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Home Pharma Courses BIOEQUIVILANCE IN TECH TRANSFER PRODUCTS
Pharmacovigilance for QPPV SAR  4,370
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BIOEQUIVILANCE IN TECH TRANSFER PRODUCTS

SAR  2,062

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Category: Pharma Courses
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Description

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.

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Date

20 & 21 September 2023

Location

Amman, Jordan

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