Online Learning Center

An Introduction to Basic Pharmacovigilance Requirements, Concepts and Processing for
Quality Professionals

Recordings of Online Training Presentations

Presenter: 

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.



Week 1: Overview and PV Legislation - recorded 19 November 2014
Week 2: Definitions and General Processes - recorded 3 December 2014
Week 3: PV Databases and Reporting - recorded 10 December 2014
Week 4: 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.

Objectives: After this course, participants 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)
RQAP re-registration credit: 0.38 GCP or non-GLP units per session (totaling 1.52 units for all four sessions) 
 

Member Price:  $510
Nonmember Price:  $660

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