FDA Regulatory Education for Industry (REdI) Conference Fall 2015 Presentation Slides

Day 1 - General Session - September 29, 2015

• Plenary - Drug / Device Combinations: a Union to Deliver the Best Medical Product to Patients

Day 1 - Drugs Track - September 29, 2015

• Safety Considerations for Product Design, Container Labels, and Carton Labeling and Best Practices in Developing Proprietary Names for Drugs
• Good Clinical Practice (GCP) Inspectional Perspective on Use of Electronic Records and Signatures in Clinical Trials
• Comparing Safety Report Requirements for Pre and Post Market
• Pediatric Drug Development: Regulatory Expectations
• Clinical Outcome Assessment Implementation in Clinical Trials

Day 1 - Devices Track - September 29, 2015

• Device Classification Overview
• Device Clinical Trials and the IDE Program - Fall 2015
• The 510(k) Program - Fall 2015
• Labeling Overview

Day 2 - Drugs Track - September 30, 2015

• Overview of FDA Expedited Programs with a Focus on the Breakthrough Therapy
• FDA's Pre-Approval Inspection (PAI) Program and How to prepare for a successful outcome
• CDER Regulatory Applications - Investigational New Drug and New Drug Applications
• Lifecycle Management of Drug Products: FDA’s Perspective
• Lifecycle Management of Drug Products
• Evidence and Data Requirements for NDA Submissions
• Demystifying Interactions with FDA-CDER: A Primer on Formal Meetings and Best Practices

Day 2 - Devices Track - September 30, 2015

• Welcome
• Overview of Quality Systems Regulation
• Design Controls - Devices
• Purchasing Controls - Devices
• Process Validation
• Unique Device Identification (UDI) - Fall 2015
• FDA Medical Device Inspections - Fall 2015