[FREE] Webinar: Clinical Trial Regulation EU 536: Regulatory & Data Strategy from Transition to Implementation Period

Clinical Trial Regulation EU 536: Regulatory and Data Strategy from Transition to Implementation Period

Wednesday, July 12th 2017
4 p.m. CET / 10 a.m. EST

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Webinar Regulatory and Data Clinical Trial Regulation EU 6

Description

Clinical Trials Directive (EU No 536) was entered into force in June 2014 and is now an EU regulation. The Clinical Trials Regulation looks to harmonize the rules on clinical trials across Member States and increase patient safety in clinical trials. While the regulation applies to the European Union, clinical trials conducted outside the EU but referred to in the marketing authorization application must follow the regulation’s principles. These new regulatory requirements will shape how Sponsors develop their clinical data strategies in order to comply with application and reporting procedures such as the EU portal for clinical data which will be accessible to the public.

This webinar will cover the following topics:

  • Overview of Clinical Trials Regulation EU No 536/2014 requirements
  • Developing a regulatory plan during the transition period
  • Regulatory considerations for applications and reporting in the EU portal (for EU members, non-EU members and SMEs)
  • Developing a clinical data strategy for Clinical Trials Regulation No 536 during the transition period: considerations for data management, biostatistics and medical writing