This course explores current opportunities made possible by the new legislation, advances in information technology and a new scientific methodology.
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 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.
What you will learn
- New legal possibilities for benefit optimisation and risk minimisation of products in the EU
- Designing benefit/risk management systems using current regulatory tools, including: EU Risk Management Plans (EU-RMPs), Risk Evaluation and Mitigation Strategies (REMS), Development Safety Update Report (DSUR), Periodic Safety Update Report (PSUR), Follow-Up Measures (FUMs), and potentially EU Benefit Risk Management Plan (EU-BRMP)
- Choice of effectiveness of study design for safety and efficacy follow-up
- How to manage a media, legal and regulatory crisis
Date and Time: On Monday November 21, 2016 at 8:00 am (ends Tuesday November 22, 2016 at 3:15 am)
URL:
Booking: https://go.evvnt.com/71323-0
Price:
Standard: EUR 1605
Category: Conferences | Science, Health and Medicine | Pharmaceuticals
Venue details: Dorint an der Messe, Schoenaustrasse 10, Basel, 4058, Switzerland
