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 an 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.
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:
- 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
Course Content
Day 01 (9:30 AM - 4:30 PM EST)- 09.30 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
- 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
Course Provider
Cynthia Brysch,
Senior Principal Consultant ,
PTS AdvanceCynthia is an accomplished executive director and chief compliance officer with over 17 years’ experience providing first-to-market solutions to the challenges sponsor face whilst using risk management strategies to mitigate ones in the future. She is an industry expert with contributions to over 450 sponsor programs with proven track record of optimization, quality, compliance, and fiscal responsibility. Cynthia is a certified Quality Assurance (QA) and Regulatory Affairs (RA) executive, principal consultant and published biotechnologist with an emphasis in fabricating quality-based process and product development strategies in regulated pharmaceutical, medical device and biopharma industries.
In her tenure, she has lead strategic partnerships to solve the complexities of the life science industry by providing tailored expertise with the time and resources necessary to mitigate the challenges sponsors face with expertly sourced solutions. She drives QBD initiatives into corporate portfolios to which traverse all phases of development and deployment from a financial, operative, quality, and regulatory vantage. As an expert in national and international GxP regulations, standards and guidance's, her expertise has been engaged as an international HA consultant for over 7yrs with support that traverses all product development phases to deploy best in class programs for industry sponsors including, but not limited to, Gilead, Daichi-Sankyo, Bristol Myers Squib, Amgen, Abbott, Novartis, and Roche.
Who Should Attend
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
