Overview
This intensive course explores current opportunities made possible by the 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 five years with the EU Risk Management Plans (EU-RMPs). Participants will learn how to take advantage of 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 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.
90% of attendees would recommend the course. (2015 attendee survey)
CONTINUING EDUCATION
The Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom has accredited this training course with CPD credits.
The Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society for Pharmaceutical Medicine (SGPM) have accredited this training course with 11.5 credits.
DIA is an authorised training organiation accredited under the number 11 99 53383 75 to the Préfet of Ile-de-France.
What participants from previous course say:
"The best part of the programme are the real examples, practical questions and most importantly the exercises that make attendees live the situation and force them to go through interesting situations"
"The course was excellent"
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