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EVENT BIO

See breakdown of all you need to know about our Summit

HOT CONFERENCE TOPICS

  • The interface of digital medicine and drug safety
  • Navigating the complexities of Reference Safety Information (RSI) in the clinical trial setting
  • Immune-Related Adverse Events in oncology
  • Artificial Intelligence and Machine Learning in drug safety
  • How to develop an overall business partner PV audit strategy?
  • New challenges in global safety governance
  • Building a drug safety department
  • Benefit-risk assessment and patient centricity in drug safetyEmerging new technologies in PV

WHO WILL YOU MEET

Members of board, C-level, Senior Vice Presidents, Vice Presidents, Directors, QPPVs, and Heads of departments from pharmaceutical industry/industries involved in:

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

Workshop A
23 October 2018 I 15.00 – 16.00

Ongoing trends in Pharmacovigilance and Risk Management

  • Digital Media to complement the current safety systems for evaluating medicines
  • Mobile Technologies and Social Media in Pharmacovigilance
  • How will technology, personalized research and pharmacovigilance impact drug safety and development in the future?
  • How to deliver a patient-centric pharmacovigilance program?
  • Incorporation of new technologies in global pharmacovigilance

Workshop B
23 October 2018 I 16.00 – 17.00

Risk Minimization and Benefit-Risk Management

  • Structured benefit-risk assessments – How differently pharmaceutical companies are implementing new FDA guidance?
  • The patient voice in Benefit-Risk Assessments: How do you include the patient in the benefit-risk assessment at an early stage in drug development?
  • Benefit-risk balance of Social Media for ADR monitoring
  • How to measure effectiveness of the risk minimization and benefit optimization
  • The relevance of literature monitoring in detecting ADRs and in monitoring the benefit-risk profile of a medicinal product after authorization

WHAT DELEGATES SAID

3rd Annual Risk Management and Pharmacovigilance America Summit
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