biologics - usp€¦ · and skills in dossier assessment and registration of biologics, so that...
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GHIP041F_2017-02
About CePAT
The U.S. Pharmacopeial Convention’s Center for Pharmaceutical
Advancement and Training (USP–Ghana [CePAT])in Accra,
Ghana, was established to help build human resource capacity
in pharmaceutical quality assurance and quality control by
training local professionals to serve as technical experts. CePAT
delivers an integrated platform of training, testing and consulting
services to support a sustainable approach to medicines quality
assurance. USP–Ghana (CePAT) is included under USP’s ISO
9001:2008 certification and its QC testing laboratory has earned
accreditation to ISO/IEC 17025:2005.
Course Overview
Regulation of biologics is a new and challenging area of
medicines regulation on the African continent. National regulatory
frameworks supporting this vary greatly among countries, as does
the degree of technical capacity of personnel to carry out dossier
evaluations that adequately assess the safety, quality and efficacy
of biologicals. CePAT offers a practical training that includes the
analysis of real dossiers, to help build the necessary knowledge
and skills in dossier assessment and registration of biologics,
so that participants can apply that knowledge to their countries’
regulatory frameworks.
Who Should Attend
National regulators, biologics manufacturers and procurement
agents involved in biologics quality assessments; professionals
involved in dossier assessments with a focus on biologics;
consultants and individuals interested in the regulatory
procedures to assess the safety, efficacy and quality of biologics
Learning Objectives � Understand the principles of biologics regulation to
ensure the safety, efficacy and quality of biologics
� Understand the details of manufacturing validation, with particular emphasis on vaccines, biologicals and sterile products
� Understand the components of regulatory safety, quality and efficacy approvals—from both clinical and quality
perspectives
Course Topics�
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Good clinical practices
Clinical trials
Aseptic sterilization
Manufacturing, GMP, validation, stability and specifications for biologics
A biologic product manufactured in a prokaryotic cell (E. coli, Insulin)
A biologic manufactured in a mammalian cell line (Erythropoeitin)
Evaluation of a monoclonal antibody (Mabs)
Manufacturing, GMP, validation, stability and specifications
for vaccines
For more information, please visit usp.org/ghana.
Biologics
Next CePAT Course
To apply and be considered a candidate, contact [email protected] or visit usp.org/cepat.
Fees may apply. A welcome dinner will be provided. Group photos will be taken during the course.
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