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Introduction to Pharmacovigilance and Rules for Expedited Reporting of Individual Case Safety Reports (ICSRs) in Europe

May 13 2014 9:00AM - May 13 2014 5:00PM | European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU United Kingdom

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Overview 

This one day course covers the pre-requisites for the three day training course on EudraVigilance - electronic reporting of ICSRs in the EEa and is therefore recommended to newcomers in pharmacovigilance, in particular individuals dedicated to data entry and expedited reporting. The attendees will learn about the essentials of pharmacovigilance, the format, structure and content of ICSRs as well as rules for expedited reporting in Europe for both Clinical Trials and Post-Marketing ICSRS.

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

 

Featured Topics 

  • Legal/regulatory basis
  • Compliance with reporting requirements for ICSRs
  • What is a pharmacovigilance case: scope, criteria for validity
  • Classification of cases: Solicited/ unsolicited, serious/not serious, etc
  • Overview of the ICH E2B requirements
  • Main differences of data elements and adverse reaction reporting during clinical trials and in the postauthorisation phase
  • Overview of the case flow in the EU
  • Concepts and data elements of an ICSR (the main part of the training, focusing on content and quality
    criteria of each important element)
  • Case Follow-up: when and how it needs to be transmitted.
  • Basic coding principles
  • Data privacy requirements 

Contact Information 

Agenda:
DIA Europe, Middle East and Africa

Kuechengasse 16
4051 Basel
Switzerland
diaeurope@diaeurope.org
Phone: +41 61 225 51 51
Fax: +41 61 225 51 52
Monday-Friday 8:00-17:00 CET

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 are kindly requested to make their own reservation. Recommended hotel close to the EMA:

Hilton London Docklands Riverside
265 Rotherhithe Street
London SE16 5HW

Tel: +44 20 7231 1001
Fax: +44 20 7231 0599
Email: reservations.docklands@hilton.com
Special negotiated DIA rate for participants of the EudraVigilance courses is GBP 139.00 per single room incl. breakfast and VAT (GBP 149.00 for double occupancy). Please book your room at least 30 days before arrival through this link.
For reservations after that date, please contact Beatriz Martinez at: beatriz01.martinez@Hilton.com.  
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.

Special Offers 

A special discount for SMEs on the standard rate is available. It is not possible to receive this discount when booking online. To proof your status as SME, a confirmation of the European Medicines Agency is necessary.
Multiple course discount available if booked together with the three-day EudraVigilance training course. Please contact diaeurope@diaeurope.org for more information.

Faculty 

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Agenda  

Day 1 Tuesday, May 13, 2014

  • 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)
€330.00
Standard
€665.00
Register Online
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