DIA 2013 49th Annual Meeting
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Certificate of Pharmaceutical Product (CPPs): How Can the Process for Obtaining from and Submitting to Health Authorities Be Made More Efficient? Moving from Ribbons and Wax to Electronic Solutions
Track
:
Track 08:Regulatory Affairs and Submissions
Program Code:
426
Date:
Thursday, June 27, 2013
Time:
10:45 AM to 12:15 PM
EST
Location:
253C
CHAIR
:
Fraser McKillop Stodart, (SCHNON), Senior Director, Global Regulatory Affairs, Emerging Markets, Eisai Limited, United Kingdom
SPEAKER
(S):
Lembit Rago, (SPKSUP), Coordinator for Quality Assurance and Safety for Medicines, World Health Organization (WHO), Switzerland Jalene W.W. Poh, RPh (SPKAGY), Director (Ag), Therapeutic Products Branch, Health Sciences Authority, Singapore Fergus Sweeney, PhD (SPKAGY), Head of Sector, Compliance and Inspection, European Medicines Agency, European Union, United Kingdom Marianne Vogt, MA (SPKNON), Manager, Regulatory Operations (CSCC), Abbott GmbH & Co. KG, Germany
Description
Most emerging market health authorities require a CPP when a marketing application is submitted. The process and timelines for requesting and accepting CPPs can cause significant delays in the execution of regulatory strategy, authority assessment and ultimately provision of new medicines to patients.
This session is a part of:
This session is a part of: