SBIA Education Events

US FDA – Center for Drug Evaluation & Research – Small Business & Industry Assistance

2018 Electronic Drug Registration & Listing Using CDER Direct – Files

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Evaluation & Certificate

October 2, 2018:

Keynote – The State of DRLS
Paul Loebach
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Session 1: Establishment Registration & Labeler Code Requests
Lalnunpuii Huber
Regie Samuel
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Session 2: National Drug Code Reservation
Troy Cu
David Mazyck
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Session 3: Drug Product Listing & Listing Certification
Julian Chun
Donovan Duggan
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Session 4: FDA DRLS Compliance Program
Tasneem Hussain
Leyla Rahjou Esfandiary
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Session 5: 503B Product Reporting for Compounding Outsourcing Facilities
Lysette Deshields
Soo Jin Park
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