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Benelux ePharma Day

Implementation of Regulation, EU 536/2014 and National adoption. What lies ahead: Impact on Clinical Trials and Stakeholders

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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

Details

The new Regulation, only less than 2 years away, 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 1st Benelux 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.

Isabelle Van der Haegen, Country Head of Clinical Operations Department at Roche in Belgium, as scientific board of the event, will lead a panel of experts to share best practices, knowledge, and experience in this field.

Prices

REGISTRATION FEE: 595,00 euro Early Bird fee until September 18th, 2017; 710,00 euro Ordinary fee (after September 18th, 2017); 540,00 euro Patronage members fee; 390,00 euro for Academy, Public Administration, Freelance. The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance.

Contact

Stefania Sarga
stefania.sarga@lsacademy.it

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