1st Information Day on Periodic Safety Update Reports -ICH E2C(R2) Periodic Benefit-Risk Evaluation Reports (PBRERs)

Day 1 Wednesday, June 19, 2013

• 9:00AM - 10:00AM

  NEW PHARMACOVIGILANCE SYSTEM AND THE NEW SCOPE, FORMAT AND CONTENT OF THE PERIODIC SAFETY UPDATE REPORTS (PSURS)

  
  Session Chair(s):

  • Sabine Brosch, PharmD,PhD
    Business Lead, EudraVigilance and International Standardisation in PhV
    European Medicines Agency, European Union, United Kingdom
  • Almath Spooner
    Pharmacovigilance and Risk Management Lead, IMB and Vice Chair, PRAC
    IMB, Ireland

  This session will present the changes to periodic reporting in the wider context of the new EU system for pharmacovigilance and risk management. Moreover, the session will present an overview of the scope, format and content of the new ‘PSUR’ and provide insight into approaches to the assessment of the risk-benefit balance as introduced by the new pharmacovigilance legislation and the new ICH-E2C(R2) guideline on the Periodic Benefit Risk Evaluation Report (PBRER).

  Speaker(s):

  • Rodrigo Postigo
    Pharmacovigilance and Risk Management
    European Medicines Agency, United Kingdom
  • Valerie E. Simmons, MD,FFPM
    EU QPPV, Global Patient Safety
    Eli Lilly and Company Ltd, United Kingdom
• 10:30AM - 12:00PM

  ASSESSMENT OF PSURS IN THE EU REGULATORY NETWORK

  
  Session Chair(s):

  • Enrica Alteri
    European Medicines Agency, United Kingdom

  This session will give a unique insight of the assessment of PSURs in the EU taking into account the role of the Pharmacovigilance Risk Assessment Committee (PRAC) and the establishment of the EU single assessment procedure. The session will also explain the role of the EU Reference Date list and the opportunity it presents for harmonisation beyond the EU.

  Speaker(s):

  • Menno Van Der Elst
    Assessor Pharamcovigilance
    Medicines Evaluation Board, Netherlands
• 1:00PM - 2:30PM

  PSUR DECISION MAKING, TRANSPARENCY AND THE ROLE OF EUDRAVIGILANCE

  
  Session Chair(s):

  • Menno Van Der Elst
    Assessor Pharamcovigilance
    Medicines Evaluation Board, Netherlands

  This session will provide clarity on the regulatory outcomes following the assessment of the PSURs and the different possible scenarios together with tips on how to optimise the PSUR drafting, submission, assessment and consultation to deliver robust regulatory action for public health. Moreover the publication of documents relating to PSURs and PSURs assessment procedures will be outlined as part for the transparency provisions established in the EU legislation and the role of EudraVigilance data will be explored.

  Speaker(s):

  • Zaide Frias, PharmD
    Head of Regulatory Affairs
    European Medicine Agency, United Kingdom
  • Jvan Burgos Garcia
    Scientific Administrator
    European Medicines Agency, United Kingdom
• 3:00PM - 4:30PM

  EXPERIENCES ON THE PREPARATION AND ASSESSMENT OF PSURS

  
  Session Chair(s):

  • Peter Arlett, MRCP
    Head of Pharmacovigilance and Risk Management
    European Medicines Agency, United Kingdom

  This session will integrate the experiences from the perspective of the pharmaceutical industry and EU regulators on the preparation and assessment of PSURs following the implementation of the pharmacovigilance legislation and the transitional period for the new content of PSURs. This session will provide an opportunity for questions and debate and will highlight the key changes, challenges and lessons learnt from PSURs preparation and assessment focusing on the importance of the reassessment of the risk-benefit balance from the perspective of patient safety and public health and the strengthening of the link between assessment and regulatory action.

  Speaker(s):

  • Laurent Auclert, MD
    QPPV
    Sanofi, France
  • Valerie E. Simmons, MD,FFPM
    EU QPPV, Global Patient Safety
    Eli Lilly and Company Ltd, United Kingdom
  • Almath Spooner
    Pharmacovigilance and Risk Management Lead, IMB and Vice Chair, PRAC
    IMB, Ireland