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ICH E2B (R3) Individual Case Safety Report (ICSR) Information Day

May 13 2014 8:00AM - May 13 2014 4:45PM | European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU United Kingdom

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Overview 

In November 2012, step 4 of the ICH E2B (R3) package has been signed off based on the ISO ICSR standard including the awaited implementation guide (IG) accompanied by several technical appendices. This step opened the way for the worldwide implementation of the ISO ICSR standard replacing progressively the current E2B (R2) version. The first package (version 1.01) was made available on 12 April 2013 to the users in order to begin the testing phase and the implementation of data exchange between partners.

In the context of the EU implementation, a regional IG is being prepared addressing EU specific requirements in relation to the application of the ISO ICSR standard and the E2B(R3) package. 

This Information Day will address and explain the key changes expected in relation to the application of the new ISO ICSR standard and how those will impact the EU adverse reaction reporting and electronic transmission activities.

What You Will Learn 

  • Key differences between the ISO ICSR International Standard and the current ICH E2B (R2) guideline
  • The ICH safety message flow in the EU
  • Processing of safety and acknowledgement messages in case of technical or system failures
  • EU specific business rules and technical ICSR validation
  • Case classification
  • ICSR specific concepts and their application in the EU (e.g. amendment report, causality assessment)
  • Coding of medicinal product information
  • Use of MedDRA in the context of the new ICSR reporting
  • Handling of attachments
  • EMA testing procedures with stakeholders

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) and EU region specific implementation
  • 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 the new ICSR format in line with EU pharmacovigilance legislation

Contact Information 

DIA Europe
Kuechengasse 16
4051 BASEL
SWITZERLAND

TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52
E-MAIL: diaeurope@diaeurope.org

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 Information Day 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 Information Day takes place at the

European Medicines Agency (EMA)
7 Westferry Circus
Canary Wharf
London E14 4HB, UK
Website: 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, May 13, 2014

  • 8:00AM - 8:45AM

    REGISTRATION
  • 8:45AM - 9:00AM

    WELCOME AND OPENING REMARKS

    Speaker(s):

    • Peter Richard Arlett, MRCP
      Head of Pharmacovigilance Department
      European Medicines Agency, European Union, United Kingdom
  • 9:00AM - 10:00AM

    Key differences between the new E2B (R3) ICSR and the ICH ICSR E2B (R2)


    Session Chair(s):

    • Sabine Brosch, PharmD, PhD
      Monitoring and Incident Management, Pharmacovigilance
      European Medicines Agency, European Union, United Kingdom
    • Anja Van Haren, MSc
      EudraVigilance Coordinator
      Medicines Evaluation Board (MEB), Netherlands

    This session will provide a summary of the differences between the new ICH E2B (R3) and the current E2B (R2) ICSR format in the context of the electronic reporting of adverse reactions in the EU. The expected benefits and the impact on the pharmacovigilance business processes will be highlighted.

    Speaker(s):

    • Gaby L. Danan, MD, PhD
      Pharmacovigilance Expert
      France
    • Key differences between the new E2B (R3) ICSR and the ICH ICSR E2B (R2)
      Anja Van Haren, MSc
      EudraVigilance Coordinator
      Medicines Evaluation Board (MEB), Netherlands

    Discussant(s):

    • Diane Farkas
      Case Management and Medical Evaluation Head
      Sanofi-Aventis, France
  • 10:00AM - 10:45AM

    Session 2: Electronic ICSR reporting process


    Session Chair(s):

    • Sabine Brosch, PharmD, PhD
      Monitoring and Incident Management, Pharmacovigilance
      European Medicines Agency, European Union, United Kingdom
    • Anja Van Haren, MSc
      EudraVigilance Coordinator
      Medicines Evaluation Board (MEB), Netherlands

    This session will describe the procedures concerning the Electronic Data Interchange (EDI) of ICSRs and the roles of all involved stakeholders taking into account the simplification of adverse reaction reporting as foreseen in Article 107(3) of Directive 2001/83/EC and Article 28(1) of Regulation (EC) 726/2004.

    Speaker(s):

    • The ICSR safety message flow in the EU
      Nick Halsey
      Scientific Administrator
      European Medicines Agency (EMA), United Kingdom
  • 10:45AM - 11:15AM

    COFFEE BREAK
  • 11:15AM - 12:30PM

    Session 3: EU specific business rules and technical ICSR validation


    Session Chair(s):

    • Sabine Brosch, PharmD, PhD
      Monitoring and Incident Management, Pharmacovigilance
      European Medicines Agency, European Union, United Kingdom
    • Anja Van Haren, MSc
      EudraVigilance Coordinator
      Medicines Evaluation Board (MEB), Netherlands

    Key changes to the business rules as currently applied in EudraVigilance will be presented. These changes are based on the new ISO ICSR standard, the ICH E2B (R3) Implementation Guide and taking into account EU specific requirements and processes.

    Speaker(s):

    • EU specific business rules and case classification
      Nick Halsey
      Scientific Administrator
      European Medicines Agency (EMA), United Kingdom
    • EU specific business rules and case classification
      Edurne Lazaro
      Pharmacist
      AEMPS (Spanish Agency), Spain
  • 12:30PM - 1:30PM

    SANDWICH LUNCH
  • 1:30PM - 3:00PM

    Session 4: ICSR specific concepts and their application in the EU


    Session Chair(s):

    • Sabine Brosch, PharmD, PhD
      Monitoring and Incident Management, Pharmacovigilance
      European Medicines Agency, European Union, United Kingdom
    • Anja Van Haren, MSc
      EudraVigilance Coordinator
      Medicines Evaluation Board (MEB), Netherlands

    This session will address the handling of amendment reports, attachments and principles of causality of assessment. Principles of handling medicinal product information will be also elaborated.

    Speaker(s):

    • Concepts of the new ICSR applied in the EU
      Anja Van Haren, MSc
      EudraVigilance Coordinator
      Medicines Evaluation Board (MEB), Netherlands
    • Handling of medicinal product information in ICSRs
      Tom Paternoster-Howe
      Scientific Administrator
      European Medicines Agency (EMA), United Kingdom

    Discussant(s):

    • Ana-Silvia Cochino
      Scientific Administrator
      European Medicines Agency (EMA), United Kingdom
    • Ilaria Del Seppia
      European Medicines Agency (EMA), United Kingdom
    • Sabine Brosch, PharmD, PhD
      Monitoring and Incident Management, Pharmacovigilance
      European Medicines Agency, European Union, United Kingdom
    • Victoria Newbould
      Scientific Officer
      European Medicines Agency, United Kingdom
  • 3:00PM - 3:30PM

    COFFEE BREAK
  • 3:30PM - 4:45PM

    Session 5: EMA testing procedures and industry perspectives


    Session Chair(s):

    • Sabine Brosch, PharmD, PhD
      Monitoring and Incident Management, Pharmacovigilance
      European Medicines Agency, European Union, United Kingdom
    • Anja Van Haren, MSc
      EudraVigilance Coordinator
      Medicines Evaluation Board (MEB), Netherlands

    Speaker(s):

    • Preparation for the new ICSR implementation from a pharmaceutical industry perspective
      Diane Farkas
      Case Management and Medical Evaluation Head
      Sanofi-Aventis, France
    • An outline of potential testing procedures for the new E2B (R3) ICSR format
      Tom Paternoster-Howe
      Scientific Administrator
      European Medicines Agency (EMA), United Kingdom

Registration Fees 

Other Fees

Charitable Nonprofit/Academia
€180.00
Government (Full Time)
€180.00
Industry
€365.00
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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