6TH ANNUAL RISK MANAGEMENT AND PHARMACOVIGILANCE SUMMIT17 - 19 SEPTEMBER 2019, VIENNA
SUMMIT IS OVER
17 September 2019 I 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
17 September 2019 I 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?
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