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.
