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Qualification course: CMC-Specialist in Regulatory Affairs

With this qualification course, you can continue your education in a structured manner in all CMC topics, with a technical focus on development methods, manufacturing processes, CMC documents, change management, and much more.

online 01/01/-31/12/2025
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
Qualification Course: EU Regulatory Affairs Manager

Participants in this qualification course will receive thorough training on the main regulatory duties, from marketing authorisation applications to lifecycle management. This is the ideal preparation for starting a career in drug regulatory affairs. After course completion a certificate will be awarded.

online 26/03/-04/06/2025
Webcast series: Global regulatory requirements for drug device combination products (DDCs)

Global regulatory requirements for drug device combination products (DDCs): You will receive a regulatory overview for the EU, the US, China, MENA, Mexico and other LATAM countries, plus you will obtain tips and tricks by (local) experts on how to speed up the approval process.

online 29/04/-27/08/2025
Marketing Authorisation Documents in the EU

This seminar provides an in-depth exploration of the marketing authorisation dossier and the electronic submission process, focusing on the CTD structure and Modules 1-5. Participants will gain practical knowledge and strategies for successful drug approval applications in the EU.

online 08-09/05/2025
SPC Update

Our speaker, one of the leading SPC experts in Europe, will discuss the SPC referrals to the ECJ with you. He will put the decisions in context and will show you the consequences for national court practice and for your application practice.

online 14-15/05/2025
Generative AI Workshop for Patent Practitioners

Join our one-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.

online 20/05/2025
KOL-Management

The seminar covers essential topics such as stakeholder identification, effective meeting preparation, and legally compliant collaboration. Tailored for Medical Science Liaisons (MSLs) and Medical Affairs teams, the seminar equips you to gain real insights from KOLs, overcome challenging situations, and elevate patient outcomes.

online 20/05/2025
The UPC Case Management System for Paralegals

This course enables attendees to master the intricacies of the UPC Case Management System.

online 21-22/05/2025
How to deal with hostile SEP licensing requests

Recently, companies outside the telecommunications sector have been receiving patent notices of hostile licencing offers and, in some cases, have even been sued.This practical course aims at showing what a recipient of a FRAND licencing request should do to avoid receiving an injunction.

online 22/05/2025