Lawyers and regulatory professionals need both the theoretical and practical knowledge of regulatory to be successful. Our legal sessions are designed to bridge those two principles and provide insights on how to address the global issues clients deal with on a daily basis. The best way to ensure regulatory compliance is to know what your regulatory team is dealing with. Gain an understanding for what global issues exist for the industry, how regulatory authorities are responding to them, and what that means for you and your organization. Get ahead of upcoming regulatory changes and challenges with four focused sessions that pull leaders from worldwide organizations that represent a broad range of regulatory expertise.
Where is the line between informing physicians of a drug or device's potential benefit in an off-label use and illegal promotion? Find out as we crack open several court cases and reveal their impact on off-label promotion. This session will provide lessons learned in these cases and how it may impact marketing efforts for drug and device manufacturers’ future campaigns.
One of the enforcement actions available to the FDA is the Park Doctrine in which responsible corporate officials can be held liable under the Federal Food, Drug and Cosmetic Act for offenses committed by the company even if they were not knowledgeable about the offenses. This session will review the authority of FDA to enact the Park Doctrine against officials of a drug or device manufacturer and examples of its use by FDA to educate regulatory affairs professionals on this action.
The Sunshine Act requires medical product manufacturers to report annually to CMS any payments or other transfers of value to physicians and teaching hospitals. Is your firm compliant with the Sunshine Act? In this session, learn the basic requirements for reporting and we’ll bring to light how this regulation and the enforcement of it in the US can impact all device, pharmaceutical and biologics manufacturers.
Intellectual property is key in product development and company valuations, and securing it should be paramount to a manufacturer’s business plan. But what happens when you haven’t secured it and already have a prototype? We’ll discuss protecting intellectual property at different stages of product development, and hear some practical advice about keeping your intellectual investments to yourself.
With the global economy, regulations such as the Foreign Corrupt Practices Act (FCPA) become increasingly important for regulatory professionals to understand the regulation, especially as it relates to product promotions and contracts with distributors and government entities outside the US. This session will provide an overview on FCPA and examples of its use against drug and device manufacturers.