Canadian Society for Pharmaceutical Sciences
Société canadienne des sciences pharmaceutiques


Workshop – Excipient

Excipients Workshop: Regulatory, Compliance and Bioequivalence
A Joint CSPS/Health Canada/IPEC-Americas Workshop
Friday, September 20, 2019

Advance registration now closed.  Late registrants may go directly to the workshop location to register:
Banting Auditorium, Sir Frederick Banting Building, 251 Sir Frederick Banting Driveway, Ottawa, ON

NOTE: There is limited paid parking in the lot across the street from the Frederick Banting Research Centre.

The workshop intends to foster scientific discussions among Health Canada, industry and academia.  The workshop gives an opportunity to identify areas of regulatory uncertainty or where clarification is needed or new directions that will be implemented in the future. The target audience for the workshop is regulatory, quality, formulation and clinical scientists.

Workshop Program

8:00 – 8:30Registration
8:30WELCOME 

Dr. Raimar Löbenberg

8:35Opening Remarks

Pierre Sabourin, Assistant Deputy Minister, Health Products and Food Branch, Health Canada

SESSION 1: PHARMACEUTICAL SCIENCE – Chair: Raimar Löbenberg
8:45 – 9:458:45         Excipients for Use in Biologics
                Janeen Skutnik Wilkinson, Biogen

9:15        Effects of Excipients of Filgrastim Products on the Structure and                            Dynamics of the Drug Substance
                Dr. Yves Aubin, Health Canada                 

9:45 – 10:00Break & Networking
10:00 – 11:00Excipients for Use in Pediatrics

10:00         Pediatric Development – Industry Perspective
                   Dr. Sibylle Reidemeister, Novartis (via webex)

10:30         Excipients in Pediatric Medicines: A Health Canada Perspective
                   Dr. Susan Lum, Health Canada

11:00 – 11:30Formulating Biologic Drugs for Subcutaneous Administration: Challenges and Excipient Solutions
Dr. Catherine Soo, Health Canada
11:30 – 12:00Clinical Relevance: Why Are Enteric Coatings Failing in vivo?
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
13:30 – 14:00Excipient Composition and Variability – Impact on QbD and Performance: The Need for Robust Formulation
David Schoneker, IPEC-Americas
14:00 – 15:0014:00      Excipient Stability, Different Approaches
               Priscilla Zawislak, Dupont

14:30      Regulatory Considerations for Excipients – Case Studies
               Jennifer Pfeiffer, Health Canada

15:00 – 15:15Break & Networking
15:15 – 15:45Novel Excipient Innovation in Drug Development
Nigel Langley, BASF
15:45 – 16:15Supply Chain Security, Appropriate GMPs and Excipient Qualification
Bretta Lichtenhan, MilliporeSigma
16:15 – 16:45Panel Discussion – Q & A with Speakers
16:45Closing Remarks

Dr. Celia Lourenco, Director General, Biologics and Genetics Therapeutics Directorate, Health Canada


Workshop Registration Fees (lunch & breaks included).

CategoryEarly bird (to August 30)After August 30Onsite registration
CSPS Members$500$700$900
Non-CSPS members$650$850$1,050
Trainees (students/postdocs)$250$450$650
Academic/Government Employees$300$500$700
Health Canada Employees$0$50$100

Email:  csps@intertaskconferences.com
Tel:   613-238-4870