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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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: Stability Testing in the ICH Region

This e-Learning programme will focus on stability testing for chemical and biological products in the ICH region.

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
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 28-29/08/2025
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
APIs in Regulatory Affairs

Are you a specialist in the pharmaceutical industry in the area of marketing authorisation and responsible for compiling the quality documentation of active pharmaceutical ingredients (APIs) and their starting material? Then this is the right seminar for you! Including an update on the new ICH Q1, M4Q(R2) and ASMF matters, as well as new regulatory trends including ICH Q12, reliance and AI.

online 22-23/09/2025
AMNOG and the EU HTA - Insights into the German Market

This seminar will focus on AMNOG and JCA dossier preparation as well as the German AMNOG procedure in comparison with the EU HTA procedure.

online 23/09/2025
Clinical Trial Project Management

This seminar offers beginners in clinical project management the opportunity to gain comprehensive insight into their responsibilities as clinical project managers and to acquire both specialized project management knowledge and skills in team leadership and communication.

online 07-08/10/2025
3rd Global Patent Litigation FORUM 2025

This topical in-person conference is about the latest developments in global patent litigation. Attendees will get insights into the 'hot' topics of global patent litigation from top speakers from the judiciary, industry and private practice.

München 23/10/2025
ExpertFORUM Labelling

This online conference covers EU regulatory developments, best practices for patient-centric labelling, digital transformation through ePI, and the latest innovations in labelling technology.

online 27-28/10/2025
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 06/11/2025