Summary
This three day course will provide you with a thorough overview and in-depth case studies on how to successfully navigate the Japanese health authorities to bring pharmaceutical products onto the Japanese market. You will become familiar with the contents of drug dossiers, and the Japanese regulatory system, including the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labor and Welfare (MHLW). We will discuss the regulatory procedures throughout the drug development phases and how to successfully consult with PMDA, e.g., in the clinical trial notification phase.
You will get the latest trends in Japanese pharmaceutical regulations and procedures. You will receive lectures from senior Japanese regulatory professionals from industry, CROs and authorities..
Keywords
- Japanese pharmaceutical regulation
- Japanese regulatory authorities
- PMDA
- Orphan Drug Designation (ODD) in Japan
- Clinical trial notification, clinical studies and Good Clinical Practice (GCP) in Japan
- Japanese new drug application
- Chemical pharmaceutical documentation requirements (CMC)
- Non-clinical and clinical documentation and requirements
- Regulations for biologics and biotechnology products
- Generic drug regulation in Japan
- Pharmacovigilance
- National Health Insurance (NHI) pricing
- Patent and regulatory data protection
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Course leader & lecturers
- Masami TamuraCourse leaderPresident and CEO, International and Regulatory Affairs
CoreMed - Ann Christine KorsgaardCourse leaderCEO, Regulatory Executive
Ozack ApS - Maiken Gy KongstadCourse leaderHead of Regulatory Affairs
LEO Pharma A/S - Ms. Shohko SekineLecturerDeputy Division Director, Office of Asia Training Center and International Cooperation
PMDA - Pharmaceuticals and Medical Devices Agency - Mr. Yoshiaki HattoriLecturerSenior Scientist, Research and Development Planning
CoreMed - Ms. Fumi SakaiLecturerSenior Specialist, Regulatory Affairs
CoreMed - Ms. Chiaki NakanishiLecturerSenior Specialist, CMC
CoreMed - Cheryl MadsenLecturerPresident and CEO
RPM Strategic Solutions, LLC
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Is this course for you?
Whether you are new to the field or have several years of experience, this course is relevant if you are a Regulatory Affairs Professional who wants to improve your knowledge and skills
What you will learn
- To understand the Japanese drug development and post-approval framework and regulatory procedure
- The do’s and don’ts of constructive interactions with Japanese colleagues and officials
- How to successfully navigate the PMDA consultations
- How to play an important role in any project team working on obtaining a marketing authorization in Japan
What your company will get
- An employee who understands the Japanese drug development, post-approval framework and regulatory procedures
- A regulatory professional who can make recommendations on how to achieve project goals in the shortest possible development time
- A regulatory professional who is able to successfully navigate the PMDA consultations
- A regulatory professional who can play an important strategic role in project teams working on obtaining a marketing authorization in Japan
Course calendar
DAY 1
- Japan's regulatory overview
- Review of new drugs in Japan
- Pricing and reimbursement
- How to include Japan in Global Development
- PMDA consultations
- Case Study - Success story in PMDA meeting
- Japanese new drug application
- Networking // Tapas
DAY 2
- GCP and Clinical trial notifications in Japan
- Clinical studies in Japan
- Non-clinical documentation and requirements
- CMC for J-NDA – Highlights that global RA and CMC RA need to know
- Compliance Inspection
DAY 3
- eData submission (CDISC)
- eCTD
- Labelling
- Pharmacovigilance in Japan
- Case study - Success story in JNDA
- Group work
Registration
Registration deadline5 Nov 2025
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.
Please familiarize yourself with the mandatory readings before starting the course.
The mandatory readings are also part of the examination syllabus.
Prerequisites
To enroll in this course, you must have a relevant educational background at bachelor level and, as a minimum, two years of experience in regulatory affairs, or other equivalent qualifications. We consider all applications upon registration.
If you do not fulfill the requirements, you can still apply for the course if you have experience in the pharmaceutical/biological area that would allow you to benefit from the training and enable you to participate actively during the module. Up to 10% of the positions on our course are filled by applicants who have no or limited experience in regulatory affairs. We consider applicants on a case-by-case basis.
Examination
The exam is held online, usually 4-6 weeks after the course.
You will receive a link with exam questions via your personal Atrium log-in.
In order to participate in the exam, you must have attended the course.
This course is a part of a diploma
The regulatory affairs diploma gives you an understanding of the entire regulatory affairs platform of the medicinal lifecycle. All courses have been designed in collaboration with highly acclaimed experts that are on our regulatory affairs Advisory Board.
Read moreCourse leaders
CoreMed
Ozack ApS
LEO Pharma A/S
Lecturers
PMDA - Pharmaceuticals and Medical Devices Agency
CoreMed
CoreMed
CoreMed
RPM Strategic Solutions, LLC
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Want to know more or need help?
Contact Educational Programme Leader Lone Rex at +45 20 62 11 46
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