New York Professional Events List

2017 Off-Label Regulatory Compliance Congress

May 22, 2017 - 08:00 AM - May 23, 05:30 PM
Hyatt Regency MorristownHyatt Regency Morristown3 Speedwell AvenueMorristown, NJ 07960,

NJ ,
ZIP: 07960
Phone: +1 929 900 1853

2017 Off-Label Regulatory Compliance Congress

2017 Off-Label Regulatory Compliance Congress

As the demand for information outside of approved labeling continues to rise, the FDA has been called by the industry to provide guidance that governs off-label communications. The regulatory landscape that monitors this space is often blamed for limiting the amount of information received by patients and restricting their ability to make well-informed decisions.

Given the public health issues at stake and the public interest involved, it is imperative that this event details the importance of the timely communication of truthful scientific information that currently challenges pharmaceutical, biotech and medical device professionals. The 2017 Off-Label Regulatory Compliance Congress also explores the ever-changing regulatory landscape and explain how professionals can work with officials to ensure that promotional practices remain compliant and expedite the transmission of relevant scientific information to advance public health.

Top Five Reasons to Attend

  1. Hear firsthand accounts from the “FDA’s Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products” public hearing

  2. Explore how the 21st Century Cures Act will transform the way that information is disseminated across the industry

  3. Establish a clear definition of scientific communication exchange without fear of persecution

  4. Discover ways to coordinate the availability of science and real-world data with the speed of the regulatory landscape

  5. Participate in panel discussions and examine case studies to identify how industry leaders develop compliant promotional practices

Who Should Attend

This conference is designed for representatives from pharmaceutical, medical device and biotechnology companies with responsibilities in the following areas:

  • Regulatory Affairs
  • Legal Affairs/Compliance
  • Medical Affairs/MSL
  • Marketing/Advertising and Promotion
  • Sales
  • Clinical/Promotional Review
  • Brand Management
  • Medical Information
  • Medical Education
  • Medical Communication
  • Product Training
  • Commercial/Scientific Legal Affairs
  • Quality Assurance

This conference is also of interest to:

  • Regulatory Affairs Service Providers/Consultants
  • Compliance Service Providers
  • Promotional Review Vendors
  • Off-Label Service Providers
  • Law Firms
  • Marketing/Advertising Agencies


Please contact the event manager Marilyn below for the following:
- For Tickets/Registrations,
- Discounts for registering  5 or more participants.
- If you company requires a price quotation.
Event Manager Contact:

marilyn.b.turner(at) or Contact:  +1 929 900 1853
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
This Event Listing is Promoted by  New York Media Technologies LLC in association
with EXL Events Inc.


Day One
 Monday, May 22, 2017
8:00AM – 9:00AM
Registration Opens and Continental Breakfast
9:00AM – 9:15AM
Chairperson’s Welcome and Opening Remarks
Geoffrey Levitt, Senior Vice President and Associate General Counsel, Regulatory, Environmental and Global Supply, PFIZER
9:15AM – 10:00AM
Align Your Promotional Practices with the FDA’s Developing Policies Regarding Off-Label Communications
10:00AM – 10:45AM
Identify Appropriate Product Communications as Defined by the FDA's New Draft Guidance Documents
Carolyn Seyss, PharmD, Senior Director, Promotional Review, Regulatory Affairs, ACORDA THERAPEUTICS
10:45AM – 11:15AM
Networking Break
11:15AM – 12:00PM
An Analysis of the Changing Landscape for Off-Label First Amendment and RICO Cases in the Supreme Court and the FDA
David Stone, Senior Managing Partner, STONE & MAGNANINI LLP
12:00PM – 12:45PM
The Great Debate: Is Off-Label Promotion Undermining Public Health?
12:45PM – 1:45PM
1:45PM – 2:45PM
PANEL DISCUSSION: Consider How the New Administration Will Enforce Off-Label Regulations
Leslie Gladstone Restaino, General Counsel, VALIDUS PHARMACEUTICALS
Kevin Ryan, Senior Director, Risk and Accountability, NOVO NORDISK INC.
Michael Ujhelyi, Senior Medical Director, BTG PLC
Jennifer A. Sanfilippo, Vice President, Commercial Integrity Counsel, Legal, THE MEDICINES COMPANY
2:45PM – 3:30PM
A Look Through the Legal Lens: Does Your Organization's Medical Affairs and MSL Field Outreach Comply with the Law?
Jennifer Williams, Ph.D., J.D., MBA, Professor, OAKLAND UNIVERSITY
3:30PM – 4:00PM
Networking Break
4:00PM – 4:45PM
Ensure Effective Compliance Programs That Keep Pace with the Changing Regulatory Landscape and Improve Your Operations
Frank Pignataro, PharmD, Director, LMR Excellence and USMA Governance, BAYER
4:45PM – 5:30PM
Best Practices for Establishing Effective Self-Regulation to Reduce Risk While Disseminating Scientific Information
Howard Dorfman, Distinguished Visiting Practitioner and Adjunct Professor, SETON HALL UNIVERSITY SCHOOL OF LAW
5:30PM – 5:30PM
Day One Concludes
Day Two
 Tuesday, May 23, 2017
8:00AM – 9:00AM
Continental Breakfast
9:00AM – 9:15AM
Chairperson’s Recap of Day One
Geoffrey Levitt, Senior Vice President and Associate General Counsel, Regulatory, Environmental and Global Supply, PFIZER
9:15AM – 10:15AM
KEYNOTE PRESENTATION: The Impact of Off-Label Communications on Public Health and Standard of Care
Geoffrey Levitt, Senior Vice President and Associate General Counsel, Regulatory, Environmental and Global Supply, PFIZER
10:15AM – 11:00AM
Communications Prior to FDA Approval: Current Requirements and Considerations for Future Change
11:00AM – 11:30AM
Networking Break
11:30AM – 12:15PM
Survey Your Social Media Communications to Comply with the Current Regulatory Landscape
Daniel Zavodnick, Senior Regulatory Counsel, Branded Pharma US, ALLERGAN
12:15PM – 1:15PM
1:15PM – 2:15PM
PANEL DISCUSSION: Differentiate Off-Label Promotion from the Need for Communication
Howard Dorfman, Distinguished Visiting Practitioner and Adjunct Professor, SETON HALL UNIVERSITY SCHOOL OF LAW
Dina Given, Chief Compliance Officer, NEOS THERAPEUTICS
Richard Liner, Senior Compliance Counsel, BAYER
Pamela Politis, J.D., Ph.D., Senior Director, Regulatory Counsel, INCYTE
2:15PM – 3:00PM
The 21st Century Cures Act: A Paradigm Shift Streamlining Clinical Regulatory Pathways
Michael Ujhelyi, Senior Medical Director, BTG PLC
3:00PM – 3:15PM
Chairperson’s Closing Remarks
Geoffrey Levitt, Senior Vice President and Associate General Counsel, Regulatory, Environmental and Global Supply, PFIZER
3:15PM – 3:15PM
Conference Concludes

Speaker Details

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