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Session Chair(s)
Sabine Brosch, PHARMD, PHD, MPHARM
Data Protection Officer
European Medicines Agency, Netherlands
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
None, United Kingdom
Senior Medical Director
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