Last year, FDA issued new draft guidelines on promotional communications, with special emphasis on the use of data that is consistent with product labeling. While highly important, this guidance is also ambiguous - and since there have not yet been many warning letters issued over violations, promotional review professionals may be unsure how to proceed without a clear guiding signal.
The
5th Promotional Review Committee Compliance & Best Practices - Midwest conference is the only industry event devoted specifically to optimizing the skill sets, teamwork, speed, and regulatory awareness of your PRC members. No other event goes into as much detail about both the latest regulatory changes facing your teams and the operations and leadership techniques they require in order to succeed!
Top Five Reasons to Attend
- In-depth examination of the use of data consistent with labels
- Evaluation of promotional materials for conventions
- New skills for compliance in VR and telemedicine
- Special insight on PRC responsibilities for Patient Support Programs
- New insights on the quality control processes essential for your PRC
Who Should Attend
Pharmaceutical, biotech and medical device professionals responsible for the following areas:
- Promotion Review / PRC / MPRC / PMRC
- Promotional Materials / Material Review
- Regulatory Promotion & Advertising / PromoAd / AdProm / AdPromo / Copy Editing
- Regulatory Affairs / Process
- Compliance / Promotional Compliance
- Labeling
- Health Economics / Outcomes Research / Outcomes / HEOR
- Editor / Editorial
- Medical Affairs / Review
- Medical Information
- Communications
- Medical Communications / Information / Medical Science Liaison
- Medical Writing / Scientific Writing
- Medical Director
- Marketing / Marketing Operations / Communications / Services
- Commercial Operations
- Brand Manager / Product Manager / Brand Marketing
- Legal Affairs / Counsel / Regulatory Counsel
This event is also of interest to:
- CRM / Data Management Software Suppliers
- MLR Process Vendors and Facilitators
- Advertising / Marketing Agencies
- Regulatory Consultants
- Medical Writing Firms
- Law Firms
Speakers
- Ilze Antons, Senior Director, Regulatory Affairs, LUNDBECK
- Jennifer Banovic, Executive Medical Communications Liaison, TAKEDA
- Leeann Bonaventura, Associate Director, Promotional Regulatory Affairs, ASTRAZENECA
- Lynn Bowen, Director, Commercial Regulatory Oversight, VERTEX PHARMACEUTICALS
- Christi Bruce, Senior Manager, MLR Operations and Platforms, SANOFI
- Rebecca Burnett, Executive Director and Head of Strategic Services, FRAMEWORK SOLUTIONS
- Elke Carter, Regulatory Manager, ZAVATION MEDICAL PRODUCTS
- Erica Chertow, Director, Regulatory Affairs, U.S. Prescription Drug Promotion, ABBVIE
- Jessica Cirillo, Director, HEOR — Acute Care Lead, MALLINCKRODT
- Sue Duvall, Head, North America Advertising and Promotion, Regulatory Affairs, MYLAN
- Megan Francis-Sedlak, Senior Manager, Medical Affairs, HORIZON PHARMA
- Marge Garcia, Associate Director, Program Review Operations, GENENTECH
- Mimi Giordano, Senior Copy Editor, UCB
- Kevin Hollister, Senior Director, Regulatory Affairs, TESARO
- Richard Kim, Associate Director, Medical Review, ABBVIE
- John Marcus, Director, Regulatory Affairs, Labeling, Advertising and Promotion, HORIZON PHARMACEUTICALS
- Michael Saad, Senior Manager, Marketing Operations, ABBVIE
- Zafar Toor, Pharm.D., Senior Director, Commercial Regulatory Affairs, LEXICON PHARMACEUTICALS
- James Vigil, Director, U.S. Regulatory Affairs, Advertising and Promotion, ABBVIE
- Alexander Zachos, Lead (Associate Director), U.S. Regulatory Advertising and Promotion, SHIRE
Please fill in your name and email to receive the conference agenda of this event.
Workshop - Thursday, May 17, 2018
Conference Day One - Thursday, May 17, 2018
Conference Day Two - Friday, May 18, 2018
The agenda is available as PDf under downloads at the right side of the page.
Venue
The venue is not yet available for this event.
Follow this event to be informed when the venue is available and stay informed on other changes.
Venue
Conrad Chicago101 East Erie Street
Chicago, IL 60611
The Conrad Chicago appeals to a new generation of luxury travelers for whom life, business and pleasure seamlessly intersect. The 20-story hotel is ideally located on Chicago’s Magnificent Mile, providing guests immediate access to premier retail shops, highly acclaimed restaurants, an array of famous landmarks, and unmatched views of the Chicago skyline and Michigan Avenue.
To make reservations, please call 844-676-2522 and request the negotiated rate for ExL. To make reservations online
Click HereThe group rate is available until April 25, 2018. Please book your room early, as rooms available at this rate are limited.
