Medicines Registration & Dossier Compilation Trainer - USP Ghana

Falsified and substandard medicines threaten recent improvements to global public health–particularly in  Africa. USP and its collaborators work across the region to ensure quality medicines availability. Join us in helping our partners develop skills needed to deliver quality assured medicines to citizens who need them most.

USP Ghana provides courses featuring lectures from working professionals in key sectors.  We are currently recruiting experts to teach Medicines Registration and Dossier Compilation.

Successful applicant should demostrate ability to teach below topics of interest and examine training candidates.

• Dossier Evaluation Introduction
• Introduction to the New Registration Guideline in CTD format
• Active Pharmaceutical Ingredients (API): General Information
• Stability of API
• Pharmaceutical Product Development
• Manufacturing: Finished Pharmaceutical Product (FPP)
• Finished Pharmaceutical Product Specification
• Process Validation and Annual Report
• Analytical Method and Validation
• Stability Data Assessment of FPP
• Introduction to Bioequivalence and Requirements
• Interchangeability and Bioequivalence
• BCS Based Biowaivers
• API Specification Assessment
• FPP Dossier Assessment in CTD
• FPP Common Deficiency and Tips
• Sterile Product: Introduction

Required Skills or Experience

• Applicant should demostrate ability and skills to teach above identified topics relating to Medicines Registrations and Dossier Compilation.
• Particular consideration will be given to current national regulators, pharmaceutical manufacturers, and international supply chain consultants