Proposal Submission

Applicant
(Person in charge) 		Name: Matthew Bellgard
Position: Chair
Organization: APEC Rare Disease Network
Country: Australia
E-mail: apecrdn@gmailcom
Topic The APEC Rare Disease Network proposes a joint AHC-RDN Workshop on Accelerating Regulatory Convergence for Orphan Medical Products Topic areas could include but are not limited to: Regulatory definitions of RD, OMP, and unmet medical need; Pre-licensing support including scientific and regulatory advice; Expeditedaccelerated development, registration, and approval pathways, including reliance; Innovative clinical trial designs, methods, and ethics approvals for small patient populations; Use of real-world evidence in the review of OMPs and in post-authorization activities; Local clinical trial waivers and use of international clinical trial data for OMPs to address small populations; Exemptions of requirements for local manufacturing, sampling, import testing, and local GMP certificates; Tax credits andor fee waivers for development activities related to RDs and OMPs; and, Establishment of a specific and enforceable market exclusivity period for OMPs
Proposal Content
(Describe your proposal, including potential areas of collaboration, purpose, and expected impact.) 		The Workshop aims to facilitate the identification and exchange of: 1 best practices for orphan medical product regulation among APEC regulatory authorities and industry; and 2 focus areas and mechanisms for cooperation in APEC to strengthen regulatory systems, build regulatory capacity, and accelerate regulatory convergence for the review and approval of orphan medical products
Expected date 2022-08-17 to 2022-08-18 (Total 2 Days)
Expected Venue (Economy) Thailand
Expected No. of Guests 40 Open
Expected Total Cost of the Event $40,000
Attach File No Attachment found.
Modify   List