Drug Information Association Logo
Corporate Tagline

Current Region: Global

About DIA Membership Get Involved
I am interested in...

[Close]

Help

Your selections will be saved and used to recommend products based on your interests.

The New Individual Case Safety Report (ICSR) International Standard and ICH E2B (R3) Information Day

Feb 5 2013 8:45AM - Feb 5 2013 5:00PM | European Medicines Agency 7 Westferry Circus Canary Wharf London E14 4HB United Kingdom

View PDF

 Add to Outlook Print Share Register Online
« Back to Listing

Overview 

In November 2012, step 4 of ICH E2B (R3) package has been signed off including the awaited implementation guide accompanied by several technical appendices. This step opens the way for the worldwide implementation of the new ICSR replacing progressively the current E2B (R2). This information day will present and explain the main and latest changes to E2B and its appendices as well as what, how and when they will be required in the EU and the US.

Who Should Attend 

  • Representatives of IT departments of medicines regulatory authorities, pharmaceutical companies and service providers
  • EU Qualified Persons Responsible for Pharmacovigilance (EU QPPVs)
  • Pharmacovigilance staff of pharmaceutical companies and medicines regulatory authorities
  • Pharmacovigilance software vendors
  • Sponsors of Clinical Trials

Learning Objectives 

At the conclusion of this course, participants should be able to:

  • Recognise the new requirements as regards the ICH E2B(R3) Implementation Guide and the ISO/HL7 messaging standards
  • Update medicines regulatory authorities in the EU, pharmaceutical companies and IT vendors on the international standardisation work and the impact in the context of the new pharmacovigilance legislation
  • Prepare for the implementation of the new ICSR standard and the adaptation of internal pharmacovigilance systems by all stakeholders involved (medicines regulatory authorities in the EU, IT vendors and pharmaceutical companies)
  • Understand the use of MedDRA for reporting of medication errors, misuse, abuse and occupational exposure

Featured Topics 

  • Key differences between the ISO ICSR International Standard and the current ICH E2B(R2)guideline/M2 messaging format
  • Initiation of pilot testing in collaboration between US FDA and EU

  • ICH E2B(R3) Implementation Guide and consolidated comments from an EU and US perspective

  • Health Level Seven (HL7) standard for electronic information exchange
  • Use of MedDRA in the context of the new ICSR reporting – impact on coding and data retrieval

Contact Information 

Registration and Agenda:
DIA Europe
Kuechengasse 16, Postfach
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 

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

DIA was able to negotiate a special rate for participants to the EudraVigilance training course. Room rate is GBP 145.00 (2012 rate) per room incl. breakfast excl. VAT

Please click here to book your accommodation at the designated hotel. In order to profit from our special rate we would kindly ask you to use our corporate number (481223696).

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).

Faculty 

Previous Next

Agenda  

Day 1 Tuesday, February 05, 2013

  • 9:00AM - 9:45AM

    Session 1

    Speaker(s):

    • HEALTH LEVEL 7: INDIVIDUAL CASE SAFETY REPORT (ICSR) AND IDENTIFICATION OF MEDICINAL PRODUCTS (IDMP) MESSAGING STANDARDS IN THE PHARMACEUTICAL AND HEALTHCARE DOMAIN
       Mick Foy
      Group Manager
      MHRA, United Kingdom
    • HEALTH LEVEL 7: INDIVIDUAL CASE SAFETY REPORTS (ICSR) AND IDENTIFICATION OF MEDICINAL PRODUCTS (IDMP) MESSAGING STANDARDS IN THE PHARMACEUTICAL AND HEALTHCARE DOMAIN
       Vada A. Perkins, BSN,MSc,RN
      Senior Regulatory Program Management Officer, OD, CBER
      FDA, United States
  • 9:45AM - 11:00AM

    Session 2

    Speaker(s):

    • DIFFERENCES BETWEEN THE NEW ISO ICSR E2B(R3) STANDARD AND THE ICH ICSR E2B(R2) GUIDELINE CURRENTLY IN USE
       Anja Van Haren, MSc
      EurdraVigilance Coordinator
      MEB, Netherlands
    • Gaby L. Danan, MD,PhD
      Hepatologist, Pharmacovigilance Expert
      GLD Conseil, France
  • 11:30AM - 12:30PM

    Session 3

    Speaker(s):

    • KEY COMMENTS FROM THE PUBLIC CONSULTATION ON THE ICH E2B(R3) IMPLEMENTATION GUIDE
       Sabine Brosch, PharmD,PhD
      Business Lead, EudraVigilance and International Standardisation in PhV
      European Medicines Agency, European Union, United Kingdom
    • USE OF MedRA: FOCURS ON THE EXTENDED SCOPE OF ADVERSE REACTION REPORTING IN THE CONTEXT OF THE NEW PHARMACOVIGILANCE LEGISLATION
       Patrick Revelle
      Director
      MedDRA MSSO , United States
  • 1:30PM - 2:00PM

    Session 4

    Speaker(s):

    • Sabine Brosch, PharmD,PhD
      Business Lead, EudraVigilance and International Standardisation in PhV
      European Medicines Agency, European Union, United Kingdom
    • JOINT PILOT TESTING OF THE NEW ISO ICSR STANDARD IN THE EU AND THE US
       Vada A. Perkins, BSN,MSc,RN
      Senior Regulatory Program Management Officer, OD, CBER
      FDA, United States
  • 2:00PM - 3:00PM

    Session 5

    Speaker(s):

    • Implementation of The New ICSR Standard - AnIndustry Perspective
       Alastair G Fowkes
      Associate Director
      AstraZeneca, United Kingdom
    • Vada A. Perkins, BSN,MSc,RN
      Senior Regulatory Program Management Officer, OD, CBER
      FDA, United States
    • IMPLEMENTATION PLANNING OF THE NEW ISCR STANDARD
       Sabine Brosch, PharmD,PhD
      Business Lead, EudraVigilance and International Standardisation in PhV
      European Medicines Agency, European Union, United Kingdom
  • 3:30PM - 4:45PM

    Session 6

    Speaker(s):

    • ICSR DATA WUALITY REVIEW IN EUDRAVIGILANCE
       Nick Halsey
      Scientific Administrator
      European Medicines Agency, United Kingdom
    • QUESTION AND ANSWER SESSION ON GVP MODULE VI-MANAGEMENT AND REPORTING OF ADVERSE REACTIONS TO MEDICINAL PRODUCTS
       Gilles Touraille
      European Medicines Agency, United Kingdom

Registration Fees 

Other Fees

Academia
€150.00
Government (Full Time)
€150.00
Industry
€300.00
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.

View PDF

 Add to Outlook Print Share Register Online
« Back to Listing Back To Top
Home Contact Us Privacy Policy Legal Site Map
© 2013 DIA