Training Course on Benefit/Risk Management

The balance of benefits and risks of a product is the basis for all key decisions in the pharma industry. Thus the balance must not be left to chance – it can be and should be effectively managed. This intensive course explores current opportunities made possible by the new legislation, advances in information technology and a new scientific methodology to enhance and modernise the approaches in the product lifecycle management.

The course starts with the current regulatory thinking about the benefit/risk methodology, including the relevant project of EMA/CHMP. It gives a basis for the second part of the course, exploring the new European Benefit/Risk Management Planning - a notion stemming from the experience gathered over five years with the EU-RMPs. Participants will learn how to take advantage from the efficacy follow-up options given by both the European Paediatric Regulation and the Advanced Therapies Regulation. A practical training in drafting key aspects of the regulatory submissions is included.

Although a lot of things might be planned and controlled, there are always unforeseen scenarios. The last part of the course will help participants to deal with the most dangerous ones – when the benefit/risk of the product is suddenly affected by emerging information. Participants will be trained to learn how to deal with such a situation, using the most effective techniques in risk communication and media crisis management.