What lies ahead: Impact on Clinical Trials and Stakeholders

Tuesday, 6 June 2017 - London

Official language: English

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What lies ahead: Impact on Clinical Trials and Stakeholders

Implementation of Clinical Trial Regulation EU 536/2014 and National adoption

The new Regulation marks substantial and important changes in the processes, procedures and documentation necessary for management of clinical trials and relationships between Sponsors, Ethics Committees, Regulatory Agencies and Researchers.

The aim of the new legislation is to streamline bureaucratic aspects through a simple authorization process, involving a centralization of the procedures and the consistent involvement of all Member States.

However, what are the potential impacts on the involved parties?

The 5th UK e-Pharma day will examine implications of the new Regulation from different viewpoints with a special focus on the national adoption.

Participants will gain an understanding of both fundamental and practical considerations impacting on drug development strategies, management of clinical trials as well as corporate governance related to implementation of the new Regulation.

Omar Ali, Visiting Lecturer on Value Based Pricing University of Portsmouth & Former Adviser to NICE , Paul Fardy, VP Data Services at CROS NT and Lorna Griffin, Regulatory Consultant at RApport Strategic Services Ltd. scientific board of the event, will lead a panel of experts to share best practices, knowledge and experience in this field.

Who should attend?

Representatives of Pharmaceutical and Biotechnology companies, Clinical Research Organizations, Academic centers, Hospital Centers, and Clinical Technology companies. Especially Clinical Research Professionals, belonging to the following departments:

  • Clinical Research and Development
  • Quality Assurance
  • Regulatory
  • Pharmacovigilance
  • Clinical Operations
  • Statistics and Data Management
  • Information Technology
  • Market Access
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