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Expert Approaches for Developing and Evaluating the Safe Use of Marketed Medical Products
Pharmacovigilance & Risk Management Strategies 2011
Preconference Tutorials: January 9
Conference: January 10-11
Renaissance Washington DC Hotel | Washington, DC
Co-located with: Risk Management and Safety Communication Strategies Training Course
Optimize your epidemiological, clinical, and pharmacological techniques and risk management strategies to create an effective organizational system, focused on developing and evaluating the safe use of marketed drug products, biologics, and medical devices.
Information & Registration | Program Agenda
FEATURED TOPICS:
- Pharmacovigilance regulatory frameworks in the US, Europe, Japan, Asia/Pacific, China, Central & South America
- Recent ICH and CIOMS multinational initiatives on drug safety update reports in clinical trial safety
- Current FDA, EMA, EU, MHLW, and ICH risk management approaches
PRECONFERENCE TUTORIALS:
- How to Prepare for a Safety Inspection
- Signal Detection, Case Assessment & Data Mining in Pharmacovigilance
- Guide to the Construction and Analysis of Periodic Update Safety Reports (PUSRs), Drug Safety Update Reports (DSURs) and Annual Safety Reports (ASRs)
- Applying MedDRA in Clinical Safety and Pharmacovigilance
- Pharmacovigilance and Risk Management Planning
PROGRAM CHAIRPERSONS:
Annette Stemhagen, DrPH, FISPE: Senior Vice President, Safety, Epidemiology, Registries
and Risk Management, United BioSource Corporation
Wenda K. Brennan, RPh: Director, Pharmacovigilance, United BioSource Corporation
SPECIAL ADVISOR:
Carol Krueger, RN, BSN: Consumer Safety Officer, Surveillance Programs Team, CDER, FDA
Tabletop Exhibit Opportunities Available:
Please contact Jeff.Korn@diahome.org for more information.
Program developed by the DIA Clinical Safety & Pharmacovigilance Special Interest Area Community
CONTACT:
Benjamin Zaitz
Phone: +1 215.293.5803
Benjamin.Zaitz@diahome.org
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