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Facilitated Regulatory Pathways

 

 

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
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)