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'.



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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: 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
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
online 02-04/12/2026
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
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