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.
10 + 2 =   

Events for „ICH“

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
e-Learning: Global Stability

Global Stability: This e-Learning provides a comprehensive introduction to global stability testing for pharmaceutical products (chemical and biological products). Including an update on revision of the guideline ICH Q1.

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
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 21/08/2026
GenAI Patent Munich Summer Camp

Join our two-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 25 - 26/08/2026
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 31/08/2026
Extractables & Leachables: Current CMC requirements in light of the upcoming ICH Q3E

E&L and CMC compliance: After having participated in the seminar you will be equipped to navigate the upcoming requirements confidently and proactively prepare your organisation for the implementation of ICH Q3E.

online 17/09/2026
Pharmacovigilance Signal Management

In this interactive two-day seminar, you will explore signal management best practices using PRAC case studies and learn how to effectively leverage digital tools such as EudraVigilance, programmable data analysis and AI. Complementary perspectives from both the marketing authorisation holder and the former authority provide valuable insights for your day-to-day work.

online 17 - 18/09/2026
ExpertFORUM Global Regulatory Affairs

This online conference offers compact expert talks and diverse perspectives on global regulatory strategies, digital transformation and evidence generation. Expect focused insights, practical takeaways and lively discussions with experienced speakers - and stay informed about the latest developments in global regulatory practices.

online 17 - 18/09/2026
Clinical Strategy China (NMPA)

This seminar equips medical device professionals with a clear regulatory and operational roadmap for clinical evaluation and clinical investigations under China's NMPA framework. Building on existing MDR approvals, it provides a structured approach to pathway selection, evidence gap analysis, study planning and compliant execution in the Chinese market.

online 23 - 24/09/2026
Market Access of Biosimilars in Europe

Biosimilar uptake in Europe, Aut idem in Germany - these are the challenges for regulatory affairs and market access

online 28/09/2026