USP and Middle East/North Africa (MENA) Stakeholders
Second Compendial Science Meeting
Quality Standards for Medicines
Cairo, Egypt
Wednesday, December 3-Thursday, December 4

Download First Announcement Document
~ Preliminary Agenda ~
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The Egypt-USP planning committee is pleased to present the second Compendial Science Meeting in the Middle East/North Africa Region. This meeting supports a science-based dialogue on compendial topics. For the second meeting in Egypt, topics will focus on the drug product and drug substance, both for export and in country use, relative to requirements for regulated markets (Europe and US) and less regulated markets.
Relative to these two pharmaceutical topics, the compendial topics chosen for emphasis are:
I. Drug Product Manufacturing and Control
II. Microbiology
III. Packaging
IV. Drug Product Performance
V. Drug Substance
VI. Third Party Certification
VII. Biologics and Biotechnology
A special “Hot Topics” panel discussion at the end of the meeting provides an opportunity for Egyptian attendees to dialogue with Egyptian and USP speakers on topics discussed throughout the two day meeting and also to introduce other topics of significance to the region.
The meeting is of interest to manufacturers of medicines and their ingredients, exporters and importers of bulk pharmaceuticals; regulatory scientists, representatives of national drug control laboratories, professional and academic scientists, policy makers, and other interested parties
Meeting Agenda |
Day One: Wednesday, December 3, 2008 |
| 8:00 a.m. |
Registration/Breakfast |
| 8:30 a.m. | Greetings from Egypt and USP
- a- Egyptian Ministry of Health/NODCAR
- b- Syndicate of Egyptian Manufacturers
- c- USP
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| 9:00 a.m. |
Plenary Session |
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a- Exporting from the Region: The Challenge |
Mr. Abou El-Eish |
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b- Importing into the U.S.: The Heparin Case
|
Dr. Williams |
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c-
WHO Activities in the MENA Region |
Dr.Mirza |
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Q&A |
|
| 10:00 a.m. |
Topic I: Drug Product Manufacturing and Control |
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a-
Egyptian Perspective: Drug Product Mfg
|
Dr. Molokhia |
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b-
Pharmaceutical Quality Systems and ICH Q10
|
FDA Speaker, invited |
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c-
Compendial Approaches |
Dr. Williams |
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d- Impurities in Medicinal Products and ICH Q3 B |
Dr. DeStefano |
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e- Validation of Analytical Procedures for Drug Product Impurities and ICH Q2 |
Dr. DeStefano |
| 11:30 a.m. |
Break |
|
| 12 noon |
Topic II – Drug Product: Microbiology |
|
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a- Egyptian Perspective |
Dr. Elenine |
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b- USP Perspective
- Harmonized Microbial Limit Tests
- Revised Sterility Tests
- Environmental Monitoring
- Microbiology Method Validation/Rapid Micro Tests
Q&A
|
Dr. Tirumalai
Dr. Tirumalai
Ms. Ceresa
Ms. Ceresa
|
| 1:30 p.m. |
Lunch |
|
| 2:30 p.m. |
Topic III: Drug Product: Packaging |
|
|
a- Egyptian Perspective |
Dr. Moniem |
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b- USP Perspective
- Glass Containers
- Plastic Material and Plastic Containers
- What QbD Means to Drug Packaging Materials
- Update on Good Shipping and Packaging Practices
- Application of Authentication and Track and Trace
Technologies to Packaging
Q&A
|
Dr. Hunt |
| 5:00 p.m. |
Adjourn |
|
| | |
| | Day Two: Thursday, December 4, 2008
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| | |
| 8:30 a.m. | Topic IV- Drug Product Performance |
| |
a- Egyptian Perspective: Drug Product Performance |
Dr. Khalafallah |
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b-
Science and Technical Overview |
Dr. DeStefano |
| |
c-
Comparator Pharmaceutical Product Reference Material |
Dr. DeStefano |
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d- Quality by Design |
FDA Speaker, invited |
| |
e- Harmonization of Bioequivalence Requirements |
Mr. Johnston |
| 10:00 a.m. | Break |
| 10:30 a.m . |
Topic V: Drug Substance |
| |
a-
Egyptian Perspective: Drug Substance |
Dr. Khalil |
| |
b- Impurities: Organic, Inorganic/Metals,
Residual Solvents, Genotoxic Impurities |
Dr. DeStefano |
| |
c-
Monographs/Certified Reference Materials |
Dr. DeStefano |
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Q&A |
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|
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| 12:00 p.m. |
Topic VI:Regulatory andThird-Party Certifications |
|
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a- WHO Perspective: Prequalification |
Dr. Mirza |
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b- Egyptian Perspective: Third-party Certification |
Dr. Khairy |
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c- European Perspective: The Certificate of Suitability |
Dr. Williams |
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d- US Perspective: Certification Programs in the US and Elsewhere |
Dr. DeStefano |
| |
|
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| 1:30 p.m. |
Lunch |
| |
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| 2:30 p.m. |
Topic VII: Biotechnology–Regulatory and Compendial Approaches |
| |
a- Egyptian Perspective |
Dr. Bayoumi |
| |
b-
USP Perspective
- Regulation of Biotechnology Medicines
- Compendial Approaches
-
Documentary Standards and Reference Materials
|
Dr. Atouf |
| 4:00 p.m. |
Closing Plenary Session |
|
| |
Hot Topics for 2009
Panel of Egyptian Speakers,
Closing Statements/Certificates |
Dr. Sakr
Dr. Kassem
Dr. Habib
Dr. Salah
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| 5:00 p.m. |
Adjourn |
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