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.

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White paper

MA and lifecycle management in Japan

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Events for „ICH“

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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
e-Learning: Common Technical Document and eCTD

Do you need know how regarding CTD/eCTD & CMC? Then this e-learning programme is the fast track to becoming knowledgeable in this field. No prior dossier experience is required.

online
2nd 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 patent offices, from the industry and from private practice.

München 23/04/2026
Pharmacometrics modeling in Monolix

Pharmacometric modeling in Monolix - various (guided) hands-on units included. After having participated in the hands-on course you will be prepared to tackle real-world challenges in pharmacometrics, ultimately improving your contributions to disease modeling and drug development projects.

online 06 - 07/05/2026
CMC for Biologicals

Get your know-how on creating and maintaining quality data for biotech products in our online training. Including an outlook on the new (Draft) ICH Q1 and ICH M4Q(R2).

online 07/05/2026
CMC Management in Regulatory Affairs

This online training will give you in-depth knowledge on the CMC requirements for marketing authorisation. Including an update on the new (Draft) ICH M4Q(R2) and the Draft of the Revision of the Classification Guideline. Take the chance to participate in our virtual seminar and get qualified.

online 18 - 19/05/2026
Employee Inventions and International R&D

This online course shall provide a sound overview about different local laws in important countries in EU and beyond with respect to employee invention rights. It shall enable the participants to address complex situations when designing and negotiating agreements for cross-border R&D.

online 20 - 21/05/2026
online 26/11/2026
Biopharmaceuticals

The compact course with a content focus on the development, production and analytics of biotech drugs. Secure your place and qualify now! All three course days can be booked individually (single day = 1.290€ plus VAT) - for booking, please contact us!

online 08 - 10/06/2026
CTD - CMC handling: A guide to content and format

More than seven experts will provide you with in-depth knowledge on how to create the quality module in the registration dossier (focus on chemically defined products). These are your booking options: Day I+II (basic training): €1,990.00 (+ VAT), Day III (focus on ASMF & CEP): €1,290.00 (+ VAT), Days I-III (complete course): €2,690.00 (+ VAT)

online 17 - 19/06/2026
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 18 - 19/06/2026
AI for Pharma Storytelling & Content

This seminar shows pharma teams how to use AI to create evidence-based content and strong cross-channel brand narratives. Through practical frameworks, real use cases and hands-on exercises, participants learn how to scale content efficiently while staying fully compliant. Ideal for marketers who want to apply AI safely and effectively in daily work.

online 02/07/2026