Introduction 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. This 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. Aims - To provide delegates with a theoretical and practical understanding of the issues involved in pharmacovigilance planning and monitoring throughout drug development programmes - To analyse the principals of risk management and illustrate their application to pharmacovigilance, including the role and application of Data Safety Monitoring Boards - To review critically pharmacovigilance regulatory requirements plus corresponding roles and responsibilities of the pharmaceutical industry in safety data management for optimal protection of patients in clinical trials Programme features - Pharmacovigilance planning and monitoring in drug development, including communication to trial subjects - Development of labelling - the developmental safety information through the core data sheet and SPC - Risk management in drug development - planning and risk minimisation - Monitoring safety in clinical trials - Data Safety Monitoring Boards - Clinical Trials Directive - current requirements, challenges and future changes - Planning for the Developmental Safety Update Report - Reporting to Eudravigilance Clinical Trial Module - practicalities and challenges - Future drug safety regulatory challenges on the horizon for clinical trials and drug development This course is offered as a stand alone short course, with CPD accreditation from the Faculty of Pharmaceutical Medicine, and as part of our postgraduate programme in pharmacovigilance in collaboration with the University of Portsmouth.
On successful completion of this course delegates should be able to: - Demonstrate an informed critical awareness of regulatory safety requirements as they pertain to clinical studies - Understand the role and situations where a study may deploy the use of Data Safety Monitoring Boards - Identify and locate the key sources of information and documentation relevant to developmental risk management activities - Critically explain the strengths and weakness of pharmacovigilance planning systems