Head of Scientific Office Austrian Medicines and Medical Devices Agency
The European Forum will explain the different platforms the European Medicines Regulatory network offers to support innovation and ways for developers of medicines to engage, illustrated on an example of an Advanced Therapeutic Medicine (ATMP). Hear from experts working at the European Medicines Agency and scientific Committee members from the Regulatory network at what point in time to come for advice, learn from the European experience with Advanced Therapies, understand the role of the various scientific committees and how they work together and what role the Rapporteurs play to bring this all together.
Explain the various European Regulatory Network platforms for sponsors to engage early in development.
Understand how ATMPs are approved in Europe, and the experience so far.
Understand the role and interplay of the various scientific committees involved in the review process.