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The European Medicines Agency’s (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine its effectiveness. It includes audit of the pharmacovigilance system which is covered by the quality system.

The GVP Modules are applicable to EU-based companies and any company marketing medicinal products on a global basis. The legally required risk based audit strategy shall cover all PV processes and tasks undertaken by or delegated to other departments, MAH affiliates, and third parties such as distributors, external service providers, and partners. The PV Audit Strategy Plan is used to prepare the PV audit program, i.e. annual PV Audit Schedule.

Why You Should Attend:

In this session we will review the EMA and FDA requirements regarding Risk Based Audits of the PV system and Quality System. We will focus on the design of the safety, pharmacovigilance (PV) audit strategy, identification of the PV processes and entities subject to PV audit, development of risk assessment methodology, and development of procedures / tools to monitor PV processes and activities, and implementation of the PV audit strategy plan.

Areas Covered in the Session : 


  • Review the EMA PV Modules at the basic level
  • Recognize post-marketing PV expectations and compliance on a global level
  • Understand the FDA and EMEA’s requirements for a risk based audit program and current interpretation.
  • Determine PV reporting responsibilities applicable to global PV submissions
  • Plan, develop and implement the PV Audit Strategy Plan
  • Identify the PV activities and processes subject to PV audit
  • Develop risk assessment criteria
  • Identify the PV audit scope and entities subject to PV audit
  • Categorize the entities subject to PV audit
  • Perform risk assessments
  • Prioritize entities for audit according to relative risk
  • Apply basic auditing concepts to assess PV compliance

Who Should Attend:

  • PV Quality Assurance Staff
  • PV Compliance professionals
  • Quality auditors
  • Pharmacovigilance Auditors
  • Relevant Pharmacovigilance Staff
  • PV Service Provider Relationship Managers
  • MAH Affiliates responsible for Pharmacovigilance
  • Heads of Pharmacovigilance Quality Assurance Departments
  • Auditors transitioning into pharmacovigilance auditing
  • Drug Safety Staff
  • Medical Information Staff
  • Safety Physicians

Course Director: MARINA MALIKOVA

Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.

Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.

In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, safety monitoring, strategic planning, and macro-management of research programs. She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance.