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 the European Medicines Agency (EMA) / Committee for Medicinal Products for Human Use (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 the past eight years with the EU Risk Management Plans (EU-RMPs). Participants will learn how to take advantage of the efficacy follow-up options given by the EU law and guidelines. A practical training in drafting key aspects of the regulatory submissions is included.
Although a lot of things may 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 on how to
deal with such a situation, using the most effective techniques in risk communication and media crisis management.
Member Industry : EUR 1420
Non-Member Industry: EUR 1550
Member Academia/Charitable/Government/Non-profit (full-time) : EUR 710
Non-Member Academia/Charitable/Government/Non-profit (full-time) : EUR 840
Speakers: Jan Petracek, Jan-Willem van der Velden
From: November 10, 2014 08:00
To: November 11, 2014 15:15
Tryp Apolo, 57-59 Avinguda del Paraŀlel, 08004, Barcelona, Spain