2-Day In-Person Seminar

The Risk-Based Approach to Pharmacovigilance Audits - A Practical Approach to Design and Implementation

BY: Natasa Mihajlovic,

Managing Director, NostraPharma Ltd

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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 has to cover all PV processes and tasks undertaken by or delegated to other departments, Marketing Authorization Holder affiliates, and third parties such as distributors, external service providers, licensing partners. In other words, has to cover all PV Universe. The PV Audit Strategy Plan is used to prepare the PV audit program, i.e. annual PV Audit Schedule. Using risk-based approach to develop an audit strategy, companies can conform to the regulatory requirements and business needs. But the questions remain: How to do it? Where to start? How to improve? What are the best industry practices?

In this two day workshop, we will review the legal GVP requirements (predominantly European, FDA and Arab League) regarding risk-based audits of the PV system and quality system. The course will focus on:

  • The design of the PV audit strategy and tactical PV audit plan/schedule.
  • Identification of the PV processes and entities subject to PV audit (understanding how to define the PV audit universe)
  • Development of risk assessment methodology for various aspects of PV world (for instance computerized systems, market research, patient support programmes, vendors, processes etc)
  • Development of procedures/tools to monitor PV processes and activities, and implementation of the PV audit strategy plan.
Learning Objectives:

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

  • Understand the legal requirements and health authority expectations for a risk based audit program and current interpretation.
  • Plan, develop and implement the PV Audit Strategy Plan, which includes the following processes:
    • Identify the PV activities and processes subject to PV audit
    • Identify the PV audit universe – entities subject to PV audit
    • Categorize the entities subject to PV audit
    • Develop risk assessment criteria specific to PV areas
    • Perform risk assessments
    • Develop a high-level PV audit strategy
    • 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
Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Review legal requirements for risk-based PV audits
  • The pharmacovigilance system and the quality system
  • Identifying PV audit universe - all entities subject to PV audit, such as:
    • Pharmacovigilance (PV) Agreements
    • Computerized systems
    • Market research/ patient support programmes
    • Vendors/ service providers
    • PV activities and critical PV processes
    • MAH affiliates
  • Risk assessment criteria
  • Strategic level PV audit planning
  • Hands on exercise
  • Q & A
Day 02(8:30 AM - 4:30 PM)
  • Categorization of the entities (PV Audit Universe)
  • Prioritization of entities for audit according to relative risk
  • 3-5 year PV audit plan
  • Procedural documents supporting PV audits and common gaps
  • Identify procedures/tools to monitor PV quality for oversight of third parties
  • Hands on exercise
  • Q & A
Natasa Mihajlovic
Natasa Mihajlovic, Managing Director, NostraPharma Ltd

Natasa Mihajlovic is an experienced European Qualified Person for Pharmacovigilance, certified trainer and certified lead auditor with over 23 years’ experience in the pharmaceutical consultancy and industry coupled with MSc in pharmacovigilance. She has worked at the corporate and affiliate level and has been consultant since 2008. During her consultancy career, Natasa has worked with big pharma as well as, a number of small and medium sized companies with headquarters in the USA, UK, Sweden, France, Spain, Belgium, Italy, Germany, India and Japan. She has been auditing since 2005 and conducted over 230+ audits and have +540 days auditing experience of headquarters, affiliates, licensing partners, PV processes and PV service providers in the EU, US, Middle East, Central and South America, Asia and Australia. Natasa has taken part in the multiple regulatory pre-inspections and inspections (including EMA, FDA, Swedish, French, German, Croatian, Turkey, Hungarian Regulatory Authority and number of MHRA inspections).

In 2008, Natasa has established NostraPharma Ltd. NostraPharma Ltd is a group of the independent Senior Consultants each with 20+ years’ experience, knowledge, and potential to provide a variety of PV and quality services. NostraPharma Ltd specializes in GVP/GCP remote and process audits and focuses on setting up and improvements of PV quality systems, QPPV office including PSMF maintenance, inspection readiness and gap analysis.

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