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The APEC Harmonization Center is now receiving 2021 application form via AHC website.
In 2021, there will be an option available to hold training virtually, and the deadline for 2021 proposal for AHC’s support is October 31st, 2020.
If you would like to apply, please click the [Write] button in the right corner of the page.

Before submission, please refer to the SOP and Financial Guidance below for your reference.
As the contents will be updated periodically, please make sure to check the most recently updated version before submission.


No Title Name Secret Date State
2021 Application
7 AHC-SCH Medical Device Workshop APEC Harmonization Center Secret 2020.10.31 Virtual
6 AHC-NIDS Medical Device Vigilance Workshop APEC Harmonization Center Secret 2020.10.31 Virtual
5 AHC-KoNECT MRCT-GCP Workshop APEC Harmonization Center Secret 2020.10.31 Virtual
4 Reliance based Regulatory Decision APEC Harmonization Center Secret 2020.10.31 Virtual
3 RHSC Biopharm and Adv Thx Roundtable Dialogue on Post-Pandemic Regulatory Innovation & Convergence In partnership with AHC, PhRMA as RHSC Research-Based Industry Coalition Co-Coordinator proposes convening an “APEC LSIF RHSC Roundtable Dialogue on Post-Pandemic Regulatory Innovation & Convergence for Biopharmaceuticals and Advanced Therapies”, which: 1 builds on discussions from “Session 3: Accelerating Regulatory Convergence in the Asia Pacific in the Next Decade” of the “APEC LSIF Policy Dialogue on Developing a New Strategic Plan for Life Sciences Innovation in the Asia Pacific” 1617 September 2020 on examining whether permanent changes are necessary to regulatory systems informed by the COVID-19 pandemic; 2 helps implement new and reaffirmed 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 new and reaffirmed 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 The APEC LSIF RHSC Roundtable Dialogue on Post-Pandemic Regulatory Innovation & Convergence could focus on practices including but not limited to: 1 Evaluating how clinical trials are designed and conducted, including use of decentralized clinical trials, use of remote monitoring of clinical trials, and collection of real-world evidence in trials; 2 Application of real-world evidence RWE in regulatory review and approval processes; 3 Modernizing inspections and audits, including through risk-based approaches for determining inspection frequency and through virtual inspections and audits; 4 Streamlining document submissions, including through electronic submissions; 5 Virtualhybrid meetings between regulators and sponsors, but not depending solely on written responses; 6 New regulations around telemedicine, virtual visits, and remote monitoring; 7 Availability of post-licensing patient materials online; 8 Remote access to electronic medical records; and, 9 Changes to regulatory authority structure to support pooling reserve resources for future crises Janet Vessotskie Secret 2020.10.31 In-person
2 2nd RHSC Workshop on Facilitated Regulatory Pathways In partnership with AHC, PhRMA as RHSC Research-Based Industry Coalition Co-Coordinator and the APEC Rare Disease Network jointly propose convening the “2nd APEC LSIF RHSC Workshop on Facilitated Regulatory Pathways” FRPs, which: 1 builds on the 1st APEC Virtual Workshop on FRPs in December 2020; 2 builds on the work completed in cooperation with the Centre for Innovation in Regulatory Science CIRS to provide an objective and observational “compendium”, or landscape, of the various FRPs currently in use by APEC regulatory authorities as of December 2020; 3 recognizes FRPs continue to be an important component to the efforts the LSIF is making to accelerate regulatory convergence through RHSCAHC and to address barriers to treatment for people living with a rare disease through RDN; 4 recognizes the recent attention on FRPs as a vehicle for accelerating the development, review, and authorization of COVID-19 vaccines and treatments; 5 responds to continued interest and activity by APEC regulatory authorities in the development and use of FRPs; 6 and implements relevant provisions in the RHSC Vision 2030 and Strategic Framework, expected to be endorsed in 2021 The 2nd APEC LSIF RHSC Workshop on Facilitated Regulatory Pathways would focus on the acceptance criteria, review criteria, decision criteria, and post-authorization activities for both primary facilitated pathways also known as expedited development pathways and secondary facilitated pathways also known as reliance mechanisms, with an emphasis on innovative medicines including advanced therapies eg, gene therapies Janet Vessotskie Secret 2020.10.31 In-person
1 RHSC Med Device Roundtable Dialogue on Post-Pandemic Regulatory Innovation & Convergence In partnership with AHC, AdvaMed as RHSC Medical Device Industry Coalition Co-Coordinator proposes convening an “APEC LSIF RHSC Roundtable Dialogue on Post-Pandemic Regulatory Innovation & Convergence for Medical Devices”, which: 1 builds on discussions from “Session 3: Accelerating Regulatory Convergence in the Asia Pacific in the Next Decade” of the “APEC LSIF Policy Dialogue on Developing a New Strategic Plan for Life Sciences Innovation in the Asia Pacific” 1617 September 2020 on examining whether permanent changes are necessary to regulatory systems informed by the COVID-19 pandemic; 2 helps implement new and reaffirmed 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 new and reaffirmed 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 The “APEC LSIF RHSC Roundtable Dialogue on Post-Pandemic Regulatory Innovation & Convergence for Medical Devices” could focus on practices including but not limited to: 1 Evaluating how medical device clinical trials are designed and conducted, including use of decentralized clinical trials, use of remote monitoring of clinical trials, and collection of real-world evidence in trials; 2 Application of real-world evidence RWE in medical device regulatory review and approval; 3 Modernizing inspections and audits, including through a risk-based approaches for determining inspection frequency, b virtual inspections and audits, and c participation in the Medical Device Single Audit Program MDSAP; 4 Streamlining document submissions, including through electronic submissions; 5 Virtual or hybrid meetings between regulators and sponsors; 6 New regulations around telemedicine, virtual visits, and remote monitoring; 7 Remote access to electronic medical records; and, 8 Changes to medical device regulatory authority structure to support the pooling of resources reserved for future crises Janet Trunzo Secret 2020.10.31 In-person
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No Title Name Secret Date
2020 Application
8 Workshop on Harmonizing Regulatory Pathways for Orphan Products Prof Matthew Bellgard Secret 2019.10.31
7 RHSC-AHC Workshop on Regulatory Reliance Camille Jackson Secret 2019.10.31
6 RHSC-AHC Workshop on Expedited Pathways Camille Jackson Secret 2019.10.31
5 Pilot CoE Workshop on Total Product Life Cycle of Medical Device You Kyoung Lee Secret 2019.10.31
4 Pilot CoE Workshop on Ensuring the Quality of Raw Materials in Advanced Therapies in APEC Economies Dr Phillip Nguyen 2019.10.30
3 CoE Pilot - Medical Device Post Market Vigilance Ananda Padmanabhan Muthalagu Secret 2019.10.29
2 Public-Private Dialogue PPD on experiences and good practices in quality control tests for Biotechnological products in APEC economies Mr Luis Enrique MORENO EXEBIO 2019.10.28
1 [Sample] Regulatory Harmonization APEC Harmonization Center 2019.09.26


No Title Name Secret Date
2019 Application
8 PILOT COE WORKSHOP ON SUPPLY CHAIN SECURITY FOR MEDICAL PRODUCTS Professor PTThomas Secret 2018.10.12
7 Biopharmaceuticals Workshop Lee, Yoo-kyoung Secret 2018.10.12
6 Introduction of Medical Device PWA roadmap Hyeonho Kim Secret 2018.10.12
5 APEC - Regulatory Convergence Awareness Workshop APEC Harmonization Center AHC Secret 2018.10.12
4 CoE Pilot training : Supply Chain Intergrity Hyeyoung Choi 2018.10.12
3 CoE Pilot Workshop: Good Registration Management GRM Dr Suchart Chongprasert 2018.10.12
2 APEC Training course on Good Registration Management GRM Lahouari Belgharbi 2018.10.10
1 [Sample] Regulatory Harmonization AHC Secretariat 2018.09.10


No Title Name Secret Date
2018 Application
8 CoE Pilot - Biotherapeutics Workshop James Leong Secret 2017.09.30
7 Medical Device Workshop on Roadmap Overview and Strategic Planning Kim, Hyeonho Secret 2017.09.29
6 APEC LSIF Global Supply Chain Integrity and Security Roadmap Pre-CoE Workshop Eun Hee Kim Secret 2017.09.27
5 [CoE Pilot]Medical Device Vigilance Tai-gwon, Kim Secret 2017.09.26
4 AHC-ICH Workshop in Biopharmaceuticals to Promote Regulatory Harmonization Lee, Yoo-Kyoung Secret 2017.09.21
3 Medical Device Workshop 2018 Jared Auclair Secret 2017.09.16
2 Multi-Regional Clinical Trials MRCTs and Good Clinical Practice GCP Barbara Bierer Secret 2017.08.19
1 [Sample] Regulatory Harmonization AHC Secretariat 2017.05.25


No Title Name Secret Date
2017 Application
9 To Promote Regulatory Convergence for Medical Device Vigilance - Establishing international cooperation for management of adverse events on medical device. Chunil Lim_ncis Secret 2016.10.11
8 Bioparmaceuticals(Biosimilar) Regulatory Harmonization Yoo-Kyoung Lee Secret 2016.09.30
7 Pharmacovigilance (PV) Regulatory Harmonization Kim, Sang Hyun Secret 2016.09.30
6 APEC RHSC CoE Pilot Workshop “Introduction to the Supply Chain Roadmap” Katherine Bond, ScD Secret 2016.09.30
5 Good Registration management regulatory science center of excellence pilot workshop Yu-Hua Huang Secret 2016.09.29
4 Pharmaceutical Supply Chain Security Kennard Brown, J.D., Ph.D. Secret 2016.09.27
3 Pharmaceutical Supply Chain Security Kennard Brown Secret 2016.09.27
2 Advanced Therapeutics Jennifer Harmon Secret 2016.09.23
1 Advanced Therapeutics Jennifer Harmon 2016.09.15