Back to Agenda
The New Standards for the Identification of Medicinal Products and Individual Case Safety Reporting Applied in Pharmacovigilance
Session Chair(s)
Sabine Brosch, PharmD, PhD, MPharm
Data Protection Officer
European Medicines Agency, Netherlands
The development of the international standards arising from the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use topics M5, Identification of Medicinal Products (IDMP) and E2B(R3), Data Elements for the Transmission of Individual Case Safety Reports, are close to finalization and implementation. In this session, attendees will hear about the status of the two related projects from an EMA and FDA perspective and the industry response to this work.
Learning Objective : Describe the ongoing international standardization work on ICSR and IDMP; Recognize the main new features of the ICSR AND IDMP standards and how they can be applied in practice; Prepare for the implementation of the new ICSR and IDMP standards for adaptation in pharmacovigilance systems.
Speaker(s)
FDA Perspective
Lise Stevens
Saturn Services LLC, United States
Prinicpal Owner
Industry Perspective
Konstadinos Kidos, MS
Takeda, United States
Vice President, Global Patient Safety Operations
Have an account?