2nd Annual Pharmacovigilance and Risk Management Strategies Summit

With concerns occurring across the board in relation to PV auditing, companies face the challenge of understanding the key considerations when presenting to auditors. Unravel the challenges in compiling and presenting the new PSUR to external regulatory bodies and determine what these regulatory bodies have learnt in the wake of its recent introduction. The introduction of the new legislation has led to a significant change in how companies present there data and safety studies to external regulatory bodies. This has ultimately led to a lack of understanding in what is expected upon data presentation.

Attend this fantastic forum to discuss the format and content of Periodic Safety Update Reports and how data integration and additional modules are incorporated into this documentation to provide a far more comprehensive overview of a drug safety and efficacy. 

Key Practical Learning Points of the Summit:

  • An update on the implementation of the new pharmacovigilance legislation with a particular emphasis on the regulatory aspects
  • New features of the pharmacovigilance legislation and their impact on regulatory activities
  • New pharmacovigilance legislation and how it is impacting drug development
  • Drug safety management across a product`s lifecycle
  • Risk management and monitoring effectiveness of risk minimalisation
  • Latest innovation and trends in drug safety
  • Big data & pharmacovigilance
  • Panel discussion on impact on drug development and approval

Who Should Attend:

CEOs, Directors, Department Heads & Managers of Leading Application Creators & Suppliers from:

  • Pharmacovigilance
  • Drug safety
  • Risk / Safety management
  • Safety Surveillance
  • Patient Safety
  • QPPV
  • GPvP
  • Inspection and Audit
  • Signal Management
  • Clinical Trials
  • Safety evaluation
  • Medical product safety assessment
  • Regulatory affairs
  • Clinical research
  • Assurance and Compliance
  • Data analysis
  • Pharmacoepidemiology
  • Medical information

From Industries Including: 

  • Pharmaceuticals
  • Health Care
  • Hospital
  • Medical Practice
  • Biotechnology
  • Biologics
  • Clinical Research Organizations
  • Academic Research Centers
  • Regulatory Agencies

 

Speakers