the expertise and resources of PrimeVigilance, a service provider that is Dear Colleague, completely dedicated to compliant and cost-effective pharmacovigilance solutions, with a harmacovigilance is becoming ever more critical for pharmaceutical companies as P validated safety database, highly qualified and experienced operational staff, and leading the public and legislative pressure to ensure drug safety increases every day. Effective expert consultants. PrimeVigilance fills the gap between the large multinational CROs that implementation of pharmacovigilance can aid drug development, benefit rational do not provide a service specifically geared towards pharmacovigilance for small- and communication and sound public understanding, taking emerging regulatory policies medium-sized companies, and the small service providers that do not have the critical mass, worldwide into account. The challenge to manage adverse events in an optimal and efficient way and, at the same time, adhere to regulatory requirements will demand a great expertise or wide international presence needed to reassure that patients and products will emphasis on pharmacovigilance in the near future. be adequately protected. isiongain’s 5th Annual Pharmacovigilance conference will discuss a range of key elements V For further information please visit www.primevigilance.com including the regulatory and legislative framework, PSUR, and risk mitigation strategies that are vital for drug safety and surveillance. With succinct themes and interactive sessions by Media Partners: key opinion leaders, the conference will bring latest insights, integrated strategies and best PharmiWeb.com is the leading industry-sponsored portal for the practices in pharmacovigilance. pharmaceutical sector. Supported by most of the leading pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, events listings By attending this conference you will gain knowledge on: and international jobs to industry professionals across Europe and the US. • valuation of risk mitigation activities: REMS and beyond from the E For further information please email: corporate@pharmiweb.com pharmacoepidemiologist’s perspective BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. It is • egulatory focus on evaluation of risk mitigation strategies, contrasting the FDAAA, R based and located in Warsaw, Poland. Biotechnology World was founded REMS and the EU-RMP in 2007 to provide the world’s biotech and pharma information and market to make it universally accessible and useful for scientific and business processes. Its first step to fulfilling • lassification of Adverse drug reactions by mechanism (the EIDOS system) and by C clinical presentation (the DoTS system) that mission was building the BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers companies • Pharmacovigilance in clinical trials of investigational medicinal products completed internet public relations, publication and marketing solutions. One of the mains • New Horizons: Proposals from the EU Commission “Pharma Package” goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe • eveloping and implementing training programs for global pharmacovigilance D to global biotechnology, pharmaceutical and life science activities. systems, bridging geographies and requirements For further information please visit www.biotechnology-europe.com Future Pharmaceuticals has forged powerful relationships with key industry Driving the Industry Forward | www.futurepharmaus.com • evelopment Safety Update Report (DSUR): Harmonising periodic safety reporting D leaders to provide a platform for successful brand recognition, and for during clinical trials senior decision-makers to have the means to procure and plan implementation strategies • pplication of text analytics to the surveillance of published literature A based on the topics covered. Positioned to be an authoritative resource within top pharma • Pharmacovigilance in early phase oncology trials (Phase I & II) companies as well as small, specialty, and biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into a highly targeted and responsive audience, bridging the gap • Implementing inspection readiness program as a guide to maximise readiness between the industries’ top issues and the solutions top-tier vendors can provide. • rug safety investigation – Pre and Post Marketing D For further information please visit: www.futurepharmaus.com InPharm is the online platform for exclusive pharmaceutical news, comment, contracts, services, jobs and events and is home to InPharmjobs.com, Pharmafile and Pharmafocus. Maninder Paul For further information please visit: www.In-Pharm.com Conference Producer ‘Pharma Connections Worldwide® is the leading professional business networking website focused in the Pharmaceutical, Biotechnology and Life Sciences research industry. Our goal is to provide a conduit for delivery of premiere content coupled with the right clientele in order to facilitate business development opportunities among industry professionals responsible for making key decisions in a global marketplace. ‘ Target Audience For further information please visit www.pharmaconnections.com Pharmaceutical and Biotechnological Companies Contract Manufacturing Organisations (CMOs) Drug Regulators, Intellectual Property/Law Firms Academia, Government Bodies, Regulatory Affairs Sponsorship and exhibition opportunities: Who should attend? This event offers a unique opportunity to meet and do business with some of the key VP’s, Directors, Managers, Scientific Advisors, Consultants of: players in the pharmaceutical and biotech industries. If you have a service or product to • Pharmacovigilance • Quality Assurance promote, you can do so at this event by: • Pharmacoepidemiology • QPPV • Hosting a networking drinks reception • Pharmacogenomics • Patient Safety/ Surveillance • Taking an exhibition space at the conference • Drug/Product Safety • Signal Detection • Advertising in the delegate documentation pack • Drug Development • Outcomes Research • Providing branded bags, pens, gifts, etc. • Information and Clinical Data • Data Analysis Management If you would like more information on the range of sponsorship or exhibition possibilities for • Epidemiology • Clinical Pharmacology visiongain's 5th Annual Pharmacovigilance Conference, please contact us: • Toxicology • Clinical Safety Ronald Magali, +44 (0)20 7549 9934 • Medical Affairs • PSUR ronald.magali@visiongainglobal.com • Regulatory Affairs and • Risk Management Compliance Christopher Clegg, +44 (0)20 7549 9943 • Research & Development • Sales & Marketing christopher.clegg@visiongainglobal.com
  3. 3. Pre-Conference Interactive Workshop 5th Annual Pharmacovigilance Conference Wednesday 17th March 2010 Safety Data Exchange Agreements (SDEA) for licensed and unlicensed products Led by: Emma Boulton Lesley Deane Timings: 9:30 - 10:00 Coffee & Registration 0 Global Head of Pharmacovigilance and 10:00 - 17:00 Workshop Medical Information and Deputy EU QPPV PhV Consultancy T iming includes lunch and refreshment breaks EUSA Pharma Key Topics: About your workshop leaders: During this one day workshop we will explore the Safety Data Emma Boulton is currently the Global Head of Pharmacovigilance Exchange Agreements (SDEA) for licensed and unlicensed and Medical Information and Deputy EU QPPV at EUSA Pharma. products and how these are scrutinised by competent authority Emma has 14 years experience in various drug safety roles in both inspectors. This workshop will be an interactive and collaborative the pharma industry and CRO. forum and help you achieve a thorough understanding on the following themes: • Safety Data Exchange Agreements (SDEA) for licensed EUSA Pharma is a specialty pharmaceutical company with a and unlicensed products i.e. those provided on a named strong and growing portfolio of specialised hospital medicines patent basis focused on oncology, pain control and critical care, which it o Strategies for clear SDEA to ensure that all parties markets predominantly in Europe and the US (as the company’s know what their responsibilities are name suggests) through a network of EUSA affiliates and • Impact of acquisition and divestment of products or distributors. companies on the pharmacovigilance system For more information http://www.eusapharma.com/ o Careful management of acquisition of a company Lesley Deane set-up a pharmacovigilance consultancy company or product to ensure transition and merger into the specialising in pharmacovigilance audits and preparing companies current pharmacovigilance system for competent authority inspections in 1997. Lesley has over o Implementation of divestment of products from 20 years experience in the pharmaceutical industry, specific to the portfolio needs to ensure that all safety data is pharmacovigilance and regulatory affairs, and membership to transferred from one MAH to another PIPA, BARQA and the British Institute of Regulatory Affairs. For more information http://www.phvconsultancy.com/
  4. 4. Day 1 5th Annual Pharmacovigilance Conference Thursday 18th March 2010 09:30 Registration and refreshments 13:10 Networking lunch 14:30 Meta-analysis for safety 10:00 Opening address from the chair • Principles and regulatory guidance • Addressing pre-approval signals • Addressing post-approval signals 10:10 Evaluation of risk mitigation activities: REMS • Case examples and challenges and beyond from the pharmacoepidemiologist’s Dr Nawab Qizilbash perspective Director, OXON Epidemiology Honorary Senior Lecturer, Imperial College, London University • harmacoepidemiologist’s role in risk management & pharmacovigilance P • ummarise the increased regulatory focus on evaluation of risk mitigation S 15:10 Developing and implementing training programs strategies, contrasting the EU & US legislation on risk mitigation for global pharmacovigilance systems, bridging evaluation (i.e. FDAAA, REMS and the EU-RMP) geographies and requirements • Case examples and current challenges to implementation • hallenges in developing and implementing a global PV training program: C A case example Dr Rachel Sobel • ow does one meet diverse customer training needs in a dynamic and H Senior Director, Epidemiology - Specialty Care BU Group Head highly regulated environment? Pfizer • lended learning approaches: How to make the most of self-study, B interactive e-learning and instructor led training? 10:50 Approaching risk management through classification • olutions for global implementation: What tools can be S of adverse drug reactions used for remote training? Dr Irene Michas • dentification of those at risk of adverse drug reactions I Director, Pharmacovigilance Education and involves: knowledge of susceptibilities; availability of monitoring Process Documentation (PEPD) techniques; availability of protective techniques; the benefit: harm balance Pfizer • Adverse drug reactions can be classified by mechanism (the EIDOS system) and by clinical presentation (the DoTS system) 15:50 Afternoon refreshments • lassification of Adverse drug reactions by mechanism (the EIDOS system) C 16:10 Quantitative safety signal detection: CIOMS and by clinical presentation (the DoTS system) Working Group VIII Prof Jeffrey Aronson • verview of different quantitative methods being applied to safety O Reader in Clinical Pharmacology, University of Oxford databases to detect potential safety signals Immediate Past-President, British Pharmacological Society • ntroduction to the concept of an ‘Observation of Disproportional Reporting’ I • ntegration of quantitative methods and traditional qualitative methods I into a signal detection program, including management of information 11:30 Morning refreshments generated by a signal detection program Paul Dolin 11:50 Guidelines on risk management systems for Head medicinal products for human use European Drug Safety • U guidelines on risk management plans - completion, data aspects, E 16:50 Application of text analytics to the surveillance of different product types published literature • RiskMAPs - FDAAA guidance, new regulations, impact for the US • utline of fundamental challenges for conducting routine post-marketing O surveillance on the published literature • oW - What are the requirements and where is this heading in the rest R • xplain why the utilisation of informatics approaches such as text analytics E of the world? potentially address some of these challenges Seema Jaitly • iscuss the success of an agile internal project in delivering a system to D VP Global Medical & Scientific Affairs employ such an approach within 6 months Stiefel Laboratories, GSK • Overview on the business impact of the new system so far • ooking ahead: Future enhancements and alternative applications of L the approach 12:30 Regulatory affairs: Pharmacovigilance in Europe Jim Weatherall • egulatory affairs: Pharmacovigilance in Europe R Global Lead, Biomedical Informatics • The EUDRA vigilance system AstraZeneca • N w Horizons: Proposals from the EU Commission “Pharma Package” e 17:30 Closing remarks from the chair Paolo Biffignandi Chief Medical Officer, EU Vigilance & 17:35 Networking drinks President, TOPRA Take your discussions further and build new relationships in a relaxed and informal setting. Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2009
  5. 5. Day 2 5th Annual Pharmacovigilance Conference Friday 19th March 2009, 2009 09:30 Registration and refreshments 14:30 Pharmacovigilance in clinical trials of investigational medicinal products 10:00 Opening address from the chair • Strategy and practicalities for collection of safety data • isk management in clinical trials R 10:10 New strategy: Proactive approach towards • Use of Data Monitoring Committees (DMC) inspections • nalysis and presentation of safety data A • Inspection objectives Dr John Talbot • Graphic thinking Director - Patient Safety, Processes & Standards • isual thinking & process mapping V AstraZeneca R&D • echnical & financial aspects to set-up a visual thinking – process mapping T approach 15:10 Development Safety Update Report (DSUR): • nspection readiness program as a guide to maximize readiness I Harmonising periodic safety reporting during • uick demo of the tool Q clinical trials r Jacques Wodelet D • CIOMS VII initiative and ICH E2F - Where are we now? Head of Quality Intelligence & Consultation • DSUR content - What is new compared to Annual Safety Reports (ASRs)? Merck-Serono, Geneva • se of DSUR to identify and assess risks in clinical trial subjects - Cross- U talk with other safety regulatory documents 10:50 The contributions of the researcher to safety Pilar Carrero specification and risk management Team Leader Safety Medical Writing • houghts about how to plan safety specification T Novo Nordisk • ow can drug utilisation studies support risk management H • Reporting cycle for PSURs of registered products 15:50 Afternoon refreshments • tudies to address potential risk, identified risk and missing information S • How to monitor risk management 16:10 Pharmacovigilance in early phase oncology trials Prof Saad Shakir – A case study Director • Phase I and Phase II trials Drug Safety Research Unit • rial document development (PIS/protocols/IBs) T 11:30 Morning refreshments • ngoing safety review and involvement in critical decisions (e.g. dose O escalation) 11:50 Drug safety investigation – Pre and Post Marketing • Writing of Annual Safety Reports (ASRs) • egulatory – Requirements and strategic consideration R Ben Jefferies Pharmacovigilance Scientist • ignal generation – Case investigation, trials, spontaneous events, S Cancer Research UK databases, data mining • ignal investigation – Study designs and resources S • Comparison of methods used at different stages of drug development 16:50 Veterinary pharmacovigilance and human health Dr William C Maier • iscuss how veterinary pharmacovigilance extends to animal health, D Vice President, Epidemiology/Drug Safety/Risk Management environmental adverse effects, safety of veterinary residues in human Registrat-Mapi food and human safety • ”Human adverse reaction” following exposure to a veterinary medicine 12:30 Pharmacovigilance - Maximising the potential: • Global legislation to deal with veterinary pharmacovigilance Data is king Dr K N Woodward • Geographic and population cover of data Head - Global Pharmacovigilance Intervet, Schering-Plough Animal Health • uality of data Q • Outputs - Relative or absolute? • The right data for the right purpose 17:30 Chair’s closing remarks Dr John Parkinson Director, General Practice Research Database (GPRD) MHRA 17:40 End of conference 13:10 Networking lunch
  6. 6. Registration Form 5th Annual Pharmacovigilance Conference 17th -19th March 2010, London UK Angel For multiple bookings Pentonville Road Photocopy this form Conf. code TS 5th Annual Pharmacovilgilance Ci ty Ro Conference ad Standard Prices 17th – 19th March 2010 Conference and workshop Fee: £1699 VAT: £254.85 Total: £1953.85 Old Street Conference only Fee: £1299 VAT: £194.85 Total: £1493.85 Location: SG Conference Centre B Old Street Workshop only Fee: £599 VAT: £89.85 Total: £688.85 Address: 226-236 City Road London City Road Promotional Literature Distribution EC1V 2TT Distribution of your company’s promotional literature to all conference attendees UK Fee: £999 VAT: £149.85 Total: £1148.85 Details How to book Forename: Surname: Email: conferences@visiongainglobal.com Web: http://www.visiongain.com/pv Job Title: Company: UK Office: Tel: +44(0) 20 7336 6100 Main Switchboard Number: Fax: +44(0) 20 7549 9932 Visiongain Ltd Address: BSG House 226-236 City Road London EC1V 2QY UK Country: Postcode: General information Venue: Directions: BSG Conference Centre 226 – 236 City Road, London, EC1V 2TT. United Phone: Fax: Kingdom. Closest tube station is Old Street (Northern Line). Accommodation: Travelodge London City Road Hotel, 7-12 City Road, London, EC1Y 1AE, Tel: 0871 984 6333, Fax: 0207 628 2503, Email: http://www.travelodge.co.uk/search_and_book/hotel_overview.php?hotel_id=340 Payment terms: Visiongain require the full amount to be paid before the conference. Visiongain Signature: Ltd may refuse entry to delegates who have not paid their invoice in full. A credit card guarantee may be requested if payment has not been received in full before the event. Visiongain Ltd reserves the I confirm that I have read and agree to the terms and conditions of booking right to charge interest on unpaid invoices. Substitutions/name changes or cancellations: There is a 50% liability on all bookings once made, whether by post, fax, email or web. There is a no refund policy for cancellations received on Methods of payment or after one month before the start of the event. 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This will be charged to the to +44 (0) 20 7549 9932 customer by credit card prior to the changes being made. By Phone: Call us on +44 (0) 20 7336 6100 with your credit card details Indemnity: Visiongain Ltd reserves the right to make alterations to the conference/executive briefing content, timing, speakers or venue without notice. The event may be postponed or cancelled By Credit Card: Fill in your card details below and fax back to +44 (0) 20 7549 9932 due to unforeseen events beyond the control of visiongain Ltd. If such a situation arises, we will try to reschedule the event. However, visiongain Ltd cannot be held responsible for any cost, damage or By Bank Transfer: expenses, which may be incurred by the customer as a consequence of the event being postponed or Visiongain Ltd A/C: visiongain Ltd cancelled. We therefore strongly advise all our conference clients to take out insurance to cover the cost of the registration, travel and expenses. 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Access MasterCard Visa American Express Please allow approximately 30 days for your removal or update request to be applied to our database. Following your removal or update request, you may receive additional pieces of communication from visiongain Ltd during the transitional period, whilst the changes are coming into effect. Fee: The conference fee includes lunch, refreshments and conference papers provided on the day. Card number: This fee does not include travel, hotel accommodation, transfers or insurance, (which we strongly recommend you obtain). VAT: VAT will be charged at the local rate on each conference. Delegates may be able to recover VAT Expiry Date: incurred by contacting Eurocash Corporation plc +44 (0) 1273 325000, eurocash@eurocashvat.com. Eurocash specialise in recovering cross-border VAT. Security number (last 3 digits on back of credit card): How we will contact you: Visiongain Ltd’s preferred method of communication is by email and phone. Please ensure that you complete the registration form in full so that we can contact you. Signature: Unable to attend Cardholder’s name: Obviously nothing compares to being there but you need not miss out. Simply tick the box and send with your payment. You will receive your copy of the event CD Rom two weeks after the event. Yes, please send me a copy of the CD for Price£550 VAT:£82.50 Total:£632.50 News updates Office use only Please tick if you do not want to receive email news updates in the future www.visiongain.com/pv