The new Clinical Trial Regulation for medicinal products in the EU

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Why you should attend: 

The new Regulation EU No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, will change the procedure for assessment and approval of multinational clinical trial authorization applications. A single authorization procedure for clinical trials will be introduced that will be performed electronically via a new EU portal.

The Regulation will ensure that no matter where a clinical trial is being performed, the fundamental rules for the protection of subjects are applied. It, therefore, includes rules for clinical trials that are conducted outside the EU but referred to in a clinical trial application within the EU. For such trials, the rules call for compliance with regulatory requirements at least equivalent to those in the EU clinical trial regulation, including rules on transparency. 

It is important to know the new procedures for approval of clinical trials to avoid delays and minimize the time for approval.

Learning Objective:

In the current situation, a common protocol is proposed in all EU Member States that participate in a clinical trial but requests for amendments may result in country-specific changes that require subsequent amendments in other countries to maintain a common protocol. In the Webinar, it will be explained how in the new procedure this problem will be avoided.

The Webinar will also discuss important changes with regard to the protection of subjects and give a detailed overview of the new procedure. Detailed knowledge of the new procedure is important to anybody involved with clinical trial applications.

Additionally, the new Regulation will affect how the conduct of a clinical trial is managed after approval has been granted. New provisions for public access to an EU clinical trial database will enforce disclosure of clinical trial data and information.

The new Regulation will change the way pharmaceutical companies handle the clinical trial approval process, and companies need to start preparing for these changes now. The timelines for implementation will be discussed in this webinar to allow optimal preparation.

Areas covered in this webinar:

The streamlined application procedure via a single entry point;

An EU portal and database, for all clinical trials conducted in Europe. 

Single authorization procedure for all clinical trials

The extension of the tacit agreement principle to the whole authorization process 

Strengthened transparency for clinical trials data. 

The concept of a 'low-intervention clinical trial'

Timelines for implementation

Who will benefit?

Regulatory Affairs personnel, CRA’s/CROs, Clinical Operations Personnel, Clinical Development managers and personnel, Clinical research associates, Quality Assurance managers and auditors, Project Managers, Regulatory Authorities

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