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Session 3: New ICH E2B(R3) ICSR and MedDRA coding
Session Chair(s)
Mick Foy
Director of Delivery
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Patrick Revelle
MSSO Director
MedDRA MSSO, United States
This session will provide explanations on how to use MedDRA in the new ICH E2B (R3) format in the context of the electronic reporting of adverse reactions in the EU. The expected benefits and the impact on the pharmacovigilance business processes will be highlighted. This will be followed by a discussion MedDRA coding best practices from a regulatory perspective and will include the highlights of a survey of industry users on MedDRA coding practices.
Speaker(s)
How to use MedDRA in the new ICH ICSR E2B(R3) format
Gaby L. Danan, MD, PhD
GLD, France
Pharmacovigilance Expert
MedDRA coding best practices from a regulatory perspective
Tahira Jan
MHRA, United Kingdom
Vigilance Development Improvements Lead
Results of MedDRA Coding Practices Survey
Barry Hammond
Terminologeze Ltd, United Kingdom
IDMP & Medical Coding Consultant
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