White paper

MA and lifecycle management in Japan

MA and lifecycle management in Japan

Additions and differences to ICH requirements
Author: Dr. Christina Juli

This white paper describes the principles of post-approval change management protocols (PACMP) and the related guideline documents. It includes the description of the process and the impact on timelines.

Download now the white paper 'MA and lifecycle management in Japan'.



Download

White paper

MA and lifecycle management in Japan

Download

Download

Once you have completed the following fields, you can download the desired content. Alternatively, log in to your customer portal. The document will then be freely available to you.
I agree that the FORUM Institut may contact me to inform me about events and relevant content.
I can revoke my permission at any time.
1 + 7 =   

Events “

Do filter
Sort
Tiles
Lists
Your pre-meeting: Be prepared for your event

Attend one of our free pre-meetings to familiarise yourself with the Learning Space and the various ways in which you can interact during the event

online
KOL-Management

The seminar covers essential topics such as stakeholder identification, effective meeting preparation, and legally compliant collaboration. Tailored for Medical Science Liaisons (MSLs) and Medical Affairs teams, the seminar equips you to gain real insights from KOLs, overcome challenging situations, and elevate patient outcomes.

online 23/06/2025
International Medical Device Regulations

This online course offers an in-depth overview of the medical device approval process in key global markets: Regulatory strategies, approval steps and timelines for global market access, with a focus on North and South America, the Asia-Pacific region and China.

online 26-27/06/2025
Munich Licensing Summer Course

This course will outline the principles of licensing and examine every stage, from taking the decision to license, through negotiation to an in-depth analysis of an international license to what happens after the agreement has been signed.

München 01-02/07/2025
AI & IP FORUM

This topical in-person conference is about the latest developments in artificial intelligence and intellectual property. Attendees will get insights into the 'hot' topics of this super trend from top speakers from the industry and private practice.

München 08/07/2025
Artificial Intelligence in Pharmacovigilance

Join our interactive course to explore how AI is transforming pharmacovigilance. Take part in discussions, hands-on workshops, and case studies while diving into AI technologies, regulations, and their applications in drug safety. Register now to participate, share insights, and collaborate with peers!

online 10/07/2025
online 19/01/2026
GCP for ATMP

Are you involved in the planning and conduction of clinical trials with ATMP? Do you require current knowledge on the latest GCP guideline (ICH E6 (R3)) AND ATMP-specific considerations? Then join this seminar to stay informed (including training certificate)!

online 05/08/2025
GenAI Patent Munich Summer Camp

Join our one-day course and discover how to revolutionize your patent work with the power of generative AI. This immersive workshop offers patent attorneys, counsels, and engineers a unique opportunity to gain hands-on experience with generative AI.

München 28-29/08/2025
EPAC 2025

Master the logic of the EPAC exam questions through hands-on mock trials with the help of IP experts! Increase your chances for success on 9 October!

online 08/09/2025
APIs in Regulatory Affairs

Are you a specialist in the pharmaceutical industry in the area of marketing authorization and responsible for compiling the quality documentation of active pharmaceutical ingredients (APIs) and their starting material? Then this is the right online seminar for you!

online 22-23/09/2025
Toxicology and beyond: Safety assessment in drug development

During our online training "Toxicology and beyond: Safety assessment in drug development" you will build a solid toxicological know-how basis and will be informed about the inclusion of toxicological data in the marketing authorisation dossier. Take the chance and participate in our interactive online training.

online 22-23/09/2025