BIOEQUIVILANCE IN TECH TRANSFER PRODUCTS

LEARNING OBJECTIVES 

• Understanding BE concepts
• The exact required studies for the drug supported by specific case TT
• Update knowledge of BE requirements in SFDA & JFDA.
• Be able to assess BE studies.
• Learn about BE requirements in different Contract manufacturing business models.
• Learn about BE study requirements for different dosage forms, inhalers, topicals, ….
• What should manufacturer do to approve efficacy in TT product
• Learn how to apply biowaivering in TT products /BCS.
• Discuss different case studies.

SPEAKER BIOGRAPHY

Dr. Hakima Hoseh, is a regulatory affairs expert of 20 years in JFDA & 12 years in Hikma pharmaceuticals… She drafted and shaped registration guidelines for Tech transfer Products, Bioequivalence, stability, and value added medicine guidelines. She holds RAC certification, a global regulatory affairs certificate from RAPs association in the United States of America.