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Benefit/Risk Management

Nov 10 2014 8:00AM - Nov 11 2014 3:45PM | Tryp Barcelona Apolo Avinguda del Parallel, 57-59 08004 Barcelona Spain

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Overview 

    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.

    Key Topics

    • 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.

    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

    Hotel & Travel 

    DIA has blocked a limited number of rooms at the following hotel:

    TRYP Barcelona Apolo Hotel
    Avinguda del Paral·lel, 57-59,
    08004, Barcelona, Spain
    Tel: (34) 93 343 30 00
    Fax: (34) 93 443 0059
    E-mail: tryp.apolo@melia.com
     
    at the rate of:
    EUR 85.00 single use
    incl. of breakfast, excl. of VAT and city tax

    To make your reservation, please click here: http://meetings.melia.com/en/DIAEUROPE.html

    Important: The room rate is available until 04 October 2014 or until the group block is sold-out, whichever comes first.
    In case of no-shows the hotel is authorised to charge the full amount corresponding to the duration of your stay.

    Contact Information 

    Registration Questions
    Phone.: +41 61 225 51 51
    Fax: +41 61 225 51 52
    Monday-Friday 8:00-17:00 CET
    diaeurope@diaeurope.org

    Agenda and Event Logistics
    Magdalena Lewandowska, Event Manager
    Phone: +41 61 225 51 65
    Fax: +41 61 225 51 52
    magdalena.lewandowska@diaeurope.org

     

     

    Agenda  

    Day 1 Monday, Nov 10, 2014

    • 8:00AM - 8:30AM (Central Europe Standard Time)

      REGISTRATION
    • 8:30AM - 8:45AM (Central Europe Standard Time)

      WELCOME AND INTRODUCTION OF FACULTY AND PARTICIPANTS
    • 8:45AM - 9:45AM (Central Europe Standard Time)

      Session 1: INTRODUCTION TO BENEFIT/RISK METHODOLOGY
    • 10:15AM - 10:45AM (Central Europe Standard Time)

      COFFEE BREAK
    • 10:45AM - 11:15AM (Central Europe Standard Time)

      Session 3: INTRODUCTION TO BENEFIT/RISK MANAGEMENT
    • 11:15AM - 12:15PM (Central Europe Standard Time)

      Session 4: SAFETY SPECIFICATION
    • 12:15PM - 1:15PM (Central Europe Standard Time)

      LUNCH
    • 1:15PM - 1:45PM (Central Europe Standard Time)

      Session 5: EFFICACY AND EFFECTIVENESS SPECIFICATION
    • 1:45PM - 2:00PM (Central Europe Standard Time)

      Session 6: DOS AND DON’TS IN SAFETY AND EFFICACY SPECIFICATIONS
    • 2:00PM - 2:45PM (Central Europe Standard Time)

      Session 7: PHARMACOVIGILANCE PLAN
    • 2:45PM - 3:15PM (Central Europe Standard Time)

      COFFEE BREAK
    • 3:15PM - 4:00PM (Central Europe Standard Time)

      Session 8: EFFICACY FOLLOW-UP PLAN
    • 4:00PM - 5:00PM (Central Europe Standard Time)

      Session 9: RISK MITIGATION
    • 5:00PM - 6:00PM (Central Europe Standard Time)

      DRINKS RECEPTION

    Day 2 Tuesday, Nov 11, 2014

    • 8:20AM - 8:40AM (Central Europe Standard Time)

      Session 10: BENEFIT OPTIMISATION
    • 8:40AM - 8:45AM (Central Europe Standard Time)

      Session 11: EXERCISE - CASE STUDY OF AN EU-RMP WITH EFFICACY FOLLOW-UP PLAN
    • 8:45AM - 9:45AM (Central Europe Standard Time)

      Session 12: BENEFIT/RISK MANAGEMENT PLAN - CASE STUDIES
    • 9:45AM - 10:15AM (Central Europe Standard Time)

      COFFEE BREAK
    • 10:15AM - 11:00AM (Central Europe Standard Time)

      Session 12 continued: BENEFIT/RISK MANAGEMENT PLAN - CASE STUDIES
    • 11:00AM - 11:45AM (Central Europe Standard Time)

      Session 13: USE OF BENEFIT/RISK MANAGEMENT PLANS IN REGULATORY SUBMISSIONS
    • 11:45AM - 12:15PM (Central Europe Standard Time)

      Session 14: BENEFIT/RISK COMMUNICATION
    • 12:15PM - 1:15PM (Central Europe Standard Time)

      LUNCH
    • 1:15PM - 2:15PM (Central Europe Standard Time)

      Session 15: USE OF BENEFIT/RISK MANAGEMENT PLANS IN CRISIS MANAGEMENT
    • 2:15PM - 3:15PM (Central Europe Standard Time)

      Session 16: EXERCISE - CRISIS MANAGEMENT
    • 3:15PM - 3:45PM (Central Europe Standard Time)

      COURSE ASSESSMENT

    Registration Fees 

    Member

    Member Academia
    €710.00
    Member Government
    €710.00
    Member Standard
    €1420.00

    Non-Member

    NonMember Academia
    €840.00
    NonMember Government
    €840.00
    NonMember Standard
    €1550.00
    Register Online
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