Compliance Architects® is once again proud to serve as a GOLD SPONSOR at this year’s FDLI’s Enforcement, Litigation, and Compliance Conference!
Be sure to catch Managing Partner Jack Garvey during the breakout session on Friday afternoon –
Enforcement & Compliance Issues and Their Impact on Due Diligence in Transactions Involving FDA-Regulated Companies and Products
- John (“Jack”) C. Garvey, Managing Partner, Compliance Architects LLC
- Michael A Swit, Sr. Corporate Counsel, Regulatory Affairs, Varian Medical Systems
- Suzie L. Trigg, Partner, Haynes and Boone LLP
- Moderated by Maya P. Florence, Partner, Skadden, Arps, Slate, Meagher & Flom LLP
With the increasing difficulties in internally-generated product development, medical product companies of all sizes increasingly are looking to deals to augment product lines. Whether in the form of single products or whole companies, transactions can make or break the future of your company. However, often lost is the critical need to ensure that regulatory, clinical and quality considerations do not undermine the value or viability of a deal. This session will address the key regulatory, clinical or quality issues – including data integrity failings – that must be reviewed when purchasing an FDA-regulated product or company and how to address those concerns in the due diligence phase.
This event brings together industry, regulators, attorneys, litigators, academics, and consultants to discuss trends and issues in enforcement and compliance, the latest developments in both civil and criminal litigation, and recent cases and settlements. This year’s conference will be an in-person event, offering an opportunity to hear from and interact with top officials from FDA, DOJ, FTC, and other government agencies. As we move out of the COVID-19 pandemic, come hear from your peers about how they are staying compliance and inspection ready as FDA ramps back up inspections, what companies need to do to plan for and manage enforcement risk, trends in criminal and civil litigation, and government priorities for the new year.
- Hear about top issues, priorities, and goals for 2022 directly from ORA and FDA’s Center Compliance Directors
- Gain practical tips and best practices on preparing for and managing enforcement and compliance risk in a post-COVID era
- Learn about trends in government and private litigation, and what happens post-emergency and enforcement discretion periods