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Programs in Pharmaceutical Law

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FDA in the Year of COVID – How FDA Tackled the Pandemic and What to Expect from FDA in 2021 (02/11/2021)

Program Number: 3144 Presenter: Alexander Alfano, Esq., Michelle Divelbiss, Esq., Chad Landmon, Esq.

Over the past year, industries all over the world have experienced disruptions and have been forced to adapt to the COVID-19 pandemic. Notably, the Food and Drug Administration (“FDA”) has been thrust to the forefront of the battle against COVID-19, and emergency use authorizations (“EUAs”) and Operation Warp Speed are now hot topics. EUAs have allowed FDA to pivot and make speedy decisions that help save lives, but EUAs aren’t without their pitfalls. Additionally, Operation Warp Speed has been an impressive scientific endeavor, helping to bring vaccines to market in record time. As FDA has adapted quickly to the most up to date knowledge about this novel virus and changing scientific data, including real world evidence, what is in store for 2021? A new administration begins on January 20, 2020, and this new administration will bring different goals and plans for fighting COVID-19. Looking to 2021, we will see whether FDA’s operations

$95.00Audio Tape Add to Cart

Weeding between the Ethical Lines: Cannabis and Conflicts (02/10/2021)

Program Number: 3120 Presenter: Dr. Sharon Meit Abrahams, Rachel K. Gillette, Esq., Jan L. Jacobowitz, Esq.

The Cannabis industry continues to grow not only increasing revenue and consumer use, but also creating issues throughout the country for lawyers advising clients. As the states continue to weave a patchwork quilt of cannabis regulations and the federal government continues to list cannabis as an illegal controlled substance, entrepreneurial clients need complex legal advice and lawyers need clear ethics advice on permissible representation of their clients. May a lawyer assist a client in establishing a dispensary? May the lawyer take an interest in a cannabis start up in lieu of fees? What are the tax implications for clients operating in multiple states? What are the possible repercussions for a lawyer using cannabis for recreational or medicinal purposes? These questions and more will inform this interesting and timely discussion.

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Ethically Dealing with Substance Abuse and Addiction in the Legal Profession (12/15/2020)

Program Number: 30276 Presenter: Joan Bibelhausen, JD

Studies show that lawyers are at greater risk for alcohol and other substance use disorders, depression, other mental illness, and stress than members of other professions or the general population. This stress has been exacerbated in 2020 as lawyers are on the front lines in our nation’s crises and major events. There is a clearly recognized continuum where unresolved chronic stress becomes a predictor for addiction and mental illness. By understanding lawyer stress, this continuum, and the facts about addiction and mental illness, lawyers can reduce their risk, encounter fewer ethical challenges, and, hopefully, get help earlier when there is a problem. Signs, symptoms, risk factors and recovery regarding these problems will be presented. The discussion will include competence (1.1), diligence (1.3), communication (1.4) and other ethical considerations and the program will offer timely tools to reduce risk as well as information on lawyer assistance programs and other resources.

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The Intersection Between Law & Medicine (11/05/2020)

Program Number: 30274 Presenter: Clifford A. Rieders, Esq.

This subject is a culmination of many years’ lecturing on the subject of law and medicine and how the two interact. Subjects covered include peer review; risks and complications; the value of good bedside manners; how to avoid medical malpractice; what to do about obstructive and difficult conduct; and many other areas. The course is useful not only to lawyers, but also healthcare professionals. The concept is that, except for a few physicians, much of what occurs in the law is alien to the medical profession. Likewise, lawyers have some difficulty in understanding the medical world. There is an intersection between these two fields based upon the requirement to work together on behalf of patients, medicine and the legal system. This seminar is intended to explore some of those topics in a novel, interesting and thoughtful manner.

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Sticking Points: What Employers Need to Know About Flu Shots And COVID-19 Vaccines (11/11/2020)

Program Number: 30266 Presenter: Phillip C. Bauknight, Esq., A. Kevin Troutman, Esq.

This webinar will provide a discussion of important legal and practical issues that employers should consider when deciding whether and how to implement a mandatory vaccination program, including shots for this upcoming flu season and for the inevitable COVID-19 vaccine once it is approved. What we’ll cover: • A General Overview of Vaccine Issues • Legal Landscape – Screening and Vaccinations *Issues Related to OSHA, the ADA and Title VII • Considering Accommodation Requests • Policy Addressing Vaccines Generally • Issues Regarding Mandatory Flu Shots • Anti-Vaxxers, Other Considerations? • May Employers require a COVID-19 Vaccine?

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Vetting Your Vendors: Pitfalls and Solutions Every Cannabis Business Needs to Know (11/10/2020)

Program Number: 30249 Presenter: Rebecca L. Rakoski, Esq.

This presentation will discuss the importance of vendor management in the cannabis industry. We will explore recent vendor- related data breaches, contract pitfalls, and explain the regulatory framework every cannabis business needs to understand. We will also highlight common pitfalls in vendor contracts that can lead to litigation and provide a three-step process to address vendor management.

$95.00Audio CD Add to Cart

Telehealth Updates: The Future of Healthcare or Just “Dialing It In?” (hint: it’s the future of healthcare) (10/08/2020)

Program Number: 30234 Presenter: Scott R. Landau, Esq.

In this presentation, healthcare regulatory and fraud and abuse experts Scott R. Landau and Kenneth M. Abell from the boutique healthcare law firm Abell Eskew Landau LLP discuss the ever evolving federal and state level telehealth policies, rules, and requirements, and the steps that providers must take to ensure compliance both during the COVID-19 crisis and in a stricter post-pandemic environment. The presenters will also telehealth address reimbursement, fraud and abuse risks and government enforcement associated with use of telehealth modalities, and the future of telehealth as a permanent part of our healthcare delivery system post-COVID.

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Reducing Regulatory and Liability Risks by Preparing for an FDA Facility Inspection and Responding to a 483 Letter (09/01/2020)

Program Number: 30210 Presenter: J. Lee Gray, Esq., Brent Johnson, Esq., Kristy M. Kimball, Esq.

In addition to evaluating data from adverse event reports, the bulk of FDA's regulatory enforcement comes from its facility inspections and resulting 483 reports. Such regulatory enforcement actions not only carry financial risks of regulatory non-compliance, but can also directly impact product liability risks as well. This practical webinar will cover numerous aspects of preparing your drug or medical device establishment for a successful FDA facility inspection and responding to any post-inspection 483 letters. The key to a successful inspection strategy is adequate preparation and implementing the inspection plan before FDA knocks on your door. Attendees will learn: • Potential product liability issues stemming from a 483 report; • What to expect during the inspection; • Strategies for preparing for an inspection; • What to expect after the inspection; and *Strategies for responding to any deficiencies noted in a 483 report

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In the Cannabis Industry, Profitability and Data Privacy/Security go Hand-in-Hand (09/17/2020)

Program Number: 30200 Presenter: Rebecca L. Rakoski, Esq.

As the legalized cannabis industry takes its place amongst other highly highly profitable mainstream businesses it is impossible to overlook the cybersecurity and data privacy issues that uniquely affect the industry and its profitability. The issues surrounding legalized cannabis and data security create a multi-front battle that can be incredibly challenging from a legal and technological perspective. The fact that the cannabis industry has intertwining issues of highly sensitive data, regulatory oversight and mandatory data collection requirements creates a very distinctive challenge for the profitability of those businesses. But many of those challenges can be addressed using some of the same practices and solutions. Preserving profit margins and exploring innovation are fundamental to staying solvent in an industry driven to deliver results. This presentation will explore the industry-specific challenges that face legalized cannabis businesses including regulatory obligations, such as the California Cannabis Track-and-Trace ("CCTT") system, the Health Insurance Portability and

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Cannabis, Coronavirus and the State Regulatory Landscape: An Examination of the Legal Horizon for Cannabis Post-Pandemic and Beyond (07/22/2020)

Program Number: 30175 Presenter: Anna C. Halsey, Esq., Gregory S. Kaufman, Esq., Meghana D. Shah, Esq., Virginia "Jenny" E. Worthy, Esq.

While public attention has focused on how the coronavirus is affecting cannabis businesses from the perspective of supply and demand, there is an equally important force receiving less attention: the evolution of the state regulatory framework for cannabis. Until now, the industry has operated against the backdrop of the state-federal conflict with the potential of several important developments—such as legalization in a number of states—on the horizon for 2020. The spread of the coronavirus has necessarily shifted legislative focus while also reviving dialogue about legalization and other regulatory expansion through a new lens. Using their recently published book, The State of Cannabis Law, as a launching pad, Eversheds Sutherland lawyers will use this webinar to take a closer look at the state cannabis landscape including how states have addressed cannabis regulation, the horizon for legalization and other important developments we can expect to see in 2021 and beyond.

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