Since the foundation of EMA with two principal scientific committees (CVMP / CHMP) the number of scientific committees has increased to seven as a result of major legislative initiatives within the European regulatory arena.
This tutorial will focus on the main interactions between the various human scientific committees as well as significant other bodies i.e. SAWP and CMD(h) involved in the product development life cycle. A number of case studies will be presented to illustrate these interactions and how they seek to address challenges in the evaluation of innovative medicines, and the emergence of personalised medicines.
The tutorial will also address the increasing transparency associated with the operation of the committees and to aid understanding of content released.
Who Should Attend
Regulatory Affairs Professionals, Project Team leaders/managers, Regulatory Intelligence Advisors
At the conclusion of this tutorial, participants should be able to:
· Understand the key interactions between the Scientific Committees and how they impact on company's development planning
· Understand uow personalised medicine is being tackled by the various different Committees
· Interpret publications released regarding the Committee operations e.g. agendas / minutes etc.