In this two day workshop conference we will review requirements of EMA and EU regulatory authorities. The course will focus on the laws and regulations for Pharmacovigilance during Pre-marketing and Post-marketing (EMA, GVP, ICH). Attendees will get different points of views on Regulatory, Scientific, Ethical, Marketing and understanding about the role of GVP (Good Vigilance Practice). You will learn to design complete strategy for PSUR/PBRER.
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.
The concept of “benefit/risk” ratio (no longer “risk/benefit”) has become the common denominator not only of pharmacovigilance (PV), but also of practically all drug-related regulatory activities, throughout the life cycle of a medicine, from preclinical to post-marketing.
This is a very scientifically sound approach and is also in line with the current clinical practice, however, it has made PV activities significantly more complex, since it implies that all data/information/knowledge about a drug have to be put in context before being analysed and acted upon.
The focus, in fact, has shifted from an “event-based” approach, i.e. making sure that all necessary data were properly and timely collected, to an approach in which the adequacy of information was somehow “taken for granted” and a much greater emphasis was placed on what could be done with such information.
Upon completing this course participants should:
Who Will Benefit:
This course is designed for people involved in the preparation/supervision/coordination of the regulatory/PV documents pertaining the different phases of the life cycle of a drug, in particular:
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