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Cannabis Law: A New Frontier in California and Beyond

On-Demand Web Briefing  On-Demand One-Hour Briefing    

From the program: Cannabis Law: A New Frontier in California and Beyond

Released on: Jan. 14, 2017

Taken from the briefing Cannabis Law:  A New Frontier in California and Beyond recorded January 2017 in New York. With a ballot initiative over 20 years ago, the citizens of California passed Proposition 215, the first medical cannabis law in the country. Despite this, California failed to pass implementing legislation that would provide clear and specific regulatory guidance for those wishing to engage lawfully in medical cannabis ...

Cannabis Law: A New Frontier in California and Beyond

Transcripts  Transcripts    

Recorded on: Jan. 14, 2017

AMY: It is now my pleasure to turn this brifing over to Larry Rosen. LARRY ROSEN: Thank you, Amy. I appreciate the introduction. And I'm going to try to introduce the other two speakers this morning who are far more knowledgeable than I about cannabis law, have been doing this for many more years than I have been. As I said, or as Amy said, I'm a technology attorney and business attorney. And so my area of interest in this field is to see that, ...

Antitrust Enforcement in the Trump Administration: What Companies Need to Know

MP3 Audio  Audio Download (MP3)    On-Demand Web Briefing  On-Demand One-Hour Briefing    

Recorded on: Sep. 8, 2017

Taken from the briefing Antitrust Enforcement in the Trump Administration: What Companies Need to Know recorded September 2017 in New York. Changes in administration bring new personnel and new enforcement priorities. The risks associated with certain business practices may have decreased while others may face increased scrutiny. This program is aimed at in-house lawyers and their outside advisors seeking to better understand the antitrust enforcement ...

Legal Ethics for Health Care and Life Sciences Attorneys – Hot Topics

MP3 Audio  Audio Download (MP3)    On-Demand Web Briefing  On-Demand One-Hour Briefing    

Recorded on: Sep. 28, 2017

Taken from the briefing Legal Ethics for Health Care and Life Sciences Attorneys – Hot Topics recorded September 2017 in New York. Attorneys practicing in the health care and life sciences fields address issues on a daily basis that touch on questions of regulatory compliance, corporate codes of conduct and ethics, and corporate social responsibility considerations, all of which are unique and specific to their industries. At the same time, ...

Legal Ethics for Health Care and Life Sciences Attorneys – Hot Topics

Transcripts  Transcripts    

Recorded on: Oct. 3, 2017

AMY TAUB: Thank you. Hello, my name is Amy Taub, and I'm a program attorney with PLI, a nonprofit learning organization. I would like to welcome you to today's briefing, legal ethics for health care and life sciences attorneys, hot topics. Before we begin, I have some administrative announcements. This briefing will be one hour in length. Please feel free to send questions at any time during the briefing. Please remember that you have access to material ...

Antitrust Enforcement in the Trump Administration: What Companies Need to Know

Transcripts  Transcripts    

Recorded on: Oct. 10, 2017

AMY TAUB: Hello. My name is Amy Taub, and I'm a program attorney with PLI, a nonprofit learning organization. I would like to welcome you to today's briefing, Antitrust Enforcement in the Trump Administration, What Companies Need to Know. Before we begin I have some administrative announcements. This briefing will be one hour in length. Please feel free to send questions at any time during the briefing. Please remember that you have access to materials ...

Life Sciences 2017: Navigating Legal Challenges in the Drug and Device Industries

On-Demand Web Programs  On-Demand Web Programs    Web Segment  Web Segment    MP3 Audio  Audio Download (MP3)    MP4 - Mobile Video Seg  Video Download (MP4)    

From the program: Life Sciences 2017: Navigating Legal Challenges in the Drug and Device Industries

Released on: Oct. 18, 2017

Join PLI’s expert faculty of life sciences practitioners, in-house counsel, government regulators, and prosecutors as we examine the current state of life sciences law and what the future might hold for the pharmaceutical, biologics, device, and health technology industries. This program will cover the broad range of issues confronting the life sciences industry: trends and best practices in FDA premarket review; recent developments in scientific ...

Across the Pond – The European Medical Devices Directive and More

Transcripts  Transcripts    

Recorded on: Oct. 12, 2017

SCOTT DANZIS: OK. We're going to start again, reconvene. And we are now going to be jumping across the Atlantic to consider many cutting edge issues that are going on in Europe. And to do that, we have a terrific panel. So first I'd like to introduce Judy O'Grady. Judy is the Corporate Vice President for Global Regulatory Affairs of Integra LifeSciences, which is a global medical device company. Judy has been within Integra since 1989. She's held ...

FDA Regulation: Hot Topics

Transcripts  Transcripts    

Recorded on: Oct. 12, 2017

SCOTT D. DANZIS: OK. So we're going to focus this morning-- the first panel is just an update, hot topics, and the most interesting things going on at FDA. I'll start with some initial remarks just on the new leadership and agenda that we we're seeing out of FDA since the turn of the administration. And then Nathan will talk about some of the key legislative developments we've seen in the past year. And there's been several that are pretty important. ...

Top Legal Issues in Pharmaceutical Pricing and Reimbursement

Transcripts  Transcripts    

Recorded on: Oct. 12, 2017

NATHAN BROWN: So our next panel is legal issues in pricing and contracting. And the panelists wanted two hours. But we said they only have an hour and 15 minutes. But we have a great panel with really a wealth of industry experience. Odalys Capriseca is the Executive Director for Pricing, Government Reporting and Contract Operations at AstraZeneca. She's been in the pharma industry for over 23 years in the area of sales and market access. She holds ...

Effective Compliance Programs and Investigations: A Hypothetical

Transcripts  Transcripts    

Recorded on: Oct. 12, 2017

SCOTT DANZIS: OK as mentioned we've made it to the final panel of the day. And we've just heard from the prosecutors, who I think did a good job to scare everyone. But now we have a panel that will help us form effective compliance programs so we never have to deal with those scary prosecutors. So to lead us through that exercise, as mentioned, we're going to be doing a hypothetical, and we have with us Reed Stephens, who's a partner at the law firm ...

Health Care Update: The Trump Administration Heads Into ACA Open Enrollment with Shaky Markets and Powerful Discretion

MP3 Audio  Audio Download (MP3)    On-Demand Web Briefing  On-Demand One-Hour Briefing    

Recorded on: Oct. 16, 2017

Taken from the briefing Health Care Update: The Trump Administration Heads into ACA Open Enrollment with Shaky Markets and Powerful Discretion recorded October 2017 in New York. The Trump Administration had hoped to be winding down Obamacare this fall, but it remains the law of the land. Now the Administration is faced with conflicting needs: 1.) to support shaky ACA markets to avoid consumer harm and political blame, and 2.) to maintain or enhance ...

Innovator and Generic Drug Manufacturers: Implications of Legal, Regulatory and Political Updates on Safety Oversight, REMS and Product Liability Risk

MP3 Audio  Audio Download (MP3)    On-Demand Web Briefing  On-Demand One-Hour Briefing    

Recorded on: Oct. 17, 2017

Taken from the briefing Innovator and Generic Drug Manufacturers: Implications of Legal, Regulatory and Political Updates on Safety Oversight, REMS and Product Liability Risk recorded October 2017 in New York. FDA, fueled by concerns about drug pricing, is adopting measures to expedite generic drug approval. Meanwhile, the continuing growth of the generic drug market, has exacerbated conflicts between innovator and generic drug manufacturers. ...

Innovator and Generic Drug Manufacturers: Implications of Legal, Regulatory and Political Updates on Safety Oversight, REMS and Product Liability Risk

Transcripts  Transcripts    

Recorded on: Oct. 18, 2017

AMY TAUB: It is now my pleasure to turn this briefing over to Howard Dorfman. HOWARD DORFMAN: Amy, thank you very much. This is Howard Dorfman. I'd like to also extend my welcome to everyone who has called in. I think you will find the one hour together will be, hopefully, interesting and, perhaps, even provide some new concepts and new ideas for you to, perhaps, think about as you continue your work. One thing that I think is very important for ...

Health Care Update: The Trump Administration Heads into ACA Open Enrollment with Shaky Markets and Powerful Discretion

Transcripts  Transcripts    

Recorded on: Oct. 18, 2017

AMY TAUB: It is now my pleasure to turn this briefing over to Mike Adelberg. MICHAEL ADELBERG: Good afternoon, everyone. It's a pleasure getting a chance to speak with the PLI audience again for this, the fourth webinar that we've had a chance to offer for PLI in the last year and a half. I want to thank PLI for its continued interest and great support as we get a chance to speak with you all. Just briefly want to mention a little bit about Faegre ...

Opioid Epidemic: Legal Issues, Patient Mismanagement, and a Path Forward

MP3 Audio  Audio Download (MP3)    On-Demand Web Briefing  On-Demand One-Hour Briefing    

Recorded on: Oct. 31, 2017

Taken from the briefing Opioid Epidemic: Legal Issues, Patient Mismanagement, and a Path Forward recorded October 2017 in New York. Opioid-related deaths in the United States have reached nearly 100 per day; opioid-related healthcare costs are nearing an estimated $100 billion annually. With this backdrop, in July 2017 Goldman Sachs released a report explaining how the increase in opioid use and abuse continues to contribute to the decline in prime-age ...

Developments in Pharmaceutical and Biotech Patent Law 2017

On-Demand Web Programs  On-Demand Web Programs    Web Segment  Web Segment    MP3 Audio  Audio Download (MP3)    MP4 - Mobile Video Seg  Video Download (MP4)    

From the program: Developments in Pharmaceutical and Biotech Patent Law 2017

Released on: Nov. 6, 2017

Technological innovation, Federal Circuit appellate oversight, and Supreme Court decisions continue to drive significant changes in the law. In this program, several different perspectives on many of the most pressing issues will be offered by experienced practitioners. It is designed to give you the information you need to maintain your practice edge, concentrating on new developments from 2016 and 2017 and placing them in the context of constantly ...

Antibody Patents: Obviousness, Written Description, Enablement and Other Challenges

Transcripts  Transcripts    

Recorded on: Nov. 2, 2017

DANIEL L REISNER: Good morning, everyone. Today's topic is all about antibodies. It's going to focus on [? (1) (12) ?] issues written description, and enablement, although we'll discuss a little bit the relationship between those defenses and obviousness. So what is an antibody? It sounds like, from a survey, that a lot of you know about antibodies. So I'll make it brief. Antibodies are y-shaped multi-chained proteins. They're produced by the immune ...

Biosimilars Litigation at the Supreme Court, Federal Circuit, and District Court Levels

Transcripts  Transcripts    

Recorded on: Nov. 2, 2017

DAVID K. BARR: I've spoken on biosimilars several times in this program. And when I first spoke on it, it was before any biosimilar application had been filed, and certainly before there had been any litigation. And some of the comments were, well, why are we really focusing on this? Why are we spending time on this? The thinking was, well, a lot of the companies that are thinking of doing follow on biosimilars to the previously-approved biologics, ...

Strategic Approaches to the Interplay Between Hatch-Waxman Litigation and Inter Partes Review

Transcripts  Transcripts    

Recorded on: Nov. 2, 2017

DAVID BARR: OK, our next speaker is Benjamin Hsing. Ben is a partner at Baker & Hostetler. He's a patent litigator possessing experience with a range of technologies and focuses his practice on the enforcement of patent rights and life sciences industry with a concentration in Hatch-Waxman based litigations. Ben is an accomplished trial lawyer, having tried numerous high profile cases on behalf of major pharmaceutical and technology companies. As ...

The Evolving Law of Section 101 and Life Sciences Patents

Transcripts  Transcripts    

Recorded on: Nov. 2, 2017

DAVID BARR: Welcome back, everyone, from the break for our last segment. And batting cleanup here is Jennifer Gordon, who's with Paul, Weiss, Rifkind, Wharton, and Garrison. And I've known Jennifer for a long time. And she's a great speaker, and I think this will be a wonderful last segment for our program. Jennifer is skilled in life sciences-related patent law. She has extensive experience in complex patent litigation involving biotechnology, pharmaceutical, ...

The Changing Scope of Prior Art: What’s New, What’s In, What’s Out

Transcripts  Transcripts    

Recorded on: Nov. 2, 2017

DAVID K. BARR: Welcome back from your lunch break, everyone. Our next speaker is Ken Sonnenfeld. Ken specializes in intellectual property, particularly in the field of biotechnology and pharmaceutical law, and practices as a partner at King & Spalding. Ken represents multinational corporations and startup companies and related IP matters. With nearly 30 years of experience in IP law and a doctorate in pharmacology, Ken represents biotechnology and ...

Opioid Epidemic: Legal Issues, Patient Mismanagement, and a Path Forward

Transcripts  Transcripts    

Recorded on: Nov. 3, 2017

AMY TAUB: Hello. My name is, Amy Taub, I'm a Program Attorney with PLI, a nonprofit learning organization. I would like to welcome you to today's briefing, Opioid Epidemic-- Legal Issues, Patient Mismanagement, and a Path Forward. Before I begin, I have some administrative announcements. This briefing will be one hour in length. Please feel free to send questions at any time during the briefing. Please remember that you have access to material for ...

Providing Legal Assistance in the Aftermath of the NorCal Wildfires -- Helping Disaster Survivors Retain or Qualify for Government Benefits

Web Segment  Web Segment    MP3 Audio  Audio Download (MP3)    MP4 - Mobile Video Seg  Video Download (MP4)    

From the program: Providing Legal Assistance in the Aftermath of the NorCal Wildfires

Recorded on: Nov. 28, 2017

Taken from the Web Program Providing Legal Assistance in the Aftermath of the NorCal Wildfires Recorded November 2017 in San Francisco Helping Disaster Survivors Retain or Qualify for Government Benefits [00:29:00] How to continue receiving benefits if relocated or circumstances changed after a disaster Types of benefits available post-disaster other than FEMA assistance Replacing damaged/destroyed documents Denials, appeals, ...

Helping Disaster Survivors Retain or Qualify for Government Benefits

Transcripts  Transcripts    

Recorded on: Nov. 28, 2017

SPEAKER 1: Welcome back, everyone. We are now turning to the question of public benefits in the aftermath of a disaster. Something that may not leap immediately to mind as a disaster issue, but people who are on public benefits already or people who may become qualified for public benefits have many concerns after a disaster. Our speaker is Lisa Newstrom. Lisa is the managing attorney of the Santa Clara regional office of Bay Area Legal Aid. She's ...


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