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P95 Webinar on Insights to Conducting Clinical Trials in Africa – A Shared Experience
You are invited to join our P95 webinar on Insights to Conducting Clinical Trials in Africa – A Shared Experience.
Date: Tuesday, 5 November 2024
Time: 12pm EST / 9am PST / 5pm GMT / 6pm CET
One of the major hurdles in conducting clinical research in Africa is navigating the cultural, socio-economic and infrastructural differences that exist across the continent. Understanding the diverse cultural norms, regulatory frameworks, ethical nuances and health-seeking behaviors of the African populations in different regions is essential for the success of any clinical trial. The expert speakers will shed light on how to effectively engage with communities and ensure that studies are both respectful of local customs and capable of generating reliable and ethical results.
In this webinar, another important aspect that will be explored is the role of unmet healthcare needs across Africa. Despite the diversity of populations, there are common health challenges that plague many African nations, including infectious diseases, maternal and child health issues and the rising burden of non-communicable diseases. The expert speakers can help attendees understand how to design studies that address these pressing health concerns while also aligning with the priorities of local health authorities and global research agendas.
Partnership is another key strategy that will be discussed. The creation of a sustainable clinical research environment is crucial for long-term success, and this can often only be achieved through strategic collaborations. The discussion will also cover the importance of understanding regulatory frameworks across different African nations.
The expert speakers will provide insights into how to work with regulatory bodies, secure approvals and maintain compliance throughout the research process. In addition to regulatory considerations, the session will cover other practical aspects of conducting clinical research in Africa, such as logistics, vendor management and capacity building. Capacity building includes training healthcare workers, establishing research institutions and creating systems for data collection and analysis.
Speakers:
Catherine Lund, Managing Director, P95 Africa
Catherine Lund has over 28 years of clinical research experience and is the Founder of OnQ Research, a South African-based CRO recently acquired by P95. She currently holds the position of CEO at P95 Africa. Throughout her career, she has secured and executed clinical trials across the continent. She was a member of the EXCO of SACRA (South Africa Clinical Trials Association). Additionally, she held the position of vice-Chair for the South African Chapter of ACRP. Her expertise includes assisting clients with drug development strategy, knowledge of regulatory pathways, identifying and training potential resources throughout the continent and site identification and assessment. This includes a framework of budget management and milestone deliverables.
Nathaniel Ramuthaga, Clinical Operations Portfolio Leader (COPL) PDG, SA & SSA and Geo Lead, Roche SA & Africa
Nataniel Ramuthaga boasts an extensive and diverse background in the medical and pharmaceutical fields and is currently the Clinical Operations Portfolio Leader (COPL) for Roche Pharmaceuticals in PDG, SA and SSA, as well as the Geo Lead for Roche – SA & Africa. Previously, he held the position of Country Head of Clinical Operations for Sub-Sahara at Roche PDG. His involvement extends to being a member of the IPASA Clinical Trials Group and the South African Clinical Trials Association (SACRA), as well as a member of the Institute of Directors in Southern Africa (IODSA). He is registered as both a Medical Scientist with HPCSA and a Natural Scientist with SACNASP abd us also a certified Co-active Coach. He holds a BSc from the University of North London (formerly Unin), a BSc Hons and MSc from the Medical University of Southern Africa (now Sefako Makgatho Health Sciences University, SMU), along with a Diploma in Business Management from Damelin Management School and a Postgraduate Diploma in Marketing Management from UNISA. His early career includes roles as a Research Fellow, Medical Technical Officer and Medical Scientist/Lecturer in Microbiology at MEDUNSA. With over 25 years of experience in the pharmaceutical industry, he has significant experience at Pfizer Global Pharmaceuticals, progressing through roles such as Clinical Research Associate, Senior CRA, Brand/Product Manager, Clinical Research Manager, Director of Clinical Research and Senior Regional Head of Clinical Operation for Africa & Middle East. He also served as a Senior Director of Compliance Oversight and a Principal Compliance Officer. Moreover, he has been trained and practiced as a mentor and coach, has handled press relations and has an Ethics Certificate from WITS University. Throughout his career, he has contributed to several peer-reviewed research publications.
Nyeleti Rikhotso, Project Oversight Lead, P95 Africa
Nyeleti Rikhotso is Project Oversight Lead at P95, based in South Africa. With an MSc in Pharmacology, specializing in Drug Safety & Pharmacovigilance, a Postgraduate Diploma in Medicines Development and a BSc in Biomedicine, she brings over 17 years of clinical research experience. Her expertise spans clinical operations leadership, project management, pharmacovigilance, quality assurance, regulatory submissions and monitoring. Nyeleti has worked across multiple African countries, including South Africa, Kenya, Ghana and Rwanda. In her current role, she focuses on expanding P95’s presence in Africa, developing strategies, managing study budgets, registering regional entities, building relationships with clinical sites and preparing study proposals.