The Ministry of Food and Drug Safety (MFDS) is enhancing the understanding of international standards in the domestic industry and strengthening global clinical trial capabilities through training on the latest global clinical trial guidelines.
According to the MFDS on June 22, the Global Regulatory Harmonization Center will host an online international training program (webinar) starting this month, aimed at industry, academia, and regulatory officials both domestically and internationally. The program will cover the latest clinical trial guidelines from the International Council for Harmonisation (ICH). This will be conducted over four sessions.
Established in 1990, the ICH is an international cooperative organization that leads the harmonization of standards related to the quality, safety, and efficacy of pharmaceuticals. This training is part of the MFDS's regulatory capacity-building program for domestic and international regulatory bodies and industries.
The training will address topics including the new Good Clinical Practice (GCP) guideline ICH E6(R3), the multi-regional clinical trial guideline ICH E17, adaptive clinical trial design related to ICH E20, and the latest clinical trial environments reflected in ICH E6(R3) Annex, among others.
It is essential for domestic pharmaceutical companies to accurately understand international standards when conducting global clinical trials. The ICH guidelines are recognized as global standards, and this training is expected to be easily accessible online for stakeholders both at home and abroad. Additionally, each session will focus on specific ICH guidelines, enhancing its practicality.
A representative from a domestic pharmaceutical company stated, "Global clinical trials are a crucial factor in determining the future of the Korean pharmaceutical industry. Domestic companies must understand international standards and strengthen their capabilities in conducting global clinical trials to secure competitiveness in the global market."
According to the MFDS on June 22, the Global Regulatory Harmonization Center will host an online international training program (webinar) starting this month, aimed at industry, academia, and regulatory officials both domestically and internationally. The program will cover the latest clinical trial guidelines from the International Council for Harmonisation (ICH). This will be conducted over four sessions.
Established in 1990, the ICH is an international cooperative organization that leads the harmonization of standards related to the quality, safety, and efficacy of pharmaceuticals. This training is part of the MFDS's regulatory capacity-building program for domestic and international regulatory bodies and industries.
The training will address topics including the new Good Clinical Practice (GCP) guideline ICH E6(R3), the multi-regional clinical trial guideline ICH E17, adaptive clinical trial design related to ICH E20, and the latest clinical trial environments reflected in ICH E6(R3) Annex, among others.
It is essential for domestic pharmaceutical companies to accurately understand international standards when conducting global clinical trials. The ICH guidelines are recognized as global standards, and this training is expected to be easily accessible online for stakeholders both at home and abroad. Additionally, each session will focus on specific ICH guidelines, enhancing its practicality.
A representative from a domestic pharmaceutical company stated, "Global clinical trials are a crucial factor in determining the future of the Korean pharmaceutical industry. Domestic companies must understand international standards and strengthen their capabilities in conducting global clinical trials to secure competitiveness in the global market."
* This article has been translated by AI.
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