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French ePharma Day

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

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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: Clinical Research and Development, Quality Assurance, Regulatory, Pharmacovigilance, Clinical Operations, Statistics and Data Management, 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 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 CaliDiabetes and Cardiovascular Medical Head, Sanofi KK 
Erick GaussensPrincipal Consultant, ProductLife Group
Bertrand SohierSenior Medical Director Global Head, Respiratory, Critical Care, Cardiovascular and endocrinology Therapeutic Areas, PAREXEL

Prices

REGISTRATION FEE: 595,00 euro Early Bird fee until 28th October 2017; 710,00 euro Ordinary fee (after 28th october 2017); 590,00 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, welcome coffee, networking lunch, coffee break, organisational office assistance, certificate of attendance.

Contact

Ilaria Butta
ilaria.butta@lsacademy.it

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