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.
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
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.
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.
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.
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.
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.
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.
This online training will give you in-depth knowledge on the CMC requirements for marketing authorisation. Take the chance to participate in our virtual seminar and get qualified.
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.
