2021 APEC GOOD REGISTRATION MANAGEMENT (GRM) REGULATORY SCIENCE CENTER OF EXCELLENCE WORKSHOP AUGUST 9-11, 2021 - VIRTUAL MEETING

Goal:


To promote the concept of GRM and thereby enhance mutual trust for regulatory convergence among the APEC member economies by 2020


Good Reviewer Practice Good Submission Practice
To strengthen the performance, predictability, and transparency of regulatory agencies through the implementation or enhancement of GRevP and quality measures stepwise in each interested APEC economy To enhance the quality and efficiency of the medical product registration process by improving the quality of submission as well as its management

The Objective:



To promote widespread awareness of the principles and effective implementation of Good Review Practice (GRevP) and Good Submission Practice (GSubP) for drug authorities and the pharmaceutical industry and to promote the concept and practices of effective and successful dossier preparation.


Target Audience:



• Regulators in APEC economies and ASEAN members with hands-on experience in the management of regulatory reviews.
• Industry Regulatory Affairs with hands-on experience in the management of regulatory submissions.



Program Highlights:



Theme: Best Practices for Application Review and Submission under Public Health Crises
• Day 1: self – learning lecture
• Days 2 and 3: work shop via virtual meeting at 5 pm - 8.30 pm
(GTM+7, Bangkok, Thailand.)


PARTNERS:

Asia-Pacific Economic Cooperation (APEC)
The APEC LSIF Regulatory Harmonization Steering Committee
Thailand Food and Drug Administration
Chulalongkorn University
Pharmaceutical Research & Manufacturers Association (PReMA)
Thai Pharmaceutical Manufacturers Association (TPMA)
Regulatory Affairs Pharmacy Association (Thailand) (RAPAT)
Thai Industrial Pharmacist Association (TIPA)
Thai Self Medication Industry Association (TSMIA)

Additional Information: grmthailand@fda.moph.go.th