ISAM/IPAC-RS Workshop in Frankfurt, 12-13 Oct. 2010
1. Introduction
2. Program
3. Presentation of Marjolein Weda, RIVM, The Netherlands
4. Presentation of Sanjeeva Dissanayake, MHRA, United Kingdom
5. Presentation of Eva Agurell, LMPA, Sweden
6. Presentation of Alfredo Garcia-Arieta, Spanish Agency for Medicines and Healthcare Products, Spain
7. Presentation of Myrna Dolovich, McMaster University, Canada
8. Presentation of Dale P. Conner, FDA, USA
9. Presentation of Dennis O'Connor, Boehringer Ingelheim Pharmaceuticals, Inc., USA
10. Presentation of Gur Jai Pal Singh, Axar Pharmaceuticals, USA
11. Presentation of Anders Fuglsang, Fuglsang Pharma, Germany
12. Presentation of Richard Ahrens, University of Iowa, USA
13. Presentation of Denis Sandell, S5 Consulting, Sweden
14. Presentation of Dave Parkins, GlaxoSmithKline, USA
15. Presentation of Günther Hochhaus, University of Florida, USA
16. Track A: Considerations for Design of Equivalence Studies
17. Track B: In-Vivo Tests (PK, PD and Biomarkers)
18. Track C: 'In-Vitro Only' Equivalence
19: Track D: Device Design Similarity and Testing Needed to Support Device Changes
20. Bios of speakers