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  5. Regulatory Education for Industry (REdI): Complex Generic Drug Product Development Workshop: September 12 & 13, 2018
  1. CDER Small Business & Industry Assistance (SBIA)

Regulatory Education for Industry (REdI): Complex Generic Drug Product Development Workshop: September 12 & 13, 2018


About this workshop
This science-focused workshop communicates to the generic industry how FDA research outcomes guide and facilitate complex generic product development. Presentations will provide a deep-dive to the complex generic drug development process. The meeting is a “boot-camp” designed to provide practical assistance to industry in submitting complete applications with a higher potential for first cycle approval. We will link GDUFA science and research on complex products to product-specific guidance development, discuss pre-ANDA meetings and review, and examine complex product science in various areas.

Who should attend? (attend in person or virtually)
Scientists, researchers, and regulatory affairs professionals who work on or are interested in working on the development of complex generic drugs.

Featured presentations include:

  • Overview of Pre-ANDA Program for Complex Generic Drug Products
  • Complex Active Pharmaceutical Ingredients (APIs)
  • Complex Formulations/Dosage Forms
  • Complex Route of Delivery: Ophthalmic
  • Complex Routes of Delivery/Dosage Forms: Topical and Transdermal
  • Complex Generic Drug-Device Combination Products and Complex Abuse Deterrent Formulations
  • Complex Routes of Delivery: Orally Inhaled and Nasal Drug Products (OINDPs)

Tommy Douglas Conference Center (TDCC)
(Ballroom C&D, Building 9)
10000 New Hampshire Avenue
Silver Spring, MD 20903

This 2-day conference has been pre-approved by RAPS as eligible for up to 12 credits
towards a participant’s RAC recertification upon full completion.
Only live attendance will qualify for the CE. Attendance Certificates are only available for TWO WEEKS after the event.

Questions? Please visit SBIAevents.com for updates, or email info@SBIAevents.com.

For more information visit our webpage CDER SBIA
(866)-405- 5367 | (301)-796- 6707 CDERSBIA@fda.hhs.gov

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