Risk management plans

All risks under control

Even after the completion of a carefully planned development programme, absolute clarity regarding the risks of a product is rare. For several years now, the authorities have therefore been demanding more of marketing authorisation holders than before – for example in the form of risk management plans when identifying the risks of products following their market launch.

Analysis of your development documentation

We analyse your preclinical and clinical documentation and ascertain which risks were not sufficiently identified during the development phase.

Preparation of the EU risk management plan

Working closely with you we draw up a risk management plan in accordance with Volume 9a and ICH E2E, in which we compare the safety profile of your medicinal product with existing data ("Safety Specification"). In the pharmacovigilance plan we define the necessary monitoring measures that extend beyond the routine programme. We also make detailed proposals for risk limitation and control.

Implementation of risk-minimising measures

We support your company in the realisation of measures designed to minimise risks. Our services include:

• Training for doctors and patients
• Provision of information material
• Planning, performance and analysis of post-marketing observation activities
• Analysis of the efficiency of our measures