EU Drugs Regulation From Discovery to Marketing and Beyond

The conference has been designed as an interesting blend of regulatory, chemical, biological, and clinical science to be suitable for delegates wanting to gain a broad multidisciplinary understanding of how to get a suitable candidate drug substance approved for clinical trials and for later sale and supply as a licensed medicine (drug product) in the European Union (EU). Delegates will see and better understand how to navigate EU pharmaceutical legislation impacting on clinical trials, licensing and postlicensing phases in the life cycle of modern medicines. They will also learn many of the important scientific and technical issues on which pharmaceutical, nonclinical, and clinical assessors must be reassured before approvals will be given. The learning experiences will be delivered by expert speakers with international experience and reputation. Six of the expert panel currently work or have worked within various regulatory authorities. The lectures will be supported by miniworkshops.