Speaker: Birka Lehmann MD
Conducting clinical trials in Europe still has its challenges. Since the first step of harmonization of requirements for clinical trials with Directive 2001/20/EC, coming into force in 2004, the need for further harmonization was discussed in respect to legislative changes which will result in a more harmonized approach by regulatory agencies for granting the clinical trial and Ethics Committees agreement. Regulation (EU) 536/2014 will set the scene for a harmonization of conditions for regulatory agencies, Ethics Committees and applicants. For the regulatory agencies and Ethics Committees a new and challenging interaction is needed, new timelines have to be respected by all involved partners and the e-handling of applications and approvals need to be taken into account. Transition periods form Directive 2001/20/EC to Regulation (EU) 536/2014 driven clinical trials are outlined.
Expected Learning Outcomes:
• Understanding the new requirements and timelines
• Learning about different approaches to receive the approval for starting the clinical trial
• Understanding the interaction between regulatory agencies, Ethic Committees national and multi-national
