IPAC-RS 2006 Conference

On November 6-8, 2006, IPAC-RS hosted its first open public conference entitled "Inhalation and Nasal Drugs: The Regulatory Landscape", where industry, regulators and other interested parties discussed best scientific and regulatory approaches for orally inhaled and nasal drug products. The Conference program is posted here: Final Program.

Click on the following links to access the slides from the Conference:

Day 1

• IPAC-RS Conference Welcome - Liuda Shtohryn
  
• Evolution of Regulatory Paradigm for OINDP - Industry Perspective - Gordon Hansen
  
• QbD for OINDP - FDA Perspective - Rik Lostritto
  
• Quality by Design for OINDP - Michael Golden
  
• Quality Risk Management and Design Space in Device Development - Laurence Huxham
  
• Change Protocols - Jon Clark
  
• Quality by Design - Jon Clark
  
• IPAC-RS Model OINDP Initiative - Terry Tougas
  

Day 2

• Keynote Day 2 - Roger Williams
  
• Track A Breakout Feedback - OINDP Industry's Use of PAT in Submissions
  
• Track B Breakout Feedback - Applying Risk Management, Risk Assessment and Design Space to OINDP Developement and Regulation
  
• Track C Breakout Feedback - Q&A on Control Strategies and linking Quality, Safety & Efficacy in a QbD Development Program
  
• Control of Suppliers, Component Quality and QbD - David Cummings
  
• Role of the IPAC-RS GMP Guideline in Promoting OINDP Component Quality - Barbara Falco
  
• Promoting Quality OINDP Components- Supplier Perspective-Tom Gaspar
  
• What Do Cascade Impaction Measurements Tell Us - Jolyon Mitchell
  
• Clinical Relevance of In-vitro Particle Sizing Data - Steve Newman
  
• ISO Process and Standards Under Development - Steve Nichols
  
• Linking Safety & Quality - Examples from L&E and Foreign Particles in OINDP - Tim McGovern
  
• Considerations for Foreign Particulates in a QbD Environment - Mikael Sundahl
  
• Considerations for Leachables & Extractables in a QbD Environment - Dan Norwood
  
• Track D - Progress Report and Q&A on ISO Standards for MDI-DPI - Hal Yeager
  
• Track D - Progress Report and Q&A on ISO Standards for Nebulizers - Ann Graham
  
• Track E - Application of PTI Tests
  
  

• Keynote Day 3 - Igor Gonda
  
• Track D Breakout Feedback - Progress Report and Q&A on ISO Standards for MDI-DPI and Nebulizers
  
• Track E Breakout Feedback - Application of PTI Tests
  
• Track F Breakout Feedback - Q&A and Discussion on Supplier QC for OINDP
  
• Canadian Approach to Regulation of OINDP - Caroline Vanneste
  
• European Approach to Regulation of OINDP - Diana van Riet
  
• Industry Perspectives on OINDP Regulatory Challenges in a Global Environment - Ray Ormiston
• Development of Inhalation Products for Systemic Applications - Regulatory Challenges - Sally Seymour
  
• Case Study 1 - Development of Inhaled Insulin for Diabetes - Nancy Harper
  
• Case Study 2 - Systemic Delivery of Small Molecules via the Lungs - Jim Blanchard (substituting for Tunde Otulana)
  
• Closing Remarks - Liuda Shtohryn