APEC Virtual Workshop on Facilitated Regulatory Pathways (FRPs)
Tuesday, December 1st 2020, 8:30 to 11:15am (Beijing/GMT+8)
Wednesday, December 2nd 2020, 8:30 to 11:15am (Beijing/GMT+8)
Virtual from Beijing, P.R. China
Wednesday, December 2nd 2020, 8:30 to 11:15am (Beijing/GMT+8)
Virtual from Beijing, P.R. China
| Time | Topic | Speaker | |
|---|---|---|---|
| Part 1 | Tuesday, December 1st 2020, 8:30 to 11:15am (2h, 45m) | Virtual from Beijing, P.R. China | |||
| 8:15am | Virtual meeting platform opens | ||
| 8:30-8:35am (5 min) |
Welcome Remarks | Dong-hee Lee (AHC) | |
| 8:35-8:45am (10 min) |
Introduction & Setting the Scene Key points: History of APEC efforts; WHO GRP; APEC Compendium; RHSC KPIs; Keynote introduction |
John LIM (duke-NUS) |
|
| 8:45-9:20am (25 min) |
How APEC Regulatory Authorities Can Enable, Design, and Implement FRPs Key points: Globally Applicable FRPs to Improve Equitable Access to Medicines |
Lawrence LIBERTI (CIRS) | |
| 9:20-9:25am (5 min) |
Break | ||
| 9:25-10:15am (5 min intro 3x10 min talks 15 min discuss) |
Diving Deep on FRP Acceptance Criteria Key points: Identifying a “serious condition” or “unmet medical need”; consensus on “innovativeness” or societal impact; fit-for-purpose; data RAs need vs. data companies can provide |
Paris Watson (FDA) Xiaoying Zheng (HeSAY) Keith Wonnacott (Pfizer) |
|
| 10:15-11:05am (5 min intro 3x10 min talks 15 min discuss) |
Diving Deep on FRP Review Process Key points: Rolling reviews; expert committees and patients; GMP inspections based on reference authority decision & PIC/S; quality and sample analysis; stability requirements; CMC flexibility |
Worasuda Yoongthong (Thai FDA) Durhane Wong-rieger (APEC Rare Disease Network) Irene Deng (Sanofi) |
|
| 11:05-11:15am (10 min) |
Concluding Remarks | Janet Vessotskie (PhRMA) | |
| Part 2 | Wednesday, December 2nd 2020, 8:30 to 11:15am (2h, 45m) | Virtual from Beijing, P.R. China | |||
| 8:15am | Virtual meeting platform opens | ||
| 8:40-9:20am (5 min intro 2x10 min talks 15 min discuss) |
Special Session: Role of Reliance in Expedited Approvals of Innovative Products Key points: lessons from the ACCESS Consortium and ASEAN Joint Assessment Coordinating Group |
John Skerri (Department of Health, Australia) Rosilawati Ahmad (NPRA) Paul Dearde (Biogen) |
|
| 9:20-10:10am (5 min intro 3x10 min talks 15 min discuss) |
Diving Deep on FRP Decision Criteria & Post-Authorization Activities Key points: local & multi-regional clinical trials & innovative trial design; use of real-world evidence; post-approval changes/variations; more pre-market flexibility for more post-market agreements |
Yonglin Jiang (NMPA) James Leong (Duke-NUS) Janet LU (Roche) |
|
| 10:10-10:45am (5 min intro 2x10 min talks 10 min discuss) |
Preparing for the Next Public Health Emergency Key points: current regulatory approaches to facilitating treatments & vaccines for COVID-19, lessons learned & remaining questions; best practices to build regulatory agility for emergencies |
Mario Alanis (CIRS) Maria Cristina Mota (AbbVie) Nobumasa Nakashima (PMDA) |
|
| 10:45-11:10am (5 min intro 2x10 min talks 10 min discuss) |
Looking Beyond Regulatory Approval to Reimbursement Decisions and Patient Access Key points: coordinating data requirements (i.e., endpoints) & data collection across regulatory & reimbursement; named patient access as a bridge between regulatory & reimbursement for RDs |
Brian O’rourke (CADTH) Heidi WANG (BMS) Lawrence LIBERTI (CIRS) |
|
| 11:10-11:15am (5 min) |
Concluding Remarks | John LIM (Duke-NUS) |
|
