This course 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
7-8 Oct 2019
& 23-24 Apr 2020
The new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC). The new regulation was originally due to come into effect in 2016, however 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 harmonise 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.
This course 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 course will highlight the most important of these key requirements and changes and how these are likely to impact on trials for biopharmaceutical companies, CROs and study sites.
Benefits of attending:
Gain an overview of the Clinical Trial Regulation and changes for trials in the EU
Review how the new regulation differs from the previous directive
Gain an update on the implementation of the Clinical Trial Regulation Delegated Acts and other implementation documents
Understand the new clinical trial authorisation process for regulatory approval and ethical approval
This course is ideal for anyone requiring an update on the new Clinical Trial Regulation. The course is relevant for those working in regulatory, clinical research, clinical operations, project management, pharmacovigilance, quality assurance (GCP auditors), vendor/CRO professionals, study sites and other professionals in pharmaceutical and biotechnology organisations conducting trials with drugs, biologics or combination products.
It will also be of interest to those departments who liaise with/support clinical trial personnel, and all other professionals who want to know more about this important new regulation.
Background to the EU clinical research regulation in Europe
Changes in the new EU Clinical Trial Regulation
Review and discuss key EU Clinical Trial Regulation Eudralex 10 documents
Clinical trial regulatory authorisation and ethical approval
Investigational medicinal product/auxiliary product guidelines
Pharmacovigilance and adverse event reporting
Ethical considerations for clinical trials conducted with minors
Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance and regulatory requirements in clinical trials in the pharmaceutical industry. She has worked in senior positions for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality systems including data protection and data integrity in clinical trials. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on pharmaceutical regulatory issues in clinical trials