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Radisson Blu Alcron Hotel, Prague, Czech Republic
Apr 26 2012 8:00AM - Apr 27 2012 4:00PM
DIA presents an intensive course for professionals involved in management of safety information from 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 overview of all the major current methodological approaches and hands-on solutions for day-to-day challenges. Attendees will learn how to produce Development Safety Update Reports (DSURs), and how to bridge a Development Risk Management Plan, EU-RMP and REMS to be ready for a marketing authorisation application.
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 AE, SAE, and SUSARs - Be able to prepare Development Safety Update Reports (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
Target Audience:
- Management of Adverse EventsUnblinding strategies
- SUSARs reporting
- How to inform Ethics Committees
- Development Safety Update Reports
- EudraVigilance CT module
- Risk Assessment in Clinical Trials
- Safety Risk Management
Event Code:
12558
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Organized by:
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DIA Europe |
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Invited Speakers:
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Jan Petracek, MD,MSc
CEO, Director of Pharmacovigilance Services
European Pharminvent Services, s.r.o., Czech Republic
Jan-Willem Van der Velden, DrMed
CEO
Mesama Consulting, Switzerland
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Deadline for Abstracts:
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Call contact
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Registration:
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DIA Europe ELISABETHENANLAGE 25, POSTFACH 4002 BASEL SWITZERLAND TEL.: +41 61 225 51 51 FAX: +41 61 225 51 52 E-MAIL: DIAEUROPE@DIAEUROPE.ORG
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E-mail:
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diaeurope@diaeurope.org
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