FDA Regulatory Education for Industry (REdI) Spring, May 15-16, 2018

 

• Office of Regulatory Affairs Update (1of14) REdI 2018    
• Human Factors Engineering in Medical Products Reviews (2of14) REdI 2018  
• Demystifying the Investigational New Drug (IND) Application for Drugs and Biologics (3of14) REdI 2018    
• Formal Meetings for PDUFA Products and Communication Best Practices (4of14) REdI 2018  
• Investigational New Drug (IND) Submission: Content/Format and First 30 Days (5of14) REdI 2018    
• Nonclinical Safety Assessment for Small Molecules and Biologic Drug Development (6of14) REdI 2018
• Chemistry, Manufacturing, and Controls (CMC) for an IND (7of14) REdI 2018    
• Benefit-Risk Considerations During Drug Product Development (8of14) REdI 2018    
• FDA Regulatory Requirements for Clinical Investigators and Case Examples (9of14) REdI 2018    
• Investigational New Drug Safety Reporting Requirements (10of14) REdI 2018  
• Good Manufacturing Practices (GMPs) from an IND Perspective (11of14) REdI 2018 
• CDER Small Business and Industry Assistance Overview (12of14) REdI 2018  
• The Active IND and Available Development Programs (13of14) REdI 2018    
• Walkthrough of a Pre-Approval Manufacturing Site Inspection (14of14) REdI 2018

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.