ISAM/IPAC-RS 2010 Equivalence Considerations EU Workshop

On 12-13 October 2010 IPAC-RS and The International Society for Aerosols in Medicine (ISAM) hosted a joint 2-day Workshop European Workshop on Equivalence Considerations for Orally Inhaled Products for Local Action in Frankfurt, Germany.

The Conference program is posted here: Program

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

Day 1

• Introduction to Workshop – Sue Holmes
  
• Overview of Plenary 1 Session – Gur Jai Pal Singh
  
• Generic Medicines: Understanding the Legal Framework in the EU, US and Canada – Mary Devlin Capizzi
  
• Experience with OIP Equivalence Determinations in the Netherlands - Focus on In-vitro Aspects – Marjolein Weda
  
• MHRA/UK Experience – Focus on In-vivo, Design of Clinical Studies, Biomarkers, PK/PD - Sanjeeva Dissanayake
  
• MPA/Swedish Experience with OIP Equivalence Determinations - Eva Agurell
  
• Spanish Interpretation and Application of the OIP Guideline - Alfredo Garcia Arieta
  
• Experience with Canadian Guidance: Similarity and Distinction Relative to European Approach - Myrna Dolovich
  
• An Overview of the FDA Position and Experience with Equivalence of Respiratory Drugs - Dale Conner
  
• Overview of Plenary 2 Session - Michael Golden and David Cipolla
  
• Synopsis of the RDD/PQRI PK Workshop - Dennis O’Connor
  
• Dose-Response and Related Mathematical Considerations - Gur Jai Pal Singh
  
• Equivalence of OIPs in Europe: Present and Past Approval Principles - Anders Fuglsang
  
• Subject Populations and Study Designs - Richard Ahrens
  
• Review of the EMEA Guidelines’ In-Vitro Equivalence Criteria for Cascade Impaction Data - Dennis Sandell
  
• Use of In Vitro vs In Vivo Data To Conclude Equivalence of Two Inhaled Products - Dave Parkins
  
• Some unresolved issues in the use of PK for equivalence of OIPs - Günther Hochhaus
  
  

• Track A: Considerations for Design of Equivalence StudiesModerators: Colin Reisner, Richard Ahrens, Sanjeeva Dissanayake
• Summary Slides from Track A
  
  
• Track B: In Vivo Tests (PK, PD and Biomarkers) Moderators: Moderators: Gur Jai Pal Singh, Robert Hermann, Dale Conner, Param Nair
• Summary Slides from Track B
  
  
• Track C: “In-Vitro Only” EquivalenceModerators: Myrna Dolovich, Bill Doub, Dave Parkins, Marjolein Weda
• Track C Extra Slides
• Summary Slides from Track C
  
  
• Track D: Device Design Similarity & Testing Needed to Support Device ChangesModerators: Dennis Sandell, Tim Chesworth, Paul Lafferty, Robert Price
• SUmmary Slides from Track D