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#363: Expedited Reviews and Other Pathways to Speed Up Access to Medicines
Chair
Vice President, Global Head of Early Access & Risk Management, RWI, QuintilesIMS
Dr Stella Blackburn is currently VP, Global Head of Early Access & Risk Management at QuintilesIMS. She joined QI in April 2014 after more than 25 years working in PhV and pharmacoepi in industry and the European Medicines Agency. Stella is a Fellow of the International Society of...
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Speakers
Senior Medical Officer, European Medicines Agency, European Union
Dr. Eichler is responsible for coordinating activities between the European Medicine Agency's (EMA) scientific committees and giving advice on scientific and public health issues. Prior to joining EMA, Dr. Eichler was professor and chair of clinical pharmacology and vice-rector at...
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Director, Office of Surveillance and Epidemiology, CDER, FDA
Gerald J. Dal Pan, MD, MHS, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the...
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Associate Executive Director (for International Programs), Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tominaga is Associate Executive Director for International Programs. He supervises the overall strategy and conduct of international operations by PMDA. He joined MHLW after acquired PhD from Faculty of Pharmaceutical Sciences, the University of Tokyo. As a career official, he...
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Wednesday June 29, 2016 4:00pm - 5:15pm EDT
201B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 08: Reg Affairs,
Session
- Credit Type ACPE, CME, IACET, RN
- Audience Intermediate
- Featured Topics Value-Based Evidence, 21st Century Cures, Regulatory Harmonization-Convergence, Approval Pathways
- Interest Area Regulatory Affairs, R&D - Strategic Issues, Clinical Safety & Pharmacovigilance
- format json
- Interest Area Regulatory Affairs,R&D / Strategic Issues,Clinical Safety & Pharmacovigilance
- Featured Topics Value-Based Evidence,21st Century Cures,Regulatory Harmonization/Convergence,Approval Pathways
- Credit Type ACPE, CME, IACET, RN
- Tags Session