A Short Course on Regulatory Affairs with emphasis on the
UNDERSTANDING ‘SMALL MOLECULE’ GENERIC MEDICINES
This Course will be a comprehensive course that blends EU pharmaceutical legislation, legal base and official guidelines with pharmaceutical science and relatively-focused elements of clinical investigation.
Building from first principles in several disciplines, delegates will learn about many important aspects of pharmaceutical development, manufacturing and control of the dosage forms, what comparator products are acceptable and the importance of comparative impurity profiles and of key pharmacokinetic parameters.
Submissions (MAAs) for generic medicines must have a substantial Common Technical Document (CTD) Module 3 and much attention in the course will be given to the Chemistry & Pharmacy components. However, some Module 4 and 5 issues will also be addressed, with emphasis on the importance of bioequivalence study report which has to be lodged in CTD Module 5.
This course is suitable for people (likely to be from analytical, formulation, pharmaceutical development, manufacturing and regulatory/registration departments) needing to understand Abridged Applications for generic and other medicines. It will also be useful to people working with innovative products who want better to understand regulatory science and scientific writing and other skills needed for the creation of successful licensing dossiers.
The Course Leaders will be Professor Derek Calam, Dr Mike Robertson, Dr David Snodin & Paul Fleming. Please sign up for future announcements