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EVENT BIO

See breakdown of all you need to know about our Summit

HOT CONFERENCE TOPICS

  • Use of Real World Data in Supporting Pharmacovigilance
  • Pharmacovigilance in the Emerging Markets
  • Strategic Partnerships in PV
  • Strategic Drug Safety & PhV: Learnings and Practical Considerations
  • QPPV Regulations in Non-EU Countries – Implications for Multi-/National MAH
  • From Clinical Monitoring to Signal Detection in Clinical Development
  • The Role of Quality Assurance in PV
  • Patient Involvement in Clinical Development of Medicines
  • Integrating Safety Evidence

WHO WILL YOU MEET

Who Should Attend – Members of board, C-level, Senior/Global Vice Presidents, Directors, Heads of departments from pharmaceutical industry involved in:

  • Pharmacovigilance
  • Drug Safety
  • Safety & Risk Management
  • Signal Detection
  • Benefit-Risk Assessment
  • Safety Evaluation
  • Regulatory Affairs, Pharmacovigilance
  • PV Governance
  • Safety Surveillance
  • Pharmacovigilance Operations
  • PV Inspection and Audit Readiness
  • Patient Support Programs
  • Market Research Programs
  • Clinical Safety
  • Medical Safety
  • Medical Information
  • Pharmacoepidemiology
  • Quality Assurance, Pharmacovigilance

Workshop A
17 September 2019 – 15:00 – 16:00

Pharmacovigilance Inspection and Audit Readiness

  • What are the most common failures found by the inspection?
  • Sufficient oversight of all third parties as a crucial step to pass the inspection
  • CAPA Management – Resolving inspection findings
  • Communication with the inspector
  • Inspection preparation and documentation

Workshop B
17 September 2019 – 16:00 – 17:00

Reporting and Data Collection in PV

  • Spontaneous reporting systems as the cornerstone of pharmacovigilance
  • The value of patient reporting to the pharmacovigilance system
  • How to stimulate reporting so it becomes an accepted and understood routine?
  • Leveraging data from multiple data sources including: Google searches, Twitter microblogs, nearly real-time hospital visit records, and data from a participatory surveillance system
  • What is new in the guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use?

WHAT DELEGATES SAID

6th Annual Risk Management and Pharmacovigilance Summit
TIME IS RUNNING OUT! DON’T RISK MISSING IT

THANK YOU FOR YOUR CALL REQUEST

You will be contacted shortly.

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