Contact Details
Tel Number:   +27 71 182 9740   Fax Number:   +27 21 945 1836
Email Address:   info@fundisa-academy.com
Fundisa African Academy of Medicines Development - Specialised in Pharmaceutical workshops in Western Cape, Cape Town

Fundisa Activities

Fundisa African Academy of Medicines Development organises strategic workshops on New Developments in Drug Regulation, together with the MCC and the National Department of Health. International and local experts from government, regulatory agencies, industry and other institutions present and discuss recent developments. These workshops provide an excellent opportunity to learn and exchange ideas and to network with colleagues.

The Clinical Investigator Certificate (CLIC) Course offers capacity building in planning and management of clinical trials, based on the PharmaTrain syllabus.

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 MCC, industry and academia. Experts from EMA, MCC, industry, WHO and academia discussed about pharmacovigilance, paediatric drug development, biosimilars and interactions between regulatory agencies (see presentations attached).
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2014

PharmaTrain Workshop

The Fundisa African Academy of Medicines Development cooperates with the European PharmaTrain Federation. Medicines development training in emerging economies was the focus of the Satellite Workshop "Training of Medicines Development and Regulation in Emerging Countries" at the World Congress of Basic and Clinical Pharmacology (WCP2014) in Cape Town, organised with the Hungarian Society for Experimental and Clinical Pharmacology andunder the auspices of PharmaTrain and the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP).

This workshop provided an excellent opportunity to discuss postgraduate education in medicines development, regulation and clinical investigation with experts working in low and middle income countries. The workshop has successfully identified the nature and volume of special needs. Several recommendations were put forward to establish regional and international cooperation in training experts in medicines development, drug regulation and clinical research.
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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) (see presentations attached). 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 theMCC) about the role of the regulator as gatekeeper and enabler for drug development.
Please click on the links below for further details:

Literature

2015

CLIC Course - March 2015

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3rd Annual Regulatory Workshop - New Developments in Drug Regulation

Fundisa Acedemy - 3rd Annual Regulatory Workship Fundisa Acedemy - 3rd Annual Regulatory Workship
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.
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Novartis Workshop

Fundisa African Academy of Medicines Development endorses the Novartis training programme on evidence-based medicine, presentation skills, clinical development and research publishing (2 x 2 days). Registration is by invitation only and has already closed for the 2015 programme.
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2016

Pharmacoeconomics Workshop

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 will present and discuss 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:

CLIC Course

2017

CLIC - October 2017

2018

CLIC Course - July 2018

2019

CLIC Course - March 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 will take place in Cape Town on 29 March - 1 April 2022 (postponed from 2020 due to the coronavirus pandemic) (https://go-wcop.org/).
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Novel Clinical Trial Methodologies Workshop - Presentations

Program 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:

Health Technology assessment for medicines in South Africa

Fundisa African Academy of Medicines Development - together with the Pharmaceutical Economic Evaluations Directorate of the National Department of Health, the University of Pretoria and Pharmacometrics Africa - organised the Pharmacoeconomic Workshop "Health Technology Assessment for Medicines in South Africa - Current Situation and International Trends".

The workshop was held 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), under the patronage of the PharmaTrain Federation. Twenty local and international experts reviewed the situation of Health Technology Assessment in South Africa and internationally, and discussed the use of health economic modelling, real world evidence and Big Data to support decision making. Needs, expectations and the way forward in the context of the new South African National Health Insurance (NHI) were discussed by key stakeholders.

This workshop provided an opportunity for networking between the invited speakers and the 34 delegates from industry, medical aids, academia, professional organisations, patient and medical doctor representatives, and the National Department of Health. This workshop was one of several 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/). Pharmacometrics Africa provided financial support to the workshop.

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

2021

We kindly invite you to our hybrid workshop "Health Economics and Pharmacoeconomics: Opportunities for German - African Cooperation" on 30-31 October 2021, with both live attendance from the delegates that are able to be present in person in Potsdam (Germany), and an online platform allowing remote attendance for those who cannot travel. At this workshop, experts from Europe and Africa will discuss potential use and applications of pharmacoeconomic tools for medicines, medical devices and diagnostics. Details are presented in the attached programme.

You are welcome to distribute the invitation to this international workshop in your professional network.

Attendance is free, but registration is required. For further enquiries and workshop registration, please contact: info@fundisa-academy.com

Publications

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