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

Monday, January 8, 2018 Drug News
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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 FDAOverview 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., MBARegulatory Health Policy Analyst, Division of Risk Management, Office of Medication Error Prevention and Risk Management, Office of Surveillance and EpidemiologyFOOD 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 EpidemiologyFOOD 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, DrPHSenior Vice President, Safety, Epidemiology, Registries and Risk ManagementUNITED 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.

AbbVieActelionBayerBiogenBioTrak ResearchCelgeneCO*REDukeEndoFDAGeisinger Health SystemGlobal ReachIndiviorJuno TherapeuticsLutoMcKessonMedicines for EuropeNorthwestern UniversityPfizerPPDSheehanShireUBCUNCZogenix

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

Thank you to our 2018 sponsors!

BioTrakHaug PartnersMcKesson – McKesson Specialty HealthUBC – An Express Scripts Company

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

 

Cision View original content:http://www.prnewswire.com/news-releases/fda-takes-the-stage-at-exls-10th-rems-summit-to-outline-fda-guidances-impacting-rems-300578308.html

SOURCE ExL Events

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