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 2018 Off-Label Regulatory Compliance Congress also explores the ever-changing regulatory landscape and explains 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
- Better understand the ever-changing FDA landscape and revised guidelines
- Participate in discussions and examine case studies to identify how industry leaders develop compliant promotional practices
- Discuss ways to sync the availability of scientific and real-world data with the speed of regulatory action
- Analyze the limitations and risks of off-label promotion
- Discuss challenges posed by the changing regulations of safety data and the implications of new guidelines
Who Should Attend
This conference is designed for
representatives at healthcare insurance, biopharmaceutical, medical
device, and formulary organizations with the following responsibilities:
- 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
Speakers
- Sergio Alegre, Vice President, Global Compliance, OSMOTICA PHARMACEUTICALS
- Jacqueline Armani, Medical Science Liaison, Surgical, ALCON
- Alma Azua-Cassady, Corporate Compliance Manager, THE MOUNT SINAI HEALTH SYSTEM
- John Paul Benitez, Counsel, ELI LIILLY AND COMPANY
- Ethan Davis, Deputy Assistant Attorney General, DEPARTMENT OF JUSTICE
- Howard Dorfman, Distinguished Visiting Practitioner and Adjunct Professor, SETON HALL UNIVERSITY SCHOOL OF LAW
- Mary Ellen Dronitsky, Senior Director, Regulatory Affairs — Advertising and Promotion, AEGERION PHARMACEUTICALS
- Bruce A. Leicher, Senior Vice President and General Counsel, MOMENTA PHARMACEUTICALS, INC.
- Richard Lem, Assistant Director, Regulatory Affairs – Advertising and Promotion, BAYER HEALTHCARE
- Ilyssa Levins, President, CENTER FOR COMMUNICATION COMPLIANCE
- Richard Liner, Senior Compliance Counsel, BAYER HEALTHCARE
- Sabrina Mays-Diagne, Senior Corporate Attorney, OTSUKA PHARMACEUTICALS
- Jennifer M. Williams, Ph.D., J.D., MBA, RN, MSM, Assistant Professor, UNIVERSITY OF SOUTHERN INDIANA
Please fill in your name and email to receive the conference agenda of this event.
The agenda is available as PDF under downloads at the right side of the page.
Venue
Hilton Washington Dulles Airport
13869 Park Center Rd, 20171
Herndon, VA, USA
Venue
Hilton Washington Dulles Airport13869 Park Center Road Herndon
Herndon, VA 20171
To make reservations over the phone, please call 703-478-2900 and request the negotiated rate for “ExL’s May Meetings.” To make reservations online
Click HereYou must book your room by April 20, 2018, in order to receive the group rate. Please book your room early, as rooms available at this rate are limited
