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
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 09-11/12/2024
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.

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e-Learning: Managing Director

With this e-learning, you and all those who want to become managing directors of a German "GmbH" will receive the tools to recognize and minimize liability risks. Learn what you need to pay special attention to. See how you can exclude liability.

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Artificial Intelligence in Pharmacovigilance

Explore the transformative potential of artificial intelligence in pharmacovigilance. This course provides an in-depth understanding of AI technologies, regulatory requirements, and practical applications in drug safety. Through expert insights and hands-on workshops, you'll learn how to leverage AI to enhance your pharmacovigilance processes. Register now to future-proof your PV operations.

online 20/01/2025
online 10/07/2025
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 17-18/02/2025
Regulatory Compliance in Clinical Trials

Are you looking for a compact knowledge update on the regulations and guidelines in clinical drug trials to perform your daily work in a compliant and responsible manner? Then get comprehensive information in this webcast series!

online 24-25/02/2025
GMP essentials for quality management

ATTENTION: Date change - now 25-26 February 2025 - Will you be involved in the implementation and sustainable maintenance of the quality management system in your pharmaceutical company in the future? Our experts will provide you with the essential understanding of the subsystem of good manufacturing practice in this seminar. Also suitable as an update for experienced specialists.

online 25-26/02/2025
Webcast: Prior Use before The UPC, The EPO, German, Chinese And U.S. Courts

Gain strategic insights into utilising prior use rights across multiple jurisdictions in this live webcast series. Learn to assert defense rights effectively before the UPC, EPO, and national courts in Germany, China, and the US, through the analysis of diverse case studies.

online 27/02/-30/04/2025
Global Regulatory Affairs Manager

This online seminar provides a comprehensive overview of global regulatory affairs, covering strategies for setting regulatory policies, developing global regulatory dossiers, understanding HTA interfaces, enhancing global communication, and staying updated on ICH guidelines, ISO IDMP updates, and global regulatory trends.

online 10-11/03/2025
All about ATMP

The online seminar with details on development, quality, CMC, approval and market access (including an update on the upcoming EU HTA) for advanced therapy medicinal products. Qualifiy now!

online 12-13/03/2025