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
- Regulatory impacts on the safety database
- Key regulatory milestones of impact 2017-2021
- E2b(R3) and the new EudraVigilance
- 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
Mayank Raizada, Managing Consultant, Navitas Life Sciences
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