Services

Risk Management

Pharmaceutical, biotechnology and medical device companies are operating in an increasingly challenging commercial and regulatory environment. New regulations in the US and Europe now require companies to provide more evidence of drug safety following product launch and, in some cases, require Product Risk Management Plans which influence indication, marketing and distribution to limit the risk associated with their products in actual clinical practice.

Recent changes to US law, have substantially increased the possibility that a product with any major safety concern (a black box) will be required to institute a Risk Evaluation and Management Strategy (REMS). All new products, and many product line extensions, submitted for licensing in the European Union now need to have a completed European Risk Management Plan (EU-RMP) at the time of submission.

The MAPI Group can provide you both strategic advice and help you to conduct all activities related to Product Risk Management Plans (REMS, EU-RMP). This includes determining the goals of your plan, investigating which risk control activities will be mostly likely to achieve these goals, and developing a plan to evaluate the effectiveness of these risk control activities. This evaluation component could include both post-marketing surveillance plans and surveys of health care professionals.

The MAPI Group has expertise in the development of many different types of risk control programs including those based at the pharmacy, general practice and specialist levels. In addition, the MAPI Group can help you prepare your Risk Management Plan for presentation at an FDA advisory committee meeting and provide the resource to write and maintain your US Risk Evaluation and Management Strategy (REMS) and European Risk Management Plan (EU-RMP) documents according to the templates and timings required by regulatory agencies in these regions.

We work together with you on your strategy, aid in regulatory negotiations, set up and conduct necessary activities and communicate results at several levels (regulatory documents, scientific publications, visual presentation aids, interactive communication and training facilities).

More information on this service? Visit the site of the Mapi Group Company that specializes in this service.