Pre-Marketing Clinical Safety

http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?pr... Course

Date(s) And Time(s):
Apr 4 2011 8:00AM - Apr 4 2011 5:00PM

Location:
Ramada Plaza Basel
Messeplatz 12
4058 Basel
Switzerland

Overview:
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:
11565

Contact Information:
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