6th annual pharmacovigilance conference (2011)


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6th annual pharmacovigilance conference (2011)

  1. 1. 6th Annual Pharmacovigilance Examining latest developments in pharmacovigilance, drug safety and risk management to ensure safer drugs to market 16th - 17th March 2011, Thistle City Barbican, London, UK BOOK NOW! Key Speakers Dr. Doris I. Stenver, Chief Medical Officer EU Pharmacovigilance, Working Party Delegate, Danish Medicines Agency Dr. William Gregory, Senior Director, Safety & Risk Management, Pfizer Dr. Sandip Chaudhuri, Director and Safety Risk Management Lead, Pfizer Dr. Vicki Edwards, Director, European Pharmacovigilance, Abbott Laboratories Rashmi Hegde, Director Pharmacovigilance, Abbott Products Dr. Ute Hoeffner, EU QPPV, Novartis Consumer Health GmbH Dr. Julia Appelskog, Drug Safety Manager, Johnson & Johnson Sandeep Bhat, Global Director, Life Sciences and Solutions Head, Matured Markets, MphasiS an HP Dr. Sumit Munjal ,Consultant Physician - UK (Global) Pharmacovigilance, Johnson & Johnson Dr. William C Maier, Vice President, Epidemiology/Drug Safety/Risk Management, Registrat-Mapi Rishi Kiran Chopra, Senior Safety Advisor, GlaxoSmithKline Dr. Anil K Dhiri, Senior Consulting Technical Manager, Oracle Health Sciences Véronique Basch, Executive Director, Safety Europe, United Biosource Corporation Paul Murphy, Healthcare Business Manager, Gael LtdAssociate Sponsor Driving the Industry Forward | www.futurepharmaus.com Organised ByMedia Partners To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/pharmacovigilance
  2. 2. Conference Introduction 6th Annual Pharmacovigilance 16th - 17th March 2011, London, UK Dear Colleague, Associate Sponsor: rug safety has long been an issue however the concern has risen again in recent years D Need PV support? archimed is your solution! following high profile scares. In 2009, FDA reported more than 1,742 recall in comparison archimed supports you to meet the increasing demands of to 426 in 2008 and fast pace of drug recalls seems to be continuing in 2010 totalled 296 Regulatory Authorities. We have dedicated and highly motivated from January through June of this year1. specialists in different areas of the pharmacovigilance process. archimed develops ccording to peer-reviewed published studies, FDA-approved prescription drugs injure 2.2 A RMP/REMS, and performs benefit-risk assessments, medical analyses, signal detection, million and kill approximately 100,000 Americans each year and more realistic estimates put issue work-up. archimed writes EU-RMP, REMS/REMS assessment reports, DSR, ASR, the number of deaths at over 200,000 people annually in the United States alone. PSURs, summary bridging report, PSUR addendum report, safety narratives, IBs, SmPC, n the other hand pharmaceutical companies continues to face pressure to develop novel O CDS, protocol, PIP, CSR/CTR, responses to Health Authority requests. archimed’s drug drugs as the patents of many blockbuster drugs are rapidly approaching expiry with at least safety scientists/specialists work remote or on site to optimally support your team. $150bn worth of blockbuster revenues due to be lost by 20152. For further information please visit: www.archimed-communication.com isiongain’s 6th Annual Pharmacovigilance Conference is designed to bring together V exclusive panel of experts who will discuss various aspects of pharmacovigilance practices in clinical trails, risk management and drug safety. The conference will feature keynote Media Partners: addresses on reporting, auditing & inspection, technical advances for the betterment of PharmiWeb.com is the leading industry-sponsored portal for pharmacovigilance practices, live-licensing and pharmacovigilance in Europe, US and Asia. the pharmaceutical sector. Supported by most of the leading Whether your interests lie in drug safety, risk management or pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, events listings and international jobs to industry professionals across Europe pharmacovigilance, attending this conference will enable you to: and the US. • ain insight about the global pharmacovigilance landscape today and perspectives G on the future For further information please email: corporate@pharmiweb.com • Understand pharmacovigilance during the pre-approval phases BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. It is based and located in Warsaw, Poland. • Develop pharmacovigilance in clinical trials Biotechnology World was founded in 2007 to provide the world’s biotech and pharma • Explore risk management plans: are they a tool for improving drug safety? information and market to make it universally accessible and useful for scientific • Assess post marketing safety strategy and business processes. Its first step to fulfilling that mission was building the • Implement new statistical tools for monitoring the safety of marketed drugs BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in • Examine advances in inspection, reporting and auditing different channels. BIOTECHNOLOGY EUROPE offers companies completed internet • Learn signal detection methodologies to support effective safety management public relations, publication and marketing solutions. One of the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to • Make the most of inspections and best practices in maintaining constant vigilance global biotechnology, pharmaceutical and life science activities. • eview current principles and practices of regulatory pharmacovigilace in Europe and US R For further information please visit: www.biotechnology-europe.com • Improve pharmacovigilance in Asia Future Pharmaceuticals has forged powerful relationships Driving the Industry Forward | www.futurepharmaus.com • Hear about role of Live-Licensing/In-Life Testing in drug development with key industry leaders to provide a platform for successful • Evaluate role of electronic data capture in clinical trails brand recognition, and for senior decision-makers to have the means to procure and • tay ahead by learning advances in computing and electronic communications in S plan implementation strategies based on the topics covered. Positioned to be an pharmacovigilance authoritative resource within top pharma companies as well as small, specialty, and • vercome challenges in pharmacovigilance for orphan, rare indications and biosimilars O biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into • Be part of a major networking opportunity a highly targeted and responsive audience, bridging the gap between the industries’ top issues and the solutions top-tier vendors can provide. I look forward to meeting you at the conference Best regards 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. Sonia Tomar For further information please visit: www.In-Pharm.com Conference Producer Who will attend? Sponsorship and exhibition opportunities VP’s, Directors, Heads, Managers, Scientific Advisors, Consultants of: • Pharmacovigilance This event offers a unique opportunity to meet and do business with some • Pharmacoepidemiology of the key players in the pharmaceutical and biotech industries. If you have • Pharmacogenomics • Drug/Product Safety a service or product to promote, you can do so at this event by: • Drug Development • Information and Clinical Data Management • Hosting a networking drinks reception • Clinical Pharmacology • Clinical Safety • Taking an exhibition space at the conference • Periodical safety update report • Risk Management • Advertising in the delegate documentation pack • Research & Development • Quality Assurance • Providing branded bags, pens, gifts, etc. • Patient Safety • Signal Detection If you would like more information on the range of sponsorship or exhibition • Safety Surveillance • Outcomes Research possibilities for visiongains 6th Annual Pharmacovigilance Conference, please • Data Analysis contact us: • Epidemiology • Medical Affairs Ronald Magali, +44 (0)20 7549 9934 • Regulatory Affairs and Compliance • Information technology ronald.magali@visiongainglobal.com • Sales and Marketing1 Gold Sheet, a trade publication on drug quality that analyzes FDA data.2 Visiongain report: Pharmacovigilance and Other Pharma Regulatory Developments 2010-2020
  3. 3. Day 1 6th Annual Pharmacovigilance Wednesday 16th March 2011 09:00 Registration and refreshments 14:20 Benefit/Risk assessments and striking the right balance • Developing systems in harmony with regulatory developments 09:30 Opening address from the chair • aintaining constant vigilance and making the best pre and post M marketing safety judgements 09:40 The global pharmacovigilance landscape today • aking accurate determinations of whether a product is in fact safe and M and perspectives on the future what can alter the determinations T oday we have unprecedented opportunities to understand emerging Dr. Sandip Chaudhuri profiles of biopharaceutical products; early understanding keeps patient Director and Safety Risk Management Lead safety as the highest priority and at the same time facilitates access to Pfizer medicines by patients who need them. This session will provide perspectives on some of the emerging trends in global pharmacovigilance: 15:00 Afternoon Refreshments • How have ICH and CIOMS set the stage? • o more digitised data and new controlled vocabularies inform or add D 15:20 Discover the benefits of using an electronic more hay? Quality Management System (QMS) within • Are there global implications of the new EU legislation? Pharmacovigilance Dr. William Gregory T o illustrate the benefits of an electronic QMS for the Pharmacovigilance Senior Director, Safety & Risk Management sector, and to demonstrate how the effective management of your Pfizer compliance processes can turn into a business benefit. 10:20 Audit and Inspection • lectronic QMS ‘v’ Manual System - why should you migrate to an E • Making most of inspections electronic version? • Best practices in maintaining constant vigilance • nalysis & Feedback on Compliance processes - how can it help staff and A Senior Management? Dr. Vicki Edwards • Ensuring Quality is organisation wide - why and how can this happen? Director, European Pharmacovigilance • chieving and maintaining compliance with industry standards/ A Abbott Laboratories regulations - how and why an electronic QMS is more cost effective 11:00 Morning refreshments and efficient Paul Murphy 11:20 Pharmacovigilance during the pre-approval phases: Healthcare Business Manager an evolving pharmaceutical industry model Gael Ltd • Pharmacovigilance during pre clinical trails • Practical pharmacovigilance analysis strategies 15:40 Principles of signal detection • redicting the clinical relevance of drug interactions from pre-approval studies P Signals have qualitative and quantitative aspects: • Methodological aspects of quantitative signal detection 12:00 Key transition between pre and post marketing • Role and approach to qualitative signal detection safety in the EU D ifferent categories of adverse effects need different methods for detection P eri-approval transition time is key in pharmacovigilance for a smooth C urrent pharmacovigilance is predominantly based on spontaneous transition. Activities include the preparation of documents to be provided reporting and is mainly helpful in detecting together with the application, but also strong planning and preparation • ype B effects (usually unrelated to dosage, serious, unexpected T of the post marketing safety system and operations. Challenges remain and unpredictable) especially for companies performing this transition for the first time. • nusual Type A effects (related to the pharmacological effects and U The presentation will focus on: are dosage- related) • Risk Management Plan E mploy data mining techniques to analyse large volumes of adverse • Company Core Safety Information event report data • Detailed Description of the PV System Other sources of signals: • QPPV role at transition time • prescription event monitoring • Post marketing documents and activities: getting operations ready • large automated data resources Véronique Basch • patient registries Executive Director, Safety Europe • Case-control surveillance and follow-up studies United Biosource Corporation Outline of limitations of methodology and data K ey messages from the european medicines agency guideline on the uses of 12:40 Networking lunch statistical signal detection methods in the eudravigilance data analysis system 13:40 Risk management plans: are they a tool for Dr. Anila Verma Director-Drug Safety & Pharmacoepidemiology improving drug safety? Amgen • RMP for an OTC drug - a contradiction? • RMP upon request of a Health Authority – Who needs to be informed 16:20 Closing remarks from the chair • Process within the Company, departments involved and responsibilities • Evaluation and assessment of risk minimisation Dr. Ute Hoeffner EU QPPV 16:50 Networking drinks Novartis Consumer Health GmbH 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, 2011
  4. 4. Day 2 6th Annual Pharmacovigilance Thursday 17th March 201109:00 Registration and refreshments 13:40 Improving Pharmacovigilance in Asia • Current status of Asia Pacific regulations relating to Pharmacovigilance09:30 Opening address from the chair • mportant insights on rapidly evolving Pharmacovigilance regulations I in these markets • ole of Harmonisation in Asian Pharmacovigilance regulations R09:40 Strategies to improve pharmacovigilance practices • trategic challenges in the evolution of Asian Pharmacovigilance S • Societal trends with impact on pharmacovigilance regulations in next decades • New pharmacovigilance legislation Rashmi Hegde • Communication and transparency Director Pharmacovigilance, Asia-Middle East-Australia-Canada • Stakeholder involvement Abbott Products Dr. Doris I. Stenver Chief Medical Officer, EU Pharmacovigilance Working Party Delegate 14:20 Advances in computing and electronic Danish Medicines Agency communications in pharmacovigilance Configurable of the Shelf (COTs) vs Customised 10:20 Pharmacovigilance of biopharmaceuticals: • Implication of ICH E2BR3(HL7) challenges remain • Software as Service (SaaS) • The importance of pharmacovigilance of biopharmaceuticals • Electronic Health Record • Challenges to ADR processing during postmarketing and clinical trials • Signals and Data Mining • Unique aspects of safety concerns T he presentation will focus on software selection, emerging standards • To be prepared for the unexpected and importance of electronic health records for signals and data mining. Additionally, the idea of a “Clearing House” for single case management Dr. Julia Appelskog will be floated Drug Safety Manager Johnson & Johnson Dr. Anil K Dhiri Senior Consulting Technical Manager, Oracle Health Sciences GBU Consulting11:00 Morning refreshments 15:00 Afternoon refreshments11:20 Regulatory Pharmacovigilace in Europe current principles and practice 15:20 The Internet and drug safety: what are the • uropean Medicines Agency and National competent authorities - role in E implications for pharmacovigilance? European Pharmacovigilance H ow many use the internet / smart phones / Social Media (S.M), • ey responsibilities of Committee for Medicinal Products for Human Use K and how many access manufacturer information through these (CHMP) and Pharmacovigilance Working Party (PhVWP) platforms, how many are pro-digital, anti-digital or not sure) • arketing authorisation procedures – Centralised/Decentralised/Mutual- M • The social media age recognition/National • New initiatives • The pharma social media debate Dr. Sumit Munjal • The implications for pharmacovigilance Consultant Physician - UK (Global) Pharmacovigilance • The future of social media in pharma Johnson & Johnson Rishi Kiran Chopra Senior Safety Advisor 12:00 New EU Pharmacovigilance and Risk Management GlaxoSmithKline Laws in Europe: What you need to do to prepare • Imminent changes to PV and Risk Management Laws in EU – detail 16:00 Social media consideration within pharmacovigilance • Likely Impact on Pharmaceutical Companies Dr. Sandeep Bhat • hat you need to do now and in the future to thrive in the new environment W Director, Life Sciences Hewlett-Packard Dr. William C Maier Vice President, Epidemiology/Drug Safety/Risk Management Registrat-Mapi 16:40 Chair’s closing remarks12:40 Networking lunch 16:50 End of Conference
  5. 5. Registration Form 6th Annual Pharmacovigilance 16th - 17th March 2011, London, UKFor multiple bookingsPhotocopy this form Conf. code VG 6th Annual PharmacovigilanceStandard Prices 16th - 17th March 2011Conference only Fee: £1299 VAT: £259.80 Total: £1558.80 Location: Thistle City Barbican Address: Central Street, ClerkenwellPromotional Literature Distribution London EC1V 8DSDistribution of your company’s promotional literature to all conference attendees UK Fee: £999 VAT: £199.80 Total: £1198.80Details How to book Email: conferences@visiongainglobal.com Forename: Surname: Web: http://www.visiongain.com/pharmacovigilance UK Office:Job Title: Company: Tel: +44(0) 20 7336 6100 Fax: +44(0) 20 7549 9932 Main Switchboard Number: Visiongain Ltd BSG HouseAddress: 226-236 City Road London EC1V 2QY UKCountry: Postcode: General information Venue: Thistle City Barbican, Central Street, Clerkenwell, London, EC1V 8DS, Phone: 0871 376 9004 / +44 845 305 8304, Fax: 0871 376 9104 / +44 845 305 8343Phone: Fax: http://www.thistle.com/en/hotels/united_kingdom/london/thistle_city_barbican/index.html Payment terms: Visiongain require the full amount to be paid before the conference. Visiongain Email: 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 Signature: right to charge interest on unpaid invoices. Substitutions/name changes or cancellations: There is a 50% liability on all bookings once I confirm that I have read and agree to the terms and conditions of booking made, whether by post, fax, email or web. There is a no refund policy for cancellations received on or after one month before the start of the event. Should you decide to cancel after this date, the full invoice must be paid. Conference notes will then be sent to you. Unfortunately, we are unable to transfer places Methods of payment between conferences. However, if you cannot attend the conference, you may make a substitution/name change at any time, as long as we are informed in writing by email, fax or post. Name changes and Payment must be made in sterling substitutions must be from the same company or organisation and are not transferable between By Mail: Complete and return your signed registration form together with your cheque payable countries. Please note that discounted delegates places at a visiongain event are non refundable.to Visiongain Ltd and send to: visiongain Ltd, BSG House, 226-236 City Road, London, EC1V 2QY, UK Invoice alterations: There will be an administration charge of £50 for any changes to an invoice, excluding substitutions/name changes, requested by the customer. This will be charged to the By Fax: Complete and fax your signed registration form with your credit card details customer by credit card prior to the changes being made.to +44 (0) 20 7549 9932 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 Phone: Call us on +44 (0) 20 7336 6100 with your credit card details 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 Credit Card: Fill in your card details below and fax back to +44 (0) 20 7549 9932 expenses, which may be incurred by the customer as a consequence of the event being postponed or cancelled. We therefore strongly advise all our conference clients to take out insurance to cover the By Bank Transfer: cost of the registration, travel and expenses.Visiongain Ltd A/C: visiongain Ltd Data Protection: Visiongain Ltd gathers and manages data in accordance with the Data Barclays Bank Sort Code: 20-71-64 Protection Act 1988. Your personal information contained in this form may be used to update you on visiongain Ltd products and services via post, telephone, fax or email, unless you state otherwise. We Piccadilly Branch Account No: 6038 7118 may also share your data with external companies offering complementary products or services. If you 48 Regent Street Swift Code: BARC GB22 wish for your details to be amended, suppressed or not passed on to any external third party, please send your request to the Database Manager, visiongain Ltd, BSG House, 226-236 City Road, London, London, W1B 5RA IBAN: GB80 BARC 20716460387118 EC1V 2QY. Alternatively, you can visit our website at www.visiongain.com and amend your details. Please allow approximately 30 days for your removal or update request to be applied to our database. Please debit my credit card: Following your removal or update request, you may receive additional pieces of communication from Access MasterCard Visa American Express 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. This fee does not include travel, hotel accommodation, transfers or insurance, (which we strongly recommend you obtain).Card number: VAT: VAT will be charged at the local rate on each conference. Delegates may be able to recover VAT incurred by contacting Eurocash Corporation plc +44 (0) 1273 325000, eurocash@eurocashvat.com. Eurocash specialise in recovering cross-border VAT.Expiry Date: 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.Security number (last 3 digits on back of credit card): Unable to attendSignature: 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.Cardholder’s name: Yes, please send me a copy of the CD for Price£550 VAT:£110 Total:£660 Office use onlyNews updatesPlease tick if you do not want to receive email news updates in the future www.visiongain.com/pharmacovigilance