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

Wednesday, October 18th, 2017 - Amsterdam

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Official language: English

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

What lies ahead: Impact on Clinical Trials and their Stakeholders

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, Researchers and the Public.

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 the consistent involvement of all Member States.

What are the potential impacts on the different stakeholders?

The Benelux ePharma 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.

Isabelle Van der Haegen, Country Head of Clinical Operations Department at Roche in Belgium, Edel Hendrickx, CSU Country Head, Clinical Study Unit Belgium at Sanofi and Laurence Yannart, Head Regulatory Affairs & Quality Assurance (BeLux) at Boehringer Ingelheim, as 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:

• 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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