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
23-24 Apr 2020
& 19-20 Oct 2020
GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 13 Mar
The new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC). 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. Once the electronic portal and database are fully functional and the European Commission has given its approval, it will take six months to become applicable. Guidelines for enacting the new Regulation have also been prepared in a number of areas including inspection, investigational medicinal products 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 programme 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:
This event is ideal for anyone requiring an update on the EU Clinical Trial Regulation (536/2014). 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 Trial Regulation (536/2014)
Changes in the new EU Clinical Trial Regulation
EU Clinical Trial Regulation documents
Clinical trial regulatory authorisation and ethical approval
Investigational medicinal product/auxiliary product guidelines
Pharmacovigilance and adverse event reporting
Considerations for clinical trials conducted with minors
Considerations for regulatory inspection
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
|23-24 Apr 2020|
|23-24 Apr 2020||Rembrandt Hotel, London||GBP 1,499.00
+ VAT @ 20.00%
Until 13 Mar*
|19-20 Oct 2020|
|19-20 Oct 2020||Rembrandt Hotel, London||GBP 1,499.00
+ VAT @ 20.00%
* Note the early booking discount cannot be combined with any other offers or promotional code