| Date:
|
Thursday,
April 8, 2010
|
| Location:
|
Theatre,
Sir Frederick G. Banting Building
Building 22, Tunney's Pasture, PL2204E
251 Sir Frederick Banting Driveway, Ottawa, ON. K1A 0K9
|
|
The Challenges of developing Biologics/Biosimilars:
Presentation and Update of Regulations
|
|
|
7:30
am.: Check-in
and Breakfast
|
|
8:30 am. - 8:35 am.: |
Word
of Welcome and introduction.
Lynda Cedar, Pharm.D., M.Sc., DESS., Ph.D.
Executive
Director, Clinical Trials.
Atlantic Life Sciences, inc. - Montreal.
|
| 8:35
am.- 8:45 am.: |
Co-Chairs/Conference
Moderators: Dr. Karen Burke and Dr. Agnes Klein. |
| 8:45
am. - 9:25 am.: |
<<Challenges
in early approval of a novel vaccine: H1N1 Pandemic.>>
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 |
| 9:25
am. - 10:05 am.: |
<< Regulation of H1N1 Pandemic Influenza Vaccine.>>
Mrs. Stephania Hardy, BSc, RAQC, MPH. Senior
Policy Analyst, Office of Policy & International
Collaboration, Biologics and Genetic Therapies Directorate
(BGTD). Health Canada. Ottawa (ON.) Canada. |
Speaker's
presentation
|
|
10:05
am - 10:30 am : Networking Coffee Break
|
| 10:30
am. - 11:10 am.: |
<< The Challenges of Developing, Licensing
and Commercialization of New Vaccines - A Global
Industry Perspective>>
Dr.
Fotula
Fegaras,
Ph.D. Senior Director, Regulatory Affairs, Sanofi
Pasteur Limited. Toronto (On.) Canada. |
Speaker's
presentation
|
| 11:10
am. - 11:50 pm.: |
<< Cold Chain 101: An evaluator's view of
cold chain and product quality.>>
Dr.
Nancy Green, Ph.D. Chief, Hormones and Enzymes
Division. Centre for the Evaluation of Radiopharmaceuticals
and Biotherapeutics. Biologics and Genetic Therapies
Directorate. Health Canada.Ottawa
(On.) Canada.
|
Speaker's
presentation
|
|
12:00
pm - 1:30 pm: Luncheon and Networking
|
| 1:30
pm. - 2:10 pm.: |
<<Current
status of subsequent entry biologics (biosimilars)
in Canada, the latest content of the guidelines.>>
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
|
| 2:10
pm. - 3:00pm.: |
<<Biosimilars
in Canada: a Perspective from Innovative Industry.>>
Dr. Karen Burke, Ph.D. Director,
Regulatory Affairs. Amgen Canada Inc. Mississauga
(On.) Canada.
|
Speaker's
presentation
|
| 3:00
pm. - 3:40pm.: |
<<IRB
Case Studies: Ethics issues - accreditations.>>
Mr. Ronald Fehst.
Consultant, IRB services. Aurora (On.) Canada
|
Speaker's
presentation
|
| 3:40
pm. - 4:30 pm.: |
<<Panel
of discussions.>>
Speakers and Panelists.
|
Generics
and Biosimilars Initiative
|
All Rights Reserved, Speakers.
|
|
|
