Less than ONE week left until the FDA REdI Complex Generic Drug Product Development Workshop – Register Today!

FDA/CDER Small Business and Industry Assistance (SBIA) presents the 

Regulatory Education for Industry (REdI) Complex Generic Drug Product Development Workshop

September 12 & 13, 2018

Silver Spring, MD

Information * Registration * Agenda

Attend in-person or virtually

Registration is free

Advanced registration is required

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.

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)

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.

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