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PREVIOUS CONFERENCE |
Joint
CVG/Therapeutic Products Directorate (TPD)
2003 INTERNATIONAL CONVENTION
"
Challenges to the analytical and Formulation Scientists:
Scientific and regulatory Perspectives"
September 25-26, 2003 (Toronto,
Ontario, Canada)
International Plaza Hotel, 655 Dixon Road, Toronto
Tel: 416-244-1711, www.internationalplaza.com
This convention will be conducted in English.
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| September
25, 2003 - Plenary Session |
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| Registration |
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8:00AM - 9:00AM |
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| Vendor Exhibits |
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8:30AM - 4:00PM |
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Opening Remarks
Click
here to view presentation |
Dr. Herman Lam, Ph.D.
President
Calibration & Validation Group |
9:00AM - 9:10AM |
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| Opening Address |
Roger Williams, M.D.
United States Pharmacopoeia |
9:10AM - 9:30AM |
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| Process Analytical Technology Click
here to view presentation |
Ajaz Hussain, Ph.D.
U.S. Food and Drug Administration
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9:30AM - 10:15AM |
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| Morning Break |
All |
10:15AM - 10:45AM |
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| USP Reference Standards (Click
here to view presentation) |
Ronald Manning, Ph.D.
United States Pharmacopoeia |
10:45AM - 11:15AM |
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| Scientific and Regulatory Challenges
in Seeking Post- Approval Changes (Click
here to view presentation) |
Krishnan Tirunellai, Ph.D.
Therapeutic Products Directorate |
11:15AM - 12:00PM |
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| Lunch Break |
All |
12:00PM - 2:00PM |
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| Update on the Harmonization of Pharmacopoeial
Requirements in Europe – Policy on General Monographs
and Impurities (Click
here to view presentation) |
Agnes Artiges, Ph.D.
European Directorate for the Quality of Medicines |
2:00PM - 2:45PM |
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| Formulation of Biotechnology products
(Click
here to view presentation) |
Alison Symington, Ph.D.
Seneca College |
2:45PM - 3:15PM |
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| Afternoon Break |
All |
3:15PM - 3:45PM |
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| Nasal Spray Formulation |
Amyn Sayani, Ph.D.
GlaxoSmithKline |
3:45PM - 4:30PM |
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| Changes to 21-CFR-11 |
Bob Giuffre
Agilent Technologies
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4:30PM - 5:00PM |
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| Conclusion of Day 1 |
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September
26, 2003 - Round Table Sessions, Half Day In The
Morning
Session
1: Pharmacopoeial
Chair/Mediator:
Ming Zhang, Ph.D., Chung-Chow Chan, Ph.D. |
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| USP reference standards
and concerns |
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| The harmonization of USP,
Ph.Eur. and JP official monographs |
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| Break |
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| The USP, Ph.Eur. and JP
microbial test methods. (Presentation) |
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Session 2: PAT
& Formulation Session
Co-organized by the Canadian Society of Pharmaceutical
Sciences (CSPS)
Chair/Mediator:
Kwok Chow, Ph.D. |
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| The Use of Laser-Induced
Breakdown Spectroscopy (LIBS) as a tool for In-Process
Testing |
Elizabeth Kwong, Ph.D.
Merck Frosst Canada & Company |
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In process Near Infra-Red
(NIR) testing
Click here to view presentation |
Andre Dominique, Ph.D.
Astra Zeneca Canada |
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| Break |
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| Can “In Suite” Cleaning
Verification be realized through Ion Mobility Spectrometry
(IMS)? |
Paul Culbert, Ph.D.
Eli Lilly Canada Inc. |
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| Electronic nose/ electronic
tongue as a development and formulation tool in the
pharmaceutical industry |
Mr. John Poling; Alpha MOS
Paul Weber; London Scientific |
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Session 3: HPLC
Analysis Group Session
Chair/Mediator:
YC Lee, Ph.D. |
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| LC-MS for routine pharmaceutical
analysis |
Fabio Garofolo, Ph.D., LC-MS Pharmaceutical
Development Corporation |
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| HPLC Method Validation
- What can go wrong? |
Geoff Carr, Ph.D., Patheon
Inc |
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| Break |
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| HPLC column equivalence |
Ron Manning, Ph.D., United State Pharmacopoeia |
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| Verification of compendial
HPLC methods |
TBD |
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Session 4: Equipment/
Dissolution Validation Session
Chair/Mediator: Herman Lam, Ph.D., Gabriel Lam |
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| Issues and learning of dissolution
apparatus calibration |
Rick Jairam
GlaxoSmithKline |
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| Recent development of 21
CFR Part 11 (ERES) |
Bob Giuffre
Agilent Technologies |
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| Break |
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| Automation of dissolution
testing |
Herman Lam, Ph.D., and Rick Jairam,
GlaxoSmithKline |
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| Instrument validation vs.
qualification (how much is enough!) |
Herman Lam, Ph.D.
GlaxoSmithKline |
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Alison lngham, Ph.D., Therapeutic
Products Directorate
Chung Chow Chan, Ph.D., EIi Lilly Canada Inc.
Elaine Vandenberg, Ph.D., GlaxoSmithKIine Canada Inc.
YC Lee, Ph.D., Patheon Inc.
Herman Lam, Ph.D., GlaxoSmithKline Canada Inc.
Steven Boyajian, Bodycote Material Testing Canada.
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Chung Chow Chan, Ph.D.
Elaine Vandenberg, Ph.D.
Gabriel Lam
Herman Lam, Ph.D.
Steve Boyajian
William Ng
William Agnew
Xue-Ming Zhang, Ph.D.
YC Lee, Ph.D.
Yu-Hong Tse, Ph.D.
Bei Wang
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Agilent Technologies, Bodycote
Materials Testing Canada Inc., Millipore Corporation,
Waters Limited, Micromeritics, Fisher Scientific,
Alpha-1 Network Solution Inc., Varian Canada Inc.,
Brinkmann Instruments (Canada) Ltd., Invensys Validation
Technologies, Chromatographic Specialties Inc., Perkin-Elmer,
Zymark Corporation, LabSphere Inc., ATS Scientific
Inc., Smiths Detection, Dionex Canada Ltd., VWR, InnovaSystem,
Rose Scientific, Rootlink Technic Inc.
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