Pre-Conference Workshop - Monday, 19th September 2016

Workshop A

09:00 AM - 1:00 PM Good Pharmacovigilance Practices (GVP) Overview and Implementation

Deepa Arora, ‎Vice President- Pharmacovigilance & Global Head, Lupin
  • Implementation of GVP
  • Preparing and Maintaining Pharmacovigilance System Master Files
  • Reporting of adverse drug reactions – criteria, SOPs, and roles of stakeholders
  • Update of PBRERs, Risk Management Plans and Post-Authorisation Safety Studies (PASS) requirements
  • How to successfully and pro-actively pass inspections and audits

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Deepa Arora

‎Vice President- Pharmacovigilance & Global Head
Lupin

Workshop C

1:00 PM - 4:00 PM A Life Cycle Approach to Writing Periodic Benefit-Risk Evaluation Reports (PBRERs)

E Stewart Geary, Chief Medical Officer, Vice President and General Manager, Eisai Co., Ltd.
  • Adherence to Pharmacovigilance Risk Assessment Committee guidelines
  • Understanding rationale, format and content for writing PSURs/PBRERs
  • Developing a “Benefit Maximisation Plan” toolbox for approved medicines
  • Reporting, evaluating and summarising safety data and signals
  • Incorporating communication within and across agencies to patient support programmes (PSP)
  • Collating patient and healthcare provider inputs from various social and digital channels
  • Managing variations in safety restrictions, license suspension and withdrawal

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E Stewart Geary

Chief Medical Officer, Vice President and General Manager
Eisai Co., Ltd.