Who are we?
We are a non-profit organization and the premier Good Clinical Practice (GCP) initiative in Nigeria. Our organization comprises of over 300 members drawn from various scientific disciplines including biomedical, pharmaceutical, and behavioural sciences professions.
The AGCPN is dedicated to creating and fostering a clinical research environment that is ethical and adheres to world-class research standards within Nigeria. Our activities include advocating for improved clinical research regulatory and conduct frameworks, training, certification and conferences and providing industry updates.
Our History
The Association for Good Clinical Practice Nigeria (AGCPN) is a non-profit organization established in 2005 by a group of Nigerian Healthcare Providers led by Prof. Ifeoma Okoye. The organization was established to address the professional development, educational and networking needs of clinical research professionals in Nigeria with the ultimate view to attract the conduct of clinical trials in Nigeria.
In May 2006, the AGCPN hosted its flagship event "Promoting Health Research Capacity in Nigeria" in Abuja. Through its training programs, conferences and partnerships the organization has evolved into the premier Good Clinical Practice (GCP) initiative shaping and driving the expansion of clinical research infrastructure in Nigeria.
The AGCPN has collaborated with the following notable bodies - the Office for Human Research Protection (OHRP), the Collaborative Institutional Training Initiative (CITI), the European and Developing Countries Clinical Trial Partnership (EDCTP), the Nigerian Federal Ministry for Health (FMOH), the National Agency for Food and Drug Administration and Control (NAFDAC), the Nigerian Medical Association (NMA), the Nigerian Medical Council (NMC), the Medical Laboratory Science Council (MDCLN), the Pharmacists Council of Nigeria (PCN), the National Institute of Medical Research (NIMR), the National Institute for Pharmaceutical Research and Development (NIPRID), the National Agency for Control of AIDS (NACA) and local/international pharmaceutical companies and Contract Research Organizations (CROs) to ensure that it provides a platform for clinical research practitioners to be trained, to exchange ideas and share best practice.
In 2012, the AGCPN held its first clinical trial summit with the aim of identifying gaps within the clinical research industry in Nigeria and proffering tailored strategic solutions which have included lobbying governmental agencies to restructure their approach to clinical research. With the ensuing success of the summit, the AGCPN resolved to hold regular summits with the ultimate goal of advancing clinical research in the region by influencing research policy and equipping clinical research professionals.
Our Vision
Promoting a thriving clinical research landscape that adheres to the highest research and ethical standards whilst protecting human participants.
Our Mission
- To be the leading strategic initiative for creating, shaping and advancing institutional frameworks that promote clinical research capacity in Nigeria.
- To facilitate knowledge sharing and transfer through:
- Discussion
- Training
- Seminars
- Conferences and Summits
- Publication
- Partnership and co-operation
Our Structure
Our Contributors
Anthony Ikeme
PhD
Dr Anthony Ikeme, is the President/CEO of Clintriad Inc., a US based corporation focused on providing clinical research consultancy services to pharmaceutical companies. He has over 2 decades of experience in pharmaceutical science, innovation, product and business development. He is a proven leader in the sphere of knowledge brokerage. He has authored original articles in peer-reviewed journals, numerous magazines and Newspapers.
Dr. Anthony Ikeme
Experience
He has made presentations, led workshops and participated at multiple international fora, including conferences organized by the Drug Information Association (DIA), WHO/TDR African Network for Drugs and Diagnostics Innovation (ANDI), African Technology Policy Studies Network (ATPS), The Nigerian Association of Pharmacists and Pharmaceutical Scientists in the Americas (NAPPSA), NAFDAC, and Informa Life Sciences, UK and many others. He serves as a board member, Chair of the Program Committee, and Secretary of the Implementation Committee for NAPPSA. He is the current National Coordinator of the ATPS. Through these channels, he has made immense contributions in improving capacity for pharmaceutical science and product innovation in Africa through strategic partnerships with governments and key players within the sector.
He obtained a BSc in Biochemistry from University of Nigeria, Nsukka; MSc in Management from Oxford University, UK, and a PhD in Development Economics from De Montfort University, in the UK
Iruka A. Ndubuizu
LL.B, B.L, LL.M
A negotiations expert, trainer and consultant whose experience spans law firms, corporations and academia. She has worked on several high profile lawsuits and provided training to leaders, both locally and internationally. She is also a trained Mediator proficient in conflict resolution and a savvy contract negotiator skilled in drafting, reviewing, negotiating and administering various types of contracts and agreements.
Iruka A. Ndubuizu
Experience
Iruka, a Certified Clinical Research Contract Professional (CRCP) and self-proclaimed "contract guru" is the Assistant Director for Contracts Administration at Emory University, in Atlanta where she leads a team of Contract Analysts responsible for reviewing and negotiating clinical trial agreements, confidential disclosure agreements and various research related agreements. Emory receives over $500 million dollars in research funding annually.
She is the Founder of Eureka Consulting, LLC (www.eurekaconsultingllc.com), a graduate of Huron Consulting's Research Administration & Management Program and a part-time student in the Masters in Bioethics Program at Emory University.
Dr. Kelechi Lawrence
Dr. Kelechi Lawrence is the Founder and President of ProjectChange International, Inc., a USA-based philanthropic and advocacy organization for healthcare improvement initiatives in the State of Delaware, and in Nigeria. Dr. Lawrence holds a doctoral degree in molecular pharmacology from the Medical University of South Carolina and completed a fellowship at the College of Physicians and Surgeons of Columbia University. He also holds an MBA in Marketing/Finance from the University of Delaware and has over 25 years of combined basic/clinical research experience. He is currently employed by GlaxoSmithKline Vaccines in Philadelphia, PA as a Manager of Operations, Medical Affairs.
Dr. Kelechi Lawrence
Experience
Dr. Lawrence, under the auspices of ProjectChange International, conducts medical missions to Nigeria, bringing quality medical care and medical supplies to many impoverished communities. A civic entrepreneur, Dr. Lawrence is an active volunteer and serves on the board of many local community organizations and charities. Dr. Lawrence has written over thirty scientific articles and has been recognized with many professional and civic honors, including commendations by then Senator Joseph R. Biden, Jr. (United States Senate), Governor Ruth Ann Minner (State of Delaware), and Mayor James Baker (City of Wilmington).
Gbolahan Fatuga
Fatuga is a social-entrepreneur who serves as Founder/President of Caligeo Clinical OneVision, a non-profit clinical trials organization and Founder/Executive director of Atlanta Premier SMO. His professional passion lies in promoting clinical trial opportunities in emerging markets (Africa, the Caribbean, East Asia, and Latin America) and among under-represented populations (in the USA). He acquired his MBA degree from Emory University/Goizueta Business School with a focus on Entrepreneurialship/Organizational Behavior & Management. He received his M.Sc. in Drug Regulatory Affairs and Health Policies from Massachusetts College of Pharmacy and Health Sciences and BS degree in Neuroscience from Brown University.
Gbolahan Fatuga
Experience
Now with more than 20 years of experience in the clinical research industry, Fatuga began his clinical research career as a study coordinator at Brown University. He has since held leadership positions including Clinical Team Manager, Project Lead, QA/QC Manager, CRA Consultant and Medical Research Associate in a variety of Contract Research Organizations (CROs), biotechnology and pharmaceutical companies.
Fatuga is currently certified as a Project Management Professional (PMP) and a Clinical Research Associate (CCRA). He is a member of Nigerian Association of Pharmacist and Pharmaceutical Scientists in the Americas (NAPPSA) and sits on the Board of the Association of Good Clinical Practices in Nigeria (AGCPN). Fatuga is also a member of the International Committee/Leadership Team of the National Biotechnology and Pharmaceutical Association (NBPA) - a US based organization involved in collaborative efforts to address challenges and opportunities of conducting clinical trials within diverse communities as well as addressing the disparity issues in the clinical trial industry.
Dr. Henrietta N. Ukwu
M.D., FACP, FRAPS
Dr. Ukwu is a physician, infectious diseases expert, professor, pharmaceutical industry executive, thought leader, and author of the landmark textbook, Global Regulatory Systems - A Strategic Primer for Biopharmaceutical Product Development and Registration. She was named to the 2011 PharmaVoice 100 list of most inspiring industry leaders and the November 2012 TOPRA award for Most Inspiring Leaders. Dr Ukwu is currently Senior Vice President Global Regulatory Affairs Otsuka Pharmaceutical (OPDC) Dr. Ukwu joined Otsuka in January 2013 from PPD Inc. where she was Senior Vice President and Head, Global Regulatory Affairs from 2010 to 2012
Dr. Henrietta N. Ukwu
Experience
Dr. Ukwu started her regulatory professional career at Merck in 1992, became vice president and head of vaccine worldwide regulatory affairs in 1998, and vice president of global regulatory policy in 2002. She joined Wyeth Pharmaceuticals in 2004 as vice president of global regulatory affairs, with responsibility for all therapeutic areas across vaccines, biologics and pharmatherapeutics platforms. In 2009, she became vice president of worldwide regulatory affairs for Pfizer Inc.
Dr. Ukwu's remarkable career includes regulatory leadership in the U.S, Canada, Europe, Asia Pacific, Latin America, Middle East, Africa and the WHO. Dr. Ukwu has led numerous successful global regulatory product development activities across all regions and is directly responsible for over 20 original and key product approvals across multiple therapy areas and platforms. Significant contribution to Public Health!. In addition Dr. Ukwu contributes to and serves on company executive and senior leadership committees and several scientific committees that enhance public health policies.
Anthonia Orobor-Akinola
MRQA
Anthonia Orobor-Akinola is a Senior Quality Assurance Auditor at Janssen Pharmaceutical Companies of Johnson & Johnson. Anthonia having had over 10 years' experience within the clinical research industry, has worked across pre-clinical through to phase IV clinical trials in various capacities. These include phase I screening management, pre-clinical study management and in the past 8 years, Quality Assurance.
As a QA Auditor, Anthonia is involved with conducting investigator site, vendor and system audits as well as conducting mock inspections. Her activities on these audits include root cause analysis and providing guidance on Corrective and Preventative Action (CAPA) implementation.
Anthonia Orobor-Akinola
Experience
Additionally, she is involved with Standard Operation Procedures (SOP) construction, implementation and review, and regularly provides broad regulatory, quality and GCP compliance advice to clinical research operations teams. Anthonia's experience includes managing sponsor audits and Health Authority Inspections including FDA, MHRA and EMEA inspections.
Anthonia is a keen trainer and provides training in the EU and Africa regions on Good Clinical Practice (GCP) and Quality Assurance. In her spare time, she provides QA consultancy services, acts as an international advisor and trainer for the AGCPN. She is also a member of the Research Quality Assurance Association (RQA) and is currently serving as a member of the recently convened Nigerian Clinical Trial Technical Working Group. Anthonia has a BSc degree in Pharmacology from the University of Portsmouth and an MSc in Pharmaceutical Medicine from the University of Surrey.
Dr. Victoria Olaiya
Dr. Olaiya is a Regulatory Affairs Consultant, for a leading Clinical Research Organisation in the United Kingdom. Dr. Olaiya started her regulatory affairs career at Medicines & Healthcare products Regulatory Agency (MHRA) in 2001 as a Scientific Assessor in the Licensing Division.
Dr Olaiya previously worked for Cancer Research UK (CR-UK), Centre for Drug Development as part of matrix project teams to obtain MHRA approval (February 2015) for the FIH (First in Human) study for a first in class IgE antibody.
Dr. Victoria Olaiya
Experience
She has provided clinical regulatory consultancy services to Pfizer and has worked for Novella Clinical, ICON Clinical Research, INC Research.
Dr Olaiya holds a degree in Dentistry from University of Lagos, a second degree in Human Physiology from University of Westminster and a Post Graduate Diploma in Clinical Drug Development from Queen Mary, University of London.
Dr Olaiya's recent publication is titled 'The Next Clinical Trials Destination: Nigeria Why?
Dr. Echeazu Ogu
Dr Echeazu Ogu is a USA based Consultant with broad expertise and in-depth experience in medicinal product and medical device development, regulation, and manufacturing.
Areas of expertise include Quality Assurance; Regulatory Affairs; Clinical Trials Compliance; the ICH and WHO Guidelines. Dr Ogu has been a Regulatory Consultant and Adviser to NAFDAC for about 10 years on Clinical Trials, Labs, and GMPs. Achievements include updating NAFDAC Clinical Trials and GMPs Regulations to ICH and US standards; training NAFDAC Senior Staff on Quality and Inspections; and collaborating to arrange training for NAFDAC Senior Management at a US Agency. He was recently appointed to The Nigerian Clinical Trial Technical Working Group.
Dr. Echeazu Ogu
Experience
Dr Ogu played a key role in the development and original FDA approval of efavirenz (brand names "Sustiva" and "Stockrin") for HIV/AIDS.
Prior to Consulting, he held senior positions with worldwide oversight responsibilities at major US multinational firms. An experienced auditor and invited speaker, he can be reached at eogu@bonscience.com
Adebukunola Telufusi
Adebukunola Telufusi is the CEO of Xcene Research, an innovative Contract Research Organization providing full service support to the pharmaceutical, biotechnology and medical device industry. She is an experienced clinical research professional with over 10 years of quality experience in the clinical research industry.
She has worked with pharmaceutical companies and Contract Research Organizations (CROs) as a Project manager and Clinical Research Associate. Before the inception of Xcene Research, she had the opportunity to work on multiple Pfizer, Merck and Johnson & Johnson Phase I-IV clinical trials. She has managed clinical sites across many therapeutic areas including cardiovascular disease, CNS, diabetics, oncology, pain management, pediatrics, rheumatology, infectious disease, neurology, therapeutic device, vaccines, and Women's health studies
Adebukunola Telufusi
Experience
Adebukunola has also worked as a consultant for major pharmaceutical and medical device companies in the US. Most recently, she led a world-wide team responsible for operational processes, training and quality management for a large pharmaceutical company. During this time she was responsible for projects assessment and adoption of cross-functional technology such as Electronic Data Capture, Electronic Document Management and Clinical Trial Management systems.
Adebukunola is a Certified CRA and an active member of Association of Clinical Research Professionals (ACRP) and The society of clinical research associate (SoCRA). She obtained a B.S degree in Biology from Rutgers University. She is passionate about health care delivery and policy reform in Africa. In her spare time, she works with NGOs that focus on access to healthcare delivery and high- quality education in remote areas across Sub-Saharan Africa