PHARMACOPOEIAL HARMONISATION- A NEVER ENDING STORY

Track:
Quality (including Falsified Medicines)

Day & Time:
March 6, 2:00PM - 3:30PM

Session Number:
0607

Room Number:
D203/D204

Type:
Session

Title:
PHARMACOPOEIAL HARMONISATION- A NEVER ENDING STORY

Chair(s):
Susanne Keitel, DrSc,RPh
Director
European Directorate For the Quality of Medicines & Healthcare (EDQM), France

Description:
The need to harmonise pharmacopoeial requirements in a globalised world has already been identified in the late 80s. However, the outcome of the Pharmacopoeial Discussion Group, an informal harmonisation initiative set up by three major pharmacopoeias, has yet to meet the pharmacopoeias’ and stakeholders’ expectation. The session will provide an update on industry needs, current harmonisation initiatives and the approaches taken, and will offer a platform for open discussion with the panel of speakers.

Presentation(s) & Speaker(s):
Pharmacopoeial Harmonisation – Stakeholder expectations
Neil Schwarzwalder
Quality Consultant Compendial Affairs
Eli Lilly and Company, United States

Current Global Pharmacopoeia Activities
Sabine Kopp, DrSc
Medicines Quality Assurance Programme, Quality Assurance & Safety: Medicines,
World Health Organization, Switzerland

Regional and PDG Activities
Susanne Keitel, DrSc,RPh
Director
European Directorate For the Quality of Medicines & Healthcare (EDQM), France