Access available presentations, abstracts and bios by clicking on appropriate link below.
| 8:00 – 8:30 | Registration |
| 8:30 | WELCOME |
| 8:35 | Opening Remarks
Pierre Sabourin, Assistant Deputy Minister of the Health Products and Food Branch, Health Canada |
| SESSION 1: PHARMACEUTICAL SCIENCE – Chair: Raimar Löbenberg, University of Alberta |
| 8:45 – 9:45 | Excipient for Use in Biologics (abstract)
Janeen Skutnik-Wilkinson, Biogen Effects of Excipients of Filgrastim Products on the Structure and Dynamics of the Drug Substance (abstract)
Dr. Yves Aubin, Health Canada |
| 9:45 – 10:00 | Break & Networking |
10:00 – 11:00
| Pediatric Development – Industry Perspective
Dr. Sibylle Reidemeister, Novartis (via webex)
Excipients in Pediatric Medicines: A Health Canada Perspective (abstract)
Dr. Susan Lum, Health Canada |
| 11:00 – 11:30 | Formulating Biologic Drugs for Subcutaneous Administration: Challenges and Excipient Solutions (abstract)
Dr. Catherine Soo, Health Canada |
| 11:30 – 12:00 | Clinical Relevance: Why Are Enteric Coatings Failing in vivo ? (abstract)
Daniela Amaral Silva, University of Alberta |
| 12:00 – 12:30 | Panel Discussion – Q & A with Speakers |
| 12:30 – 13:30 | Lunch & Networking |
| SESSION 2: QUALITY & REGULATORY – Chair: Co Pham, Health Canada |
| 13:30 – 14:00 | Excipient Composition and Variability – Impact on QbD and Performance: The Need for Robust Formulation
David Schoneker, IPEC-Americas |
14:00 – 14:30
| Excipient Stability, Different Approaches (abstract)
Priscilla Zawislak, Dupont Regulatory Considerations for Excipients – Case Studies (abstract)
Jennifer Pfeiffer, Health Canada |
| 15:00 – 15:15 | Break & Networking |
| 15:15 – 15:45 | Novel Excipient Innovation in Drug Development (abstract)
Nigel Langley, BASF |
| 15:45 – 16:15 | Supply Chain Security,Appropriate GMPs and Excipient Qualification (abstract)
Bretta Lichtenhan, MilliporeSigma |
| 16:15 – 16:45 | Panel Discussion – Q & A with Speakers |
| 16:45 | Closing Remarks
Dr. Celia Lourenco, Director General, Biologics and Genetics Therapeutics Directorate, Health Canada |