Regulatory Compliance Training in Japan: A Must for Pharmaceutical Professionals
In an increasingly competitive global market, understanding and complying with Japanese regulations has become a crucial aspect of bringing pharmaceutical products to this lucrative market. To help professionals navigate these complexities, a comprehensive three-day course is being offered to provide an in-depth overview of the Japanese health authorities and their regulations.
Course Overview
The course, led by senior Japanese regulatory professionals from industry, CROs, and authorities, will delve into the intricacies of Japan’s pharmaceutical regulations and procedures. Participants will gain a thorough understanding of the Japanese drug development framework, including:
- The Pharmaceuticals and Medical Devices Agency (PMDA)
- The Ministry of Health, Labor and Welfare (MHLW)
Key Topics Covered
The course will cover key topics such as:
- Regulatory procedures throughout the drug development phases
- Successfully consulting with PMDA
- Orphan drug designation in Japan
- Clinical trial notification
- Clinical studies and Good Clinical Practice (GCP) requirements
- Chemical pharmaceutical documentation requirements
- Non-clinical and clinical documentation
- Regulations for biologics and biotechnology products
- Generic drug regulation
- Pharmacovigilance
- National health insurance pricing, patent, and regulatory data protection
Who Should Attend
The course is designed to cater to both new and experienced regulatory affairs professionals who want to improve their knowledge and skills in navigating Japan’s complex regulatory landscape. This includes:
- Regulatory affairs professionals with a relevant educational background at bachelor level
- Minimum of two years of experience in regulatory affairs or equivalent qualifications
Course Benefits
Upon completion of the course, participants will gain a deeper understanding of the Japanese drug development and post-approval framework, enabling them to make informed recommendations on how to achieve project goals in the shortest possible development time. The course is part of a diploma program in Regulatory Affairs, which provides an understanding of the entire regulatory affairs platform of the medicinal lifecycle.
Enrollment
To enroll in this course, please contact us with your relevant educational background and experience in regulatory affairs or equivalent qualifications. The course is expected to be popular among regulatory affairs professionals seeking to expand their knowledge and skills in navigating Japan’s pharmaceutical regulations.