San Francisco, California
London, United Kingdom
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.
As a matter of fact, in the past few years drug companies – especially the major ones – have been required to put a lot of effort and resources on activities like signal detection and signal management. In addition, Product Safety Update Reports (PSURs) and Risk Management Plans (RMPs), for a certain period considered essentially as “formalities”, have recently been analysed and criticized by Regulatory Authorities, in greater and greater depth.
This process - which could be summarized in the phrase “from data to knowledge to action” - has continued in the following years, too.
The RMP and the PSUR can be also considered as a “proactive PV” attempt, since it gives great importance not only to what we know about a drug, but also to what we do not know and to what can be done to minimize the possible consequences and/or to fill the gaps.
The preparation of such documents – in the most consistent and cost/effective way - now requires a relevant level of cooperation among the different departments of a Pharma company, and a “knowledge base” (vs. a “data based”) approach, which is the object of this two-day course.
Upon completing this course participants should:
- Understand the concept of benefit/risk (B/R) ratio, also in the light of the existing EU regulations
- Evaluate the data/information available on the B/R ratio of a drug
- Critically examine the different “Regulatory” and “Pharmacovigilance” documents pertaining to the different phases of the life cycle of a drug.
- Perform a “gap analysis” of the existing documentation
- Plan the different phases of the preparation of a PSUR/RMP
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:
- Medical Affairs
- Medical Departments
- Regulatory Affairs
- Medical Writing
Note: Use coupon code < NB5SQH8N > and get 10% off on registration.
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When & Where
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.