Drug Information Association Logo

15th EudraVigilance Information Day

Mar 12 2014 8:15AM - Mar 12 2014 5:00PM | European Medicines Agency Canary Wharf, 7 Westferry Circus London E14 4HB United Kingdom

« Back to Listing

Overview 

EudraVigilance Information Days provide a forum to update stakeholders about the achievements and latest developments with regard to EudraVigilance in the broader context of implementation of the pharmacovigilance legislation.

A dedicated session on EudraVigilance will provide a summary of the EudraVigilance functionalities, which are, according to Article 24 of Regulation 726/2004, subject to an independent audit. A progress update on the preparation for literature monitoring services by the Agency as well as on the finalisation of the EU ICSR Implementation Guide will be also provided.

This Information Day will also provide an insight into the three year EU-wide pharmacovigilance project coordinated by MHRA and referenced as “Strengthening Collaboration for Operating Pharmacovigilance in Europe” (SCOPE). This Joint Action aims to further strengthen pharmacovigilance with main focus on operation at Member States level.

Other topics addressed will include the communication and follow up of safety signals, frequently raised implementation questions related to GVP module VI and commonly encountered data quality issues in relation to ICSR reporting.

Featured Topics 

  • Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE)
  • EudraVigilance functionalities to be audited
  • Monitoring of medical literature by the Agency and the entry of relevant information into EudraVigilance
  • EudraVigilance data quality
  • Experience following publication of PRAC recommendations based on safety signals
  • GVP Module VI – questions and answers session
  • Notification process on withdrawn products

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 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 Information Day  for a limited number of rooms is GBP 139.00 per room incl. breakfast and VAT. Please book your room at least 30 days before arrival through this online link:
http://www.hilton.com/en/hi/groups/personalized/L/LONNDHI-GDIAE-20140201/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 Information Day 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 

Previous Next

Agenda  

Day 1 Wednesday, Mar 12, 2014

  • 8:15AM - 8:45AM

    REGISTRATION
  • 8:45AM - 9:00AM

    WELCOME NOTE

    Speaker(s):

    • Peter Richard Arlett, MRCP
      Head of Pharmacovigilance Department
      European Medicines Agency, European Union, United Kingdom
  • 9:00AM - 9:45AM

    Session 1: EudraVigilance


    Session Chair(s):

    • Sabine Brosch, PharmD, PhD
      Monitoring and Incident Management, Pharmacovigilance
      European Medicines Agency, European Union, United Kingdom

    This session gives insight into the EudraVigilance functionalities to be audited in accordance with Article 24 of Regulation (EC) 726/2004 and a status update on the preparations for the literature monitoring activities by the Agency in line with Article 27 of the Regulation.

    Speaker(s):

    • EudraVigilance functionalities to be audited
      Sabine Brosch, PharmD, PhD
      Monitoring and Incident Management, Pharmacovigilance
      European Medicines Agency, European Union, United Kingdom
    • EudraVigilance functionalities to be audited
      Nick Halsey
      Scientific Administrator
      European Medicines Agency (EMA), United Kingdom
    • Status update on the monitoring of medical literature and the entry of relevant information into EudraVigilance
      Steven Le Meur
      Scientific Administrator
      European Medicines Agency (EMA), United Kingdom
  • 9:45AM - 10:15AM

    Session 2: EU ICSR Implementation guide update


    Session Chair(s):

    • Sabine Brosch, PharmD, PhD
      Monitoring and Incident Management, Pharmacovigilance
      European Medicines Agency, European Union, United Kingdom

    The audience will be updated on the finalisation of the EU ICSR Implementation Guide, which is key to the preparation for the implementation of the ISO ICSR standard.

    Speaker(s):

    • ICH E2B (R3) – EU ICSR Implementation Guide
      Nick Halsey
      Scientific Administrator
      European Medicines Agency (EMA), United Kingdom
  • 10:15AM - 10:45AM

    COFFEE BREAK
  • 10:45AM - 12:00PM

    Session 2: EudraVigilance cont.


    Session Chair(s):

    • Sabine Brosch, PharmD, PhD
      Monitoring and Incident Management, Pharmacovigilance
      European Medicines Agency, European Union, United Kingdom

    Aspects related to expedited compliance monitoring and frequently encountered data quality issues related to Individual Case Safety Reports (ICSRs) submitted to EudraVigilance will be addressed.

    Speaker(s):

    • The duplicate detection algorithm in EudraVigilance
      Gianmario Candore
      Scientific Administrator
      European Medicines Agency (EMA), United Kingdom
    • Data quality management – expedited reporting compliance and frequently encountered data quality issues in ICSRs
      Tom Paternoster-Howe
      Scientific Administrator
      European Medicines Agency (EMA), United Kingdom
  • 12:00PM - 1:00PM

    SANDWICH LUNCH
  • 1:00PM - 2:30PM

    Session 3: Signal Management


    Session Chair(s):

    • Sabine Brosch, PharmD, PhD
      Monitoring and Incident Management, Pharmacovigilance
      European Medicines Agency, European Union, United Kingdom

    As of September 2013, PRAC recommendations on signals are published on a monthly basis. This session provides an overview of signals related activities from a regulators’ and pharmaceutical industry’s perspective.

    Speaker(s):

    • Management of signals from an EU regulator’s perspective
      Sabine Straus, MD
      Head of Pharmacovigilance
      Medicines Evaluation Board (MEB), Netherlands
    • Management of signals from an EMA perspective
      Georgy Genov, MD
      Head of Signal Management
      European Medicines Agency (EMA), United Kingdom
    • Experience with PRAC signals (follow-up and communication) from an industry perspective
      Laurent Auclert, MD
      Qualified Person Responsible for Pharmacovigilance (QPPV)
      Sanofi-Aventis R&D, France
  • 2:30PM - 3:00PM

    COFFEE BREAK
  • 3:00PM - 4:15PM

    Session 4: Pharmacovigilance legislation implementation


    Session Chair(s):

    • Sabine Brosch, PharmD, PhD
      Monitoring and Incident Management, Pharmacovigilance
      European Medicines Agency, European Union, United Kingdom

    Speaker(s):

    • GVP Module VI – questions and answers
      Gaby L. Danan, MD, PhD
      Pharmacovigilance Expert
      France
    • GVP Module VI – questions and answers
      Izabela Skibicka
      Scientific Administrator
      European Medicines Agency (EMA), United Kingdom
    • Notification process of withdrawn products
      Kelly Plueschke
      Scientific Administrator
      European Medicines Agency (EMA), United Kingdom
  • 4:15PM - 5:00PM

    Session 5: SCOPE


    Session Chair(s):

    • Sabine Brosch, PharmD, PhD
      Monitoring and Incident Management, Pharmacovigilance
      European Medicines Agency, European Union, United Kingdom

    This session will provide an overview of the key objective of SCOPE aiming to enable national Competent Authorities in Member States to further progress from implementation of the pharmacovigilance legislation to the operation of the legal requirements to the highest possible standards against agreed benchmarks and best practices.

    Speaker(s):

    • SCOPE
      Paul Barrow
      Head of Special Projects
      MHRA, United Kingdom

Registration Fees 

Other Fees

Charitable Nonprofit/Academia
€180.00
Government (Full Time)
€180.00
Industry
€365.00
Register Online
« Back to Listing Back To Top