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Follow on Google News | Conference on Pharmacovigilance To be held at 18th - 19th May 2009, London, UKTo be held at 18th - 19th May 2009, London, UK. In 2009 and beyond, safety concerns are becoming ever more important. This conference is about averting the descent into the catastrophe that is a post- marketing approval drug withdrawal.
By: bharatbook.com Key Speakers Dr Wytske Kingma, Senior Vice President Pharmacovigilance and Medical Information, Genzyme Dr Barry Arnold, Qualifi ed Person for Pharmacovigilance, Astrazeneca Dr Sybil Eng, Senior Director, TA Group Head, Epidemiology, Pfizer Dr Beat Widler, Global Head of Clinical Quality, Hoffmann-La Roche Dr Jan-Willem van der Velden, Senior Vice President – Global Drug Safety, International Institute for Safety of Medicines Dr William C. Maier, Head, MAPI-EPI Salvatore Curti, Senior Director and Head, Pharmacovigilance Quality Assurance, UCB Pharma Professor Dr Klaus Kümmerer, Department of Environmental Health Sciences, University Medical Center Freiburg Dr Giuseppe Alvaro, Director – Drug Safety & Pharmacovigilance, Santhera Pharmaceuticals Benoit Nauge, Senior Manager – compliance regional team, Amgen Dr Graeme Ladds, Director, Pharsafer Dr Elizabeth Ursell, Director, Verius Dr Pipasha Biswas, Director, Symogen UK Professor Dr. Saad Shakir, Director, Drug Safety Research Unit Dr Sandip Chaudhuri, Director and Safety Risk Management Lead, Pfizer Dear Colleague, In 2009 and beyond, safety concerns are becoming ever more important. This conference is about averting the descent into the catastrophe that is a post- marketing approval drug withdrawal. Visiongain brings you its 4th Annual Pharmacovigilance Conference which will arm you with the latest insights, tools and knowledge to ensure that you and your firm are up to speed with the state of the art in terms of pharmacovigilance. Understanding the latest developments in pharmacovigiance will ensure that you can implement or continue to improve your organisation- • Engage with regulatory experts on pharmacovigilance and absorb their perspectives on best practice and future trends • Have unique access to novel trends in the areas of: PV in India, pharmacoenviromentology, pharmacogenomics, and PV for rare/orphan diseases • Hear from, learn from and network with leading pharma company executives about cutting edge pharmacovigilance systems, undertaking audits and surviving and thriving as a result of PV inspections • Stay ahead of regulatory developments and improve PV and risk management strategies in a cost effective way that will actually work across your organisation • Meet leading qualifi ed people for pharmacovigilance and learn about the challenges and complexities of the role I look forward to seeing you there Yours sincerely, Who Should Attend? VP’s, Directors, Heads and Managers of: • Pharmacovigilance strategy • Drug safety/risk management • Information and clinical data management • Clinical research • Research & development and product safety/assurance assessment • Patient safety and outcomes research and data analysis • Epidemiology project management and pharmacoepidemiologists • Regulatory affairs and compliance • Pharmacovigilance/ • Sales & Marketing Pre-Conference Interactive Workshop on Pharmacovigilance Morning Session: A detailed description of pharmacovigilance systems; introduction to electronic reporting; the Risk Management Plan and the role of the EU QP PV as well as regulatory inspections Key Topics: • The advent of EU legislation requiring Companies in licence submissions to provide comprehensive information concerning how the Company conducts its pharmacovigilance means that there are added considerations to be made by Companies other than the standard Quality, Safety and Efficacy information that needs to be supplied. • The detailed description of Pharmacovigilance Systems (DDPS) is a document which must accompany licence submissions for all products (generic and innovator) and serves as an almost preliminary Inspection exercise in ensuring that the facets of drug safety are ready to be performed before the Regulators have made an appearance. Such a document is separate from the Risk Management Plan (RMP) which is product specific pharmacovigilance and must also accompany the licence submission. Overall responsibility for both of these systems rests with the EU QP PV and the role of the EU QP PV will also be discussed. • Finally, there has been a legal requirement to perform ADR reporting electronically in the EU since Nov 2005, and this aspect will also be discussed because without documentation demonstrating the Company is ready to perform ADR reporting electronically, this too may cause licence approval delay. For more information kindly visit: http://www.bharatbook.com/ End
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