2012 Biosimilars Workshop
Apr 3-5, 2012 | Seoul, Korea
- Apr 3(Tue) ~ 5(Thu)
- Grand Hilton Seoul Hotel, Korea
2012 APEC Harmonization Center Biosimilars Workshop
- [Announcement and Invitation] APEC LSIF Drug Safet... 2011-06-15
- [AHC WORKSHOP]2010 MULTI-REGIONAL CLINICAL TRIALS ... 2010-12-30
- APEC Japan 2010 Meeting Schedule 2010-12-30
- APEC Senior Officials' Meeting I (SOM1) and LSIF P... 2010-12-30
- Global Harmonization Task Force(GHTF) Meeting Nov.... 2010-12-30
- Essentials of Clinical Study Management Training Course2012-05-23
- DIA Benefit/Risk Management Training Course2012-05-24
- ICH meeting2012-06-02
- AHC WORKSHOP ON PHARMACOVIGILANCE 2012-06-12
- DIA 2012 Annual Meeting - Collaborate to Innovate2012-06-24
APEC Harmonization Center has organized ten successful international workshops since it has established, building the network among the experts in the field of pharmaceuticals and medical devices.
In 2011, four international workshops on Asia’s Role in Global Drug Development, Implementation of GHTF Documents, ICH Q8, Q9 and Q10 Guidelines and Multi-Regional Clinical Trials, respectively, drew attention of healthcare experts from all over the world.
Asia Regulatory Conference : Asia’s Role in Global Drug Development
The workshop was the first event co-sponsored and presented by the APEC Harmonization Center (AHC), Drug Information Association (DIA) and International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). The workshop has focused on to strengthen cooperation between regulatory authorities and the pharmaceutical industry, to facilitate discussion of common Asia Pacific region regulatory and technical issues and to encourage greater harmonization of regulatory requirements in the Asia Pacific region.
- dateApril 26(Tue) – 28(Thu), 2011
- venueGrand Hilton Seoul Hotel, Seoul, Korea
AHC Workshop on Medical Devices : Implementation of GHTF Documents
As the second series of the APEC Harmonization Center Workshop in 2011, the workshop provided training on implementation of GHTF documents for medical device regulators of the APEC economies. The training contained not only lectures on how to implement them but also discussion on each economy’s experiences. This workshop also supported to enhance cooperation among APEC economies’ medical device regulatory authorities.
- dateJuly 4(Mon) – 5(Tue), 2011
- venueNovotel Ambassador Gangnam Hotel,Seoul, Korea
Official Integrated Training Workshops for ICH Q8, Q9 and Q10
APEC Harmonization Center (AHC) and International Conference on Harmonization (ICH) hold a workshop on ICH Quality by Design Guidelines in Seoul, Republic of Korea on October 4-5, 2011. The workshop was hosted by Korea Food & Drug Administration (KFDA) and organized by Korea Health Industry Development Institute (KHIDI). The main purpose of the workshop was to focus on promoting accurate understanding on ICH QbD so that the economies in the region can endeavor to reach regulatory convergence in the pharmaceutical sector.
- dateOctober 4(Tue) – 5(Wed), 2011
- venueGrand Hilton Seoul Hotel, Seoul, Korea
APEC the Multi-Regional Clinical Trials (MRCT) Tokyo Workshop highlighting KOREA, CHINA and JAPAN Tripartite ymposium
The objective of this workshop was to bring together a group of stakeholders of Multi Regional Clinical Trial (MRCT) from corporate, academic and government sectors with the goal of facilitating discussion to further develop regulatory framework of MRCT in the APEC region. The content of this workshop included lecture sessions, case study session and panel discussion session which has been presented by guest lecturers from USA, Canada, EU as well as Korea, China and Japan, followed by session chairs’ report and concluding recommendations. A case study session handled clinical trials in the area of oncology taking into account the disease prevalence in the APEC region. This workshop featured deliberation on the ethnic factors to be considered when conducting MRCT. It contained a report session of China-Japan-Korea Director Generals’ meeting which has been held on October 31, 2011.
- dateNovember 1(Tue) – 2(Wed), 2011
- venueHitotsubashi Memorial Hall, Tokyo, Japan
