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 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.
- 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 Risk Management Plans (EU-RMP), 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)
- Learn which 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
Who Should Attend
Professionals most likely to benefit from this training have 2-5 years of experience in regulatory affairs, risk management, pharmacovigilance, drug safety, medical affairs or similar positions within the pharmaceutical industry. Those charged with the design and maintenance of risk management systems, Qualified Persons for Pharmacovigilance (QPPVs) and heads of benefit/risk management, patient safety, or lifecycle management will find all the necessary information and skills needed for successful benefit/risk management included in this course.
At the conclusion of this course, participants should be able to:
- Describe safety, efficacy, and effectiveness profiles of drugs
- Plan safety and efficacy follow-up systems, including the best choice of study designs and available registries
- Optimise benefits and minimise risks of products, including the best use of an evidence-based toolbox
- Present the first three bullet points to key regulatory authorities and health technology assessment bodies
- Measure effectiveness of the planned actions – both risk minimisation and benefit optimisation
- Save the product if things go wrong and benefit-risk seems negative
Hotel & Travel
DIA has blocked a limited number of rooms at the:
Hotel Novotel Praha Wenceslas Square
At the special rate of EUR 148.35 per room/night inclusive of breakfast and VAT/taxes.
In order to make a reservation, please use this booking form
The agreed room rate will be available until 19.08.2013 or until the group block is sold-out, whichever comes first.
30 days before arrival without charge
29 - 15 days before arrival 50% charge
14 - 9 days before arrival 75% charge
8 - the day of arrival or no show 100% charge