Pharmaceutical Regulation and Registration Procedures in Japan

THE REGULATORY AFFAIR ENVIRONMENT IN JAPAN

Understand how to successfully navigate the Japanese health authorities and bring pharmaceutical products into the Japanese market.

This course will provide:

A thorough overview and in-depth case studies on how to successfully navigate the Japanese health authorities and bring pharmaceutical products onto the Japanese market.
The do’s and don’ts of constructive interactions with Japanese colleagues and officials
The participant will become familiar with the contents of drug files, and the Japanese regulatory system, including the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labor and Welfare (MHLW).
The regulatory procedures will be discussed 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.
Understand the Japanese drug development and post-approval framework and regulatory procedure in CMC, clinical and regulatory audits.
The company will be benefited from an employee who understands the Japanese drug development, post-approval framework and regulatory procedures and a regulatory professional who can make recommendations on how to achieve project goals in the shortest possible development time
A regulatory professional who can play an important strategic role in project teams working on obtaining a marketing authorization in Japan

Introduction to Japanese market place
Culture differences and points to avoid while negotiating with Japanese customers/regulatory bodies
Introduction to the Japanese regulatory bodies
Sakigake system
Biosimilars and advance therapies trend in Japan
Strategic consultation
Clinical trial notification
Clinical studies and GCP in Japan
Japanese new drug application: submission and approval
Generic drug regulation in Japan
Introduction to JP pharmacopeia and major differences to USP/Ph. Eur.
Analytical methodology requirements in Japan
Reference standards
Reagents and Solvents

Registration Form

Course title: Pharmaceutical Regulation and Registration Procedures in Japan

Information

Live online training via Zoom;
View presenter and interact with attendees;
Certificate will be sent after completing the course;
Before attending the course, you will be sent the meeting ID, passcode and link for the course.

Registration Fee

Early Registration: $700 (Until 23 Mar 2024)

Regular Registration: $780 (Until 11 Apr 2024)

Late Registration: $900 (Until 18 Apr 2024)

$900

Per person (Tax included)

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