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Session 2
Session Chair(s)
Sabine Brosch, PharmD, PhD, MPharm
Data Protection Officer
European Medicines Agency, Netherlands
Session 2 will focus on the use of MedDRA to code clinical data. Following an overview of the “key principles in the ICH-endorsed MedDRA Term Selection: Points to Consider” document, the practical use of MedDRA in coding will be discussed based on various examples from both an industry and regulatory perspective. Specific questions from the audience will be addressed as part of a panel discussion.
Speaker(s)
Overview of the MedDRA Term Selection Points to Consider Document and Key Coding Principles
Judy Harrison, MD
United States
Chief Medical Officer
A Pharmaceutical Industry Perspective in Coding Clinical Trials and Post-authorisation Data
Christina Winter, MD, FFPM
Glaxosmithkline, United Kingdom
Safety Evaluation and Risk Management
A Regulator’s Perspective in Coding with MedDRA and Practical Examples
Sarah Vaughan
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Head of Vigilance Operations
Discussant
Barry Hammond
Terminologeze Ltd, United Kingdom
IDMP & Medical Coding Consultant
Gaby L. Danan, MD, PhD
GLD, France
Pharmacovigilance Expert
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