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| Program Committee |
Stephen A. Goldman
MD, FAPM, DFAPA
Managing Member, STEPHEN A. GOLDMAN CONSULTING SERVICES, LLC, Former Medical Director, MEDWATCH, US FDA, US (Conference Chairperson)
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L. Paul Starkey
MD, FAAFP
Executive Director, Medical Affairs – Americas, PRA INTERNATIONAL, US |
Brian Edwards
MB MD, MRCP
Scientific Advisor, Pharmacovigilance and Drug Safety, NDA REGULATORY SCIENCE LIMITED, UK, Former Deputy EU Qualified for Pharmacovigiliance, JANSSEN-CILAG, UK |
John McEwen
PSM, MBBS, MSc, MPS
Adjunct Associate Professor, Discipline of Pharmacy, UNIVERSITY OF CANBERRA, Australia |
HOW WILL YOU ACHIEVE OPTIMAL MEDICAL PRODUCT SAFETY?
During this conference, international and regional experts will offer strategies to overcome critical safety challenges faced in a pharmaceutical’s life cycle from premarketing clinical trials to postmarketing safety surveillance/pharmacovigilance, and application of risk management principles throughout.
You will learn about current national and international regulatory standards, state-of-the-art methods and techniques in premarketing testing and assessment, quality safety-related compliance and procedures, effective signal detection and evaluation, adverse event reporting, and the latest risk management approaches in a global medical product safety environment.
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- Review current postmarketing pharmaceutical safety reporting
requirements in the US, EU, Japan and Asia/Pacific Rim (China, India,
Singapore & Australia)
- Explain the integration of preclinical animal and human clinical pharmacology data into premarketing development, safety assessment and risk management
- Describe the ICH Development Safety Update Report E2F guidelines and implications for premaking safety reporting
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- Compare regulatory agency approaches to clinical trial safety and postmarketing pharmacovigilance inspections in US and Europe
- Recognize the relative contributions of data quality, data mining and periodic safety update reports to signal detection and evaluation
- Define current risk management approaches in a global medical product safety environment
- Summarize ongoing assessment of a medical product’s benefit/risk profile throughout its life cycle
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Why you can’t miss this event:
- Asia’s ONLY Drug Safety conference designed by former regulatory agency officials & members of industry
- Expert panel of practitioners and regulators sharing invaluable knowledge, experiences and success stories
- Comprehensive coverage of safety along the drug lifecycle, from preclinical through clinical trials to post approval and marketing
- 2 separately bookable workshops to equip you with practical safety management tools & strategies
- Over 20 hours of networking with Key Opinion Leaders, former/current Qualified Persons for Pharmacovigiliance & former/current Regulators from US, EU and Asia
PLUS! Post-Conference Workshops
23 February 2011
A: Preparing for FDA and EMEA Clinical Safety & Postmarketing
Pharmacovigilance Inspections:
Forewarned is Forearmed
B: The Basics of Medical Product Safety and
Risk Management in a Global Company:
Finding Your Way About
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