| Date:
|
Thursday
September 25, 2003 |
| Topic: |
The
True Challenges in Bioequivalence Studies Performance. |
| 7:15
- 8:15 AM |
Registration
- Breakfast
|
|
Wayne
Bryant, B.A, B.P.E.,
President, Spectrum Medical Market Consultants. |
Word
of Welcome
|
|
|
Doctor
Agnes V. Klein. Manager, Clinical Evaluation Division
Biologics and Radiopharmaceuticals Evaluation, Centre Biologics
and Genetic Therapies Directorate.
Professor Jake J Thiessen. Professor and Associate
Dean, University of Toronto, Faculty of Pharmacy. |
8:30
- 9:00 AM
|
John
Cobby, Ph.D.
President, Galenos. |
<<
Review of Basic Concepts Related to Bioequivalence>>
(English) |
9:00
- 9:40 AM
|
Jake
J Thiessen, Ph.D.
Professor and Associate Dean, Faculty of Pharmacy, University
of Toronto. |
<<
Nonlinear Drugs and Bioequivalence>>
(English) |
9:40-10:10
AM
|
Jian
Wang, MD., PhD.
A/Head - New Drug Submissions - Unit Clinical Evaluation
Division - Biological and Radiopharmaceutical Evaluation
Centre - Biologic and Genetic Therapies Directorate - Health
Canada. |
<<
Issues of using BE/BA studies for Biologics >>
(English) |
| 10:10-10:30
AM |
Health
break and Networking
|
|
10:30
- 11:00 AM
|
Jim
Keon, M.A. in Economics.
President, The Canadian Generic Pharmaceutical Association
(CGPA).
|
<<
The Canadian Generic Prescription Drug Market Drug and
the Related Regulatory Approval Systems.>> (English)
|
|
1100
- 11:30 AM
|
Zaidoon
El-Zubaidy,.Ph.D.
Head, Biopharmaceutics - Rhoxalpharma Inc.
|
<<
Bioequivalence and Interchange ability>> (English)
|
|
11:30
- 12:05 AM
|
W.
Craig Simon, Ph.D.
Acting Manager - Division of Biopharmaceutics Evaluation
1 - Bureau of Pharmaceutical Sciences - Health Canada.
|
<<An
Update on Canadian Bioequivalence Requirements>>
(English)
|
| 12:05
- 1:05 PM |
Lunch
and Networking
|
| 1:15
- 1:55 PM |
Mostapha
Akbarieh, Ph.D.
Vice-president R&D, Pangeo Pharma inc. |
<<
Precautions to be taken for a successful Biostudy: in vivo
in vitro Correlation, Formulation Issues>> (English). |
1:55
- 2:25 PM
|
Lynda
Cedar, Ph.D.
General Manager, Atlantic Life Sciences inc |
<<
BE Studies Performance: Key Elements of a BioStudy. >>
(Bilingual). |
2:25
- 3:00 PM
|
Laszlo
Endrenyi, Ph.D.
Professor, University of Toronto.
|
<<Determination
of bioequivalence for highly-variable drugs >> (English)
|
| 3:00
- 3:20 PM |
Diane
Potvin, Associate Director,
Pharmaceutical Statistics and R&D - PK/PD, MDS Pharma
Services.
|
<<Understanding
Pharmacokinetic and statistical aspects related to bioavailability
and bioequivalence: Theoretical aspects, case studies and
global recommendations>> |
| 3:20
- 3:30 PM |
Health
break and Networking
|
| 3:30
PM |
Roundtable
of discussions
|
| Chair
persons: |
Doctor
Agnes V. Klein and Professor Jake Thiessen. |
| Speakers: |
Dr.
John Cobby, Dr. Jake Thiessen, Dr. Jian Wang, Mr. Jim Keon,
Dr. Zaidoon El-Zubaidy, Dr. Simon Craig, Dr. Mostapha Akbarieh.
Dr. Lynda Cedar, Laszlo Endrenyi. |
| Invited
to the roundtable: |
Mr.
Eric Ormsby, Coordinator of Expert Advisory Committee
on Bioavailability and Bioequivalence.Therapeutic Products
Directorate, Health Canada. (Ottawa)
Mr. Pierre Morin, Responsible of the GPIM Association.(Montreal)
Mr. Wayne Bryant, President Spectrum Medical market
Consultants. (Montreal)
Dr. François Chouinard, Director, Pharmaceutical
Development, Novopharma (Toronto). |
| End
of Meeting |
Thanks
and Draws of Gift Certificates
|
