Beth P. Weinman, Counsel, Ropes & Gray LLP to Speak at The Knowledge Group’s Webcast

July 31, 2020 - For further details, please visit:

About Beth P. Weinman
Beth Weinman focuses her practice on FDA regulation and enforcement of laws governing pharmaceuticals, biologics, medical devices and dietary supplements. Beth provides counseling on issues related to off-label promotion, good manufacturing practices, good clinical practices, compounding, product recalls and withdrawals, False Claims Act (FCA) and Federal Food, Drug, and Cosmetic Act (FDCA) investigations.
Prior to joining Ropes & Gray, Beth spent nearly eight years as Associate Chief Counsel for Enforcement within FDA’s Office of Chief Counsel. In that role, she worked closely with FDA’s Office of Criminal Investigations, the Department of Justice and other government agencies to investigate and, when appropriate, prosecute alleged violations of the FDCA and related crimes under Title 18.

Before starting at FDA, Beth was an associate in the litigation department of a large New York law firm.

About Ropes & Gray LLP
Ropes & Gray is a leading global law firm with 11 offices located around the world. Our Washington, D.C.-based FDA regulatory team includes seasoned lawyers knowledgeable in all areas of FDA regulation. The team’s varied backgrounds bring a breadth of perspectives to the practice which includes attorneys who have worked at the FDA, as in-house counsel at life sciences companies and as key policy advisors in Congress.

As part of our multidisciplinary life sciences group, our FDA regulatory team has a broad view of the commercial and regulatory forces affecting life sciences companies. In addition to traditional regulatory counseling and administrative litigation, we advise clients on corporate and transactional matters, government enforcement investigations, compliance program design and implementation, and FDA-related intellectual property analyses and litigation.
Event Synopsis:

The COVID-19 pandemic has resulted in a major shift in FDA regulatory and enforcement priorities and has had a drastic impact on the broader regulatory landscape. At the end of 2019, the agency was focused, among other issues, on opioids, youth vaping, food safety, compounding and overhauling the regulatory framework for dietary supplements. Today, FDA is focused on helping industry bring to market drugs, devices and vaccines critical to fighting the pandemic. Its enforcement efforts are focused on those who peddle false cures or distribute counterfeit or otherwise poor quality products. The world has changed, and with it the regulatory environment.

FDA has issued guidances and templates to help industry develop substantive emergency use authorization requests with sufficient information to enable effective and streamlined review, exercised enforcement discretion where it deemed the benefits outweighed the risks, and waived regulatory requirements to help get products to market quickly. And FDA has indicated its willingness to “course correct” when evidence has demonstrated that the agency’s flexibility resulted in more harm than good. FDA is also providing significant trial design assistance and wading into thorny ethical issues in connection with the race to develop a vaccine.

There may be long-lasting effects from the pandemic even after the immediate threat abates. Going forward, companies may opt to reevaluate their supply chains, taking into consideration the shortages seen during the pandemic attributable in part to the country’s reliance on foreign sources of API, finished drugs, and devices like N95 masks. FDA has also shown willingness to use real world evidence as it evaluates COVID-19 therapeutics and has welcomed digital health applications that enable remote monitoring of clinical trial subjects and remote evaluation and treatment of sick patients. Certain changes may remain after the pandemic subsides and the current public health emergency declaration is lifted.

In this webcast, Beth P. Weinman (Ropes & Gray LLP) and Jennifer Mallory (Nelson Mullins Riley & Scarborough LLP) will address the above topics as they provide an overview of the impact of COVID-19 on the FDA regulatory environment.

About The Knowledge Group
The Knowledge Group is a leading provider of Continuing Legal Education, CLE, for lawyers, Continuing Professional Education, CPE, for accountants and a variety of other types of continuing education for other professions. Our mission is to deliver quality continuing education programs utilizing industry trends and the latest technology to communicate regulatory shifts and contributions made to different fields. Our insightful and engaging webcasts are brought to you by leading influencers to offer a multitude of perspectives and outlooks.

In bringing together thought leaders, regulators, and subject matter experts from around the world, The Knowledge Group strives to be the best-in-class provider of continuing education. The experts we engage with analyze the latest trends, insights, and developments in their industries to bring forth content you can’t get anywhere else.

We can be reached via our website, over the phone at (646) 844-0200 or email us at info ( @ ) theknowledgegroup dot org. We look forward to having you learn with The Knowledge Group.

Contact Information
Rochelle Empig
The Knowledge Group
35 Journal Square, Suite 822 Jersey City, NJ

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