Clinical Trials In Africa – Towards Priority Reviews For Essential Medicines
Mr Eugene Liebenberg
Associate Director, Clinical Monitoring, Africa, PPD South Africa, Johannesburg, South Africa
Eugene has more than 20 years of experience in Community pharmacy and has been working in Clinical Research, working across different therapeutic areas including Infectious Diseases, Circulatory, Digestive System, Endocrinology and Oncology for the past 19 years.
Eugene is responsible for the line management of Clinical Management staff at a country level, including recruitment and selection, training, coaching and performance management. Eugene conducts regular performance appraisals/reviews with direct reports and facilitates their professional development.
Eugene develops and provides training on procedural documents and other processes relating to Clinical Management. Eugene supports Clinical Team Managers in local troubleshooting and achieving project deliverables in EMEA region, contributing to the successful delivery of clean data from evaluable patients. Eugene acts as a source of local knowledge and expertise on country specific laws, practices and procedures.
Eugene leads the Clinical Management team in EMEA responsible for the US Government work in the Africa region. In this role, he liaises with other departments to support cross-functional teams. Eugene is currently leading an initiative to develop the functional role of the Lead CRA on a global basis.
Mr Eugene LiebenbergAssociate Director, Clinical Monitoring, Africa, PPD South Africa
Eugene has more than 20 years of experience in Community pharmacy and has been working in Clinical Research
Ms Bisola Ashiru Filchak
MPH – Head of Regulatory Affairs, Africa at Novartis Pharma AG, Basel, Switzerland
Bisola Ashiru Filchak is a Global Regulatory Affairs Professional with almost 20 years of expertise in investigational and marketed products including regulatory strategy and health authority interactions resulting in regulatory submissions and regulatory approvals in over 100 approvals including Europe, Asia, Africa, Middle East, North and South America. Her experience expands early drug discovery to Phase III/IV trials, and post-approval activities. Bisola’s global regulatory experience also includes supporting compliance, launch, and commercialization activities.
Ms Bisola Ashiru FilchakMPH - Head of Regulatory Affairs, Africa at Novartis Pharma AG, Basel, Switzerland
Bisola Ashiru Filchak is a Global Regulatory Affairs Professional with almost 20 years of expertise.
Ms Delese Mimi Darko
Ag. Deputy Chief Executive, Safety Monitoring and Clinical Trials Division
Delese Mimi Darko is currently the Acting Deputy Chief Executive responsible for Clinical Trials, Safety Monitoring and regulation of Vaccines & Biological Products at the Food and Drugs Authority (FDA), Ghana.
She is a pharmacist with 26 years’ experience in regulation of medicines, vaccines and biologicals, herbal medicines and medical devices with respect to clinical trials regulation, marketing authorization and pharmacovigilance
After graduating from the university Delese worked first with the then Pharmacy Board for seven years as a drug enforcement officer. Following that she joined the Food and Dugs Board and rose to become the Head of Drug Evaluation and Registration Department, ensuring appropriate systems for regulation of medicines and medicinal products in Ghana.
She has played key leadership roles in pharmacovigilance and in the regulation of clinical trials in Africa, resulting in the FDA Ghana, in 2013, to be designated by the NEPAD/AMRH as a Regional Centre for Regulatory Excellence (RCORE) in Clinical Trials, Pharmacovigilance and Drug Registration.
Mrs. Darko serves and contributes expert advice on several international committees and working groups and initiatives including The UN Commission on Life-Saving Commodities for Women and Children, The CIOMS Vaccine Safety Working Group, the Technical Coordinating Committee of the African Regulators’ Network, African Vaccine Regulatory Forum, Member of the Scientific Advisory Group (SAG) for the R&D Blueprint for Action to Prevent Epidemics, Global Vaccine Safety Initiative and many others.
She is the Secretary to the three Technical Expert Advisory Committees of the FDA for Safety, Clinical Trials and Vaccines and Biologicals including Blood. She has chaired and made presentations on regulation of medicines marketing authorization, clinical trials regulation and pharmacovigilance in various national and international conferences.
Since the establishment of the Food and Drugs Authority, she has mentored her staff to achieve excellence in all areas of professional work. This has helped to ensure business continuity in the field of medicine regulation in Ghana.
Ms Delese Mimi DarkoAg. Deputy Chief Executive, Safety Monitoring and Clinical Trials Division, Food and Drugs Authority (FDA), Ghana.
Ms Delese Mimi Darko is currently the Acting Deputy Chief Executive responsible for Clinical Trials.
Mr Vinny Naidoo
Deputy Dean Research: Research, Faculty of Veterinary Science
University of Pretoria
Overview of Veterinary Clinical Trials
Vinny is a specialist veterinary pharmacologist. He qualified as a veterinarian from the Medical University of Southern Africa and completed his post-graduate training at the University of Pretoria.
He is currently based at the Faculty of Veterinary Science of the University of Pretoria. As Deputy Dean Research, he chairs the institutional animal research ethics committee and is responsible for the controlled animal housing centre of the University.
Vinny is also directly involved in the drug research and development, including the contract development of over 60 products in the last ten years for the local pharmaceutical industry. His main area of expertise is preclinical toxicity testing including pharmacokinetic analysis, in numerous species from the mice to rhinos.
Vinny also been involved in the training of specialists in veterinary pharmacology and laboratory animal science, including the supervision of 18 post-graduate candidates at the Masters and PhD level. He has authored 82 peer-reviewed publications and seven book chapters. Vinny’s most prominent research has been on the toxicity of diclofenac in vultures, which is focused on understanding the reason(s) behind the species susceptibility to the non-steroidal anti-inflammatory drugs.
Vinny also serves on numerous advisory boards including the Medicines Control Council of South Africa, and chairs the Veterinary Clinical Committee of the MCC.
Mr Vinny NaidooDeputy Dean Research: Research, Faculty of Veterinary Science, University of Pretoria
Vinny is a specialist veterinary pharmacologist. He qualified as a veterinarian from the Medical University of Southern Africa and completed
Mr Deon Bezuidenhout
Mr Deon Bezuidenhout (RN, CAPM, MAP), Site Relationship and Operations Lead, Clinical Research Manager, Global Clinical Operations, South East Africa Region
Biopharma | Global Clinical Operations, Merck
Deon Bezuidenhout has been in the pharmaceutical industry for 11 years and served various roles from clinical monitoring to study management and oversight in a variety of therapeutic areas in the clinical research contract organization milieu.
Deon is currently the Site Relationship and Operations Lead and Clinical study manager for Merck South East Africa. Deon is responsible for vendor oversight, maintaining investigator relationships and oversight of investigator sponsored trials. Deon also serves as a core member in an international consortium involved in developing solutions for neglected tropical diseases and as such fulfils the role of clinical trial leader in an African Development Paediatric Study. Deon also serves on the IPASA Clinical Research Technical Working Group.
Mr Deon BezuidenhoutRN, CAPM, MAP - Site Relationship & Ops Lead & Clinical Study Manager for Merck South East Africa
Deon Bezuidenhout has been in the pharmaceutical industry for 11 years and served various roles.
Regulatory Harmonization Or Convergence?
Mr Celestine Kumire
Celestine Kumire is a pharmacist by profession and holder of B Pharm (Hons); MA Strategic Studies and MBA degrees.
Celestine has many years of experience across the spectrum of pharmacy areas including hospital pharmacy, community/retail pharmacy, military pharmacy with emphasis on medical logistics, pharmaceutical manufacturing industry and now in health systems strengthening with emphasis on access to medicines through application of robust pharmaceutical supply chain management (PSCM) systems
Celestine served as a Member of Registration Committee of MCAZ (Medicines Control Authority of Zimbabwe), on the 5th Essential Drugs List for Zimbabwe Review Committee, and serves on the SADC Technical Review Committee on Pharmaceuticals.
As Programme Director at SARPAM he coordinates pharmaceutical procurement cooperation activities among the SADC countries via the SADC Secretariat and other key stakeholders.
Mr Celestine KumireProgramme Director, The Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM)
Celestine Kumire is a pharmacist by profession and holder of B Pharm (Hons); MA Strategic Studies and MBA degrees.
Ms Merce Caturla
Mercè Caturla is the Global Access Regulatory Lead / Regulatory Policy (Africa & WHO) Lead at Janssen Pharmaceutical Companies of Johnson & Johnson. In this role, Mercè is primarily responsible for leading and overseeing coherent and unified regulatory strategies to make medicines accessible in resource limited settings, and Africa in particular. Mercè participates in internal & external regulatory harmonization efforts and policy advocacy through proactive engagement with NGOs, Regulatory Agencies or governments.
Mercè is acting as the Janssen WHO Regulatory liaison and facilitates processes for the listing of its drugs in the WHO List of Prequalified Medicinal Products to allow for faster access to essential treatments.
Mercè studied Biology at the University of Barcelona and has a PhD degree in Molecular Biology from the Free University of Brussels (ULB), Belgium.
Ms Merce CaturlaPhD - Global Access Regulatory Lead / Regulatory Policy (Africa & WHO) Lead at Janssen Pharmaceutical Companies
Mercè Caturla is the Global Access Regulatory Lead/Regulatory Policy Lead at Janssen Pharmaceutical Companies.
Mr Mwesigye John Patrick
Currently a Senior Health Officer at the East African Community Secretariat, responsible for Medicines Regulation Harmonization Project, since 1st July 2013. From September 2009 to June 2013, Head of Pharmaceutical Policy and Medicines Regulatory Services at the Ministry of Health and Chair of the National Pharmaceutical Establishments Committee, Republic of Rwanda. Also a member of the National Technical Requirements and Specification Committee in Rwanda, and coordinator for the health commodities committee and including Coordinated Procurement and Distribution System activities in Rwanda. An Active Member of the EAC Technical team on matters related to food and medicines safety committee, including the various TWGs on MRH from 2009. In addition an inspector of pharmaceutical establishments in the Republic of Rwanda 2005 – 2009.
Received a B.Pharm from the Tamil Nadu Dr. MGR Medical University Chennai – India April 2003 and a Master’s degree in Clinical Pharmacy from the University of Nairobi, Kenya Dec 2008. In addition, has undergone a number of other professional supportive and professional carrier development training progrmmes in Health and related sectors.
Mr Mwesigye John PatrickSenior Health Officer at the East African Community Secretariat, responsible for Medicines Regulation Harmonization Project
Currently a Senior Health Officer at the East African Community Secretariat, responsible for Medicines Regulation Harmonization Project.
Ms Lesley Wentworth
Lesley Wentworth is programme manager for NEPAD Business Foundation’s Southern Africa Business Forum, which facilitates collaboration between the public and private sector for the delivery of economic projects in the SADC region – with sustainable economic and social benefits for Member States. Lesley has worked inter alia for the World Bank’s Multilateral Investment Guarantee Agency on capacity development projects supporting FDI in developing regions, and for the South African Institute of International Affairs as programme manager of economic diplomacy focusing on the Africa’s role in global economic governance; SADC investment and trade policy; and the private sector’s role in regional integration in Southern Africa.
Ms Lesley WentworthProgramme Manager - NEPAD Business Foundation’s Southern Africa Business Forum
Lesley Wentworth is programme manager for NEPAD Business Foundation’s Southern Africa Business Forum
Education And Training
Prof David Katerere
David Katerere holds a PhD in Pharmaceutical Sciences and has previously worked at Parexel CRO and South African Medical Research Council (MRC). He has published over 40 peer reviewed articles, three book chapters and one book, and supervised numerous postgraduate students, serving as trainer and mentor for the MRC and NRF Young Scientists Summer Programme (SA-YSSP). Currently he is Professor at Tshwane University of Technology (TUT) in Pretoria, South Africa, where he teaches Advanced Research Methods among other subjects and conducts training on Regulatory Science. He is an expert committee member of two MCC committees. David is an accomplished competitive Toastmaster.
Prof David KatererePhD - Tshwane University of Technology
David Katerere holds a PhD in Pharmaceutical Sciences and has previously worked at Parexel CRO and South African Medical Research Council.
Prof Norman Nyazema
Norman Nyazema is currently a professor of Pharmacology at the University of Limpopo and visiting professor Department of Clinical Pharmacology, University of Zimbabwe. He is a former vice chairman of the Medicines Control Authority of Zimbabwe. He was responsible as chairman, for the Medicines Registration and Adverse Drug Reaction Monitoring Committees. He is a director of Zimpharm a generic manufacturing company in Zimbabwe. He has been a technical adviser on a number of WHO short term assignments on essential drugs and treatment guidelines.
Prof Norman NyazemaProf of Pharmacology- University of Limpopo
Norman Nyazema is currently a professor of Pharmacology at the University of Limpopo and visiting professor Department of Clinical Pharmacol
Prof Gill Enslin
Gill Enslin is currently Head of the Department of Pharmaceutical Sciences at the Tshwane University of Technology (TUT). The department offers programmes from diploma level, the four year professional BPharm degree, to the doctorate level. Gill completed her Dip Pharm at Technikon Pretoria and subsequently her MPharm at University of Pretoria and the DTech in Pharmaceutical Sciences at TUT. She was promoted to associate professor in May 2016.
Since qualifying in 1980 Gill has been practised various sectors of pharmacy including community, industrial and academic pharmacy. Gill has spent the bulk of her career in the world of teaching and learning at TUT. She is involved the HEQSF alignment of diplomas and degrees.
In addition to teaching and learning, supervision of postgraduate students, academic administration, management and quality, Gill is a member of the Phytochemistry research group
Prof Gill EnslinDTech - Tshwane University of Technology
Professor Gill Enslin is currently Head of the Department of Pharmaceutical Sciences at the Tshwane University of Technology (TUT). She was
Dr. Lloyd Matowe
Director of the Organization Pharmaceutical Systems Africa (PSA)
Dr. Lloyd Matowe is the Director of the Organization Pharmaceutical Systems Africa (PSA). PSA is an international health organization providing consultancy and capacity building services to developing countries to strengthen pharmaceutical supply value chain and to address systems and management challenges. The firm has offices in the USA, Liberia, Nigeria, Uganda, Tanzania, and Zambia.
Dr Matowe has vast experience on strengthening the Pharmaceutical Value Chain Systems in Africa, having worked in over 20 countries in Africa on the subject matter. Previously he has worked with the Global Fund in Geneva, with Management Sciences for Health and a consultant on supply chain systems for various organizations including USAID, WHO, the East African Community, the Southern African Development Community, and the Global Fund among others. Dr. Matowe is active in academia being on staff at the University of Iowa, School of Pharmacy in the USA, at Kwame Nkrumah University of Science and Technology School of Pharmacy in Ghana, at Makerere University in Uganda and at the Schools of Pharmacy in Liberia and Zambia. Dr. Matowe has published widely in the field of public health pharmaceutical systems and has given in excess of 100 talks in over 30 countries, on pharmacy and supply systems strengthening.
Dr. Matowe holds a PhD in Health Systems Research form from the University of Aberdeen in the UK, a Masters’ degree in Clinical Pharmacology from the same institution, a Bachelor of Pharmacy Degree from the University of Zimbabwe, and a Diploma in Health Systems Evaluation from Johns Hopkins School of Public Health in the USA. He sits of various Boards of international organizations and has received several awards for services to the Pharmacy profession including recognition by the government of Liberia for resuscitating the training of pharmacists in the country, after the war.
Dr. Lloyd MatoweDirector of the Organization Pharmaceutical Systems Africa (PSA)
Dr. Lloyd Matowe is the Director of the Organization Pharmaceutical Systems Africa (PSA)
Mr David Woo
Mr David Woo, Technical Office, Programme for Local Production, World Health Organization (WHO)
David Woo recently joined the WHO Programme for Local Production for the Department of Essential Medicines and Health Products under Dr. Jicui Dong, Programme Manager for Local Production. Previously he was with the WHO in the Regulatory Systems Strengthening team, giving technical support to EAC and SADC Medicines Regulatory Harmonization Projects. David trained as pharmacist at the University of British Columbia in Canada. After working as a community pharmacist in Vancouver, BC for 7 years, he moved to Singapore in 2002 to work as a community pharmacist and also support training of pharmacy students for entry as licensed pharmacists.
In 2007, he joined the Health Sciences Authority (HSA) in Singapore (the NRA) as an assessor of CMC dossiers submitted for drug registration. While at HSA, he was involved with developing policies for the review of applications for registering of generic drugs, developing guidelines for applicants on registration procedures, conducting training workshops for applicants and representing HSA in international collaborative initiatives (e.g. ASEAN, Malaysia Singapore bilateral collaboration, IGDRP).
Mr David WooTechnical Office, Programme for Local Production, World Health Organization (WHO)
David Woo recently joined the WHO Programme for Local Production for the Department of Essential Medicines and Health Products under
Local Manufacturing For Local Needs
Dr Skhumbuzo Ngozwana
Dr Ngozwana is the President & Chief Executive Officer of Kiara Health. He is an internationally renowned African Pharma expert, who has served as a consultant to the World Health Organization (WHO), United Nations Industrial Development Organization (UNIDO), the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the United States Pharmacopeia Convention (USP) among others. As the International lead consultant for UNIDO, Dr. Ngozwana co-authored the Pharmaceutical Manufacturing Plan for Africa that was adopted by the African Union heads of state and government in 2012.
He is also the chairman of the board of Directors of the Biovac Initiative (a South African Public Private Partnership Vaccine manufacturer). Dr Ngozwana holds qualifications in Medicine, Medical Pharmacology and Business Administration.
Dr Skhumbuzo NgozwanaMBChB, M.Med (Pharm), MBA, KiaraHealth, South Africa
Dr Ngozwana is the President & Chief Executive Officer of Kiara Health.
Juergen Reinhardt, Ph.D.
Senior Industrial Development Officer, Investment Promotion Division,
Trade, Investment and Innovation Department, United Nations Industrial Development Organization (UNIDO)
Juergen Reinhardt, a Senior Industrial Development Officer at UNIDO, has been responsible for an array of technical cooperation interventions mainly in the fields of private sector development, small and medium enterprises development, investment promotion and industrial policy in Asia and Africa. His current portfolio includes a global UNIDO project that seeks to improve access to essential generic medicines in developing and least developed countries. This objective is pursued
through a combination of advisory and capacity building support aimed at the strengthening of local pharmaceutical production capacities, with a specific focus on sub-Saharan Africa. The joint preparation with the African Union Commission of a Business Plan for the Pharmaceutical Manufacturing Plan for Africa (PMPA) is one of the major outcomes of the project to date.
Prior to joining UNIDO in 1992, Mr. Reinhardt, a German national, was a Research Assistant at the Institute of Development Research and Development Policy of the Ruhr University of Bochum, Germany, from where he obtained a Ph.D. in Economics.
Juergen ReinhardtSenior Industrial Development Officer, Investment Promotion Division
Juergen Reinhardt, a Senior Industrial Development Officer at UNIDO, has been responsible for an array of technical cooperation intervention
Dr Eugenia Barros
Dr Eugenia Barros graduated with a PhD degree in Microbiology from the University of Cape Town and did a Post-Doctoral study at CEA in France in the field of Molecular Biology. She has published over 25 peer reviewed articles, 4 book chapters, edited 1 book and is the author of 2 invention disclosures. She is a Principal Researcher in the Biosciences Operating Unit of the CSIR. She has over 25 years’ experience in molecular biology with expertise in the fields of DNA and protein fingerprinting technologies for the development of molecular markers with application in agriculture, forestry and health industries as well as in the diagnostic and forensic fields. She is an expert committee member of the Advisory Committee for Genetically Modified Organisms at DAFF. She is currently responsible for the mammalian expression system platform in CSIR Biosciences for the production of biopharmaceuticals including biosimilars.
Dr Eugenia BarrosPhD - CSIR Biosciences South Africa
Dr Eugenia Barros graduated with a PhD degree in Microbiology from the University of Cape Town.
Abraham Gebregiorgis Kahsay
Abraham Gebregiorgis Kahsay
Technical officer, World Health Organization (WHO), responsible for Regulatory Networking and harmonization.
A pharmacist by training with MSC in Pharmaceutical Services and Medicines Control, University of Bradford, UK.
Abraham is responsible for supporting regulatory systems strengthening activities in the context of the African Medicines Regulatory Harmonization Project and other regional regulatory collaboration and harmonization efforts. He is responsible for providing technical assistance to Regional Economic Communities (RECs) and networks on Harmonization medicine regulation.
He has extensive experience in effective implementation of WHO Medicines Strategy, facilitating collaboration among Essential Medicines units in the WHO CO, WHO AFRO and WHO HQ and other stakeholders in the pharmaceutical sector, to help develop, implement and monitor national medicines policies and improve access to essential medicines. He has also coordinated the development and implementation of the national strategic plan for development of local pharmaceutical manufacturing in Ethiopia. Abraham has previously worked as National Project Manager at the United Nations Office on Drugs and Crime (UNODC) and served the Ethiopian health sector in various capacities.
He had been a member of different national and international forums, including the Country coordination mechanism (CCM) for the Global Fund to fight ATM, United Nations development assistance framework (UNDAF), Local Expert Network on substance abuse and lectured on different topics in university and other training programs.
Abraham Gebregiorgis KahsayTechnical officer, World Health Organization (WHO)
A pharmacist by training with MSC in Pharmaceutical Services and Medicines Control, University of Bradford, UK.
Mr Fred Makgato
Mr Fred Makgato : Head of Legal and Regulatory Affairs ASASA
Fred Makgato, Head of Legal and Regulatory Affairs, has been with ASASA since 2008. He started his career by serving his articles with Haarhoff Fourie and Partners in 1999. Fred was admitted as an attorney of the High Court of South Africa in 2000 and has practiced as such for a period of eight years.
Fred worked as a professional assistant for Mashile-Nthloro Inc. and later moved to Madlhopa Attorneys as a senior professional assistant. In 2002 he joined Langa Attorneys for a year before forming his own law firm: Makgato Attorneys, until 2008.
Fred holds a BProc. degree from the University of Natal (now KwaZulu-Natal). He also has an Advanced Banking Diploma from RAU (now University of Johannesburg). Further, he obtained MBA with Milpark Business School.
Mr Fred MakgatoHead of Legal and Regulatory Affairs ASASA
Fred Makgato, Head of Legal and Regulatory Affairs, has been with ASASA since 2008
Mr Wayne McDuling
Mr Wayne McDuling – Chairman of Marketing Code Authority (MCA)
Wayne is Head: Integrity & ComplianceSANDOZ South Africa (Pty) Ltd and Chairman of the MCA
2014 MCA Board Member
2017 Chairman – MCA
Henley Diploma in Management
MBA – University of Free State cum laude
Currently completing an Advanced Diploma in Business Project Management (June 2017)
Marketing Code Authority (MCA)
This body is responsible for the Marketing Code of Practice for Health Products which are subject to registration in terms of the Medicines Act. The body enforces the code through self-regulation and seeks regulatory endorsement in terms of the Medicines Act.
A voluntary body established by Constitution by the industry, funded at arm’s length and independently administered.
Mr Wayne McDulingChairman of Marketing Code Authority (MCA)
Chairman of Marketing Code Authority (MCA). 25 years with FirstRand Group – Asset based Finance Lending