Canadian Society for Pharmaceutical Sciences
Société canadienne des sciences pharmaceutiques


Presentations – Excipient Workshop

Access available presentations, abstracts and bios by clicking on appropriate link below.

8:00 – 8:30Registration
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 – 10:00Break & 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 – 12:00Clinical Relevance: Why Are Enteric Coatings Failing in vivo ? (abstract)
Daniela Amaral Silva, University of Alberta
12:00 – 12:30Panel Discussion – Q & A with Speakers
12:30 – 13:30Lunch & Networking
SESSION 2: QUALITY & REGULATORY – Chair: Co Pham, Health Canada
13:30 – 14:00Excipient 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 – 15:15Break & Networking
15:15 – 15:45Novel Excipient Innovation in Drug Development  (abstract)
Nigel Langley, BASF
15:45 – 16:15Supply Chain Security,Appropriate GMPs and Excipient Qualification (abstract)
Bretta Lichtenhan, MilliporeSigma
16:15 – 16:45Panel Discussion – Q & A with Speakers
16:45 Closing Remarks
Dr. Celia LourencoDirector General, Biologics and Genetics Therapeutics Directorate, Health Canada