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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. 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 efficacy 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, efficacy, 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, efficacy, 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 certificate of achievement. Course Topics Principles of Dossier Assessment Dossier Evaluation: Introduction Drug Substance: General Information, Specification 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, efficacy, 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 scientific 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. Next CePAT Course
