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FDA Takes the Stage at ExL's 10th REMS Summit to Outline FDA Guidances Impacting REMS

Are you adapting well to the new FDA guidance's?

ARLINGTON, Va., Jan. 8, 2018 /PRNewswire/ -- Are you adapting to the new FDA guidance's?

Since the release of the 10th REMS Summit brochure, the FDA has released two guidances that amplify your need to attend the event that has every REMS professional talking. In light of these changes, we are excited to announce the expansion of the 10th Annual REMS Summit program to address the evolving REMS landscape!

BRAND NEW SESSIONS BY THE FDA
Overview of Recent FDA Guidances Impacting REMS

Introduce the new REMS document template
Provide an overview of how to use a Drug Master File (DMF) for shared REMS submission
Summarize the expected benefits of these guidances on REMS submissions

Gita Toyserkani, Pharm.D., MBA, Regulatory Health Policy Analyst, Division of Risk Management, Office of Medication Error Prevention and Risk Management, Office of Surveillance and Epidemiology, FOOD AND DRUG ADMINISTRATION

Suzanne Robottom, Pharm.D., Regulatory Health Policy Analyst, Division of Risk Management, Office of Medication Error Prevention and Risk Management, Office of Surveillance and Epidemiology, FOOD AND DRUG ADMINISTRATION

Hot off the Press: New FDA Initiatives and Guidelines

Understand most current FDA guidelines about REMS
Learn about current FDA initiatives on risk management
Understand practical applications of new FDA initiatives

Annette Stemhagen, MPH, DrPH, Senior Vice President, Safety, Epidemiology, Registries and Risk Management, UNITED BIOSOURCE CORPORATION

Click here to see the fully updated agenda.

Thirty other speakers representing pharmaceutical companies, health systems, and regulatory agencies join Gita, Suzanne, and Annette on the 10th Annual REMS Summit speaking faculty. Connect with and learn from your industry peers at the REMS Summit on January 29–30 in Arlington, VA.

Register today to reserve your seat at the most anticipated REMS Summit yet! Save 15% off the standard rate when you use Discount Code C988PRNW

75+ ATTENDEES ALREADY REGISTERED!
Join your peers from the following organizations and more.

AbbVie
Actelion
Bayer
Biogen
BioTrak Research
Celgene
CO*RE
Duke
Endo
FDA
Geisinger Health System
Global Reach
Indivior
Juno Therapeutics
Luto
McKesson
Medicines for Europe
Northwestern University
Pfizer
PPD
Sheehan
Shire
UBC
UNC
Zogenix

If you have any questions please reach out to Mercy Lister, Conference Producer, at mlister@exlevents.com.

Thank you to our 2018 sponsors!

BioTrak
Haug Partners
McKesson – McKesson Specialty Health
UBC – An Express Scripts Company

For more information, contact:
ExL Events
Phone: 866-207-6528
Email: registration@exlevents.com

SOURCE ExL Events