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..
Upon completing of this course, participants should be able to:
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:
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)
Day 02(8:30 AM - 4:30 PM)
Michelleanne Bradley has worked in Drug Safety and Pharmacovigilance in a variety of roles. She has been the “Pharmacovigiliance department of one” with three organizations and counting. Her specialty is consulting with small companies as they start Drug Safety/Pharmacovigilance departments. Michelleanne has also worked for small, medium, and large biotech and pharmaceutical organizations, performed audits, advised on audit-readiness activities, written SOPs, and installed databases. She consults for Edge Alliance, and is the President of Metis Consulting Services Inc.