KEY SPEAKERS CONFERENCE HIGHLIGHTS. PLUS AN INTERACTIVE POST-CONFERENCE WORKSHOP Wednesday 16th March 2011, Copthorne Tara Hotel, London, UK

Transcription

1 REGISTER BY 17TH DECEMBER AND RECEIVE A 200 DISCOUNT SMi present their 2nd annual conference on... Pharmacovigilance Monday 14th & Tuesday 15th March 2011 Copthorne Tara Hotel, Central London, UK KEY SPEAKERS Peter Schiemann Global Head of Quality Risk Management, Stewart Geary Vice President, Deputy Director, Corporate Regulatory Compliance and Quality Assurance Headquarters, Eisai Mariska Kooijmans-Coutinho, Vice President Drug Safety and Risk Management, and QPPV, Biogen Idec George McCormick, Vice President, Drug Safety & Disposition, Cephalon Shelley Gandhi Unit Manager-Signal Management GroupVigilance & Risk Management of Medicines, MHRA Pharmacovigilance is now more necessary than ever. With the sharp increase in product recalls and litigation cases in recent years, the need to scrutinise a drugs activity and effect from pre- to postdevelopment has become of paramount importance. Karen Pattenden Senior Director Drug Safety & Public Health/EEA QPPV, Gilead Sciences International Michèle Sangeleer Medical Information & Pharmacovigilance Manager, Eli Lilly CONFERENCE HIGHLIGHTS Preparing for and surviving PhV inspections Risk management and internal auditing strategies Periodic safety reporting and the Development Safety Update Report (DSUR) Post-marketing surveillance activities and EudraVigilance PLUS AN INTERACTIVE POST-CONFERENCE WORKSHOP Wednesday 16th March 2011, Copthorne Tara Hotel, London, UK Optimizing Pharmacovigilance in Affiliates Hosted by Katja Kusche, Global Head of Safety Science for Mature Products, 8.30am 1.00pm Register online and receive full information on all of SMi s conferences Alternatively fax your registration to +44 (0) or call +44 (0)

2 Pharmacovigilance Day One Monday 14th March Registration and coffee 9.00 Chairman's opening remarks Peter Schiemann, Global Head of Quality Risk Management, INSPECTIONS AND AUDITING 9.10 Practical issues in Pharmacovigilance inspections Case study: A 2010 MHRA PhV inspection in Stirling, Scotland Internal and external communication Obstacles, surprises, practical recommendations Expenditure of time and costs The importance of team work Be calm and keep your sense of humour! Mechthild Waldeyer, Head Pharmacovigilance Department, medac GmbH 9.50 Quality risk management as the quality management principle What are regulators expecting from a Quality Management System? Quality Management in Pharmacovigilance - How is it done? Preparing for the challenge of risk based inspections Peter Schiemann, Global Head of Quality Risk Management, Morning coffee Managing clinical safety when manufacturing experiences significant glitches Safety monitoring of medicines Implementing an effective response action plan Case studies Mariska Kooijmans-Coutinho, Vice President Drug Safety and Risk Management, and QPPV, Biogen Idec Inspections... Are you ready? Background to inspections Pharmacovigilance inspections scope Common inspection findings Inspection preparation so you are inspection ready Personal inspection experience Survival tips from experience Karen Pattenden, Senior Director Drug Safety & Public Health/EEA QPPV, Gilead Sciences International Preparing for and surviving PV inspections The legal obligations of a QPPV Safety audits Supporting Pharmacovigilance Qualified Persons and Responsible Person Clarifying the level of appropriate training for qualified and responsible persons Mary O'Hare, Compliance Area Lead, Pharmacovigilance, Astrazeneca 1.00 Networking lunch RULES AND REGULATIONS 2.00 Periodic safety reporting during clinical development and the DSUR Purpose and rationale for periodic reporting during clinical development Current regulations for periodic reporting during clinical development The US IND Annual Report, European Annual Safety Report and Japanese 6-monthly Periodic Report During Development ICH E2F and the DSUR The challenges for preparing the DSUR Stewart Geary, Vice President, Deputy Director, Corporate Regulatory Compliance and Quality Assurance Headquarters, Eisai 2.40 Pharmacovigilance inspections involving the MHRA and FDA Keeping up with challenging new regulations to ensure compliance Effectiveky implementing new legislation Aspiring towards global harmonisation Patricia Bocciarelli, International Pharmacovigilance Expert Clinical Quality & Compliance, Sanofi-Aventis 3.20 Afternoon tea 3.50 Panel Discussion The impact of new legislation on pharmacovigilance activities and the harmonisation of new regulations An International Perspective Stewart Geary, Vice President, Deputy Director, Eisai Mariska Kooijmans-Coutinho, Vice President Drug Safety and Risk Management, and QPPV, Biogen Idec Vijay Annapareddy, Senior Pharmacovigilance Specialist, Sanofi- Aventis 4.30 Recent changes to the pharmacovigilance legislation Impact of new legislation Development safety update reports (ICH E2F) New rules on Pharmacovigilance enabling patients and health professionals to work more effectively together An increased level of transparency of safety information. Vijay Annapareddy, Senior Pharmacovigilance Specialist, Sanofi- Aventis 5.10 Chairman s closing remarks and close of day one Register online at Alte Who should attend: Delegates at our last year s Pharmacovigilance conference came from a wide range of Euro-centric locations, and represented a diverse range of current opinions regarding the current drug safety practices. Whilst stimulating debates arose amongst some of the largest international pharmaceutical organisations. Delegate Breakdown Supported by

3 11pharmacovigilance.asp Pharmacovigilance Day Two Tuesday 15th March Re-registration and coffee 9.00 Chairman's opening remarks Mariska Kooijmans-Coutinho, Vice President Drug Safety and Risk Management, and QPPV, Biogen Idec RISK MANAGEMENT AND SAFETY 9.10 Drug safety in early phase oncology trials - Case studies A non-commercial sponsor s perspective Early phase oncology trials in patients Recurring themes in case studies: - Underlying illness vs. Disease progression vs. Safety signals - Dealing with independent expert reviews (IMP quality issue with an impact on safety) Internal decision making processes and communication Catarina Macedo, Pharmacovigilance Manager, Cancer Research UK 9.50 Optimizing the clinical safety contribution to the management of manufacturing quality issues Approach for medical assessments for product complaints possibly impacting patient s safety Challenges for clinical safety Organizational structure to allow high quality medical assessments Monitoring the safety database for events which may result from product defects Barbara Donner, Global Head of Safety Science Business Support, Morning coffee Risk management What are we learning? Relationship between safety specification and risk management Developing strategies to answer relevant questions Managing the stakeholders Saad Shakir, Director, Drug Safety Research Unit (DSRU) Managing benefit/risk for mature medicines: A case study Mature products' BR can be challenged after decades on the market External researches generating new data and hypotheses Poor quality data in house: Case data from spontaneous reporting and 'historic' dossiers Lack of expertise - Need to reach out to experts in the disease area Limited awareness of the needs for continued support of these products in a development organisation Resource constraints while health authority expectations and demands are growing Katja Kusche, Global Head of Safety Science for Mature Product, Adverse event(s) reporting from a non-clinical safety perspective Relationship between safety specification and risk management What constitutes the necessity to report Adverse Events / Serious Adverse Events (SAE) / Adverse Drug Reactions (ADR) clinically Non-clinical safety assessment in support of clinical safety Traditional endpoints in non-clinical safety testing Predictability of non-clinical safety (animal safety testing) results to drug/chemical-induced safety in humans Classification of toxicities that may be expected during the course of toxicology testing Non-clinical adverse events reporting to domestic and international regulatory agencies George McCormick, Vice President, Drug Safety & Disposition, Cephalon 1.00 Networking lunch POST-MARKETING ACTIVITIES 2.00 Pharmacovigilance in promotion: Necessity or argument? The legal and deontological requirements for fair safety info in informational/promotional materials for HCPs (including timelines) The challenges of wording and presentation The role of the QPPV and the legal responsible for material review: How far do they have to go? The DDLs and risk management activities integrated in promotion The reaction of European customers (HCP, patients, etc) to safety information Michèle Sangeleer, Medical Information & Pharmacovigilance Manager, Eli Lilly 2.40 Signal detection in the UK Challenges faced by Signal Management systems The tools used for Signal data management at MHRA? Signal Evaluation and Prioritisation Is data quality important for signal generation? What are the future challenges in this area? Shelley Gandhi, Unit Manager-Signal Management GroupVigilance & Risk Management of Medicines, MHRA 3.20 Afternoon tea 3.50 Management of safety data from related research activities Registration of clinical activities in a company tracking database Minimum requirements for safety data collection Vendor contract and the program protocol/description (if applicable) will contain the applicable safety language Vendor safety training Heide Cunning, Director, Safety Operations, Ortho-Mcneil Janssen (A Johnson and Johnson Company) 4.30 Improved pharmacovigilance reporting system for effective drug safety management The benefits of an adequate IT solution to drug safety management The importance of implementing a standardised data management system Regulatory requirements Ronald Meyboom, Medical Adviser, World Health Organisation (WHO) 5.10 Chairman s closing remarks and close of conference rnatively fax your registration to +44 (0) or call +44 (0) Who should attend: Executive Directors, Vice Presidents, Directors, Heads, Managers, Team Leaders of: Patient Recruitment Pharmacovigilance Pharmacoepidemiology Pharmacogenomics Drug/Product Safety Drug Development Clinical Pharmacology Information and Clinical Data Management Clinical Safety PSUR Risk Management Research & Development Quality Assurance SPONSORSHIP AND EXHIBITION OPPORTUNITIES SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company s marketing strategy. Prime networking opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry. Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick on +44 (0) or almalick@smi-online.co.uk Want to know how you can get involved? Interested in promoting your pharmaceutical services to this market? Contact Margaret Mugema, SMi Marketing on +44 (0) , or mmugema@smi-online.co.uk

4 HALF DAY POST-CONFERENCE WORKSHOP Wednesday 16th March am 1.00pm Copthorne Tara Hotel, London, UK Optimizing Pharmacovigilance in Affiliates Hosted by Katja Kusche, Global Head of Safety Science for Mature Products at Overview of Workshop Developing and maintaining an effective system for the monitoring of clinical trial status and activities in affiliate and outsourced organisations is essential. This runs especially true when the number of affiliates and their external partners can number in the hundreds. The aim of this briefing is to address the importance of working with your affiliates in order to ensure optimal pharmacovigilance, and to ensure that processes are in place to enable an oversight by central functions and the EUQPPV. The format of the workshop will be presented as an interactive experience with ideas exchanged, and opportunities will be presented and strategies outlined for overcoming challenges faced when developing Pharmacovigilance activities. Programme will include: Facts and case studies of key Roche affiliates Why not knowing what is going on with global affiliates is a vulnerability to the company Effective risk management and mitigation Agenda 8.30 Registration and coffee 8.50 Welcome and introductions 9.00 Introduction into the topic 9.30 Presentation of the Roche initiative to optimise PV in affiliates Discussion: The interaction between global safety departments and safety affiliate organisations Morning coffee Role and responsibility of Local Safety Responsible (LSR) Exercise/brain storming session Local study activities - Ways to maintain central oversight Cross functional collaboration at the affiliate - How to link to global drug safety Local risk management activities and related assessments Wrap up with summary and questions Close of workshop For more information and updates visit the conference website at About the Workshop Leader: Katja Kusche, MD PhD is an Anaesthesiologist by training with 7 years hospital experience and 13 years in the Pharma Industry working on Drug safety. She spent her first 3 years on the affiliate level (HMR Germany), and since 2000 has worked at the Roche Global Safety Risk Management division. Katja is currently the Global Head Mature of Products in Safety Science at Hoffmann-La Roche.

5 PHARMACEUTICAL FORWARD PLANNER December /02 Cold Chain Distribution January /18 Pharmaceutical Microbiology 19/20 Pre-Filled Syringes 24/25 Paediatric Clinical Trials 26/27 Social Media for Pharmaceuticals 31/01 Biomarkers Summit February /03 Adaptive Designs in Clinical Drug Development 07/08 Pharmaceutical Parallel Trade 21/22 Advances and Progress in Drug Design 23/24 Stem Cells March /08 Imaging in Cancer Drug Development 14/15 Pharmacovigilance 16/17 Superbugs & Superdrugs 23/24 Accelerating patient recruitment & Retention in Clinical Trials 30/31 Controlled Release April /14 Asthma & COPD May /12 Generics, Supergenerics and Patent Strategies 16/17 Clinical Trial Logistics June /02 Pain Therapeutics 27/28 Nanotechnology 27/28 RNAi 29/30 Pharmaceutical Portfolio & Product Lifecycle Management 29/30 KOL Europe (Munich, Germany) July /07 BioBanking 06/07 ADMET 11/12 Freeze Drying 18/19 Clinical Trial Logistics Asia (Singapore) 20/21 Pre-Filled Syringes Asia (Singapore) All conferences take place in central London, UK unless indicated otherwise in brackets ABOUT THE SMi PHARMACEUTICAL TEAM SMi have been involved in the pharmaceutical industry since 1993 and have developed a series of informative and niche events, covering the latest issues and developments surrounding the industry. Events bring together senior industry professionals and serving companies who have a focus on being at the forefront of developments in this area. SMi aim to generate informed and topical discussion through the medium of both conferences and executive briefings. Our pharmaceutical events are research-based and content driven with regular contact with major industry personnel and cover a wide range of industry sectors. For more information, please visit

6 PHARMACOVIGILANCE Conference: Monday 14th & Tuesday 15th March 2011, Copthorne Tara Hotel, London, UK FAX your booking form to +44 (0) PHONE on +44 (0) WAYS TO REGISTER Workshop: Wednesday 16th March 2011, London POST your booking form to: Events Team, SMi Group Ltd, Great Guildford Business Square, 30 Great Guildford Street London, SE1 0HS, UK EARLY BIRD DISCOUNT Book by 17th December to receive a 200 off the conference price Unique Reference Number Our Reference LVY07 DELEGATE DETAILS Please complete fully and clearly in capital letters. Please photocopy for additional delegates. 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