Please join Goodwin’s team of experts for a one-day CLE seminar addressing key legal trends and risks in the healthcare and biotech industries. Attend one or multiple sessions, including breakfast, lunch and networking with your in-house counsel peers.
Topics covered throughout the day include:
9:00 am - 10:00 am
The Regulation of Digital Health and Health IT
The session will discuss FDA regulation of digital health products, including software as a medical device, mobile medical applications and potential issues with these products. The session also will cover HIPAA, corporate practice of medicine, telemedicine, and relevant fraud and abuse statutes of interest to companies in this space.
10:15 am - 11:15 am
Enforcement Trends and Risks in Healthcare and Life Sciences
This session will focus on current trends and priorities in the federal government’s healthcare and life sciences enforcement practices, including recent cases, policy developments and key risks in criminal and civil enforcement actions. The session will also discuss best practices for navigating government inquiries.
11:30 am - 12:30 pm
Social Media Hygiene: Ethics and Social Media for Healthcare and Biotech Attorneys
Twitter, Facebook, Blogs… the platforms of social media create enormous opportunities for lawyers to socialize, learn, educate and communicate. On the negative side, the inherent nature of the platforms gives rise to significant ethical risks. This session will explore shocking, but also shockingly frequent, examples of attorney behavior on social media, explore the relevant ethical rules and guidelines, and provide take-away guidance on how to minimize the risk of losing a law license through on-line behavior. New York State Ethics Credit is currently pending for this session.
1:30 pm - 2:30 pm
Biosimilars at the Federal Circuit: Recent Decisions and Cases to Watch
In 2019, the Federal Circuit will hear argument and render decisions in many appeals concerning patent issues related to biosimilar products. The pending appeals are from decisions of district courts in BPCIA litigations as well as rulings by the Patent Trial and Appeal Board in inter partes reviews concerning biologics patents. This session will provide background on the issues in these appeals, a discussion of recent decisions, and an overview of the cases to watch.
2:45 pm - 3:45 pm
Trends and Hot Topics in Securities Litigation and SEC Enforcement for the Life Sciences Industry
Life sciences companies currently face more securities class action lawsuits and regulatory scrutiny than any other industry. This session will focus on current litigation and SEC enforcement trends, recent key decisions in securities class action lawsuits against life sciences companies, the SEC’s interest in disclosures about interactions with FDA, and practical advice for mitigating litigation risk.
4:00 pm - 5:00 pm
Structuring Life Sciences Partnering and M&A Agreements
This session will discuss structuring licensing, collaboration and M&A agreements, and best practices to anticipate, mitigate or avoid future disputes, and discuss international considerations and dispute resolution. The session will provide both transactional and litigation perspectives on key provisions in these important agreements.
To register for this event, please click here.