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 ~

_______________________________

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
 
9:00 a.m. Plenary Session
  a- Exporting from the Region: The Challenge
Mr. Abou El-Eish
b- Importing into the U.S.: The Heparin Case
Dr. Williams
c- WHO Activities in the MENA Region Dr.Mirza
Q&A  
10:00 a.m. Topic I: Drug Product Manufacturing and Control
  a- Egyptian Perspective: Drug Product Mfg
Dr. Molokhia
b- Pharmaceutical Quality Systems and ICH Q10
FDA Speaker, invited
c- Compendial Approaches Dr. Williams
d- Impurities in Medicinal Products and ICH Q3 B Dr. DeStefano
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
a- Egyptian Perspective Dr. Elenine

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

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

   
8:30 a.m. Topic IV- Drug Product Performance
  a- Egyptian Perspective: Drug Product Performance Dr. Khalafallah
  b- Science and Technical Overview Dr. DeStefano
  c- Comparator Pharmaceutical Product Reference Material Dr. DeStefano
  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
  Q&A  
     
12:00 p.m. Topic VI:Regulatory andThird-Party Certifications  
  a- WHO Perspective: Prequalification Dr. Mirza
  b- Egyptian Perspective: Third-party Certification Dr. Khairy
  c- European Perspective: The Certificate of Suitability Dr. Williams
  d- US Perspective: Certification Programs in the US and Elsewhere Dr. DeStefano
     
1:30 p.m. Lunch
 
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
5:00 p.m. Adjourn