Pharmacovigilance and Risk Management Planning

Drug development is all about managing risk against benefit. Effective planning is required for pharmacovigilance activities during the development phase and product launch. It is especially important for the drug safety knowledge to be based within the Client organisation and yet the Client may from time to time need additional expertise or an "outside eye" to evaluate the emerging drug safety issues. TranScrip Partners have extensive experience in pre-approval risk management, including study and programme design, data collection, monitoring and analysis, mandatory reporting and development of labelling. TranScrip's mix of pharmacovigilance specialism and therapeutic expertise aids writing and review of risk benefit sections of the Common Technical Document, PSURs and tackling challenges, from critical safety issue evaluation to MedDRA version control. Partners have experience in setting up and chairing Drug Safety Monitoring Committees and have been involved in the design and implementation of drug safety procedures from early safety reporting to post-licensing risk management strategy.