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Pre-marketing Clinical Safety

Jun 16 2014 8:45AM - Jun 17 2014 2:50PM | NH Musica van Leijenberghlaan 221 1082 GG Amsterdam Netherlands

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Overview 

DIA is presenting an intensive course for professionals involved in management of safety information of clinical trials in the EU. Participants will be guided through all the regulations and guidelines pertinent to pre-marketing safety in the EU. The course offers an overview of all the current major methodological approaches and hands-on solutions for day-today challenges. Attendees will learn how to produce Development Safety Update Reports (DSURs), and how to bridge a Development Risk Management Plan, EU-Risk Management Plan (EU-RMP) and Risk Evaluation and Mitigation Strategies (REMS) to be ready for a marketing authorisation application.

What You Will Learn 

  • Management of adverse events
  • Unblinding strategies
  • SUSARs reporting
  • How to inform of ethics committees
  • Development safety update reports
  • EudraVigilance CT module
  • Risk assessment in clinical trials
  • Safety risk management

Who Should Attend 

  • Drug safety managers, specialists and directors involved in clinical trials
  • Clinical trial monitors and managers wishing to acquire deeper knowledge of drug safety science and regulations
  • Pharmacovigilance professionals involved in pre-marketing safety

Learning Objectives 

At the conclusion of this course, participants should be able to:

  • Understand key concepts of drug safety and pharmacovigilance and their application to clinical development
  • Know how to comply with European regulations for clinical safety, including production, management and submission of an Adverse Event (AE), Serious Adverse Event (SAE), and Suspected Unexpected Serious Adverse Reactions (SUSARs)
  • Be able to prepare DSURs
  • Understand regulatory reporting requirements for products already marketed while their development continues
  • Understand risk assessment methodology and its use in the development risk management plans, forming basis for EU-RMP and REMS

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 

This training course will take place in:

Hotel NH Musica
van Leijenberghlaan 221
1082 GG Amsterdam
the Netherlands
Tel: +31 20 79 56 088
E-mail: nhmusica@nh-hotels.com

DIA has blocked a limited number of rooms at the rate of EUR 128.33 per room/night, including VAT and tax, excluding breakfast. To make the reservation, please click here.

Important: The room rate is available until 21 April 2014 or until the group block is sold-out, whichever comes first. Please make your reservations as soon as possible.

Contact Information 

DIA Europe
Kuechengasse 16
4051 Basel
Switzerland

Tel: +41 61 255 51 51
Fax: +41 61 255 51 52
E-Mail: diaeurope@diaeurope.org

Faculty 

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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

CANCELLATION POLICY: All cancellations must be made in writing and received at the DIA office five working days prior to the event start date. Full event cancellations are subject to an administrative fee:

  • Industry (Member/Non-member) = €200.00
  • Academia/Charitable/Government /Non-profit (Full-Time) (Member/Non-member) = €100.00
  • Tutorial cancellation: €50.00

If you do not cancel five working days prior to the event start date and do not attend, you will be responsible for the full registration fee. DIA reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA is not responsible for airfare, hotel or other costs incurred by registered attendees. Registered attendees are responsible for cancelling their own hotel and travel reservations.

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