The activities of Fundisa African Academy of Medicines Development include Conferences, workshops, webinars and courses to support the professional development of young scientists, in cooperation with local and international academic institutions, industry, regulatory agencies, and other stakeholders.
At an
international Workshop organised by Fundisa African Academy of Medicines Development in Cape Town in 2014, experts clearly defined the need for a defined competency framework and involvement of local and international professional networks to overcome the lack of professional expertise in medicines development and regulation on the Continent.
As a joint initiative with the South African Medicines Control Council (MCC) and the CHMP in Europe, Fundisa African Academy of Medicines Development organised three 2-day
Regulatory Workshops in Pretoria in 2013 - 2015 to discuss current topics related to medicines regulation.
Fundisa African Academy of Medicines Development provides strong leadership in a major recently established initiative that addresses long-term strategy, conceptual frameworks and implementation of
capability enhancement and professional career development of African regulatory personnel. This programme is driven by several African Regulatory Agencies, together with other stakeholders. Two courses have been successfully presented to participants from six African Regulatory Agencies.
Since 2015, Fundisa African Academy of Medicines Development has been offering a series of 5-day
Clinical Investigator Certificate Courses (CLIC). These are based on the syllabus developed by PharmaTrain.
Special clinical trial workshops focused on
medical writing (2013),
novel methodologies (2019) and
controlled human infection challenge studies (2020).
Three
Health Economics Workshops were presented together with the South African National Department of Health (2016, 2019 and 2021). Experts from Europe and Africa explored pharmacoeconomic tools and upcoming trends in health technology assessment (HTA).
The Board members provided leadership to the
3rd World Conference on Pharmacometrics (WCoP2022 in Cape Town) which demonstrated the capability and capacity strengthening efforts for clinical research and the science of pharmacometrics in Africa and across the world.
At this occasion, the South African regulator (SAHPRA), in collaboration with Fundisa African Academy of Medicines Development and other stakeholders, hosted two regulators expert sessions on
capacity strengthening for African regulators and on competency development for using
model-based analyses and pharmacometrics to support regulatory decision making.
Fundisa African Academy of Medicines Development provides a significant contribution to the
South African Covid-19 Country Report prepared on behalf of the Presidency. This document outlines and critically discusses the measures implemented by government to combat and mitigate the effects of the pandemic. The First Edition was launched in June 2022. The Second Edition which addresses recent developments, lessons learnt and recommendations for good governance, pandemic preparedness and future disaster risk management is expected to be published in 2023.
Together with the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP), Fundisa African Academy of Medicines Development co-hosted a webinar to discuss
Covid-19 in Sub-Saharan Africa in 2021. At this timely event, experts discussed experiences from South Africa, other African countries, vaccine policy and legal responses, including human rights considerations.
A significant number of
publications by its Directors provide strong evidence of the successful contributions of Fundisa African Academy of Medicines Development to medicines development, health economic and capability enhancement in these important fields.
2023
CLIC Course - April 2023
The Clinical Investigator Certificate (CLIC) Course (CPD and GCP accredited) was held again as face-to-face event on 24 to 28 April 2023- our first on-site event after the pandemic. The programme was a great success; with over 55 delegates (clinical research investigators, site support staff, scientists, and members of Health Authorities) from across South Africa and neighbouring countries. The live format offered the delegates and presenters an excellent networking platform for exploring future collaborations.
Content covered during the course:
2022
Regulatory Capability Enhancement
The regulatory short course was again successfully presented to a second round of delegates from six Regulatory Agencies in 2022 (South Africa, Ghana, Zimbabwe, Nigeria, Kenya, Tanzania) (details presented for the 2021 course).
Click here to find out more
3rd World Conference on Pharmacometrics (WCoP2022) - March/April 2022
Fundisa African Academy of Medicines Development and its Board members provided leadership to the 3rd World Conference on Pharmacometrics (
WCoP2022) which - after being postponed in 2020 due to the pandemic - was arranged as a hybrid event, with live attendance by 110 delegates at the Century City Convention Centre in Cape Town, and virtual attendance via an online platform. The Conference demonstrated the capability and capacity strengthening efforts for clinical research and the science of pharmacometrics in Africa and across the world.
At this occasion, SAHPRA, in collaboration with the Bill & Melinda Gates Foundation, CP+ Associates GmbH and Fundisa African Academy of Medicines Development, and after several consultations with other African Regulators, hosted two regulators expert sessions (
3rd World Conference on Pharmacometrics WCOP). The first reported on progress on capacity strengthening for African regulators, whereas the second had a specific focus on competency development for using model-based analyses and pharmacometrics to support regulatory decision making.
South African Covid-19 Country Report
In 2020, the Department of Planning, Monitoring and Evaluation (DPME) in the South African Presidency has initiated a scientific project to develop the South African Covid-19 Country Report which outlines and critically discusses the measures implemented by government to combat and mitigate the effects of the pandemic. Scientists across various academic disciplines are invited by the National Research Foundation (NRF) to contribute to this major project which is supported by National Treasury. On behalf of Fundisa African Academy of Medicines Development, Prof Rosenkranz serves as convenor of Chapter 2, "Leadership, governance and institutional arrangements".
The First Edition of the South African Covid-19 Country Report covering the first year of the pandemic was launched on 30 June 2022 (
South Africa Covid-19 Country Report. The Chapter teams continue working on the Second Edition which addresses recent developments, lessons learnt and recommendations for good governance, pandemic preparedness and future disaster risk management.
2021
Health Economic Workshop - October 2021
On 30-31 October 2021, Fundisa African Academy of Medicines Development hosted a hybrid workshop "Health Economics and Pharmacoeconomics: Opportunities for German - African Cooperation", with both live attendance from delegates in Potsdam (Germany) and Pretoria (South Africa), and an online platform for remote attendance. Co-hosts were the South African National Department of Health, the Faculty of Health Sciences Brandenburg, Germany and Scenarium, Berlin, Germany.
At this workshop, experts from Europe and Africa will discuss potential use and applications of pharmacoeconomic tools for medicines, medical devices and diagnostics.
Webinar on Covid-19 in Sub-Saharan Africa - November 2021
Together with IFAPP, Fundisa African Academy of Medicines Development co-hosted a webinar to discuss "Covid-19 in Sub-Saharan Africa" in November 2021. This timely event was chaired by Prof Wolfgang Preiser, Head of the Division of Medical Virology, Stellenbosch University and National Health Laboratory Service (NHLS), Tygerberg, South Africa and Prof Bernd Rosenkranz.
Speakers were Prof Rhoda Wanyenze, Dean of Makerere University School of Public Health, Kampala, Uganda ("Covid-19 - Experiences from Uganda, Democratic Republic of Congo, Senegal, and Nigeria"), Prof Charles Wiysonge, Director of Cochrane South Africa, Medical Research Council, Cape Town ("Vaccine policy, usage and vaccine hesitancy in South Africa"), and Prof Elmien du Plessis, Associate Professor, Faculty of Law, Northwest University, Potchefstroom, South Africa ("Legal responses to the pandemic in South Africa, including human rights considerations").
Regulatory Capability Enhancement
Fundisa African Academy of Medicines Development is strongly involved in a major recently established regulatory talent-building initiative that addresses long-term strategy, conceptual frameworks and implementation tactics for training and professional career development of African regulatory personnel.
This initiative is driven by African Regulatory Agencies: SAHPRA, MCAZ (Zimbabwe) and Ghana FDA, together with Pharmacometrics Africa NPC, the Bill and Melinda Gates Foundation, WHO, and other stakeholders, including Fundisa African Academy of Medicines Development. Following a virtual consensus meeting hosted by SAHPRA (
The Innovation Meeting - June 2020 Report) in June 2020, the project started with a fully virtual Short Course, in collaboration with academics from local Universities, international institutions and Regulatory Agencies is accredited by the University of Witwatersrand, Johannesburg.
The course was successfully presented to delegates from three Regulatory Agencies in 2021 (South Africa, Ghana, Zimbabwe) (
Clinical Assessors within African Regulatory Agency Report).
2020
Together with Pharmacometrics Africa, CP+ Associates and the COVID-19 Clinical Research Coalition, Fundisa African Academy of Medicines Development has presented a webinar on Controlled Human Infection Challenge Studies on 01 September 2020.
Experts from South Africa, Ethiopia, Kenya, Switzerland, the United Kingdom, the Netherlands, and Australia discussed ethical and scientific principles for such studies, risk mitigation steps taken in previous malaria human challenge studies, and possible applications and practical concerns in the context of COVID-19 vaccine development.
The presentations and a list of recommended reading material can be found at:
www.pmxafrica.org
2019
Novel Clinical Trial Methodologies Workshop - February 2019
Together with Pharmacometrics Africa, Fundisa African Academy of Medicines Development organised the workshop "Novel Clinical Trial Methodologies 2019" in Cape Town on 25 February 2019. It was attended by more than 50 delegates. Speakers from USA, Canada, Switzerland, UK, and South Africa informed about the use of modelling and simulations, innovative trial designs, and real-world evidence. Practical aspects included investigator experiences, the South African National Clinical Trials Register, and the Trials Methodology Research Partnership.
This workshop formed one of the capacity building initiatives held across Africa in connection with the World Conference on Pharmacometrics (WCoP) which took place in Cape Town in March/April 2022 (
https://go-wcop.org/).
Please click on the links below for further details:
CLIC Course - March 2019
In March 2019, Fundisa African Academy of Medicines Development offered the second Clinical Investigator Certificate and Site Staff (CLIC) Course, according to the EU PharmaTrain syllabus.
Pharmacoeconomic Workshop - October 2019
Fundisa African Academy of Medicines Development - together with the National Department of Health, the University of Pretoria and Pharmacometrics Africa - has organised the Pharmacoeconomic Workshop "Health Technology Assessment for Medicines in South Africa - Current Situation and International Trends". This workshop was at the University of Pretoria on 8 and 9 October 2019, as satellite of the 53rd Annual Conference of the South African Society for Basic and Clinical Pharmacology (SASBCP, 5 - 7 October 2019 in Pretoria) and under the patronage of the PharmaTrain Federation. Local and international experts reviewed the current situation of pharmacoeconomics and HTA in South Africa in the local (including the National Health Insurance NHI) and international context. The 54 participants discussed needs, expectations and the way forward. This workshop provided an excellent opportunity for networking between different groups affected by HTA of medicines, and for capacity building. This workshop was one of the capacity building initiatives organised by Pharmacometrics Africa in connection with the World Conference on Pharmacometrics (WCoP, Cape Town, 6 - 9 April 2020,
https://go-wcop.org/).
Please click on the links below for further details:
2018
CLIC Course - July 2018
In July 2018, Fundisa African Academy of Medicines Development offered the second Clinical Investigator Certificate and Site Staff (CLIC) Course, according to the EU PharmaTrain syllabus.
2017
CLIC - October 2017
In October 2017, Fundisa African Academy of Medicines Development offered the second Clinical Investigator Certificate and Site Staff (CLIC) Course, according to the EU PharmaTrain syllabus.
2016
CLIC Course - September 2016
In September 2016, Fundisa African Academy of Medicines Development offered the second Clinical Investigator and Site Staff Certificate (CLIC) Course, according to the EU PharmaTrain syllabus.
Please click on the links below for further details:
Pharmacoeconomics Workshop - October 2016
Together with the National Department of Health, Fundisa African Academy of Medicines Development has organised the Workshop "Pharmacoeconomics in South Africa: Now and the Future - Value-Based Patient-Centred Healthcare in South Africa". The workshop was held at the Glenhove Conferencing Centre in Johannesburg from 19 - 21 October 2016. It consisted of an introductory day to provide a basic understanding of pharmacoeconomics, followed by a 2-day scientific workshop at which local and international experts discussed the current situation of pharmacoeconomics from a global perspective and in South Africa, as well as future developments.
Please click on the links below for further details:
2015
CLIC Course - March 2015
In March 2015, Fundisa African Academy of Medicines Development offered the first Clinical Investigator and Site Staff Certificate (CLIC) Course, according to the EU PharmaTrain syllabus.
Please click on the links below for further details:
Regulatory Workshop - September 2015
The Third Regulatory Workshop held at the University of Pretoria on 08 and 09 September 2015 was attended by more than 150 delegates from the MCC, industry, and academia. Experts from EMA, Swissmedic, MCC, the Department of Health, WHO, industry and academia discussed vaccines, Ebola, antibiotic resistance, benefit-risk assessment, accelerated approvals, medical devices, and capacity building. The financial support by Boehringer Ingelheim was highly appreciated.
Please click on the links below for further details:
Novartis Training Programme - July and November 2015
Fundisa African Academy of Medicines Development supported a Novartis training programme on evidence-based medicine, presentation skills, clinical development and research publishing (2 x 2 days).
Please click on the links below for further details:
2014
PharmaTrain Workshop - July 2014
In 2014, Fundisa African Academy of Medicines Development organised a Satellite Workshop of the World Congress of Basic and Clinical Pharmacology (WCP2014) in Cape Town to discuss competency strengthening in low-and-middle-income countries with representatives from the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP), PharmaTrain, academic institutions, the Medicines Control Council (MCC, the former South African medicines regulatory agency, now South African Health Products Regulatory Authority, SAHPRA), and the Bill & Melinda Gates Foundation.
The participants agreed that development of professional expertise on the Continent would require a structured approach, a defined competency framework and involvement of local and international professional networks and experts (
CLick here to find out more).
Please click on the links below for further details:
Second Regulatory Workshop 2014
The Second Regulatory Workshop held at the University of Pretoria on 09 and 10 October 2014 was attended by more than 130 delegates from MCC, industry and academia. Experts from EMA, MCC, industry, academia and a law firm discussed about medical devices, diagnostics, generic drugs, new anti-infectives, and advanced-therapy medicinal products (ATMPs). The workshop was concluded with presentations by Dr Tomas Salmonson and Dr Shabir Banoo (Head, Pharmaceutical Services and Policy Support Division, Right to Care and member of the MCC) about the role of the regulator as gatekeeper and enabler for drug development.
Please click on the links below for further details:
Literature
Please click on the links below for further details:
2013
Regulatory Workshop 2013
The First Regulatory Workshop held at the University of Pretoria on 26 - 27 September 2013 was attended by more than 180 delegates from the former Medicines Control Council (MCC), industry and academia. Experts from EMA, MCC, industry, WHO and academia discussed about pharmacovigilance, paediatric drug development, biosimilars and interactions between regulatory agencies.
Please click on the links below for further details:
Publications (by Directors of Fundisa African Academy of Medicines Development)
Capacity Building Initiatives
Rosenkranz, B.: South Africa pushes postgraduate education in pharmaceutical medicine. IFAPP World: 12-12 (2011)
Walubo, A., Barnes, K., Kwizera E., Greeff, O., Rosenkranz, B., Maartens, G.: Clinical Pharmacology becomes a specialty in South Africa. S Afr Med J 103: 150-151 (2013)
Kerpel-Fronius, S., Rosenkranz, B.: Training of Medicines Development and Regulation in Emerging Countries. IFAPP World 2: 4 (2014)
Kerpel-Fronius, S., Rosenkranz, B., Allen, E., Bass, R., Demotes-Mainard, J., Dodoo, A., Dubois, D.J., Hela, M., Kern, S., Massud, J., Silva, H., Whitty, J.: Education and training for medicines development, regulation and clinical research in emerging countries. Front Pharmacol 6:80. doi:10.3389/fphar.2015.00080 (2015)
Rosenkranz, B., Reid, M., Allen, E.: Pharmaceutical Medicine in Africa. Faculty of Pharmaceutical Medicine e-newsletter 46: 13-16 (2015)
Rosenkranz, B., Reid, M., Allen, E.: Medicines development and regulation in Africa. J Med Dev Sci 1(2): 33-36 (2015)
Semete-Makokotlela, B., Mahlangu, G.N., Mukanga, D., Darko, D.M., Stonier, P., Gwaza, L., Nkambule, P., Matsoso, P., Lehnert, R., Rosenkranz, B., Pillai, G.: Needs-driven talent and competency development for the next generation of regulatory scientists in Africa. Br J Clin Pharmacol 2021; 1-8 DOI: 10.1111/bcp.15020
Rosenkranz, B.: Fundisa African Academy of Medicines Development - Capability and capacity strengthening in Africa. IFAPP Today 26: 9-12 (2022)
Health Economics and Usage of Medicines
Kastien-Hilka T., Abulfathi A., Rosenkranz, B., Bennett, B., Schwenkglenks, M., Sinanovic, E.: Health-related quality of life and its association with medication adherence in active pulmonary tuberculosis- A Systematic Review of global literature with focus on South Africa. Health and Quality of Life Outcomes, 14:42. doi: 10.1186/s12955-016-0442-6 (2016)
Kastien-Hilka T., Rosenkranz, B., Sinanovic, E, Bennett, B., Schwenkglenks, M.: Health-related quality of life in South African patients with pulmonary tuberculosis. PLoS ONE 12(4): 1-20 (2017)
Kruger, M., Makiwane, M., Ramoroka, S., van Elsland, S.L., Rosenkranz, B.: Off-label use in ambulatory paediatric clinics in a central South African hospital. J Trop Paediatr 65: 380-388 (2019)
Makiwane, M., Decloedt, E., Chirehwa, M., Rosenkranz, B., Kruger, M.: Adverse drug reactions in paediatric in-patients in a South African tertiary hospital. J Trop Paediatr 65: 389-396 (2019)
Pillay-Fuentes Lorente V, van Rensburg R, Moolla S, McCaul M, Parker A, Taljaard J, Reuter H, Decloedt E.: Bleeding and thrombosis outcomes in hospitalised COVID-19 patients on low molecular weight heparin and antiplatelet therapy. S Afr Med J 2022; 112(7):472-477
Ytterberg SR, Bhatt DL, Mikuls TR, Koch GG, Fleischmann R.: ORAL Surveillance Investigators. Cardiovascular and Cancer Risk with Tofacitinib in Rheumatoid Arthritis. N Engl J Med 2022; 386(4):316-326. doi: 10.1056/NEJMoa2109927
Strong J, Mann T, Tarr GS, Reuter H.: Development of active tuberculosis in patients treated with biologic disease modifying anti-rheumatic drugs. S Afr Med J 2022;112(2):76-80.
Find out more.
Van Rensburg R, Decloedt EH, Reuter H, Parker A, Schrueder N, Lahri S. Ivermectin for COVID-19: Promising but not yet conclusive. S Afr Med J 2021;111(3):188.
Find out more.
Du Toit T, Esterhuizen T, Tiffin N, Abulfathi AA, Reuter H, Decloedt EH.: Incident tuberculosis disease in patients receiving biologic therapies in a high tuberculosis burden setting. BMC Infectious Diseases 2020; 20 (1): 1-8.
Find out more.
Decloedt EH, Reuter H, Allwood B, Parker A, Koegelenberg CFN, Blockman M, Taljaard JJ.: Benefit v. risk when using chloroquine in patients with severe COVID-19 disease. S Afr Med J 2020; 110(5):336.
Find out more
Clinical Drug Development
Rosenkranz, B.: Biomarkers and surrogate endpoints in clinical drug development. Appl Clin Trials 12: 30-40 (2003)
Fasinu, P.S., Bouic, P., Rosenkranz, B.: An overview of the evidence and mechanisms of herb-drug interactions. Front Pharmacol 3:69.doi:10.3389/fphar.2012.00069 (2012)
Rosenkranz B., Nachega J.B.: Diagnosis and management of malaria: An updated report on a deadly disease of global impact. Infectious Disorders – Drug Targets 13: 215-216 (2013)
Awortwe, C., Makiwane, M., Reuter, H., Muller, C., Louw, J., Rosenkranz, B.: Critical Evaluation of Causality Assessment of Herb-Drug Interactions in patients. Br J Clin Pharmacol,, 84(4): 679-693 (2018) doi: 10.1111/bcp.13490
Abulfathi, A.A., Chirehwa, M., Rosenkranz, B. Decloedt, E.H.: Evaluation of the effectiveness of dose individualization to achieve therapeutic vancomycin concentrations. J Clin Pharmacol. 2018 May 10. doi: 10.1002/jcph.1254. [Epub ahead of print]
Abulfathi A.A., Chaba L.A., Svensson E.M., Pillai G.C. and Rosenkranz B.: Editorial: Pharmacometrics—tools to assure optimal medicine use in low- and middle-income countries. Front. Pharmacol. (2022) 13:1034807. doi: 10.3389/fphar.2022.103480
Ollewagen T, Tarr GS, Myburgh KH, Reuter H, Smith C.: Therapeutic Benefit in Rheumatoid Cachexia Illustrated Using a Novel Primary Human Triple Cell Coculture Model. Int J Inflam 2022, Article ID 1524913, 14 pages.
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Lopez-Varela E, Abulfathi AA, Strydom N, Goussard P, van Wyk AC, Demers AM, van Deventer A, Garcia-Prats AJ, van der Merwe H, Zimmerman M, Carter CL, Janson J, Morrison J, Reuter H, Decloedt E, Seddon JA, Svensson EM, Savic R, Dartois V, Hesseling AC.: Drug concentration at the site of disease in children with pulmonary tuberculosis. J Antimicrob Chemother 2022;
Find out more.
Abulfathi AA, de Jager V, van Brakel E, Reuter H, Feyt H, Gupte N, Vanker N, Barnes GL, Nuermberger E, Dorman SE, Diacon AH, Dooley KE, Svensson EM.: The population pharmacokinetics of meropenem in adult patients with rifampicin-sensitive pulmonary tuberculosis. Frontiers in Pharmacology 2021; 12:1-8. doi: 10.3389/fphar.2021.637618
Abulfathi AA, Donald PR, Adams K, Svensson EM, Diacon AH, Reuter H.: The pharmacokinetics of para-aminosalicylic acid and its relationship to efficacy and intolerance. B J Clin Pharmacol 2020; 1-10. DOI: 10.1111/bcp.14395.
Abulfathi AA, Assawasuwannakit P, Donald PR, Diacon AH, Reuter H, Svensson EM.: Probability of mycobactericidal activity of para-aminosalicylic acid with novel dosing regimens. EJCP 2020; 76 (11): 1557-1565. DOI: 10.1007/s00228-020-02943
Policy
Rosenkranz, B., Anelich, L., Harrison, P., Mubangizi, C. B., Ndevu, Z., Rabie, B., Rumbold, K.: Leadership, governance and institutional arrangements. South African Covid 19 Country Report: First Edition. Development of a Country Report on the Measures Implemented to Combat the Impact of Covid -19 in SA. DPME (Department of Planning, Monitoring and Evaluation), GTAC (Government Technical Advisory Centre) & NRF (National Research Foundation), Pretoria (2021). ISBN: 978-0-621-49710-6 (
Full Report)
Du Plessis, E., van Niekerk, D., Rosenkranz, B., Preiser, W.: After the Covid-19 state of disaster in South Africa. Nat Hum Behav. 2022 Jun 30. doi: 10.1038/s41562-022-01409-4.
The Third Regulatory Workshop held at the University of Pretoria on 08 and 09 September 2015 was attended by more than 150 delegates from the MCC, industry, and academia. Experts from EMA, Swissmedic, MCC, the Department of Health, WHO, industry and academia discussed vaccines, Ebola, antibiotic resistance, benefit-risk assessment, accelerated approvals, medical devices, and capacity building. The financial support by Boehringer Ingelheim was highly appreciated.
Please click on the links below for further details:
