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
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 20 - 21/11/2025
Management Board Members in German Financial Institutions

Our experienced speakers will help you prepare for all the challenges facing board members in German banks. Including Fit & Proper requirements for management board members according to § 25c KWG, new BaFin circular on FAP (fit and proper) of October 22, 2025.

online 21/11/2025
Supervisory Board Members in German Financial Institutions

Our experienced speakers will help you prepare for all the challenges that supervisory boards face. Including Fit & Proper requirements for supervisory board members according to § 25c KWG, new BaFin circular on FAP (fit and proper) of October 22, 2025.

online 21/11/2025
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
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 27/11/2025
Munich Winter Course on US and EU Patent Licensing

This course provides drafting and negotiating advice for EU practitioners, with precise references to existing US law.

München 04 - 05/12/2025
Preclinical development: From bench to first in human

Preclinical drug development: The online training course for preclinical newcomers with a focus on small molecules and biologics. Learn about the fundamentals and regulatory requirements and take the opportunity to discuss the challenges in your practice with our experts and industry colleagues.

online 09 - 11/12/2025
Regulatory Affairs and CMC Conference

The conference will cover recent updates and practical implications of the EU pharmaceutical legislation, the application of AI in RA, and the new EU Variation regulation. Additionally, it will address the latest developments in quality (draft) guidelines: ICH M13a and M13B, ICH M4Q(R2), EU GMP Annex 11, New Annex 22 on AI, and an update on the ongoing discussions on nitrosamine "contaminations".

online 11/12/2025
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 19/01/2026