IPAC-RS 2008 Conference

On September 22-24, 2008 IPAC-RS hosted its second open public conference entitled "Doing the Right Thing" in the Changing Culture of Design and Development of Inhalation and Nasal Drug Products: Science, Quality, and Patient-Focus 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.

The Conference Executive Summary is available here: Executive Summary

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

Day 1

• Keynote Address: Embracing Challenges & Opportunities to Enhance Quality of OINDP- Jim Spavins
  
• Quality by Design and OINDP: Setting the Stage - John Berridge
  
• Panel - Lessons Learned from Implementation of ICH Q8, Q9 and Q10 - Regulatory Agency Perspectives
  Co-Moderators: Carol DeSain and Bill Paulson
  Panelists: John Berridge, Michael Golden, Chris Marriott, Moheb Nasr, Krishnan Tirunellai
• Patient Perspective: John Walsh (Alpha-1 Foundation)
  
• Evolving Regulatory Developments - Stefan Leiner
  
• Role of Standards in Drug and Device Development - Pat Picariello
  
• Panel - Application of Evolving Regulatory Landscape to OINDP
  Moderator: Michael Golden
  Panelists: John Berridge, Blair Fraser, Sabina Hoekstra-van den Bosch, Stefan Leiner, Joseph Lim
• Day 1 Summary Slides
  
  

• Keynote Address: Changing the Culture: Why Walking the Green Walk Globally Matters - Paul Narog
  
• Panel - Potential for Green Chemisty and Green Engineering in OINDP: Design for Environment
  Sharon Austin
  David Constable
  Buzz Cue
  
• Industry Roundtable Discussion: Green Product Development is Good Business - Highlighting Industry's Best Green Practices
  Moderator: Barbara Falco
  Panelists: Paul Atkins, David Constable, Joanne Jaeger, Paul Narog, Elizabeth Girardi Schoen
  
• Patient Perspective: Nancy Sander (Allergy & Asthma Network - Mothers of Asthmatics)
  
• Panel - Design Control for OINDP
  Moderator: John Hart
  Panelists:Guillaume Brouet, Tim Chesworth, Paul Lafferty, Dave Christopher
  Polling Results
  
• Practical Perspectives in the Application of QbD to OINDP - Dave Parkins
  
• Day 2 Summary Slides
  
  

• Keynote Address: Future Opportunities in OINDP Development - Paul Huckle
  
• Lessons Learned from Other Industries - Overcoming Supplier-Manufacturer Challenges: Perspectives from Toyota North America and ArvinMeritor,LVS - Dennis Cuneo and Sherry Welsh
  
• QbD & Manufacturer-Supplier Partnerships - Barbara Falco and Jo Ward
  
• Case Study: Optimization of Cascade Impactor Methods - The AIM (Abbreviated Impactor Measurement) Concept - Jolyon Mitchell
  
• Lifecycle Approach to Specification Setting - Dave Christopher
  
• Patient Perspective: Suzanne Pattee (Cystic Fibrosis Foundation)
  
• Panel - Application of QbD to Clinical Trial Design for OINDP: Regulatory CMC & Clinical Perspectives
  Moderator: Don Chambers
  Panelists: Wally Adams, Badrul Chowdhury, Ken Furnkranz, Joseph Lim, Prasad Peri, Jun Zhang
  
• Clinical Relevance of Aerosol Quality Attributes: Exubera Case Study - Nancy Harper
  
• Moving Towards the Desired State - Roundtable: Regulatory and Industry Perspectives
  Moderator: Andy Rignall
  Panelists: Sabina Hoekstra-van den Bosch, Chuck Hoiberg, Rich Levy, Joseph Lim, Rik Lostritto, Reggie Saraceno, Terry Tougas
  

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  IPAC-RS 2008 Conference Poster Session

  The Conference plenary sessions were supplemented by a scientific poster session that addressed a wide range of topics such as bioequivalence requirements for OINDP, optimized cascade impaction and other analytical methods, statistical design of experiments for device-drug combination products, extractables and leachables, and approaches to managing the supply chain.
   
  Copies of the posters presented at the IPAC-RS 2008 Conference are available here:  Posters.