Risk Management planning is a necessity for bringing products to the market in a timely fashion. These plans are rapidly becoming a prerequisite for approval by Health Agencies outside of the US, and are gaining popularity within the FDA. Not only the submission of Risk Management plans, but the overall Risk Management strategy, poses challenges to many pharmaceutical and biotechnological companies. Only a proactive and integrative risk management strategy cumulating into a credible Risk Management plan will enhance a timely approval by Health Agencies.
PAREXEL Pharmacovigilance (PPV) has a wealth of experts in the field of Risk Management planning and strategy, many with FDA and MHRA backgrounds. This ensures that PAREXEL Risk Management experts can provide highly credible input in the design of Risk Management strategy and plans, supporting the regulatory acceptance of such documents. In addition, the complete range of PPV safety solutions can support the infrastructure required for appropriate risk management through the application of state-of-the art methodology.
PACE works very closely will the PPV team and can offer a complete service to implement the additional Pharmacovigilance activities falling out from risk management plans. For more information on risk management planning and our global capability to support your Pharmacovigilance requirements, contact the PACE group.