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

Nov 12 2013 9:00AM - Nov 12 2013 5:00PM | European Medicines Agency Canary Wharf, 7 Westferry Circus London E14 4HB United Kingdom

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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

 

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 

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 negotiated rate for participants to the EudraVigilance training courses for a limited number of rooms is GBP 139.00 per room (2013 rate) incl. breakfast excl. VAT.
Please use this link to book your room:
http://www.hilton.com/en/hi/groups/personalized/L/LONNDHI-GDIAL-20131003/index.jhtml?WT.mc_id=POG

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 

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Agenda  

Day 1 Tuesday, November 12, 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)
€330.00
Standard
€665.00
Register Online
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