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
    Head of Safety and Efficacy of Medicines
    European Medicines Agency, United Kingdom
  • Julie Williams, PhD
    MHRA, 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):

  • EU PSUR Single Assessment Procedure
    Heidi Janssen
    Scientific Administrator
    European Medicines Agency, United Kingdom
  • List of EU reference dates and frequency of submission of PSURs
    Kelly Plueschke
    European Medicines Agency, United Kingdom
  • PSUR assessment under the mandate of the PRAC and PRAC recommendations
    Julie Williams, PhD
    MHRA, United Kingdom
• 1:00PM - 2:30PM

  PSUR DECISION MAKING, TRANSPARENCY AND THE ROLE OF EUDRAVIGILANCE

  
  Session Chair(s):

  • Heidi Janssen
    Scientific Administrator
    European Medicines Agency, United Kingdom
  • Michael Richardson, MD,FFPM
    International Head GPV&E and EU QPPV
    Bristol-Myers Squibb, United Kingdom

  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):

  • How EudraVigilance data are used in the context of the PSUR assessment
    Francois Domergue
    European Medicines Agency, United Kingdom
  • Zaide Frias, PharmD
    Head of Regulatory Affairs
    European Medicine Agency, United Kingdom
  • Publication of the outcome of PRAC assessments of PSURs in the European Medicines web-portal
    Juan 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):

  • Industry perspective on the PSUR preparation and assessment process
    Omer De Mol
    Genzyme Netherlands, Netherlands
  • Valerie E. Simmons, MD,FFPM
    EU QPPV, Global Patient Safety
    Eli Lilly and Company Ltd, United Kingdom
  • EU Regulatory network perspective on the PSUR assessment process
    Almath Spooner
    Pharmacovigilance and Risk Management Lead, IMB and Vice Chair, PRAC
    IMB, Ireland