ABOUT GRM
2019 APEC Good Registration Management (GRM)
Regulatory Science Center of Excellence Pilot Workshop
October 28-30, 2019 - Bangkok - Thailand
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
Objective:
Both APEC and ASEAN share a common goal, which is enhancing connectivity by placing emphasis on synergies between ASEAN and APEC. By sharing best practices and new methodologies for the development of capacity building projects that with the ultimate goal to benefit patients with timely access of medical products of safe, efficacious, and good quality
• To promote Good Registration Management, among ASEAN regulatory authorities and applicants
• To encourage the implementation of regulatory convergence and, possibly, harmonization across APEC and ASEAN economies
• To serve as a platform for better communication and capacity building in the area of GRM, where regulatory convergence would be in science and best practices.

Target Audience: • Regulators 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:
3-days with plenary sessions for all attendees and parallel sessions for regulators and industry based professionals.
In person training is designed with lectures, group discussions and applied case studies.
• Good Registration Management Concept including Good Reviewer Practice and Good Submission Practice
• Importance and Fundamentals of Communications between applicants and regulatory authority
• Regulatory Competency Framework for Formal Training Framework for Regulatory Professionals


Additional Information: grmthailand2019@gmail.com