CBSA and Hogan Lovells bring you 2021’s Regulatory Symposium in four virtual sessions every Thursday from 9:00—10:00am MT starting in July.

Topics include:

• July 15: Employment Issues and Returning to Work – Including Mandatory Vaccinations
  Speakers: Michael E. DeLarco, Office Managing Partner (New York), Hogan Lovells, and Eleanor deGolian Kasper, Associate (Colorado Springs), Hogan Lovells
• July 22: The Future of Litigation – Prep Act, Government Authorizations, and Liability
  Speakers: Michael C. Theis, Partner (Denver), Hogan Lovells, and Emily Lyons, Senior Associate (Washington, D.C.), Hogan Lovells
• July 29: FDA Emergency Use Authorization and the Transition Back to Normal Health Approvals – A Look at the Next 9-18 Months (End of Public Health Declaration)
  Speakers: Jodi Scott, Partner (Denver), Hogan Lovells and Wil Henderson, Senior Associate (Denver), Hogan Lovells
• August 5: Digital Health and its Evolution Since the Beginning of COVID-19
  Speakers: Brooke Bumpers, Counsel (Washington, D.C.), Hogan Lovells and Lowell Zeta, Counsel (Washington, D.C.), Hogan Lovells and TBA

Complete Four-Session Series: Complimentary to CBSA Members/$25 Non Members
Please select all sessions you wish to attend on the registration page.

Session Details

July 15: Employment Issues and Returning to Work– Including Mandatory Vaccinations
Speakers: Michael E. DeLarco, Office Managing Partner (New York), Hogan Lovells, and Eleanor deGolian Kasper, Associate (Colorado Springs), Hogan Lovells

As COVID-19 lockdowns ease and more employees are getting back into the workplace, employers are faced with addressing a range of critical challenges and an ever-evolving regulatory landscape. This timely presentation will feature best practices for Colorado employers to help navigate key employment issues in today’s pandemic environment. We will take a focused look at state specific regulations as well as important considerations for companies operating in the life sciences and health care sector. During the session, we will also provide practical guidance on how to implement health and safety policies to keep you and your employees safe and to help get everyone back to working together in person.

July 22: The Future of Litigation – Prep Act, Government Authorizations, and Liability
Speakers: Michael C. Theis, Partner (Denver), Hogan Lovells, and Emily Lyons, Senior Associate (Washington, D.C.), Hogan Lovells

This presentation will focus on investigation and litigation risks in the post-pandemic world.  Through the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the Paycheck Protection Program (PPP) and related emergency stimulus legislation, the federal government provided massive infusions of cash into the private and public sectors. Individuals and entities had to make a variety of representations and certifications to the government to establish eligibility and, in some cases, to describe how the funds were used.  Knowingly making false claims on these programs comes with risks for civil liability and penalties under the False Claims Act (FCA). Pursuing such cases is a high priority for the Department of Justice, and historically, the Department has ramped up investigations and prosecutions in periods of increased government spending in the wake of natural and man-made crises. The CARES Act itself created a new inspectors general office—the Office of the Special Inspector General for Pandemic Recovery—that is specifically tasked with the duty to conduct investigations of loans, loan guarantees, and other investments under the Act.  We will address the risks presented under these programs, and discuss the investigation and prosecution priorities of the Department of Justice in the Covid-19 economy, including telehealth, data privacy, and compliance with the Food Drug and Cosmetic Act.  The presentation will also discuss the emergency public health declaration providing targeted immunity liability under the Public Readiness and Emergency Preparedness Act (PREP Act) for the COVID-19 pandemic.

July 29: FDA Emergency Use Authorization and the Transition Back to Normal Health Approvals – A Look at the Next 9-18 Months (End of Public Health Declaration)
Speakers: Jodi Scott, Partner (Denver), Hogan Lovells and Wil Henderson, Senior Associate (Denver), Hogan Lovells

In response to the COVID-19 pandemic the FDA has issued, and continues to issue, a large number of emergency use authorizations (EUAs) across a number of medical product categories. These authorizations are a mechanism to facilitate the availability and use of medical countermeasures (including medical devices) during public health emergencies. Under an EUA, FDA may allow the use of uncleared or unapproved medical products, or uncleared or unapproved uses of cleared or approved medical products to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met.  But what happens when the pandemic ends? This presentation will provide an overview of how an EUA is obtained, the limitations for marketing under an EUA, and what happens to the devices that have been manufactured or placed into the market under an EUA when the public health emergency comes to an end.  This latter topic will include a review of past FDA precedent dating back to the first use of an EUA during the 2009 swine flu pandemic and an assessment of the likely FDA actions as the COVID-19 pandemic, hopefully soon, comes to an end; as well as what companies ought to be doing now to plan for the period when the pandemic comes to an end (and the EUAs are no longer in effect) to protect their ability to continue to market their products.

August 5: Digital Health and its Evolution Since the Beginning of COVID-19
Speakers: Brooke Bumpers, Counsel (Washington, D.C.), Hogan Lovells and Lowell Zeta, Counsel (Washington, D.C.), Hogan Lovells and TBA

This presentation on digital health and its evolution since the beginning of the COVID-19 pandemic will address the wide range of ways digital health technologies have been implemented or expanded, and which of these changes are here to stay.  Almost overnight the use of telehealth services exploded in order to accommodate the need to limit face-to-face interactions, and we’ll address the changes in federal and state regulations, as well as government and commercial payer policies, that were required to accommodate that method of delivering health care services in a wide range of settings. We’ll also talk about the pros and cons of health care delivered through digital technologies, where it works and where it doesn’t, how policymakers are looking to the future of telehealth, and which of these changes necessitated by the pandemic are likely to remain.  The pandemic also had a dramatic effect on clinical trials, and we’ll also address some of the ways the pandemic has accelerated the use of digital technologies health innovation have been implemented in the context of research and patient monitoring, and how the FDA is viewing these changes.