Monitoring Safety in Clinical Trials & Drug Development Novotel London West

Monitoring Safety in Clinical Trials & Drug Development Novotel London West
January 27 2021, 01:00
in Novotel London West ( events)
Address: 1 Shortlands, W6 8DR London, United Kingdom
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. 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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