Joint
CVG/Therapeutic Products Directorate (TPD)
2004 INTERNATIONAL CONVENTION AND EXHIBITIONS
" Active pharmaceutical ingredient
to drug product:
Global issues from Scientific and regulatory Perspectives
"
September 27-28, 2004 (Toronto,
Ontario, Canada)
Double Tree International Plaza Hotel, 655 Dixon Road,
Toronto
Tel: 416-244-1711, www.internationalplaza.com
This convention will be conducted in English.
|
 |
| September
27, 2004 - Plenary Session |
|
| Registration |
|
8:00AM - 9:00AM |
|
| Vendor Exhibits |
|
8:30AM - 4:00PM |
|
| Opening Remarks |
Dr. Herman Lam, Ph.D.
President
Calibration & Validation Group |
9:00AM - 9:10AM |
|
| Key Note Address: Regulatory Challenges
in the Quality Arena |
Sultan Ghani, TPD
Health Canada |
9:10AM - 9:30AM |
|
| Selection of the Best Candidate for
Active Pharmaceutical Ingredients |
Elizabeth Vadas, Ph.D.
In SciTech Inc. |
9:30AM - 10:15AM |
|
| Morning Break |
All |
10:15AM - 10:45AM |
|
| Regulatory Requirements in Canada for
Active Pharmaceutical Ingredients |
Alison Ingham, Ph.D. TPD
Health Canada |
10:45AM - 11:15AM |
|
| Flexible Monograph for API |
Karen Russo USP |
11:15AM - 12:00PM |
|
| Lunch Break |
All |
12:00PM - 2:00PM |
|
| Physical Properties Characterization
of API |
Bernie Olsen, Ph.D.
Eli Lilly and Company |
2:00PM - 2:45PM |
|
| Analytical Validation for API and Reference
Standards for Early Drug Development |
Stephen Houldworth, Ph.D.
Dalton Chemicals |
2:45PM - 3:30PM |
|
| Afternoon Break |
All |
3:30PM - 4:00PM |
|
| Implementation of Q7A in Canada |
Matthew Bown, HPFBI
Health Canada |
4:00PM - 4:30PM |
|
| API Manufacture in India |
Dr. N. Chodankar
Sekhsaria Chemicals |
4:30PM - 5:00PM |
|
| Conclusion of Day 1 |
|
|
|
| Exhibition |
Analytical Instruments, Lab Supplies
& API Suppliers |
6:00PM - 7:30PM |
|
| |
| September
28, 2004 - AM Morning Sessions |
|
| The Current Status of API Development
in P.R.China |
David He, Ph.D.
Molcan Corporation |
9:00AM - 9:45AM |
|
New Source of an API-Regulatory
and Scientific Challenges
(an FDA viewpoint) |
Paul Schwartz, Ph.D. FDA |
9:45AM - 10:30PM |
|
| Break |
All |
10:15AM - 10:45AM |
|
| Organic Volatile Impurities (OVI) Analysis |
Geoff Carr, Ph.D. Patheon Inc. |
10:45AM - 11:30AM |
|
| Polymorphs in API and Implications
in Drug Development |
Steve Byrn, Professor
Purdue University |
11:30AM - 12:15PM |
|
| Lunch Break |
All |
12:15PM - 1:30PM |
|
| |
September
28, 2004 Round Table Parallel Discussion Sessions
Session 1: Pharmacopoeial
Chair/Mediator: Chung-Chow Chan,
Ph.D. |
|
| Excursion Study Requirements |
|
1:30PM - 2:00PM |
|
| Excipient Harmonization |
|
2:00PM - 2:30PM |
|
| Break |
|
2:30PM - 3:00PM |
|
| Starting Material for Synthetic
Drug Substance |
3:00PM - 3:30PM |
|
| Open Discussion |
|
3:30PM - 4:30PM |
|
Session 2: Equipment
Qualification/Validation
Chair/Mediator: Rick Jairam |
|
| Issues in Calibration of
Dissolution Apparatus |
1:30PM - 2:00PM |
|
| Data Back-up and Archive
Strategy |
2:00PM - 2:30PM |
|
| Break |
|
2:30PM - 3:00PM |
|
| 21 CFR Part 11 ERES Update |
3:00PM - 3:30PM |
|
| Open Discussion |
|
3:30PM - 4:30PM |
|
Session 3: Pharmaceutical Analysis: HPLC Separation & Discussion
Chair/Mediator: YC Lee, Ph.D. |
|
| HPLC Column Equivalence |
|
1:30PM - 2:00PM |
|
| Analytical Method Transfer |
|
2:00PM - 2:30PM |
|
| Break |
|
2:30PM - 3:00PM |
|
| Practical Experience with
USP Dissolution Apparatus 3 and 4 |
3:00PM - 3:30PM |
|
| Open Discussion |
|
3:30PM - 4:30PM |
|
Session 4: Process
Analytical Technology
Chair/Mediator: Herman Lam, Ph.D. |
|
| Trends in the Use of Laser-Induced Breakdown
Spectroscopy for On-, In, or At-Line Process Monitoring |
Louis St-Onge, Ph.D.
National Research
Council |
1:30PM - 2:00PM |
|
| On-Line Particle Size and
Shape Characterization Combined with Color Analysis
for Granular Material |
Bruno Albano
Cambridge Controls |
2:00PM - 2:30PM |
|
| Break |
All |
2:30PM - 3:00PM |
|
| NIR Applications for PAT |
Perkin Elmer |
3:00PM - 3:30PM |
|
| E-Nose & E-Tongue as a Development
and Formulation Tool for the Pharmaceutical Industry |
Mr. Vincent Schmitt
Alpha MOS |
3:00PM - 3:30PM |
|
| Blend Uniformity Monitoring by Thermal
Effusivity |
Yves Roy, Ph.D.
Mathis Instruments Inc. |
3:00PM - 4:00PM |
|
| Open Discussion |
|
4:00PM - 4:30PM |
