Nordic ePharma Day 2016

Thursday, 21 April 2016 - Copenhagen, Park Inn by Radisson Copenhagen

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Challenges with the new European Regulation and Data Transparency

On 16 April 2014, the new Regulation EU No 536/2014 of the European Parliament on clinical trials on medicinal products for human use was adopted.

The new Regulation, better known as the “Clinical Trials Regulation”, aims to create an environment that is favorable for conducting clinical trials, with the highest standards of patient safety, for all EU Member States. Intrinsic to this is the simplification of current rules, for example:

• a streamlined application procedure via a single entry point;
• a single authorisation procedure for all clinical trials;
• the extension of the tacit agreement principle to the whole authorisation process.

Not less important the strengthened transparency for clinical trials data.

All information in the EU database submitted in the clinical trials application and during the assessment procedure shall be in principle publically accessible unless the confidentiality of the information can be justified on the basis of any of the below listed grounds:

• protection of commercially confidential information;
• protection of personal data;
• protection of confidential communication between the Member States in relation to the preparation of the assessment report.

Additionally, the Regulation obliges the sponsor to submit to the Database a summary of results and a lay person summary 1 year after the end of the trial in the EU.

In consideration of the big changes and the new requirements, Sponsors are all focusing in understanding the impacts on their good practice and clinical systems, trying to anticipate any grey areas, critical issues and risks.

Discussion is still open and not all the new processes are clearly defined.

Sponsors, Investigators, CROs, Members States and Institutions are all committed in this new challenging arena.

Scientific Board

Hanne Hvidberg, Senior Project Manager at Novo Nordisk
Rhianon Ebsworth, Senior Corporate Counsel at Novo Nordisk A/S
Fernando Martinez, PhD, MBA, Executive Director Operations at Covance

Who should attend?

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

• Clinical Research and Development

• Quality Assurance

• Pharmacovigilance

• Clinical Operations

• Statistics and Data Management

• Information Technology

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

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