Compliance with the New EU Clinical Trial Regulation

Why Should You Attend:

The new EU Clinical Trials Regulation and will replace the European Clinical Trials Directive (2001/20/EC). The new guideline was originally due to come into effect in 2016, however the implementation has been delayed until the new portal and clinical trial database have been completed and audited.

Key aims of the new regulation are to harmonize procedures for carrying out clinical trials across the EU and to simply the clinical trial approval dossier through submission through a new clinical trial database and portal.

Guideline for enacting the new regulation are also being prepared in a number of areas including inspection, investigational medicinal product and trial documentation etc.

This webinar will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU.

Learning Objectives

• Understand the new requirements of the EU Regulation for Clinical Trials
• Consider the challenges and opportunities in implementing the new regulation and implementation guidelines
• Review the new requirements for the Sponsor
• Update on the implementation and the EU portal and database progress
• Explore the new approach for working in the EU under the regulation
• Consider changes for running trials in the EU
• Review best practice of these additional new EU Clinical Trial Regulation requirements

Areas Covered in the Webinar:

• Understand the new requirements of the EU Regulation for Clinical Trials
• Consider the challenges and opportunities in implementing the new regulation and implementation guidelines
• Review the new requirements for the Sponsor
• Update on the implementation and the EU portal and database progress
• Explore the new approach for working in the EU under the regulation
• Consider changes for running trials in the EU
• Review best practice of these additional new EU Clinical Trial Regulation requirements

Who Will Benefit:

The session is relevant for professionals working in pharmaceutical, biotechnology, CRO, regulatory authorities and study sites including investigator initiated studies involved in clinical trials. It will also be of interest to those departments who liaise/support clinical trial personnel such as:

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

Laura Brown
Independent QA and Training Consultant, Laura Brown Training and Development

Dr Laura Brown is an independent Pharmaceutical QA, Management and Training Consultant, and Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. Laura has more than 20 years' experience of Quality Assurance and managing international clinical trials including risk identification and management. She has worked for several companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has consulted with numerous pharmaceutical companies, suppliers to the pharmaceutical industry as well as academic institutions.

Dr Brown has an MBA with specialization in project management including risk management. She is also the external project management expert for a pharmaceutical e-learning MSc module in project management covering risk management, and the author of two books on project management including the leading book “Pharmaceutical Project Management” (Gower).

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