Proposal Submission

Applicant
(Person in charge) 		Name: Dr Suchart Chongprasert
Position: Director, Bureau of Drug Control
Organization: Food and Drug Administration of Thailand
Country: Thailand
E-mail: drsuchart@gmailcom
Topic CoE Pilot Workshop: Good Registration Management GRM
Proposal Content
(Describe your proposal, including potential areas of collaboration, purpose, and expected impact.) 		Overall:

1 To promote Good Review Practice GRevP and Good Submission Practice GSubP cooperatively between drug regulatory authority and applicants in order to successfully
- Help to achieve timeliness, predictability, consistency, transparency, clarity, efficiency and high quality in the content and management of the review; and
- Enhance the quality and efficiency of the medical product registration process by improving the quality and management of submission
with the ultimate goal to benefit patients with timely access of medical products of safe, efficacious, and good quality
2 To serve as a platform for promoting regulatory convergence and possible harmonization, capacity building and cooperation in the area of Good Registration Management GRM where the focus of regulatory convergence would be in science and best practices
3 To enhance a better understanding and encourage the implementation of regulatory convergence across the economies Regulatory convergence represents a voluntary process whereby the regulatory requirements across economies become more similar or “aligned” over time as a result of the gradual adoption of internationally recognized technical guidance documents, standards and scientific principles, and common or similar practices and procedures

4 To develop an effective core curriculum of GRM and its implementation workshop in both Good Review Practice GRevP for regulators and Good Submission Practice GSubP for applicants

5 To serve as a venue for building up better communication and dialogues between regulators and applicants in a medical product registration process
Expected date 2019-06-25 to 2019-06-27 (Total 3 Days)
Expected Venue (Economy) Bangkok, Kingdom of Thailand
Expected No. of Guests 80 Open
Expected Total Cost of the Event US$ 40,000
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