IPAC-RS 2011 Conference: Bringing Value to the Patient in a Changing World

On March 29-31, 2011, IPAC-RS hosted its third open public conference entitled "Bringing Value to the Patient in a Changing World" 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.

A Conference Report is available here: Conference Report.

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

Day 1

• Welcome – Sue Holmes
  
• Keynote Address: Asthma and its Many Unmet Needs: Directions for Novel Therapeutic Approaches – William W. Busse
  
• COPD Patient’s Needs – Stephen I. Rennard
  
• It’s Easy, Just Take Two Puffs: A Global Perspective on Patient Educational Requirements and Needs Related to Inhaled Therapies – Monica Fletcher
  
• Matching Patient to the Device – Søren Pedersen
  
• FDA Efforts on Liaising with Patients – Deborah J. Miller
  
• Summary of the 2010 ISAM/IPAC-RS Equivalence Workshop, with a Focus on Patient-Related Aspects – Dennis O’Connor
  
• The MDI – In Vitro Measures to Confirm Patient Perceptions: HFA vs CFC – Bill Doub
  
• Lifting Medication Adherence: Lessons from Internet Connected Packaging – Joshua Wachman
  
• Talking Packs: Making Packaging Part of the Treatment – Tim Chesworth
  
• Regulatory Expectations for User Testing – Paul Lucas
  
• Human Factors and the Design of Inhalation Devices – Stephen Eason and Julia Dixon
  
• Human Factors "Usability" in the Review of New Medical Devices at FDA’s Center for Devices and Radiological Health (CDRH) – Ronald D. Kay
  
  

• Keynote Address: FDA View on Assessing Quality of Inhaled Products and Links to Efficacy and Safety – Prasad Peri
  
• Applying Quality by Design Principles to Analytical Methods Associated with OINDPs – Andy Rignall
  
• So You Want to Use Parametric Tolerance Testing for Control of Delivered Dose Uniformity? – Greg Larner
  
• Overview of Effective Data Analysis – Terry Tougas
  
• Dissolution Testing for Inhaled Products – Trevor Riley and Dave Christopher
  
• Strong Foundations: Building Quality Through the Supply Chain – Barbara Falco
  
• Collaborating with the Global Supply Chain on Materials Requirements and a Rationalized Testing Paradigm – James Mullis
  
• Supply Chain Approaches to Ensuring Component Quality – Ken Chesney
  
• Regulatory Perspectives on Supply Chain Quality and Security – Vibhakar Shah
  
  

• Brief Overview of PQRI Recommendations Challenges and Successes – Daniel Norwood
  
• Leachables and Extractables: Evolution of Regulatory Aspects and Perspectives on PQRI Recommendations – Guirag Poochikian
  
• Work of the PQRI PODP – Tom Feinberg
  
• Case Study: A Problematic Extractable for a Pulmonary Delivery Device System – William Beierschmitt
  
• A Step-wise Approach for Leachables & Extractables Evaluation in pMDI Product Development – Andrea Mieth
  
• Experiences with Adoption of the PQRI Best Practice Guidelines When Applied to Development of an E&L Development Package for DPI – Jason Creasey
  
  

• Lifecycle Strategies for Using EDA, AIM and Full Resolution Impactor – Terry Tougas
  
• Control Strategies for APSD – Rajni Patel
  
• Equipment Options for AIM and Beyond – Jolyon Mitchell
  
• Precision and Accuracy of AIM – Dave Christopher and Rajni Patel
  
• Considerations for Applying EDA to an Existing Product - Helen Strickland
  
• Road to Adopting AIM/EDA as a Standard – Adrian Goodey
  
  

• The Voice of the Patient – Nancy Sander
  
• Patient Perspective – Sandra Fusco-Walker
  
• Patient Perspective – John Walsh
  
• Heath Care Provider Perspective – Barbara Yawn and Suzanne Lareau
  
• Disease Management and Health Outcomes Perspective/Purchaser Perspective – Len Fromer
  
  
  

  ---

  IPAC-RS 2011 Conference Poster Session

  The Conference was supplemented by a scientific poster session that addressed a wide range of topics.
   
  Copies of the posters presented at the IPAC-RS 2011 Conference are available here:  Posters.