CDER Small Business and Industry Assistance (SBIA) Regulatory Education for Industry (REdI): Generic Drugs Forum April 4-5, 2017

Presentations

• Keynote – Office of Generic Drugs (1/28) Generic Drugs Forum 2017
• Keynote – Office of Pharmaceutical Quality (2/28) Generic Drugs Forum 2017
• ANDA Performance/Operations Update (3/28) Generic Drugs Forum 2017
• Office of Pharmaceutical Quality Policy Update (4/28) Generic Drugs Forum 2017
• GDUFA Regulatory Science Research Update (5/28) Generic Drugs Forum 2017
• Preparing for GDUFA II User Fees (6/28) Generic Drugs Forum 2017
• eCTD (7/28) Generic Drugs Forum 2017
• Panel Discussion (8/28) Generic Drugs Forum 2017
• GDUFA II (9/28) Generic Drugs Forum 2017
• Development of Single, Shared System REMS (10/28) Generic Drugs Forum 2017
• Introduction to “The ANDA Review Pathway” (11/28) Generic Drugs Forum 2017
• ANDA Policy and Regulatory Considerations Prior to Filing (12/28) Generic Drugs Forum 2017
• Panel Discussion (13/28) Generic Drugs Forum 2017
• Filing Review – Do’s and Don’ts (14/28) Generic Drugs Forum 2017
• RPM Communications Associated with “Take Action” Process (15/28) Generic Drugs Forum 2017
• FDA’s Bioequivalence Recommendations for Generic Drugs (16/28) Generic Drugs Forum 2017
• Review of Clinical Endpoint Bioequivalence Studies in ANDAs (17/28) Generic Drugs Forum 2017
• Generic Labeling: Strategies for Providing High-quality Submissions (18/28) Generic Drugs Forum 2017
• Panel Discussion (19/28) Generic Drugs Forum 2017
• OPQ Integrated Quality Assessment (IQA) Process (20/28) Generic Drugs Forum 2017
• OPQ Communications with Industry (21/28) Generic Drugs Forum 2017
• Drug Substance Review - ANDA (22/28) Generic Drugs Forum 2017
• Generic Drug Product Quality Review (23/28) Generic Drugs Forum 2017
• Dissolution Method Development for Generic Drugs (24/28) Generic Drugs Forum 2017
• Manufacturing Process and Controls (25/28) Generic Drugs Forum 2017
• Facility Evaluation and Inspection (26/28) Generic Drugs Forum 2017
• Product Quality Microbiology Assessment (27/28) Generic Drugs Forum 2017
• Panel Discussion (28/28) Generic Drugs Forum 2017

You are invited to this two-day FDA led Regulatory Education for Industry (REdI): Generic Drugs Forum 2018. Join over 1000 participants from across the globe as we gather together in this opportunity to interact with FDA subject matter experts involved in the Generic Drug Review Program.  You will obtain up-to-date information on program progress and current initiatives