FORUM INSTITUT COURSE | Variations in Europe

This practical seminar is aimed at anyone involved in planning, creating or submitting variations.

February 27, 2023

| Clinical development stage, CMC, Drugs, EU, EU Local, Preclinical development stage, Procedures, Registration

Online- 17+18 April, 2023

Join ASPHALION experts Lidia Cánovas and André Mota in another edition of this course who, together with other three excellent lecturers, will share their in-depth knowledge with you and will address the variations process in Europe.

The online training course organized by @FORUM INSTITUT will cover the following topics:

· Basics, classification and submission

· Type IA notification, Type IB and Type II variations

· Grouping and worksharing

· Special notification of change

· Variation submission and management

· Quality-related variations: Changes in the production process, analytics, formulation and packaging & production

The seminar will provide you with the latest information in planning, classification and submission of variations, addressing regulatory requirements in detail, as well as classification and handling of quality-related changes.

There will be practical examples and case studies to reinforce your knowledge.

🔝 Use this link to register and benefit of a 10% discount on the course price:

https://www.forum-institut.de/seminar/23042450-variations-in-europe/17/N/0/161850/7ea0ec7

For further information, you can contact us at: info@asphalion.com

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FORUM INSTITUT COURSE | Variations in Europe

This practical seminar is aimed at anyone involved in planning, creating or submitting variations.

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FORUM INSTITUT COURSE | Variations in Europe

This practical seminar is aimed at anyone involved in planning, creating or submitting variations.

Search

Filter by category

Related news and events

siNPAIN project meeting in Barcelona | Regulatory Workshop

WEBINAR RECORDING | Reactivation of EMA Policy 0070: Introduction and key recommendations for a successful Publication

HORIZON | siNPAIN meeting in Barcelona

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