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 – 8:30 | Registration |
| 8:30 | WELCOME Dr. Raimar Löbenberg |
| 8:35 | Opening Remarks Pierre Sabourin, Assistant Deputy Minister, 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 |
| 9:45 – 10:00 | Break & Networking |
| 10:00 – 11:00 | Excipients for Use in Pediatrics 10:00 Pediatric Development – Industry Perspective 10:30 Excipients in Pediatric Medicines: A Health Canada Perspective |
| 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 |
| 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).
| 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