APEC Roundtable Dialogue on Global Regulatory Convergence for Medical Devices & Accelerating Digital Health Regulatory Convergence in the Asia-Pacific From November 8(TUE) TO 10(THU),2022 COEX Conference Room 402

APEC Roundtable Dialogue on Accelerating Digital Health Regulatory Convergence

2nd APEC Roundtable Dialogue on Regulatory Convergence for Vaccines and Therapeutics

Rare Diseases & Orphan Medical Products Regulatory Convergence Workshop

USP-APEC CoE for Advanced Therapies Pilot Virtual Workshop

Public-Private Dialogue on Biotechnological Products

2nd APEC Virtual Workshop on Facilitated Regulatory Pathways

ACH-NIDS Workshop : Medical Device Vigilance

ACH-KoNECT Workshop : MRCT-GCP Inspection

ACH-SCH Medical Device Forum

APEC Roundtable Dialogue on Post-Pandemic Regulatory Innovation & Convergence

2020 AHC-SCH Medical Device CoE Pilot Training

2020 APEC Virtual Workshop on Facilitated Regulatory Pathways

2019 APEC LSIF Policy Regulatory

2019 AHC Biotherapeutics Workshop

2019 APEC CoE Pilot Training on Supply Chain Security for Medical Product

Good Registration Management (GRM) Regulatory Science CoE Pilot Workshop

2018 APEC RHSC Center of Excellence Pilot Training on MRCT-GCP

2018 AHC Global Supply Chain Integrity Training

2018 APEC Harmonization Center Medical Device Workshop

2018 AHC-NIDS Medical Device Vigilance CoE Pilot Training

2018 APEC RHSC CoE Pilot Workshop on Biotherapeutics and Biosimilars

APEC RHSC Regulatory Science CoE Pilot for Product Quality & Supply Chain

APEC CoE Pilot program for Global Medical Product Quality & Supply Chain Security

APEC RHSC CoE Pilot Workshop on Advanced Therapies

APEC Harmonization Center Pharmacovigilance Workshop

APEC Harmonization Center Medical Device Vigilance Workshop

APEC Harmonization Center Biotherapeutics Pre-CoE Training

APEC LSIF Training Program on Medical Product Integrity and Supply Chain Security

APEC Harmonization Center Pharmacovigilance Workshop

APEC Harmonization Center Medical Device Vigilance Workshop

APEC Biotherapeutics CoE Pilot (NEU)

APEC Biotherapeutics CoE Pilot (SNU)

APEC Good Registration Management Regulatory Science CoE Pilot

APEC LSIF Training Program on Medical Product Integrity and Supply Chain Security - Good Distribution Practices, Product Security, and Establishment of Global Single Point of Contact Systems

APEC Harmonization Center Biotherapeutics Workshop

APEC LSIF Training Program on Medical Product Integrity and Supply Chain Security - Detection Technologies, Internet Sales, Good Import and Export Practices, Good Manufacturing Practices, Track and Track Systems

APEC Harmonization Center Pharmacovigilance Workshop and Training Program

APEC Harmonization Center Generic Drugs workshop

APEC LSIF Joint Multi-Regional Clinical Trials (MRCTs) and Good Clinical Practice (GCP) Inspection Workshop

APEC Harmonization Center Biotherapeutics Workshop

APEC Harmonization Center - Health Sciences Authority
Cell and Tissue-based Therapeutic Products (AHC-HSA CTT) Workshop

APEC Harmonization Center - Asian Harmonization Working Party (AHC-AHWP) Joint Workshop on Medical Devices

APEC LSIF Workshop on Medical Products Safety and Public Awareness and Establishing of a “Single Point of Contact System (SPOCs)”

APEC Harmonization Center Biotherapeutics Workshop

APEC Harmonization Center Pharmacovigilance Workshop

APEC Harmonization Center Awareness Workshop

APEC Harmonization Center Biosimilars Workshop

APEC Harmonization Center / Regulatory Harmonization Steering Committee Awareness Workshop

APEC Harmonization Center Pharmacovigilance Workshop

APEC Harmonization Center - Asian Harmonization working Party (AHC-AHWP) Joint Workshop on Medical Device Combination Products

First Asia Regulatory Conference
- Asia’s Role in Global Drug Development

APEC Harmonization Center Workshop on Medical Devices:
Implementation of GHTF Documents

Official Integrated Implementation Training Workshop for ICH Q8,Q9 and Q10

Multi-Reginal Clinical Trials Tokyo Workshop highlighting Korea China apan Tripartite Symposium

APEC Harmonization Center Pharmaceutical Supply Chain Workshop

APEC Harmonization Center Multi-Regional Clinical Trials Seoul Workshop highlighting Korea-China-Japan Tripartite Symposium

APEC Harmonization Center Workshop on Medical Devices :Use of Clinical Evidence in the Medical Device Premarket Conformity Assessment Process

APEC Harmonization Center Inauguration Ceremony and APEC Harmonization Center 1^st Multi-Reginal Clinical Trials workshop in conjunction with 1^st Regulatory Harmonization Steering Committee Meeting

APEC Harmonization center Biosimilar Workshop in conjunction with BIO KOREA 2009

Korea presents a proposal for the establishment of the
APEC Harmonization Center at the APEC LSIF VI in Lima, Peru.

APEC Harmonization Center received specific endorsement by APEC leaders in their Joint Ministerial Statement by stating: “Recalling our commitment to promoting regulatory reform and harmonization, we welcomed and endorsed the establishment of the APEC LSIF Harmonization Centre in Seoul as a key step forward.” Korea presented at the ICH meeting in Brussels, on the establishment of the APEC Harmonization Center, and was supported widely by the members. ICH will support the AHC in developing program and delegating speakers

ICH Quality Guidelines Workshop in Seoul takes place in response to the requests made during the 2006 APEC LSIF IV.

Participating regulators and private sector experts during APEC LSIF IV in Vietnam recommended for the enhanced support for regulatory harmonization of good manufacturing practices to international best practices standards, especially for ICH Guidelines related to Good Manufacturing Practices.

Ministers and officials during the third APEC Life Sciences Innovation Forums recommended for APEC leaders to endorse the “capacity building for the harmonization of standards and regulatory practices for bio-medical products and services according to international best practices where the need is most pressing and obstacles are the greatest.”