About

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

Wednesday, 3 May 2017 - Frankfurt am Main

Official language: German

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

What lies ahead: Impact on Clinical Trials and Stakeholders

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 pharmaceutical industry?

The 8th German e-Pharma day will examine implications of the new Regulation from different viewpoints with a special focus on the national adaptation.

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.

Martine Dehlinger-Kremer, Vice President, Global Medical and Regulatory Affairs, Synteract HCR and & EUCROF President, Heike Schön Managing Director, LUMIS International and Herbert Eskötter, Medical Consultant, 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