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Showing 1 - 25 of 94 Results


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FDA Deskbook: A Compliance and Enforcement Guide

Treatise  Treatise

Published: May 2016
Last Updated: November 2018

FDA Deskbook: A Compliance and Enforcement Guide provides a comprehensive description of the complexities of compliance under The Federal Food, Drug, and Cosmetic Act (FDC Act) and practical suggestions on how FDA-regulated entities can avoid being the subject of an enforcement action by the federal government. It explains the legal framework created by the FDC Act and subsequent statutes, regulations, guidance and policies governing the food and ...

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

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

Recorded on: Nov. 2, 2017

Taken from the Web Program Recorded November 1, 2017 in New YorkThe Changing Scope of Prior Art: What’s New, What’s In, What’s Out [00:58:48]• How the scope of prior art has changed with the enactment of the AIA • New territoriality considerations for prior art and exceptions to overcome prior disclosures • What constitutes a sale for prior art purposes: Medicines Company v. Hospira, Inc. • When does a sale ...

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

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

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

Released on: Nov. 3, 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 ...

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 ...

Pharmaceutical and Biotech Patent Law

Treatise  Treatise

Published: November 2017

Pharmaceutical and Biotech Patent Law provides you with the legal, scientific, and technical information you need to help clients obtain, defend, and challenge patents in these important business areas. This practical guide shows you how to craft problem-free patent applications, including how to partner with the government to bring patented inventions quickly to the marketplace • invalidate competitors’ patents by proving that they ...

Nuts and Bolts of Medicare & Medicaid 2017: What All Attorneys Need to Know

Handbook  Course Handbook

Course Handbook from the program Nuts and Bolts of Medicare & Medicaid 2017: What All Attorneys Need to Know, held December, 2017.

Health Care Law Institute 2017

Handbook  Course Handbook

Course Handbook from the program Health Care Law Institute 2017, held December, 2017.

Fundamentals of Privacy Law 2017

Handbook  Course Handbook

Course Handbook from the program Fundamentals of Privacy Law 2017, held December, 2017.

Marijuana Compliance Challenges in 2018 and Beyond

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

Recorded on: Feb. 12, 2018

Marijuana Compliance Challenges in 2018 and Beyond

Transcripts  Transcripts    

Recorded on: Feb. 20, 2018

SPEAKER 1: [INAUDIBLE]. AMY TAUB: Thank you. Hello. My name is Amy Taub. And I am a Program Attorney with PLI, a nonprofit learning organization. I would like to welcome you to today's briefing, Marijuana Compliance Challenges in 2018 and Beyond. 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 ...

Bipartisan Budget Act of 2018: Examining the Many Health Care Provisions of a Law That Was Not Supposed to Be About Health Care

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

Recorded on: Mar. 12, 2018

Taken from the One-Hour Briefing Recorded March 2018 in New York Bipartisan Budget Act of 2018: Examining the Many Health Care Provisions of a Law That Was Not Supposed to Be About Health Care [Total RunTime: 01:04:35] The recently-passed Bipartisan Budget Act included a handful of expected healthcare provisions, such as the so-called Medicare Extenders that enable continued payments to providers for particular services. The new law also contains ...

Bipartisan Budget Act of 2018: Examining the Many Health Care Provisions of a Law That Was Not Supposed to Be About Health Care

Transcripts  Transcripts    

Recorded on: Mar. 19, 2018

SPEAKER 1: It is now my pleasure to turn this briefing over to Nick Manetto. NICK MANETTO: Well, good afternoon, and thank you very much for taking the time to join this session today. This happens to be our team's sixth PLI session over the past three years. We're really looking forward to this discussion about the many health care provisions that were enacted into law a little more than a month ago through the bipartisan Budget Act. Our goal will ...

Advocacy for Low-Income Children with Disabilities in California 2018

Handbook  Course Handbook

Course Handbook from the program Advocacy for Low-Income Children with Disabilities in California 2018, held April 2018.

Hot Topics in Child Custody, Visitation & Guardianship for New York Practitioners 2018

Handbook  Course Handbook

Course Handbook from the program Hot Topics in Child Custody and Visitation for New York Practitioners 2018, held April 2018.

Patent Law Institute 2018: Critical Issues & Best Practices -- Breakout Session No. 4b: Prosecution – Recent Developments in Chem/Pharma and Bio Patents

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

From the program: Patent Law Institute 2018: Critical Issues & Best Practices

Recorded on: Apr. 16, 2018

Taken from the Web Program Patent Law Institute 2018: Critical Issues & Best Practices Recorded April 2018 in New York. Breakout Session No. 4b: Prosecution – Recent Developments in Chem/Pharma and Bio Patents [01:01:11] Claim interpretation from District Court Decisions Claim interpretation as it relates to infringement and validity Rule 12 motions: 35 USC 101 patent subject matter eligibility  Laura Donnelly, Gerald ...

Breakout Session No. 4b: Prosecution – Recent Developments in Chem/Pharma and Bio Patents

Transcripts  Transcripts    

Recorded on: Apr. 16, 2018

JOHN M. WHITE: Good morning, and welcome to the second day of the PLI Patent Institute. This is the breakout session for prosecution. Over the next two hours, we will be focusing on chemistry and life sciences. And there will be two sessions. The first hour will run nine to 10 o'clock. There'll be a seamless transition as we change speakers and slide decks and stuff like that. And then we'll go from 10 to 11, where we'll have our first break, coffee ...

Breakout Session No. 5b: Prosecution – PTAB Decisions for Chem/Pharma and Bio Patents

Transcripts  Transcripts    

Recorded on: Apr. 16, 2018

JOHN M. WHITE: And this announcement is primarily for those watching online as opposed to those in the room. But again, John White here. I'm the co-chair of the patent prosecution segment of this PLI Patent Law Institute. And this is the second hour of our chemical and life sciences [? break out ?] in the prosecution area. We just wrapped up one hour. And we're about to begin another. And so we have changed our speaker. And I'll reintroduce Gerry ...

Food and Beverage Labeling and Marketing – Latest Trends

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

Recorded on: Apr. 18, 2018

Taken from the One-Hour Briefing Recorded April 18 2018 in New York Food and Beverage Labeling and Marketing – Latest Trends [01:02:40] Labeling, marketing, and advertising are critical parts of a food and beverage company’s business and can be fraught with risk.  Although similar in many ways, distinguishing between “labeling” and “marketing and advertising” is an important part of a company’s risk-assessment ...

Psychological Issues in the Workplace 2018 -- Resolving Highly Emotional Workplace Complaints and Claims

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

From the program: Psychological Issues in the Workplace 2018

Recorded on: Apr. 26, 2018

Taken from the Web Program Psychological Issues in the Workplace 2018 Recorded April 2018 in New York Resolving Highly Emotional Workplace Complaints and Claims [01:01:27] Emotional factors that complicate complaints and employer responses Negotiating the resolution of emotionally charged disputes Mediating  harassment, discrimination, and other highly emotional workplace disputes Managing emotional issues during litigation The ...

Food and Beverage Labeling and Marketing – Latest Trends

Transcripts  Transcripts    

Recorded on: Apr. 25, 2018

SPEAKER 1: It is now my pleasure to turn this briefing over to Marc Roth. MARC S ROTH: Thank you very much, Amy, very much appreciate the introduction and the opportunity to speak today. Today's program was originally developed a couple of months ago, when my colleague Allie Condra and I had seen a bunch of activity going on in the food labeling space that may be relevant to marketers in that area. Also with respect to labeling and advertising, which ...

Resolving Highly Emotional Workplace Complaints and Claims

Transcripts  Transcripts    

Recorded on: Apr. 26, 2018

STEPHEN SONNENBERG: All right. So as our panel locates itself, I'm going to start with the introductions. To my very far right, is Wayne Outten. And Wayne Outten is founding and managing partner of Outten & Golden, LLP. His practice focuses exclusively on representing individuals in all areas of employment law and, in particular, high-level employees and professionals and, in there too particularly, in negotiation of employment, compensation, and ...

Update on Mental Disability and Emotional Distress Claims – The “Employee Rights” Perspective

Transcripts  Transcripts    

Recorded on: Apr. 26, 2018

ZACHARY D. FASMAN: Steve, thank you very much. It's a pleasure to see everybody here. Steve, it's a pleasure to be on the panel with you. What Steve did not say in his production was that we were partners together for many years at Paul Hastings. And when I left Paul Hastings, the one number I did not forget was his. Because every time I had a mental or emotional distress issue in the workplace, who better than to call than a therapist who knows ...

30th Annual Elder Law Institute

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: 30th Annual Elder Law Institute

Released on: May. 4, 2018

At PLI’s 30th Annual Elder Law Institute, expert faculty will explore developing issues and key considerations for elder law practitioners and also will review elder law fundamentals such as Medicare, Medicaid, Supplemental Needs Trusts, and assisted living options.  The program also will address Social Security Benefits, with special attention to applying for and appealing decisions concerning Disability Insurance Benefits and Supplemental ...

Supplemental Needs Trusts

Transcripts  Transcripts    

Recorded on: May. 1, 2018

DOUGLAS CHU: Now I do double duty because right after me as always, Jeff. And Jeff Abrandt, my co-speaker, my co-chair, is going to now do a section on supplemental needs trusts. And with him, he has assembled a panel to assist and present portions of the programs. So Jeff already has been introduced. So you can look at his bio and everything-- and everyone's bios are in the material. But also on the day as today, we have Adam DiLeo, who is Assistant ...

Senior Housing Options and Assisted Living Update

Transcripts  Transcripts    

Recorded on: May. 1, 2018

JEFFREY G. ABRANDT: Good afternoon. Welcome back everyone from lunch. I hope you enjoyed it. We're going to start right up. I'm very excited to introduce Judy Grimaldi. Judy's going to be speaking about senior housing options in assisted living. I can go on and on about Judy. Judy is a partner in the first all-female elder law firm, I think in the state. Judy is a fabulous practitioner who does great work. Judy I know for many years. Judy was a social ...


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