Proposal Submission

Applicant
(Person in charge) 		Name: Janet Vessotskie
Position: Deputy Vice President
Organization: PhRMA
Economy: United States
E-mail: jvessotskie@phrmaorg
Topic In partnership with AHC, PhRMA as RHSC Research-Based Industry Coalition Co-Coordinator, proposes jointly convening the “2nd APEC Roundtable Dialogue on Post-Pandemic Regulatory Innovation & Convergence for Vaccines and Therapeutics”, which:
1 builds on the 1st Virtual APEC Roundtable Dialogue on Post-Pandemic Regulatory Innovation & Convergence on Vaccines and Therapeutics in November 2021;
2 helps implement commitments by the LSIF in its Statement on COVID-19 12 June 2020 to continue advancing regulatory convergence and building skilled human capacity needed to effectively and efficiently respond to future pandemics; and,
3 helps implement commitments by the APEC Ministers Responsible for Trade in its Statement on COVID-19 5 May 2020 to intensify efforts to make global supply chains more resilient and less vulnerable to shocks
4 helps implement commitments set forth by the 2021 APEC Ministerial Meeting 9 November 2021 to accelerate access to safe and effective vaccines, diagnostics, and therapeutics for COVID-19
The 2nd APEC Roundtable Dialogue on Post-Pandemic Regulatory Innovation & Convergence for Vaccines and Therapeutics could focus on key regulatory flexibilities identified in the November 2021 dialogue including but not limited to:
1 Multiple pathways in performing clinical trials, including decentralized and hybrid trials;
2 Removing local trial requirements and permitting operational flexibilities in the vaccine and therapeutics approval process by allowing waivers to trial location restrictions;
3 Enabling rolling submissions or other expedited regulatory actions in both the development and filing;
4 Permitting remote inspections;
5 Allowing multiple sites on a single license and using regulatory tools to manage post approval changes
6 Providing labelling flexibilities, including e-labelling and QR codes with no redressing and allowing for seamless language translation; and
7 Removing requirements for certificates of pharmaceutical product CPP
The 2nd APEC Roundtable Dialogue on Post-Pandemic Regulatory Innovation & Convergence would focus on fostering a discussion of how certain regulatory flexibilities imposed during the COVID-19 pandemic by APEC regulatory authorities can be maintained and harmonized
Proposal Content
 (Describe your proposal,
including potential areas of collaboration,
purpose, and expected impact.) 		The 2nd APEC Roundtable Dialogue on Post-Pandemic Regulatory Innovation & Convergence would seek to:
1 foster deeper understanding of regulatory flexibilities employed during the pandemic for vaccines and therapeutics; and,
2 identify and recommend opportunities for the LSIF and RHSC to advance regulatory cooperation and capacity building efforts related to maintain certain regulatory flexibilities post-pandemic in order to provide expedited access to vaccines and therapeutics in the APEC region, considering local context and domestic priorities
Course Running Time 2 hours
Access Period 2022-10-18 to 2022-10-20 (Total 2 Days)
Expected Participants 75 Open
Attach File No Attachment found.
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