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Generic Industry Challenge Perspectives – GDUFA Science and Research Initiatives Public Workshop

Presentations discuss perspectives on generic industry challenges. Topics and titles as follows:
Model-Integrated Evidence for Generic Drug Development
Community Trust in Modelling & Simulation: The Move from Scientific Curiosity to Ingrained Industrial Applications – Amin Rostami, PhD, Prof. of Systems Pharmacology, Univ. of Manchester / CSO, Certara
Model-Integrated Evidence for Generic Drug Development – Liang Zhao, PhD, Director, DQMM, ORS, OGD, FDA
Complex Product Characterization/Analysis
Complex Product Characterization and Analysis Challenges for Oligonucleotide and Liposomal Drug Products- Zdenko Casar, PhD, Head Early Stage Development Slovenia, Lek Pharm. d.d., Sandoz Pharm.
Scientific Approaches for the Analytical Characterization of Complex Generic Products – Rachel Dunn, PhD, Director, DPA, OTR, OPQ, FDA
In Vitro & In Vivo BE Approaches: Challenges & Opportunities
Challenges and Opportunities of Complex Clinical Bioequivalence Studies – Beatriz North, MPH, Senior Director, Global Clinical Affairs, Perrigo Pharm
Advancing Regulatory Science Through Innovative Bioequivalence Approaches – Partha Roy, PhD, Director, OB, OGD, FDA
Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/fy-2021-generic-drug-science-and-research-initiatives-public-workshop-06232021-06232021
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.  

Upcoming Training – https://www.fda.gov/cdersbia   
SBIA Listserv – https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2021 Playlist – https://youtube.com/playlist?list=PLey4Qe-UxcxYS1MaTusSgyifQDqdeepyD
SBIA LinkedIn – https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance  
SBIA Training Resources – https://www.fda.gov/cderbsbialearn  
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