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:
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:
Cynthia Cabrera, runs Global Solutions & Services, Inc. which provides training in international logistics and trade, provides export management services and logistics process consulting. She is a certified member of ASTL (American Society of Transportation & Logistics), is a registered speaker with the Nightingale Conant Speakers Bureau, teaches International Trade at Broward College, and serves on various not for profit boards. She has 15 years of experience in international trade and logistics and travels frequently to speak on the subject.