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

Wednesday, May 31st, 2017 - Copenhagen

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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 Stakeholders

All professionals involved in the clinical research process are focusing their attention on the forthcoming entry into force of the new European Regulation 536/2014 on clinical trials on medicinal products for human use, scheduled for October 2018.

The new regulation demand substantial and important changes in the methods for conducting clinical trials and in the relationships between Sponsors, Ethics Committees, Regulatory Agencies and Researchers.

The Regulation 536/2014 (Clinical Trial Regulation) is more than an incremental advance on the previous legislation. This is a major revision that will take considerable adjustment in both clinical operations and in the supporting structures.

The aim of the new legislation is to streamline the bureaucratic aspects, through a simple authorization process, which provides a centralized procedure with a consistent approach in all Member States. The administrative management of clinical studies should also be easier through the use of a new EU portal.

Other important new features include low level intervention clinical trials; compensation for damage (with a proportionate approach to risk); the concept of co-sponsorship; new guidance on informed consent; eligibility of the experimental sites; guidance on trials in vulnerable populations and in emergency situations; new opportunities for more transparency and dissemination of information on clinical trials; the role of ECs; the certification for independent research and risk based monitoring.

Janet Fernihough, PhD MBA, Senior Consultant at Navitas Life Sciences, and Christina Songhurst, Director of Project Management at PPD, scientific board of the event, will lead a panel of experts in order to share best practices, knowledge and experience in this field.

Who should attend?

The conference is aimed at all Clinical Research Professionals, belonging to the following departments:

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

from Pharmaceutical and Biotechnology companies, Clinical Research Organizations, Academic Centers, Hospital Centers, and Clinical Technology companies.

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