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.
Are you new to pharmacovigilance and looking to kick-start your career? Then this online course is just for you. Gain a comprehensive overview of pharmacovigilance, regulatory requirements in the EU and implementation in only two days. Book now!
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.
Our speakers will show you strategies for a Patent Due Diligence. You will learn how a Patent Due Diligence can be conducted efficiently. You will be able to test your Patent Due Diligence skills by the means of practical exercises under the guidance of the speakers.
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.
IP Strategy! - the interactive online course which helps you setting up convincing IP strategy plans.
Would you like to plan your paediatric clinical trials strategically and conduct them efficiently in practice? Then attend this online seminar and benefit from comprehensive knowledge transfer and the practical experience of paediatric experts!
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.
