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

Nov 4 2014 9:00AM - Nov 4 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:

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. 

TRAVEL INFORMATION
The European Medicines Agency (EMA) is moving in summer 2014. The course takes place in the new offices at
30 Churchill Place
Canary Wharf
E14 5EU London
Website:www.ema.europa.eu

Please click here for a map on how to find the EMA.

Closest DLR and tube (Jubilee line) station is Canary Wharf. Pease calculate a delay of 05-10 minutes to enter the EMA building (special security procedure) and note that 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, Nov 04, 2014

  • 9:00AM - 10:00AM (GMT Standard Time)

    Pharmacovigilance background and regulatory framework
  • 10:00AM - 12:00PM (GMT Standard Time)

    Key concepts and definitions including exercises
  • 12:00PM - 1:00PM (GMT Standard Time)

    Reporting requirements for expedited ICSR
  • 2:00PM - 3:45PM (GMT Standard Time)

    Requirements for data quality in ICSRs
  • 4:00PM - 5:30PM (GMT Standard Time)

    Coding, MedDRa, Data Privacy Protection

Registration Fees 

Other Fees

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