Canadian Society for Pharmaceutical Sciences
Société canadienne des sciences pharmaceutiques


Workshop – Excipient

REGISTRATION IS NOW OPEN!

Interested in being a workshop sponsor?  Sponsorship opportunities are available.

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

Date: September 20, 2019
Location: 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 – 8:30 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
8:45 – 9:45 8:45         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 – 10:00 Break & Networking
10:00 – 11:00 Excipients for Use in Pediatrics

10:00         Dr. Sibylle Reidemeister, Novartis (via webex)

10:30         Dr. Susan Lum, Health Canada

11:00 – 11:30 Formulating Biologic Drugs for Subcutaneous Administration: Challenges and Excipient Solutions

Dr. Catherine Soo, Health Canada

11:30 – 12:00 Clinical Relevance: Why are Enteric Coatings Failing in vivo?

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

 

 

13:30 – 14:00 Excipient Composition and Variability – Impact on QbD and Performance: The Need for Robust Formulation

David Schoneker, IPEC-Americas

14:00 – 15:00 14:00      Excipient Stability, Different Approaches
               Priscilla Zawislak, Dupont

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

15:00 – 15:15 Break & Networking
15:15 – 15:45 Novel Excipient Innovation in Drug Development

Nigel Langley, BASF

15:45 – 16:15 Supply Chain Security, Appropriate GMPs and Excipient Qualification

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


Workshop Registration Fees (lunch & breaks included): click on category to register

Category Early bird (to August 30) After August 30 Onsite 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