The New European Union Clinical Trials Regulation: An Analysis of the Key Changes and their Implications for Future Clinical Trials

Why Should You Attend:

The new European Union ("EU") Clinical Trials Regulation was adopted on April 15, 2014. The Regulation will enter into effect at latest two years following its publication in the Official Journal of the European Union. The Regulation, which will replace the existing Clinical Trials Directive, introduces a complete overhaul of the existing regulation of clinical trials for medicinal products in the EU.

This Regulation imposes new obligations on clinical trial sponsors, including increased disclosure obligations related to trial results. However, it also introduces new opportunities, such as the possibility for trial participants to extend their informed consent to include future scientific review of the trial results.

This webinar will analyze the new obligations on trial sponsors and the new opportunities introduced by the Regulation. It will help attendees to prepare for the changes introduced by the new Regulation.

Areas Covered in the Webinar:

• New authorization procedure for clinical trials
• Extension of clinical trials to other EU Member States
• Increased disclosure obligations
• New reporting requirements
• Extending informed consent for future uses
• Indemnity and insurance
• Co-sponsorship

Who Will Benefit:

This webinar will provide guidance to those involved in the field of clinical research in the EU, particularly sponsors of clinical trials. In addition, the webinar will help regulatory compliance officers and managers in ensuring compliance with the new requirements of the clinical trials regulation.

• Sponsors and non-commercial sponsors
• Consultants
• Laboratories analyzing samples from clinical trials
• Regulatory affairs
• Clinical trial supply
• Clinical development managers and personnel
• Clinical operations
• Clinical research associates
• Clinical research archiving and document management personnel
• Quality assurance managers and auditors
• Clinical development managers and personnel
• CROs using laboratories to analyze clinical trial samples
• Project management

Instructor Profile:

Elisabethann Wright's experience in the area of European Union law has included both periods in private practice and periods working with international institutions. She focuses on European Union (EU) law relating to life sciences, with particular emphasis on pharmaceutical law, medical devices, food law, and the environment. This includes assisting clients in classification of their products, establishment of a pathway to authorization and marketing of their products in the EU (including related regulatory obligations), pharmacovigilance obligations, promotion and marketing of products, sales agreements, clinical trial agreements, adverse event reporting, product withdrawals and data privacy obligations. She also challenges national authority and EU Institution decisions concerning classification and marketing of medicinal products and medical devices. Her practice is ranked number one in the PLC, Life Science Industry Super League as well as band 1 in Chambers Global 2013. Elisabethann has been recognized as one of the five "most highly regarded individuals" worldwide under the Regulatory section of the Who's Who Legal: Life Sciences 2014 edition.

Ciara Farrell is an Associate at Hogan Lovells Brussels and is a member of the Government Regulatory/Life Sciences practice, with particular experience in European Union (EU) and national regulatory law including pharmaceutical law, medical devices, food law, and the environment. Her experience includes advising on marketing authorization procedures, promotional and marketing activities in the pharmaceutical sector, and food labelling regulatory compliance, including health and nutrition claims. Her experience also includes EU data protection law and regulation.

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