Header graphic for print
FDA Life News and Trends Impacting the FDA and Life Science Industry

Susan Winckler Featured Keynote Speaker This Week at 8th Annual Pharmaceutical and Medical Device Conference in Chicago on November 10

Posted in Advertising and Promotion, Animal Drugs, Antitrust, Biological Products, Clinical Studies, Drugs, Emerging Growth, Enforcement, European Union, FDA Organization, Healthcare, Intellectual Property, Legislation, Litigation, Medical Devices, Meetings, Patents, Regulation

159161119On November 10, 2016, McGuireWoods LLP and McGuireWoods Consulting (“McGuireWoods”) will be holding its 8th Annual Pharmaceutical and Medical Device Conference in Chicago.  Kicking off the Conference will be Keynote Speaker, Susan Winckler, the Chief Risk Management Officer for Leavitt Partners as well as a lead contributor in the firm’s alliance management and regulatory consulting activities.  Winckler, a pharmacist and attorney by training, is the former FDA Chief of the Staff and former President and Chief Executive Officer of the Food and Drug Law Institute, a nonprofit organization based in Washington, D.C., which provides a marketplace for discussing food and drug law issues through conferences, publications, and member interaction.

Following Winckler will be an interactive conference addressing key legal and business matters focusing on innovation, investing, and regulatory issues in the pharmaceutical and medical device sectors.

Topics Include 

  • Executive Roundtable – Life Sciences Industry Update
  • FDA Update – Recent Developments and New Initiatives Impacting Pharmaceutical and Medical Device Companies
  • HCP Relationships and Enforcement Issues
  • Brexit Update
  • Financing Alternatives for Life Sciences Companies
  • Business and Legal Issues for Early-Stage Companies
  • Patent Prosecution and Litigation Issues for Life Sciences Companies
  • Hot Button ‎Antitrust Issues for Life Science Companies
  • Business and Legal Issues in Clinical Research Arrangements
  • Company Presentations

HCP Relationship and Enforcement Issues Feature

  • Seth Axelrad, Associate General Counsel, Baxter International, Inc
  • Katherine DeKam, Director of Compliance and Chief Compliance Officer, Acumed LLC
  • David J. Pivnick, Partner, McGuireWoods LLP
  • Samuel C. Bernstein, Attorney, McGuireWoods LLP (Moderator)
    • Some topics to be addressed include:
      • New FDA/CDRH Whistleblower Website
      • Off-Label Promotion
      • False Claims Issues
      • Sales Representatives Issues
      • Foreign Enforcement Issues
      • Discount Safe Harbor Issues
      • Sunshine Act Update

For full Agenda, click here.

Who Should Attend

Executives, legal counsel and compliance officers of life sciences companies; investors in manufacturers, distributors, and start-up companies.

CLE applications will be made.

Location:

Swissôtel Chicago, 323 E Upper Wacker Dr., Chicago, IL 60601

Registration

FDA Life readers can register for the conference at 50% off using the code PHARMA50.  To register for the conference, click here.

Accommodations

A block of hotel rooms has been reserved at Swissotel at a discounted rate of $309 per night.

For details, click here.

For more information

Karna Pruiett +1 312 849 8137 kpruiett@mcguirewoods.com