Forming Strategic Partnerships for Enhanced Regulations for Food and Pharmaceutical Packaging скачать в хорошем качестве

Forming Strategic Partnerships for Enhanced Regulations for Food and Pharmaceutical Packaging

ABOUT THE TALK The National Medicines Regulatory Agencies (NMRAs), similar to the US Food and Drug Administration (FDA), are responsible for regulating food, drugs, and medical devices in West African countries. This oversight enforces compliance with standards required to make regulated products safe for human consumption. Within the West African subregion, the FDAs of Ghana, Nigeria, and Senegal have attained the World Health Organization’s (WHO) maturity Level 3. However, a review of the countries’ NMRA websites suggests that they currently do not have regulatory guidelines for monitoring the packaging of food and drugs manufactured within the region. Similarly, their National Standards Authorities, which set standards for manufacturing locally produced products, do not have robust systems for Packaging Standards. On inquiry, it was determined that only one University in Ghana offers a packaging science program. The MSU School of Packaging seeks to fill these gaps by partnering with various stakeholders from the three countries to institutionalize the course within the academic and regulatory sectors. The program has a long-term vision of incorporating other countries within the sub-region as it expands. ABOUT THE SPEAKER Mercy A. Okezue, Ph.D., has over 20 years of experience in the regulatory sciences sector (pharmaceutical, medical device, and combination products). Dr. Okezue holds a B. Pharm degree and over 15 years of experience working as a GMP inspector and a QC/QA specialist with Nigeria's FDA (NAFDAC). She obtained both her MS and Ph.D. in Biotechnology Innovation and Regulatory Sciences from Purdue University, West Lafayette, Indiana. She has two years of Postdoctoral training from the Colleges of Pharmacy at Purdue University and the University of Michigan. As a Teaching Fellow at Purdue, Dr. Okezue developed and delivered specialized topics in regulatory sciences to equip students with the skills required to work in quality-regulated environments. She has worked on several early-stage drug development projects and successfully synthesized and elucidated five salts of bedaquiline (a drug for treating multidrug-resistant TB) as new molecular entities. Dr. Okezue has published several peer-reviewed articles based on her research. She has received several awards and, most recently, attained ISTA Packaging Dynamics Professional (PDP) Certification and was honored as Michigan State University (MSU) CANR 2025 Global Scholar in Education. At MSU School of Packaging, Dr. Okezue focuses on synergizing expertise in regulatory science and pharmaceutical product stability to deliver real-world solutions to current medical packaging needs.