Navitas Networks Webinar: The safety database in a pharma company - tactical considerations for delivering on compliance and efficiency

 Date & Time: September 14th, 2017
11:30 am – 13:00 pm GMT, 4:00 pm to 5:30 pm IST 
Agenda:
  • Regulatory impacts on the safety database
    • Key regulatory milestones of impact 2017-2021
    • E2b(R3) and the new EudraVigilance
    • IDMP
    • WHOdrug B3/C3
    • General Data Protection Regulation (GDPR)
  • Increasing efficiency in case processing by utilising functionalities and interfaces
    • What is industry doing to manage ICSR caseloads
    • Options for safety database integrations and pros and cons of available functionalities
  • Handling market complexities
    • Managing/configuring  increasingly disparate local reporting requirements
    • What are the technology options for managing patient support programs
    • Multiple PSMFs, multiple efforts?
  • Dilemmas for using the safety database for aggregate reporting and analytics
    • A look at different models and their pros and cons
  • Looking forward
    • What is on the horizon?
    • The PV Automation working group

Speakers
Mayank Raizada, Managing Consultant, Navitas Life Sciences

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