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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, partners (the PV Universe). The PV Audit Strategy Plan is used to prepare the PV audit program, i.e. annual PV Audit Schedule.

In this two day workshop conference we will review the EMA and FDA requirements regarding Risk Based Audits of the PV system and Quality System. The course will focus on the design of the PV audit strategy, identification of the PV processes and entities subject to PV audit (define the PV audit universe), development of risk assessment methodology, development of procedures/tools to monitor PV processes and activities, and implementation of the PV audit strategy plan. Additionally, we will review methods of quality oversight and management of third parties performing PV activities..

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

Upon completing of this course, participants should be able to:

  • Understand the FDA and EMEA’s requirements for a risk based audit program and current interpretation. Plan, develop and implement the PV Audit Strategy Plan, which includes the following processes:
    • Develop a high-level PV audit strategy
    • Identify the PV activities and processes subject to PV audit
    • Develop risk assessment criteria
    • Identify the PV audit universe – entities subject to PV audit
    • Categorize the entities subject to PV audit
    • Perform risk assessments
    • Prioritize entities for audit according to relative risk
    • Prepare a 3-5 year PV audit plan
  • Identify procedures/tools to monitor PV quality of third parties

Who will Benefit:

This course is designed for people with some PV experience and tasked with developing, maintaining, updating and/or reviewing the PV quality system audit strategy plan, risk assessment and/or the annual PV audit schedules. It is also beneficial for staff responsible for the quality oversight of third parties conducting PV activities.

The following personnel will benefit from the course:

  • PV Quality Assurance Staff
  • PV Compliance professionals
  • Quality auditors
  • Pharmacovigilance Auditors
  • Relevant Pharmacovigilance Staff
  • PV Service Provider Relationship Managers
  • MAH Affiliates responsible for Pharmacovigilance
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There will be a 15 minute morning break, 1 hour lunch break, and 15 minute afternoon break on each training day.

Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Review of FDA and EMEA requirements for risk based PV audits
  • The pharmacovigilance system and the quality system
  • Strategic level audit planning
  • Hands on exercise
  • PV activities and processes subject to PV audit
  • Risk assessment criteria
  • The PV audit universe - all entities subject to PV audit
  • Safety data exchange agreements (SDEAs) and vendor contracts
Day 02(8:30 AM - 4:30 PM)
  • Stability (shelf-life) studies
  • Categorization of the entities (PV Audit Universe)
  • Risk assessments
  • Prioritization of entities for audit according to relative risk
  • 3-5 year PV audit plan
  • Hands on exercise
  • Procedural documents, e.g. SOPs
  • Identify procedures/tools to monitor PV quality for oversight of third parties
  • Q & A
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Marina Malikova

Marina Malikova
Executive Director at Boston University School of Medicine

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.

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