|Webcasts|October 28, 2021

New EU (536/2014) Clinical Trial Regulation Set to Attract More Studies and Innovation

The way clinical trials are conducted in the European Union will undergo a major change when (EU) No 536/2014 comes into effect in January 2022. But just being compliant with the regulation should not be considered enough – forward-looking organizations are rethinking how technology can play an important part in bringing efficiencies to clinical trials, by reducing failures and driving operational changes beyond compliance.

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Event Overview:

The way clinical trials are conducted in the European Union (EU) will undergo a major change when (EU) No 536/2014 comes into effect in January 2022. This new regulation is binding across all member states.

Intrinsic to the new regulation is the simplification of procedures – with only one submission required vs. up to 31 under the old directive – which are streamlined to remove duplication and delays in launching new clinical studies, the introduction of a lighter regulatory regime for trials conducted with medicines that have already been authorized, and the simplification of reporting requirements.

But just being compliant with the regulation should not be considered enough for any forward-looking organization. The regulation provides sponsors and CROs alike with opportunity to rethink how technology plays an important part in bringing efficiencies to clinical trials, by reducing failures and driving operational changes beyond compliance.

Key Learning Objectives:

The shortcomings of the 2001/20/EC Directive and how this impacted clinical trials being conducted in EU countries.
The intended purpose of EU 536/2014, and the main changes coming into effect.
What organizations stand to gain from adopting the updated regulation, versus the compliance and other costs they’re likely to incur.
Challenges and potential impediments to the attractiveness of the EU 536/2014 for the conduct of early-phase studies.
How harmonization and standardization of submissions provides an opportunity to reduce failures and drive operational changes beyond compliance, by increasing predictability during country selection.
How technology can help both in the tracking, and reporting of submissions, and in proactive planning based on machine learning.

Who Should Attend:

Sponsor and CRO roles who are responsible for:
- Country and site identification, feasibility assessment, selection, and activation
- Clinical data management, collecting and evaluating trial metrics
- Project management of studies, process optimization, and operational excellence

Speakers

Marcy Kravet
Head, Operational Design Center
EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany

Leona Fitzgerald
Executive Director Regulatory Affairs, PPD
ACRO committee member

Patrecia Flynn-Valone
Pharmaceutical Consultant & formerly Senior Director, Clinical Development Operations
Daiichi Sankyo, Inc

Sebastian Payne
Director & Life Science Leader
Deloitte

Elvin Thalund
Director, Industry Strategy
Oracle Health Sciences

Sponsors

Oracle Health Sciences

Deloitte

Acro

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