Date(s) And Time(s):
May 19 2011 8:00AM - May 20 2011 3:15PM
Radisson BLU Alcron Hotel
11 000 Prague
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.
Course Key Topics
Take advantage of the new legal possibilities for benefit optimisation and risk minimisation of your products in the EU
Enjoy a comprehensive and practical training in designing benefit/risk management systems using current, as well as new, regulatory tools, including EU-RMP, REMS, DSUR, PSUR, FUMs, and potentially EU-BRMP
Learn what study designs are best for safety and efficacy follow-up, and how to measure their effectiveness
Get trained for situations when benefit-risk of your product is at stake and you need to manage a media, legal and regulatory crisis
TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52