Recorded Online Training Series - An Introduction to Basic Pharmacovigilance Requirements, Concepts and Processing for Quality Professionals
Presenter: Christina Colon, DSP Global Compliance Manager, Novartis Consumer Health
Pricing: $510 for members; $660 for nonmembers
Lesson 1: Overview and PV Legislation
Lesson 2: Definitions and General Processes
Lesson 3: PV Databases and Reporting
Lesson 4: PV Auditing
This four-session GxP online training course was presented to a live webinar audience in November and December 2014. The recorded lessons provide a solid understanding of Good Pharmacovigilance Practices (GPvP) 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. Learners 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, learners will understand how quality professionals fit into the world of GPvP in relation to Product Quality Compliant (PQC) handling and providing accurate quality investigation/supporting documentation to help meet quality standards. Finally, the course covers key areas of concern based on known auditor/inspector observations made during routine or "for-cause" GPvP related audits and inspections.
Objectives: After this course, learners shall be able to:
- 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)
Each lesson is approximately 90 to 100 minutes long.
You cannot purchase the individual lesson recordings; this course is only available as a series of four lessons.