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USP Convention and the Middle East/North Africa (MENA) Stakeholders Fourth Annual Science Meeting:
   "Quality Standards for Medicines"

Sheraton Amman
Al Nabil Hotel & Towers
Amman, Jordan

November 30, 2008–December 1, 2008

Agenda

The Jordanian Association of Pharmaceutical Manufacturers (JAPM) and the United States Pharmacopeial Convention (USP) are pleased to present the Fourth Annual Science Meeting in the Middle East/North Africa Region. This Annual Meeting supports a science-based dialogue on compendial topics. For the Fourth Annual Meeting, the topics will focus on both drug products and drug substances 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 emphasis is on the following compendial topics:

  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: Sunday, November 30, 2008

8:00 a.m. Registration and Coffee  
8:30 a.m. Greetings from Jordan and USP
  a. JFDA, Jordan Food & Drug Administration Prof. Rawashdeh
  b. JAPM, Jordanian Association of Pharmaceutical Manufactures Dr. Badwan
  c. U.S. Pharmacopeial Convention Dr. Williams
9:00 a.m. Plenary Session
  a. Exporting from the Region: The Challenges Local Speaker
  b. Importing into the U.S.: Challenges and Opportunities Mr. Johnston
  c. Importing into the U.S.: The Heparin Case Dr. Williams
  Q&A
10:00 a.m. Topic I: Drug Product Manufacturing and Control
  a. Pharmaceutical Quality Systems :ICH Q8,Q9,Q10 Mr. Johnston
  b. Compendial Approaches: Overview Dr. Williams
  c. Adulterants-Heparin, Diethylene Glycol Case Studies & Compendial Implications Dr. DeStefano
  d. Method Development in a QbD Environment – Compendial Implications Dr. DeStefano
11:30 a.m. Break
12:00 p.m. Topic II – Drug Product: Microbiology
  a. Harmonized Microbial Limit Tests Dr. Tirumalai
  b. Revised Sterility Tests Dr. Tirumalai
  c. Environmental Monitoring Dr.Ceresa
  d. Rapid Microbioloby Tests Dr.Ceresa
  Q&A
2:00 p.m. Lunch
3:00 p.m. Topic III: Drug Product: Packaging Mr. Sparks
  a. Glass Containers
  b. Plastic Material and Plastic Containers
  c. Update on Good Shipping and Packaging Practices <1079>
  d. Application of Authentication and Track and Trace Technologies to Packaging
  Q&A
5:00 p.m. Adjourn

Day 2: Monday, December 1, 2008

8:30 a.m. Topic IV- Drug Product Performance
  a. Science and Technical Overview Dr. Williams
  b. Performance Testing of Pharmaceutical Dosage Forms Dr. DeStefano
  c. Dissolution in Solid Forms Dr. Fahmy
  d. Quality by Design Dr. Fahmy
  e. Harmonization of Bioequivalence Requirements Mr. Johnston
  Q&A
10:30 a.m. Break
11:00 a.m. Topic V: Drug Substances
  a. Impurities: Inorganic/Metals, Residual Solvents, Genotoxic Impurities Dr. DeStefano
  b. Monographs/Certified Reference Materials: US and Europe Dr. Williams
  Q&A
12:00 p.m. Topic VI: Regulatory and Third-Party Certifications
  a. European Perspective: The Certificate of Suitability Dr. McMath
  b. US Perspective: Certification Programs in the US and Elsewhere Dr. Williams
1:30 p.m. Lunch
2:30 p.m. Topic VII: Biotechnology–Regulatory and Compendial Approaches Dr. Atouf
  a. Regulation of Biotechnology Medicines
  b. Compendial Approaches
  c. Documentary Standards and Reference Materials
4:00 p.m. Closing Plenary Session
  Hot Topics for 2009
  Closing Statements/Certificates
5:00 p.m. Adjourn