| Date:
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Monday,
June 21, 2010
|
| Location:
|
At:
Salle de Reception PALACE.
1717 boulevard Le Corbusier. Laval, QC H7S 2K7
|
|
Expert Opinion: New Canada Guidance
of Biosimilars.
Update about Canada Guidance of Generics
The challenges surrounding their Regulations and
their Development.
|
|
|
8:00
AM.
- 9:30 AM.:
|
Check-in
and Breakfast
|
9:35
AM.
- 9:40 AM.:
|
Word
of Welcome by
the organizer.
Benoît
Chedhomme, M.Sc.
Sales Manager/Pharmaceutical Cold & Temperature
Chain Expert.
Alternatives Techno Pharma, inc. Laval (Qc.).
|
|
9:40 AM.
- 9:45 AM.: |
Word of CO-chair
Karen Burke, Ph.D. Director, Regulatory Affairs.
Amgen Canada Inc. |
| 9:45AM.
- 9:15 AM.: |
"A compliant
cold chain management for the integrity of biological
products. "
Cyril Chaput, Ph.D. Cold chain compliance specialist.
Alternatives Technologies Pharma Inc. Laval (QC).
|
Speaker's
presentation |
| 9:15
AM. - 9:45 AM.: |
"Subsequent Entry Biologics: Comparability
and Other Product Quality-Related Issues."
Anthony Ridgway,Ph.D.
Senior Regulatory Scientist. Biologics & Genetic
Therapies Directorate. Health Canada. Ottawa (ON.)
Canada. |
Speaker's
presentation
|
|
9:45
am - 10:15 am.: Networking/Coffee Break.
|
| 10:15
AM.- 10:45 AM.: |
''Guidance
of Subsequent Entry Biologics (biosimilars) in Canada:
Information and Submission Requirements"
Dr. Agnes Klein, MD, DPH. Director, Centre
for Evaluation of Radiopharmaceuticals and Biotherapeutics,
the Biologics and Genetic Therapies Directorate.
Health Canada.Ottawa
(ON.) Canada.
|
Speaker's
presentation
|
| 10:45
AM. - 11:15 AM.: |
''Biosimilars
in Canada: a Perspective from Innovative Industry"
Karen Burke, Ph.D. Director, Regulatory Affairs.
Amgen Canada Inc. Mississauga (ON.) Canada. |
Speaker's
presentation
|
| 11:15
AM. - 11:45 AM.: |
''Subsequent
Entry Biologics: Interchangeability/Substitution,
Liability"
Lynda Cedar, Ph.D. Executive Director, Clinical
Trials. Atlantic Life Sciences Inc. Montreal (QC.)
Canada. |
Speaker's
presentation
|
|
12:00
pm - 1:30 pm: Luncheon and Networking
|
| 2:00
PM. - 2:30 PM: |
"
Regulatory Requirements for Pharmaceutical Generics"
Eric Ormsby, M.Sc. Manager, Office
of Science, Health Canada Therapeutic Product Directorate.
Health Canada.Ottawa
(ON.) Canada. |
Speaker's
presentation
|
| 3:40
PM - 4:30 PM: |
<<Panel of discussions.>>
Invited panelist: Sandy, Pagotto, Senior Director
Common Drug Review Directorate, CADTH. Ottawa. |
Selected documents
Document
1
Document
2ected
documents
|
All Rights Reserved, Speakers and
Authors.
|
|
|
