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Benefit/Risk Management

May 19 2014 8:00AM - May 20 2014 3:45PM | Hotel Grand Majestic Plaza Truhlarska 16 110 00 Prague 1 Czech Republic

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The information about the next course taking place in Barcelona, Spain in November 2014 will be available shortly

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.

What the participants from previous Benefit/Risk courses say:

"Practical cases/exercises definitely help in understanding this complex process"

"Very engaging, kept our interest for even complex and difficult topics"

"Very good presenters, provided good examples and knowledge"


What You Will Learn 

  • 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 (EUBRMP)
  • 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.

Learning Objectives 

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

Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.

    Hotel & Travel 

    NEW COURSE VENUE! The course has been moved from Century Old Town to Grand Majestic Prague!

    The course will take place at:

    Grand Majestic Prague
    Truhlarska 16
    110 00 Prague 1
    Czech Republic
    Tel: +420 211 159 100
    E-mail: reception@hotel-grandmajestic.cz 

    Please contact the hotel for availability and prices.

    How to get there: from the airport take the Airport Express to Námestí Republiky/Republic Square (travel time 35 min, price CZK 60). From there turn into Truhlarska street. The hotel is located 200 m from the Republic Square.

    Contact Information 

    DIA Europe
    Kuechengasse 16
    4051 BASEL

    TEL.: +41 61 225 51 51
    FAX: +41 61 225 51 52
    E-MAIL: diaeurope@diaeurope.org


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