Life Sciences and the Law 2025: Episode #2 Life Sciences Regulatory Overview

Life Sciences and the Law 2025: Episode #2 Life Sciences Regulatory Overview

• Tuesday, June 10, 2025 1:00 PM - 2:00 PM EDT

In this episode, we explore the complex regulatory landscape of the life sciences industry, providing attorneys with critical insights into the compliance requirements that govern pharmaceuticals, medical devices, and diagnostics. Whether you advise biotech startups, multinational pharmaceutical companies, or investors, understanding regulatory frameworks is essential for mitigating legal risks and ensuring compliance in product development and commercialization.

Attorneys will gain an overview of key regulatory bodies—including the FDA (United States), EMA (Europe), and other global authorities—and learn how evolving regulations shape product approvals, safety standards, and market access. This session will also highlight legal strategies for navigating regulatory challenges, minimizing liability, and advising clients on compliance best practices.

Learning Objectives:

• Approval Pathways
  • Small Molecules
  • Biologics
  • Generics
  • Devices
  • Diagnostics
• Manufacturing
• Clinical stage therapeutics
• Commercial stage therapeutics
• Devices
• Marketing

This webinar is delivered in Plain English, understandable to you even if you do not have a background in the subject. It brings you into an engaging, even sometimes humorous, conversation designed to entertain as it teaches. It is specifically designed to be viewed as a stand-alone webinar, meaning that you do not have to view the other series’ episodes to get a lot out of it.

About the Series:

This webinar is part of a series titled “Life Sciences & The Law 2025.”
"We Bring Good Things to Life" was an advertising slogan used by General Electric between 1979 and 2003, focused mainly on General Electric's appliances and lighting fixtures. We’d argue that it would be an even better slogan for the Life Sciences industry.

The Life Sciences Industry encompasses companies and organizations that are dedicated to researching, developing, manufacturing, and distributing products and technologies to improve human and animal health. Key sectors within life sciences include biotechnology, pharmaceuticals, medical devices, and diagnostics. The industry’s work ranges from bench research and small-scale manufacturing to performing small and large-scale clinical trials, developing manufacturing processes on a commercial scale, working closely with regulatory agencies, to developing pricing, marketing, and distribution strategies. The life cycle of a drug or medical device often involves many parties controlling the product at various times, involving the bench of university researchers, development by small startup companies, commercialization by larger industry players, diversification by sublicensees, and distribution by resellers.

Life sciences is a highly regulated field due to its direct impact on health and safety, with strict compliance standards overseen by regulatory bodies like the FDA in the United States and EMA in Europe. The industry is characterized by high research and development (R&D) costs, long development timelines, and significant investment in innovation and technology. The life sciences industry is also increasingly interdisciplinary, intersecting with data science, artificial intelligence, and bioinformatics to drive advancements in personalized medicine, gene therapy, and diagnostics.

As with every Financial Poise webinar, each episode in this series is delivered in Plain English understandable to investors, business owners, and executives without much background in these areas, yet is also valuable to attorneys, accountants, and other seasoned professionals. And, as with every Financial Poise webinar, each episode brings you into engaging, sometimes humorous, conversations designed to entertain as they teach. Each episode in the series is designed to be viewed independently of the other episodes so that participants will enhance their knowledge of this area whether they attend one, some, or all episodes.

This live webinar is eligible for both CLE and CPE credit.

Click here to register and for more information.