Monitoring Safety in Clinical Trials and Drug Development
 

The implementation of the Clinical Trials Directive was a critical event for clinical research and pharmacovigilance, which impacted on all those working in this area. Its standards have influenced regulatory expectations, together with new ICH standards such as the Development Safety Update Report and pharmacovigilance planning, bringing new challenges to safety personnel. Through the new Clinical Trial Regulation, the Directive is being further enhanced and evaluated, challenging the traditions of approaches to clinical trials with respect to safety data management and protocol designs. In addition, post authorisation GVP provides specific guidance on the management of Post Authorisation Safety Studies. Our Monitoring Safety in Clinical Trials and Drug Development course is aimed at providing delegates with an overview of some of the challenges companies faced in implementation of safety standards and best practice in managing their implementation in order to comply with applicable legislation and guidance both pre- and post-authorisation.

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University of Liverpool

Block A: Waterhouse Buildings

1-5 Brownlow Street

Liverpool L69 3GL

Email: nelsdon@liverpool.ac.uk

 

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