On-Demand   On-Demand Web Programs

Life Sciences 2018: Navigating Legal Challenges in the Drug and Device Industries

Released on: Nov. 24, 2018
Running Time: 06:13:35
Join our 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 affected parties. This program will cover the broad range of issues confronting the life sciences industry: structuring of compliant financial and other relationships; recent developments in scientific discourse and promotional guidelines affecting FDA-regulated companies; and federal and state enforcement of health care fraud and abuse laws, including the federal False Claims Act, the federal Anti-Kickback Statute, the Stark law, and similar state laws.

Lecture Topics [Total time 06:13:35]

Segments with an asterisk (*) are available only with the purchase of the entire program.

  • Opening Remarks* [00:07:05]
    Nathan A. Brown, Scott D. Danzis
  • Digital Health, Diagnostics, and Other Hot Topics in FDA Law [01:18:08]
    Nathan A. Brown, Scott D. Danzis
  • Across the Pond – The European Medical Devices Directive and More [00:55:25]
    Robin Blaney, Scott D. Danzis
  • Top Legal Issues in Pharmaceutical Pricing and Reimbursement [01:20:40]
    Thomas F. Felton, Heide Bajnrauh
  • Enforcement Trends impacting the Drug and Device Industries [01:17:31]
    Paul Kaufman, Charlene Keller Fullmer, Jacob T Elberg, Geoffrey R. Kaiser
  • Effective Compliance Programs and Investigations: A Hypothetical [01:14:44]
    T. Reed Stephens, Shireen M Becker

The purchase price of this Web Program includes the following articles from the Course Handbook available online:

  • COMPLETE COURSE HANDBOOK
  • Draft Guidance for Industry and Food and Drug Administration Staff (December 8, 2017)
  • Scott Gottlieb, FDA’s Comprehensive Effort to Advance New Innovations: Initiatives to Modernize for Innovation (August 29, 2018)
    Nathan A. Brown
  • Health Industry Alert (January 2, 2018)
    Nathan A. Brown
  • Digital Health Checkup: Key Questions Market Players Should Be Asking (Part One) (August 29, 2017)
    Scott D. Danzis
  • Digital Health Checkup (Part Two): Key Commercial Questions When Contracting for Digital Health Solutions (September 26, 2017)
    Scott D. Danzis
  • Digital Health Checkup (Part Three): Key Questions About AI, Data Privacy, and Cybersecurity (December 5, 2017)
    Scott D. Danzis
  • FDA Outlines Updated Approach to Regulating Digital Health Technologies (December 20, 2017)
    Scott D. Danzis
  • ICO Consults on Privacy “Regulatory Sandbox” (September 17, 2018)
    Scott D. Danzis
  • European Union
    Robin Blaney, Grant Castle
  • Draft Memorandum of Understanding Addressing Certain Distributions of Compounded Drug Products Between the State [insert STATE] and the U.S. Food and Drug Administration
    Nathan A. Brown
  • American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (May 2018)
    Nathan A. Brown
  • FDA Releases Revised Memorandum of Understanding That Would Ease Restrictions on Interstate Shipment of Compounded Drugs (September 10, 2018)
    Nathan A. Brown
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on New Steps to Help Ensure the Quality of and Preserve Access to Compounded Drugs by Pursuing Closer Collaboration with States (September 7, 2018)
    Nathan A. Brown
  • Trump Administration Drug Pricing Blueprint: Overview and Analysis (May 15, 2018)
    Nathan A. Brown
  • Daniel A. Kracov, Mahnu Davar and Abraham Gitterman, Ch. 13: Enforcement and Government Investigations Relating to Medical Devices, Practising Law Institute, Medical Devices Law and Regulation Answer Book (2019 Edition)

Presentation Material

  • CDRH's Approach to Tumor Profiling Next Generation Sequencing Tests
  • Expecting the Unexpected
  • New CMS Coverage Determination and FDA Regulatory Approach: the Next Generation for NGS Testing Policy
  • The Rise of Parallel Proceedings in Health Care Fraud Investigations
  • Digital Health, Diagnostics, and Other Hot Topics in FDA Law
    Nathan A. Brown, Scott D. Danzis
  • Across the Pond - The European Medical Devices Directive and More
    Robin Blaney
  • Effective Compliance Programs and Investigations: A Hypothetical
    Shireen M Becker, T. Reed Stephens
  • Hypothetical
    Shireen M Becker, T. Reed Stephens
Co-Chair(s)
Nathan A. Brown ~ Akin Gump Strauss Hauer & Feld LLP
Scott D. Danzis ~ Covington & Burling LLP
Speaker(s)
Heide Bajnrauh ~ Akin Gump Strauss Hauer & Feld LLP
Shireen M Becker ~ Jones Day
Robin Blaney ~ Covington & Burling
Jacob T Elberg ~ Assistant U.S. Attorney, United States Attorney's Office, District of New Jersey
Thomas F. Felton ~ Senior Corporate Counsel, Celgene Corporation
Geoffrey R. Kaiser ~ Rivkin Radler LLP
Paul Kaufman ~ Vice President, Office of Legal Affairs, Northwell Health
Charlene Keller Fullmer ~ US Attorney's Office, Eastern District of Pennsylvania
T. Reed Stephens ~ McDermott Will & Emery LLP
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PLI’s live and on-demand webcasts are single-user license products intended for an individual registrant only. Credit will be issued only to the individual registered.


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New York

Experienced Attorneys:  All PLI products can fulfill New York’s CLE requirements for experienced attorneys. There is no limit to the number of credits an attorney can earn via PLI products.

Newly Admitted Attorneys:  PLI’s transitional on-demand web programs can be used to fulfill the requirements for New York newly admitted attorneys. Only professional practice and law practice management credits may be earned via transitional on-demand web programs. Ethics and skills credits may not be earned via on-demand web programs.

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Texas:  All PLI products can fulfill Texas’ CLE requirements. There is no limit to the number of credits an attorney can earn via PLI products.

Utah:  PLI’s on-demand web programs qualify as “self-study” credit. Attorneys are limited to 12 credits of self-study per reporting period.

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Virgin Islands:  All PLI products can fulfill the Virgin Islands’ CLE requirements. There is no limit to the number of credits an attorney can earn via PLI products.

Virginia:  PLI’s on-demand web programs qualify as “pre-recorded” credit. Attorneys are limited to 8 credits of pre-recorded programs per reporting period.

Washington:  All PLI products can fulfill Washington’s CLE requirements. There is no limit to the number of credits an attorney can earn via PLI products.

West Virginia:  PLI’s on-demand web programs qualify as “online” credit. Attorneys are limited to 12 credits of online instruction per reporting period.

Wisconsin:  PLI’s on-demand web programs qualify as “repeated, on-demand” credit. Attorneys are limited to 15 credits of repeated, on-demand programs per reporting period. No ethics credits can be earned via on-demand web programs.

Wyoming:  PLI’s on-demand web programs qualify as “self-study” credit. Attorneys are limited to 6 credits of self-study per reporting period.


CPD Jurisdictions

British Columbia (CPD-BC):  PLI’s on-demand web programs are not eligible for CPD-BC credit unless viewed with at least one other attorney or an articled student. In this case, the credit must be recorded as a “study group.”

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Quebec (CPD-QC):  PLI’s on-demand web programs can fulfill Quebec’s CPD requirements.

Hong Kong (CPD-HK):  PLI’s on-demand web programs are not approved for CPD-HK credit.

United Kingdom (CPD-UK):  PLI’s on-demand web programs can fulfill the United Kingdom’s CPD requirements.

Australia (CPD-AUS):  PLI’s on-demand web programs may fulfill Australia’s CPD requirements. Credit limits for on-demand web programs vary according to jurisdiction. Please refer to your jurisdiction’s CPD information page for specifics.

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Dubai (CLPD-DUBAI):  PLI’s on-demand web programs may fulfill CLPD credit requirements.


Other Credit Types

CPE Credit (NASBA):  Select on-demand web programs qualify as the “QAS Self-Study” delivery method. Please check the Credit Information box on the right-hand side of this page to verify CPE credit availability.

IRS Continuing Education (IRS-CE):  PLI’s on-demand web programs may fulfill IRS-CE requirements. To request IRS-CE credit, please notify PLI at plicredits@pli.edu of your request and include your Preparer Tax Identification Number (PTIN).

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IAPP Continuing Privacy Credit (CPE):  PLI’s on-demand web programs may fulfill Privacy CPE credit requirements.

HR Recertification (HRCI):  PLI’s on-demand web programs may fulfill HR credit requirements.

SHRM Recertification (SHRM):  PLI’s on-demand web programs qualify as "self-paced" credit. SHRM professionals are limited to 30 credits of self-paced programs per recertification period.

Compliance Certification Board (CCB):  PLI’s on-demand web programs qualify as “self-study” credit. Candidates are limited to 10 self-study credits per 12-month period, and certification holders are limited to 20 self-study credits per 2-year renewal period.

Certified Anti-Money Laundering Specialists Certification (CAMS):  PLI’s on-demand web programs are not approved for CAMS credit.

New York State Social Worker Continuing Education (SW CPE):  PLI’s on-demand web programs are not approved for SW CPE credit.

American Bankers Association Professional Certification (ABA):  PLI’s on-demand web programs may fulfill ABA credit requirements.

Certified Financial Planners (CFP):  PLI’s on-demand web programs are not approved for CFP credit.

 

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