Katherine Norris, Director, Berkeley Research Group,LLC to Speak at the Knowledge Group’s Speaking Opportunity - FDA’s New Off-Label Guidance: Significant Issues Explored
The Knowledge Group/The Knowledge Congress Live Webcast Series, the leading producer of regulatory focused webcasts, has announced today that Katherine Norris, Director, Berkeley Research Group, LLC will speak at the Knowledge Group’s webcast entitled: “FDA’s New Off-Label Guidance: Significant Issues Explored!” This event is scheduled for December 19, 2018 from 3:00pm – 4:00pm (ET).
- (1888PressRelease) December 08, 2018 - The Knowledge Group/The Knowledge Congress Live Webcast Series, the leading producer of regulatory focused webcasts, has announced today that Katherine Norris, Director, Berkeley Research Group, LLC will speak at the Knowledge Group’s webcast entitled: “FDA’s New Off-Label Guidance: Significant Issues Explored!” This event is scheduled for December 19, 2018 from 3:00pm – 4:00pm (ET).
For further details, please visit:
https://theknowledgegroup.org/event-homepage/?event_id=3831
About Katherine Norris
Ms. Norris brings 17 years of compliance experience to support life sciences companies in a broad range of strategic and operational compliance objectives. As an industry professional, Ms. Norris has developed and overseen all aspects of compliance programs, including CIA implementation; HCP engagement and Fair Market Value determination; auditing and monitoring; interactions and engagements with health care professionals; strategic marketing and sales initiatives; transparency reporting; class-wide REMS compliance for controlled substances; and clinical, R&D and post-market surveillance. She has managed global FCPA/ABAC programs as well as a complex OFAC/ITAR/EAR compliance program for the manufacture, sale and distribution of chemical weapons antidotes sold exclusively to US and foreign militaries. Ms. Norris has also performed substantial internal investigations and supported extensive federal investigations with the U.S. DOJ, HHS OIG, and SEC, among others.
About Berkeley Research Group, LLC
Berkeley Research Group, LLC (BRG) is a global consulting firm that helps leading organizations advance in three key areas: disputes and investigations, corporate finance, and strategy and operations. Headquartered in California with offices around the world, BRG is an integrated group of experts, industry leaders, academics, data scientists, and professionals working beyond borders and disciplines. BRG has in-depth experience across a wide range of industries and markets, from construction and energy to technology and life sciences.
BRG’s Corporate Compliance and Risk Management experts have extensive pharmaceutical and medical device industry expertise and advise companies on developing and implementing effective corporate compliance and risk management programs. Our professionals have firsthand experience in C-suite corporate compliance, government enforcement, and advanced transactional data analysis; therefore, they have a greater understanding of the operational, technical, and legal challenges that compliance officers must address. BRG experts leverage this industry and enforcement knowledge, and leading compliance best practices to provide innovative, data-driven, cost-effective, and practical solutions to enhance operational efficiency, inform business decision making, and proactively address and remediate key compliance risks.
Event Synopsis:
Previous Off-label Guidance left unclear boundaries on what exactly is there to abide that only resulted in repeated incidences of violations. Hence, pharmaceutical companies continue to push the U.S. Food and Drug Administration (FDA) as well as the court system to elucidate on the issue.
Recently, the FDA put into print two additional guidance documents, one addressing how insurance companies and other payors can share economic and other information, and the other addressing how companies can communicate information that is not contained in a product's labeling but is still consistent with the labeling. Thus, the latest published documents casts light for pharmaceutical companies and manufacturers in avoiding possible risks and pitfalls when comparing the safety and efficacy of one drug to another.
In this LIVE Webcast, a panel of thought leaders and professionals assembled by The Knowledge Group will provide the audience with an in-depth analysis of the FDA’s New Off-Label Guidance. Speakers will also present the fundamentals and legal considerations of the guidance, as well as tips and strategies to avoid prevalent drawbacks.
Key issues that will be covered in this course are:
- FDA’s New Off-Label Guidance: An Overview
- Scope, Triggers and Limitations
- Common Risks and Pitfalls
- Current Issues and Developments
- What Lies Ahead
About The Knowledge Group/The Knowledge Congress Live Webcast Series
The Knowledge Group was established with the mission to produce unbiased, objective, and educational live webinars that examine industry trends and regulatory changes from a variety of different perspectives. The goal is to deliver a unique multilevel analysis of an important issue affecting business in a highly focused format. To contact or register for an event, please visit: http://theknowledgegroup.org/
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