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USP and Middle East/North Africa (MENA) Stakeholders Second Compendial Science Meeting
"Quality Standards for Medicines"

Cairo, Egypt Wednesday, December 3-Thursday, December 4

Semiramis Intercontinental Cairo Corniche El Nile, Cairo

Preliminary Agenda

The Egyptian Chamber for Pharmaceutical Manufacturing and the United States Pharmacopeial Convention (USP) are 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, topics will focus on the drug products and drug substances, both for export and in-country use, relative to requirements for regulated markets (Europe and U.S.) and less regulated markets.

Relative to these two pharmaceutical topics, the compendial topics chosen for emphasis are:

  1. Drug Product Manufacturing and Control
  2. Microbiology
  3. Packaging
  4. Drug Product Performance
  5. Drug Substances
  6. Third-Party Certification
  7. Biologics and Biotechnology

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.

Day 1: Wednesday, December 3, 2008

8:00 a.m. Registration/Breakfast  
8:30 a.m. Greetings from Egypt and USP
  a. The Minister of Health and Population
  b. WHO Representative
  c. The U.S. Ambassador to Egypt
  d. Egyptian Chamber for Pharmaceutical Manufacturing
e. U.S. Pharmacopeial Convention Dr. Williams
9:15 a.m. Plenary Session
  a. Exporting from the Region: The Challenges Mr. El-Eish
  b. Importing into the U.S.: The Heparin Case Dr. Willliams
  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 Manufacturers Dr. Molokhia
  b. Pharmaceutical Quality Systems: ICH Q8, Q9, and Q10 Mr. Johnston
  c. Compendial Approaches Dr. Williams
  d. Adulterants – Heparin, Diethylene Glycol
Case Studies and Compendial Implications		 Dr. DeStefano
  e. Method Development in a QbD Environment
Compendial Implications		 Dr. DeStefano
  Q&A
12 noon Break
12:30 p.m. Topic II – Drug Product: Microbiology
  a. Egyptian Perspective Dr. Elenine
  b. USP Perspective
    i. Harmonized Microbial Limit Tests Dr. Tirumalai
    ii. Revised Sterility Tests Dr. Tirumalai
    iii. Environmental Monitoring Ms. Ceresa
    iv. Rapid Micro Tests Ms. Ceresa
  Q&A
2:00 p.m. Lunch
3:00 p.m. Topic III: Drug Product: Packaging
  a. Egyptian Perspective Dr. Moniem
  b. USP Perspective
  1. Glass Containers
  2. Plastic Material and Plastic Containers
  3. Update on Good Shipping and Packaging Practices
  4. Application of Authentication and Track and Trace Technologies to Packaging
 Dr. Sparks
  Q&A
5:00 p.m. Adjourn
Evening Reception and Dinner

Day 2: 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. Performance Testing of Pharmaceutical Dosage Forms Dr. DeStefano
  d. Dissolution in Solid Dosage Forms Dr. Fahmy
  e. Quality by Design Dr. Fahmy
  f. Harmonization of Bioequivalence Requirements Mr. Johnston
  Q&A
10:30 a.m. Break
11:00 a.m. Topic V: Drug Substances
  a. Egyptian Perspective: Drug Substances and Excipients Dr. Khalil
  b. Impurities: Inorganic/Metals, Residual Solvents, Genotoxic Impurities Dr. DeStefano
  c. Monographs/Certified Reference Materials Dr. DeStefano
  Q&A
12:00 p.m. Topic VI: Regulatory and Third-Party Certifications
  a. WHO Perspective: Prequalification Dr. Mirza
  b. Egyptian Perspective: Third-party Certification Dr. Khairy
  c. US Perspective: Certification Programs in the US and Elsewhere Dr. DeStefano
  Q&A
1:30 p.m. Lunch
2:30 p.m. Topic VII: Biotechnology–Regulatory and Compendial Approaches
  a. Egyptian Perspective Dr. Bayoumi
  b. USP Perspective
  1. Regulation of Biotechnology Medicines
  2. Compendial Approaches
  3. Documentary Standards and Reference Materials
 Dr. Atouf
  Q&A
4:00 p.m. Closing Plenary Session
  Hot Topics for 2009
  Panel of Egyptian Speakers Dr. Sakr
Dr. Kassem
Dr. Habib
Dr. Salah
5:00 p.m. Adjourn