Introduction to Pharmacovigilance and Electronic Transmission of Individual Case Safety Reports (ICSRs) for the Use of Eudravigilance

Jun 18 2013 9:00AM - Jun 18 2013 5:00PM | European Medicines Agency Canary Wharf, 7 Westferry Circus London E14 4HB United Kingdom

View PDF

Add to Outlook Print Share Register Online

« Back to Listing

Overview

This one day course is designed for newcomers in pharmacovigilance, in particular individuals dedicated to data entry and quality review of ICSRs. The attendees will learn about the essentials of pharmacovigilance, the format, structure and content of ICSRs as well as data quality and coding principles, which are prerequisites to comply with EU and international reporting requirements. This introductory course is strongly recommended to individuals that will be transmitting ICSRs to EudraVigilance.

Who Should Attend

This course is intended for newcomers in pharmacovigilance, who need to understand the basics of ICSRs
with main focus on EU requirements.

Learning Objectives

Participants who complete this course should be able to:

Understand the ICSR reporting requirements
Understand the basic vocabulary of pharmacovigilance
Complete properly the components of an ICSR
Compare ICSR components for post-authorisation and clinical trials
Identify the resources available for further guidance

Contact Information

Registration and Agenda:
DIA EUROPE
KUECHENGASSE 16
4002 BASEL, SWITZERLAND
PHONE: +41 61 225 51 51
FAX: +41 61 225 51 52
E-MAIL: DIAEUROPE@DIAEUROPE.ORG

For technical questions or registration to EudraVigilance:
Eudravigilance helpdesk for Sponsors:
eudravigilance@ema.europa.eu
EudraVigilance registration team:
eudravigilanceregistration@ema.europa.eu

Hotel & Travel

HOTEL INFORMATION
Attendees have to make their own reservation. Recommended hotel close to the EMA:

Hilton London Docklands Riverside
265 Rotherhithe Street,
London , SE16 5HW,
United Kingdom

Telephone: +44 (0)20 7231 1001
Fax: +44 (0)20 7231 0599
Email: reservations.docklands@hilton.com

Special negotiate rate for participants to the EudraVigilance training course for a limited number of rooms is GBP 145.00 per room (2012 rate) incl. breakfast excl. VAT. Please enter the corporate number 481223696 when booking your room. Click here to book.
The hotel is situated opposite of Canary Wharf conveniently connected by a shuttle boat. The landing stage is in walking distance to the EMA (2 min).

TRAVEL INFORMATION
The training course takes place at the

European Medicines Agency (EMA)
7 Westferry Circus
Canary Wharf
London E14 4HB
Web site: www.ema.europa.eu
Please click here for a map on how to find the EMA.
Please click here for some useful transport information.

For the special security access procedure to enter the EMA building, please calculate a delay of up to 10-15 minutes. It is not possible to enter the building before 8.00 am.

Faculty

Previous Next

Francois Peterlongo, MD

EV instructor
France

Agenda

Day 1 Tuesday, June 18, 2013

9:00AM - 10:00AM
Pharmacovigilance background and regulatory framework
10:00AM - 12:00PM
Key concepts and definitions including exercises
12:00PM - 1:00PM
Reporting requirements for expedited ICSR
2:00PM - 3:45PM
Requirements for data quality in ICSRs
4:00PM - 5:30PM
Coding, MedDRa, Data Privacy Protection

Registration Fees

Other Fees

Academia: €330.00
Government (Full Time): €300.00
Standard: €665.00

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.