Register now for the online course Market Approval! For more info and registration go to: https://lnkd.in/dTjPtrV3
Register now! On March 4th, 2024 we will start with the next edition of the online course Market Approval. In this 5-week interactive learning-by-doing online course, you’ll learn how to identify the relevant regulatory guidelines that will steer you through the development process using our free Market Approval Navigator tool. This course uses real-world case studies such as the development of a gene therapy product, an antibiotic and also a fictitious mRNA-based vaccine to familiarize you with common issues that can arise during product development, and you’ll learn how to assess an IMPD (Investigational Medicinal Product Dossier) using the relevant guidelines and how to set up a Target Product Profile (TPP). The course includes our educational documentary The Rise, Fall and Return of Thalidomide, with several important take home messages for current drug developers. Contributions are from spiros vamvakas (Head Scientific Advice, European Medicines Agency), Murray Lumpkin (former Director CDER, FDA), Onno van de Stolpe (former CEO Galapagos), Jerry Zeldis (former CMO Celgene), Eline Bunnik (Erasmus MC), Henk Schuring (former Vice President Head Rare Neurological Disease, Genzyme ), Bert Leufkens (former Chairman College ter Beoordeling van Geneesmiddelen), Sjaak Bot (former Vice President Regulatory Affairs, The Janssen Pharmaceutical Companies of Johnson & Johnson), mentor Ineke Jonker-Hoogerkamp and more. For more information, free demo and brochure go to https://lnkd.in/eMhGYn8h #professionaldevelopment #onlineeducation #onlinelearning #lifelonglearning #marketapproval #fda #EMA #regulatoryaffairs #pharma #biotech #medtech