Course Overview

The way clinical trials are conducted in the European Union (EU) will undergo a major change when the Clinical Trial Regulation comes into effect on 31 January 2022. This new regulation will enhance the requirements within the previous Clinical Trial Directive with harmonised clinical trial assessments and supervision processes throughout the EU. There will be consistent rules for conducting clinical trials within the EU, increased transparency of information on clinical trial and increased efficiency with enhanced collaboration, information sharing and decision making.

While this new guidance will apply within the EU, many clinical trial programs are run globally and so we do also need to consider other global Clinical Trial requirements namely the FDA requirements and where these may differ to the EU. In addition, post authorisation GVP provides specific guidance on the management of Post Authorisation Safety Studies, which also need to be evaluated when implementing a new post authorisation study.

Our Monitoring Safety in Clinical Trials and Drug Development course is aimed at providing delegates with an overview of the current regulations pertaining to safety within Clinical Trials, practical application from a safety perspective as well as highlight some of the challenges companies faced in the implementation of safety standards and best practice in order to comply with applicable legislation and guidance both pre- and post-authorisation.

*Please note that the course dates and programme may be subject to change.

This course is aimed at:

• Pharmaceutical industry personnel from areas including pharmacovigilance, clinical research, medical affairs, medical writing, regulatory affairs and medical information
• Staff from regulatory authorities