2-Day Course: The New Clinical Trial Regulation - Overview & Impact (London, United Kingdom - April 11-12, 2019) - ResearchAndMarkets.com
DUBLIN--(BUSINESS WIRE)--Feb 22, 2019--The “The New Clinical Trial Regulation: Overview and Impact” conference has been added to ResearchAndMarkets.com’s offering.
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.
Why You Should Attend
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 etc.
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 now and in the future for biopharmaceutical companies, CROs and study sites.
Key Topics Covered
Who Should Attend?
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/support clinical trial personnel, and all other professionals who want to know more about this important new Regulation.
Introduction and Objectives
Background to the EU clinical research regulation in Europe
Changes in the new EU Clinical Trial Regulation
Clinical trial regulatory authorisation and ethical approval
Clinical trial transparency requirements in the EU
Investigational medicinal product/auxiliary product guidelines
Pharmacovigilance and adverse event reporting - key safety changes
Considerations for regulatory inspection - review of the delegated act
Summary and close
For more information about this conference visit https://www.researchandmarkets.com/research/2h6jt2/2day_course_the?w=4
View source version on businesswire.com:https://www.businesswire.com/news/home/20190222005339/en/
Laura Wood, Senior Press Manager
For E.S.T. Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics:Clinical Trials,Medical Law
KEYWORD: UNITED KINGDOM EUROPE
INDUSTRY KEYWORD: EDUCATION HEALTH CLINICAL TRIALS TRAINING
SOURCE: Research and Markets
Copyright Business Wire 2019.
PUB: 02/22/2019 10:46 AM/DISC: 02/22/2019 10:46 AM