Joint
CVG/Therapeutic Products Directorate (TPD)
2008 CONFERENCE AND EXHIBITIONS
"From
Block Buster to Boutique Products -
Copping with Changes"
October 9-10
2007 (Toronto,
Ontario, Canada)
Double Tree International Plaza Hotel, 655 Dixon Road, Toronto
Tel: 416-244-1711, www.internationalplaza.com
Program and Presentations in PDF
|
 |
|
|
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| Introduction and Start of
Program |
David
Mayers |
8:40AM - 8:45AM |
|
| Opening Remarks |
Herman Lam, Ph.D.
|
8:45AM - 8:50PM |
|
Key Note Address:
Blockbuster to Boutique Products - A
regulatory perspective
|
Dr. Alan Viau
Acting Director, BPS, Health Canada
|
8:50AM - 9:35AM |
|
|
Regulatory
Modernization and the Quality Endeavor |
Dr.
Chris Watts
FDA |
9:35AM - 10:20AM |
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| Morning Break |
|
10:20AM - 10:50AM |
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| Heavy
metal in pharmaceutical ingredients |
Dr.
Kahkashan Zaidi
USP
|
10:50AM - 11:25AM |
|
|
Regulatory challenges in product
characterization
|
Dr. Denis Girard
Senior Scientific Advisor, BPS
|
11:25AM - 12:00PM |
|
| Lunch Break |
|
12:00PM - 2:00PM |
|
| Continues
coating process |
O'Hara Technologies Inc.
Mr. Jim Matjeram
|
2:00PM - 2:35PM |
|
| The
Impact of Automation on Routine Performance Verification Testing |
Dr. Michael Allen
ThermoFisher
|
2:35PM - 3:10PM |
|
| Break |
|
3:10PM - 3:40PM |
|
| From
Tox to Phase 1: What Do You Need? |
Dr. Chung Chow Chan
Technical Director,
Azopharma
|
3:40PM - 4:15PM |
|
|
Personalized medicine: opportunity or
threat – an overview of technology trends and biotech industry
activities.
|
Dr. Robert Foldes
Executive Director
YORKBiotech Inc.
|
4:15PM - 4:50PM |
|
| Wrap Up for the Day and Door Prizes |
Elaine Vandenberg Ph.D.
|
4:50PM - 5:15PM |
|
| |
| October
5, 2007: Discussion
Group Sessions |
|
| Breakfast |
|
8:30AM - 9:00AM |
|
| Round Table Parallel Discussion Sessions |
|
9:00AM - 12:15PM |
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| |
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Round
Table Parallel Discussion Sessions (9:00AM-12:15PM)
Session
1: Analytical Sciences
Chair:
David Mayers, Purdue Pharma
|
|
| TeraHertz
Spectroscopy |
Mr.
Mark Kemper
(Picometrix LLC) |
|
| Calibration
of NIR Spectrophotometers |
Dr.
Herman Lam
Wild Crane Horizon |
|
| Break |
|
|
| Sub
2um Particles for Reverse Phase Chromatography: Benefits, Concerns
and a Guide to Column Selection |
Dr.
Christine Hand
Waters |
|
| Mechanical
calibration for dissolution apparatus |
Ms.
Judy Clucas
Varians |
|
Session 2: Pharmaceutical Quality and Regulatory Round Table
Discussion
Chair:
Elaine Vandenberg, Ph.D., GlaxoSmithKline Canada Inc.
|
|
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Case
studies in product characterization
|
Dr.
Phillip Hurst Senior Reviewer BPS,
TPD |
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| From
Phase 1to Phase 2: What Do You Need? |
Dr.
Chung Chow Chan
Technical Director,
Azopharma |
|
| Break |
|
|
| Round
Table discussion |
Dr.
Chris Watts
FDA |
|
| Round
Table discussion |
Dr.
Kahkashan Zaidi
USP |
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