New Clinical Trial Regulation, EU 536/2014 and national adoptions: challenge or opportunity?

Tuesday, 28 November 2017 - Paris

Official language: French

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New Clinical Trial Regulation, EU 536/2014 and national adoptions: challenge or opportunity?

All you need to know on the changing face of clinical drug development in Europe

The new Regulation, that will come into application during 2019, 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 and harmonized authorization process, involving a centralization of the procedures and consistent involvement of all Member States.

What are the potential impacts for involved parties?

The French 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.

Speakers from regulatory Authorities, Ethics Committees, pharmaceutical industry and associations as well as representatives from CROs will be involved.

The Scientific Board here below presented, will lead a panel of prestigious experts to share best practices, knowledge, and experience in this field:

Anna Cali, Head of DCV Medical Affair, Sanofi Japan
Erick Gaussens, Executive Advisor and Chief Scientific Officer, ProductLife Group
Bertrand Sohier, Global Head, Respiratory, Critical Care, Cardiovascular and endocrinology Therapeutic Areas, PAREXEL

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:

  • Research & Development
  • Clinical Operations
  • Regulatory
  • Quality Assurance
  • Pharmacovigilance
  • Statistics and Data Management
  • Medical Affairs
  • Information Technology

Please click here to read the code of good conduct

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