Christina Colon, DSP Global Compliance Manager, Novartis Consumer Health
Christina Colon is a pharmacovigilance (PV) professional with over 12 years experience in Drug Safety case processing, quality assurance, clinical development/research, training and compliance within the pharmaceutical industry.
Overview and PV Legislation - recorded 19 November 2014
Definitions and General Processes - recorded 3 December 2014
PV Databases and Reporting - recorded 10 December 2014
PV Auditing - recorded 17 December 2014
This four-session GxP online training course provides a solid understanding of Good Pharmacovigilance Practices requirements to non-PV professionals or fresh entrants into the PV arena. The course material ranges from a historical perspective to present day monitoring and reporting activities. Attendees will gain experience in defining what adverse event reporting is, what regulators and health authorities require in the US and the European Union, general processing guidance, risk management/mitigation strategies, along with PV and quality system structure. Additionally, attendees will learn how quality professionals fit into the world of Good Pharmacovigilance Practices in relation to Product Quality Compliant (PQC) handling and providing accurate quality investigation/supporting documentation to help meet quality standards. Finally, the course will cover key areas of concern based on known auditor/inspector observations made during routine or "for-cause" Good Pharmacovigilance Practices related audits and inspections.
After this course, participants shall be able to:
RQAP re-registration credit:
- Define the basic requirements of Good Pharmacovigilance Practices
- Determine the appropriate duties and oversight required by PV staff and quality staff
- Ensure that quality practices are designed and implemented to
guarantee compliant PV reporting and risk minimization/mitigation
strategies (including signal detection and escalation measures to key PV
and quality decision makers)
0.38 GCP or non-GLP units per session (totaling 1.52 units for all four sessions)