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Compliance with EU Regulation for Clinical Trials (536/2014)
- 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
Overview of the webinar
The new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC). The new regulation is expected to be implemented in 2018. Key aims of the new regulation are to harmonize procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submission through a new clinical trial database and portal. Guidelines for enacting the new regulation are also being prepared in a number of areas including inspection, investigational medicinal product and trial documentation etc.
Who should attend?
- Clinical Development Managers and Personnel
- Clinical Research Associates
- Clinical Research Archiving and Document Management Personnel
- Quality Assurance Managers and Auditors
- Consultants
- Regulatory Affairs Specialists
- Pharmacovigilance /Drug Safety
Why should you attend?
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.
The session will highlight the most important of these key requirements and changes and how these are likely to impact on trials now and in the future for biopharmaceutical companies, CROs and study sites.
Faculty - Dr.Laura Brown
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).