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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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

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AI Patent Application Drafting

Learn how to write AI patent applications which get granted and are infringed upon! This online course will give you the best practical tips to improve your skills in drafting applications for AI patents. Apply your knowledge in a practical test including feedback from our expert speakers.

online 25/04/2024
Digital Patents: Claim Drafting

Learn how to write digital patent applications which get granted and are infringed upon! This online course will give you the best practical tips to improve your skills in drafting claims for digital patents. Apply your knowledge in a practical test including feedback from our speaker, an experienced litigation expert.

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Current Medical Affairs Trends 2024

Digital Transformation in Medical Affairs

online 23/05/2024
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IP Strategist - the interactive online course which helps you setting up convincing IP strategy plans.

online 04-18/06/2024
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The IP Strategist

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IP Protection for Plant Innovation 2024

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Amsterdam, optional Online 13-14/06/2024
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 (a single day of your choice = 1.190€ plus VAT) - for booking, please contact us!

online 24-26/06/2024
Artificial Intelligence in Pharmacovigilance

Artificial intelligence is being hailed as the next key innovation. This course will show you how to integrate suitable systems and applications into your daily workflow and simplify business processes between your PV and IT departments using AI. Register now to stay ahead.

online 05/07/2024
Webcast series "Technical development of RNA-based drugs and oligonucleotides"

RNA-based drugs and oligonucleotides: gain a solid understanding of the complexities involved in the development and regulatory approval of RNA-based drugs and oligonucleotides. Meet outstanding and longtermin experienced experts in the field of research.

online 11/09/-11/12/2024
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 17-18/09/2024