Join USP and the Gates Foundation for this free webinar focused on developing better business plans for contract research organizations (CROs) conducting bioequivalence studies in Africa, Asia, and beyond. This webinar will introduce a new business planning resource developed by USP, and guide established and emerging CROs in low- and middle-income countries, regulators, stakeholders, and other potential users on its use. The event will also highlight current challenges for CROs, best practices, and tips for navigating regulatory environments.
Speakers
- Dr. Delese Mimi Darko, CEO, Ghana Food & Drugs Authority (FDA)
- Dr. Amanda Lewin, Senior Technical Advisor, USP (Moderator)
- Dr. David Mukanga, Deputy Director of Africa Regulatory Systems, Gates Foundation
- Dr. Porranee Puranajoti, Managing Director, International Bio Service Co
- Chomduen Leeyakart, Acting Quality Assurance Section Chief, International Bio Service Co
- M’sandine Sakala, Chairperson of BA/BE Technical Working Group, African Medicines Regulatory Harmonization (AMRH)
- Hendrick B. Theron, Business Development Executive, FARMOVS
- Mekonnen Teferi, Director, Clinical Trials Directorate, Armauer Hansen Research Institute (AHRI)
Download the resource guide Speaker bios
Background
Bioequivalence (BE) studies are essential to ensuring that generic medicines match the safety, efficacy, and quality of their brand name counterparts. Yet, one of the biggest hurdles in conducting BE studies in low- and middle-income countries is a lack of financial investment in CROs, which specialize in BE studies. Without critical BE studies to ensure quality, patients are at greater risk of receiving poor-quality generic products.
Bettering the business case for bioequivalence studies in Africa
A guide for contract research organizations conducting BE studies.
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Expanding bioequivalence studies in Africa
Supporting CROs to increase regional production of quality-assured medicines.
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Speaker bios
Dr. Delese Mimi Darko
With over 33 years of experience in food and medical product regulation, Dr. Delese Mimi Darko serves as the CEO of the Ghana Food and Drugs Authority (FDA). Under her leadership, the FDA achieved WHO Maturity Level 3 for medicines and vaccines (non-producing) in 2020 and in 2022, the FDA’s Drugs Laboratory achieved WHO Maturity Level 4 and became the first WHO-Prequalified Quality Control Laboratory in West and Central Africa. Dr. Darko also chairs the Steering Committee of the WHO African Vaccines Regulatory Forum (AVAREF) and serves as a member of the CEPI Advisory Board and the COVAX Maternal Immunization Working Group. She holds a bachelor’s degree in pharmacy from the Kwame Nkrumah University of Science and Technology (KNUST), an MBA from the University of Northampton, and a PhD in pharmacology from KNUST.
Dr. David Mukanga
Dr. David Mukanga is the Deputy Director of Africa Regulatory Systems at the Gates Foundation. With 27 years of experience in regulatory affairs, health systems development, clinical research, and product development, Dr. Mukanga previously served as CEO of the African Field Epidemiology Network (AFENET), Chair of the African Medicines Regulatory Harmonization (AMRH) Partners’ platform, member of the Board of the Drug Information Association (DIA), and faculty at Makerere University. Dr. Mukanga holds bachelor’s and master’s degrees in pharmacy and public health from Makerere University, a master’s in epidemiology from Johns Hopkins University, and a PhD in international health from the Karolinska Institute.
M’sandine Sakala
Mr. M’sanide Sakala has more than 10 years of experience in regulatory affairs as a resource person under the Zambia Medicines Regulatory Authority (ZAMRA) and consults for other national medicines regulatory authorities (NMRAs) and the WHO Prequalification Team – Medicines (WHO-PQTm). Mr. Sakala is the current chairperson of the Bioavailability/Bioequivalence (BA/BE) Technical Working Group under the African Medicines Regulatory Harmonization (AMRH) and is also the WHO-PQTm representative to the Bioequivalence Working Group for Generics under the International Pharmaceutical Regulators Programme (IPRP).
Dr. Porranee Puranajoti
Dr. Porranee Puranajoti is the Managing Director of International Bio Service Co., Ltd., bringing over 15 years of leadership in bioanalytical and clinical research services. She oversees business strategy, operations, and client relations, ensuring high-quality service delivery in compliance with global regulatory standards.
Chomduen Leeyakart
Chomduen Leeyakart is a Quality Assurance Section Chief at International Bio Service Co., Ltd with over 10 years of experience in clinical research and regulatory compliance. She oversees QA programs, audits, and inspections, ensuring adherence to GCP, GLP, and international standards while supporting data integrity and continuous improvement.
Hendrick B. Theron
Hendrick B. Theron started his analytical chemistry career as an assistant researcher for the South African Pulp and Paper Industry (SAPPI). In 2002, he joined FARMOVS as a bioanalyst, where he developed and validated over 30 bioanalytical methods. He joined the FARMOVS international business development team in 2007 to promote the CRO's clinical and bioanalytical services. In 2014, he became Director of Bioanalytical Services, spearheading business development, driving strategic initiatives, and overseeing the daily operations of the bioanalytical laboratory, which received ISO15189 accreditation under his leadership. Mr. Theron holds a master's degree in bioanalytical chemistry from the University of the Free State in Bloemfontein, South Africa.
Mekonnen Teferi
Mekonnen Teferi is a researcher at the Armauer Hansen Research Institute (AHRI) in Addis Ababa, Ethiopia where he leads the clinical trials and bioequivalence (BE) unit. He is trained in pharmacology and has broad experience in clinical research and clinical trials for infectious diseases, including leading and co-investigating clinical research projects and participating in multi-country clinical trials such as STREAM and WHO SOLIDARITY. In addition, he is currently leading BE clinical studies at AHRI and working to establish a regulatory compliant BE center with clinical, bioanalytical, and public CRO functions.
Dr. Amanda Lewin
Amanda Lewin, Ph.D. is a Senior Technical Advisor at US Pharmacopeia, where she leads the development and implementation of technical strategies that align with international standards for medical products regulation specifically related to bioequivalence studies. She provides high-quality technical assistance globally, advocates for the adoption of data standards, and delivers training on bioequivalence and clinical trials. Dr. Lewin has over six years of experience with the US FDA, specializing in oversight of bioequivalence and bioavailability studies, and holds a Ph.D. in Pharmacology from Georgetown University.