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 certifi cation and its QC testing laboratory has earned
accreditation to ISO/IEC 17025:2005. For more information please visit usp.org/ghana.
Course Overview
National regulatory frameworks for pharmaceutical products
vary greatly among countries, as does their degree of technical
capacity to carry out dossier evaluations that adequately assess
the safety, quality, and effi cacy of medicines. CePAT offers
hands-on training and analysis of real dossiers to help build
the necessary knowledge and skills in dossier assessment and
registration of medicines, so that participants can apply that
knowledge to their countries’ regulatory framework.
Who Should Attend
National regulators, manufacturers, and procurement agents
involved in product quality assessment; professionals involved
in product dossier assessment; consultants; and individuals
interested in the regulatory procedures to assess the safety,
effi cacy, and quality of medicines.
GPH012F _ 2016-10
Learning Objectives
By the end of the course, participants will:
Understand national and international medicines regulatory policies, guidance, and procedures;
Understand the principles of medicines regulation to ensure the safety, effi cacy, and quality of medicines;
Recognize the roles of national regulatory authorities;
Understand the principles of dossier evaluation and risk management;
Upon successful completion of the course, participants will receive
a certifi cate of achievement.
Course TopicsPrinciples of Dossier Assessment
Dossier Evaluation: Introduction
Drug Substance: General Information, Specifi cation Control, and Stability
Pharmaceutical Products Development
Control of Drug Product Components (excipients, packaging materials, etc.)
Analytical Methods and Method Validation
Product Dossier Assessment in Common Technical Documents: Generics
Sterile Products: Manufacturing and Validation
Bioequivalence: Introduction and Principles; Design; Regulatory Requirements; Analytical and Statistical Considerations
Variation and Post-Registration
Additional Information
This training module offers in-depth discussion and case studies on
the principles of product dossier safety, effi cacy, and quality evaluation
prior to and after marketing authorization of a medicine. It is based
on current standards and guidance of the World Health Organization,
the International Conference on Harmonisation, and other national
regulatory agencies. Participants will have the opportunity to better
understand the current scientifi c advancements and requirements
for pharmaceutical products’ dossier evaluation, strengthening their
product dossier evaluation skills. Sample dossiers, case studies,
exercises, and interactive, open discussions are designed to enable
participants to understand the theoretical principles presented.
Medicines Registration and Dossier Compilation
Duration:
Location:
Format:
Date:
To apply and be considered a candidate, contact [email protected], or visit usp.org/cepat.
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