EVENT BIO

See breakdown of all you need to know about our Summit

HOT CONFERENCE TOPICS

  • Lessons learned from the risk minimization strategies
  • Function of the Safety Management Teams
  • Safety Review of products in development and post-marketing
  • What are the potential uses for social media to improve drug safety?
  • Vendor management and outsourcing of pharmacovigilance services
  • New definitions in the Maternal Immunization (MI) Pharmacovigilance
  • Risk Management Plans rule amendments
  • Evolving themes for Safety Signal Detection in Clinical Development and post-Marketing
  • New technologies in Pharmacovigilance
  • Benefit-Risk Management

WHO WILL YOU MEET

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

  • Drug Safety
  • Pharmacovigilance
  • Risk Management
  • Clinical Safety
  • Data management and data mining
  • 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
  • Medical Safety
  • Medical Information
  • Pharmacoepidemiology

PRE-CONFERENCE WORKSHOPS

Workshop A 15:00 - 16:00

Global harmonization of Pharmacovigilance

24 October 2017, 15:00 – 16:00

  • How should a global RM strategy for a product be implemented in local countries?
  • How to adapt to changes in regulations from worldwide regulators?
  • Understand CIOMS guidelines and methods of implementation by regulators
  • How do different countries deal with multiple different requirements for PV reports?
  • How are various ICH regions working to implement global harmonization practices in the areas of drug safety and risk management?

Workshop B 16:00 - 17:00

Risk Management Strategies and Risk Management Plans

24 October 2017, 16:00 – 17:00

  • RMPs rule amendments and its implementation
  • How to measure the effectiveness of RM strategies not only in the US and EU, but worldwide, wherever we market products?
  • What new approaches and priorities should be considered in the Risk Minimization Activities?
  • Main challenges and practical ways to approach safety measures
  • What new approaches and mindset is required given the enhanced regulations?

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