News

Second iteration of Clinical Assessors course for African regulators celebrates its graduates

5 June 2023

In the digital age, learning has become more accessible than ever, and online courses have gained immense popularity. Recently, we had the privilege of hosting a memorable graduation ceremony for the second iteration of our course, “Clinical Assessors within African Regulatory Agencies.” It was a celebration of their remarkable achievements, a testament to their dedication, and a reminder that education knows no boundaries. The objective of developing this 12-week course was to address the critical skills gap in regulatory sciences on the African continent. The course, accredited by The University of Witwatersrand, was attended by participants from five (5) regulatory agencies – Ghana Food and Drugs Authority, Kenya’s Pharmacy and Poisons Board, Nigeria’s National Agency for Food and Drug Administration and Control, SAHPRA, Tanzania’s Medicines and Medical Devices Authority, the Medicines Control Authority of Zimbabwe. “The tutorial sessions in the course created a rich, mutually valuable learning environment for the regional and international faculty who endeavoured to discuss examples of work at the five participating African regulatory agencies. This assisted in contextualising international best practice of regulatory sciences with the local environment,” said Professor Colin Pillai, CEO of Pharmacometrics Africa. We remain inspired by their achievements and look forward to witnessing the impact they will make in their respective fields.

Training Opportunity: Clinical Investigator (+ Site Staff) Certification Course [24-28 April 2023]

31 March 2023

PharmaTrain and the European Clinical Research Infrastructures Network (ECRIN) have developed an international standardised Clinical Investigator Certification (CLIC) Course syllabus as training platform for investigators, site staff as well as regulatory and other scientists. This course, led by our colleagues at the Fundisa Academy African Academy of Medicines Development and the Tiervlei Trial Centre (TTC), provides training and important insights for clinical trial investigators and site staff wishing to attain certification. For more information, please download the informational brochure and apply today! Description: The planning, preparing, and organising of clinical trials has become a highly complex task that includes important issues such as: the need to protect patients, generate reliable data, perform trials efficiently within short timelines, fulfil quality requirements according to current legislation and inspection requirements, and conduct clinical trials within budget to ensure sustainable business. Since COVID-19 emerged in 2020, it has caused unprecedented disruption of clinical trials. To protect patient safety and trial integrity, the pharmaceutical industry made strides to accelerate trial innovations such as digital tools and virtualization, with support from regulatory authorities. The increased complexity of medicines development and regulatory requirements require well-trained staff in industry, CROs and Regulatory Agencies. The 2018 SAHPRA draft guidance on “Capacity Building and Transformation in Clinical Trials Research in South Africa” requires public or private clinical trial sites to offer training at all staff levels. PharmaTrain and the European Clinical Research Infrastructures Network (ECRIN) have developed an international standardised Clinical Investigator Certification (CLIC) Course syllabus as training platform for

Perspective Paper: What are current barriers to a true global pharmacometric community?

25 March 2023

Barriers to global pharmacometrics: educational challenges and opportunities across the globe Robin Michelet, along with several members of the global Pharmacometrics communiity, recently published a perspective paper based on a symposium held at the World Conference on Pharmacometrics (WCOP). This talk and panel discussion, titled “Training of the Next Generation of Pharmacometric Talent Around the World” explored the issues around good pharmacometrics education and provided an overview of different aspects that aid or hamper this goal. This paper focuses on the challenges and opportunities related to the movement of human capital (so-titled “Brain Drain”), the multidisciplinary nature of the field and the unbalanced spread of pharmacometrics across regions and regulatory agencies. You can read the article free of charge here. To learn more about how you can help support our efforts to strengthen the pharmacometric community in Africa, please visit our Get Involved page.

Travel Grants Available: Uppsala Pharmacometrics Summer School 2023

6 March 2023

Pharmacometrics Africa is pleased to offer travel grants for students from African universities to attend the 11th Uppsala Pharmacometrics Summer School in August. For more information and to apply, please refer to the application form linked below: Course informationThe Pharmacometrics Research Group at Uppsala University is happy to invite PhD students (and recent graduates) from all around the world to the 11th Uppsala Pharmacometrics Summer School (UPSS). Dates: August 14th-25th, 2023Place: Uppsala, Sweden

Sponsor Highlight: Journal of Pharmacokinetics and Pharmacodynamics

5 March 2023

Donating to Pharmacometrics Africa is an excellent way to support the development of clinical pharmacology and quantitative skills in Africa. With limited resources and infrastructure in many African countries, it can be challenging for researchers and healthcare professionals to access the latest tools and techniques in pharmacometrics. By supporting Pharmacometrics Africa, donors can help to bridge this gap by providing training, mentoring, and networking opportunities for African pharmacometricians. Thanks to the generous financial support of the Journal of Pharmacokinetics and Pharmacodynamics, we can continue to offer robust programs across the continent. Thank you! If you’d like to get involved in supporting our offerings through time, financial support or other resources, please get in touch with us directly.

Call for Papers: A themed issue on “Best practices in pharmacokinetic modelling, rational design and interpretation of clinical studies.”

28 February 2023

The British Journal of Clinical Pharmacology is calling for papers for a new series on; Best practices in pharmacokinetic modelling, rational design and interpretation of clinical studies, led by guest editors Catriona Waitt, Aida Kawuma and Francis Williams Ojara. The use of pharmacokinetic and pharmacokinetic/pharmacodynamic modelling and simulation techniques continues to grow rapidly with applications in various stages of drug development, drug regulatory approval and clinical use. Understanding what can be achieved with modelling is important to harness the full strengths of these novel techniques and broaden their use in improving patient care. We are seeking submissions that highlight the use of pharmacokinetic or pharmacokinetic/pharmacodynamic modelling techniques in the entire spectrum of drug development, regulation and clinical use; from early preclinical studies to late-stage studies including in post-marketing surveillance and therapeutic drug monitoring. We are especially interested in international perspectives and particularly welcome original research articles, as well as reviews, commentaries, and short reports. We hope this issue will be a springboard of ideas and an excellent resource that supports collaborative dialogue between pharmacokinetic/pharmacodynamic modelers, clinicians, and all relevant stakeholders. If you have any questions about this series, please get in touch with the BJCP Editorial Office: BJCPedoffice@wiley.com

Animation: Citizens Jury on use of data from electronic medical records [Video]

27 January 2023

To maximise impact and share knowledge from the Citizens Jury on the ethical use of data from electronic medical records in Uganda, a British Pharmacological Society Engagement grant enabled production of this 3-minute animation.

Uganda Chapter – Maternal and Infant Lactation pharmacoKinetics (MILK) study newsletter (July – September 2022)

30 September 2022

This newsletter from the Uganda chapter of Pharmacometrics Africa offers unique insights into the current status of the Maternal and Infant Lactation pharmacoKinetics (MILK) project. This edition includes updates from World Breastfeeding Week, conference presentations and study updates, together with a profiles of pharmacokinetic research nurse Christine Turyahabwe. Read more about the program below, or view the newsletter here. About MILKAbout half of all women worldwide require medication whilst breastfeeding. Historically, breastfeeding women have been excluded from drug research, largely with the intention of protecting the mothers and their infants from harm. However, lack of data to inform safe medication use in this population itself brings risk. In low-income settings drugs are frequently used ‘off-label’ through necessity and in high-income settings the ‘safest’ recommendation may be to avoid breastfeeding. MILK strengthens existing collaborations and my existing work on HIV antiretrovirals by studying treatments for several priority infections (tuberculosis, malaria and maternal infection around the time of delivery) in breastfeeding mother-infant pairs. Carefully designed clinical studies with mathematical (pharmacometric) approaches to data analysis will elucidate drug transfer from mother to breastfed infant. Work with patient groups and policymaking stakeholders maximises impact through data sharing and prioritisation of ongoing work.

Second Year of Fellowship Program in Africa for Applied Pharmacometrics Training

28 September 2022

Applied Pharmacometrics Training fellowship continues into the second year – Apply by 15 October 2022! Pharmacometrics Africa is pleased to announce the continuation of its Applied Pharmacometrics Training (APT) fellowship program for doctoral-level scientists from Africa, in partnership with Certara, Inc, CP+ Associates, and other industry and academic partners. After its successful first year with sixteen fellows, the program has opened the call for applications for its second cohort. The APT in Africa is comprised of a 3-month virtual program that provides fellows with training to conduct regulatory-quality pharmacometrics analyses and reports. Afterward, fellows can continue for another 3 months in an immersion program where they conduct a data analysis project leading to a publishable unit, under the supervision of subject matter experts. The second cohort will begin the virtual program of the fellowship in January 2023. “I am thrilled with the engagement and progress of the first cohort of scientists – this has exceeded our initial expectations. I encourage recent doctorate graduates who have completed core training in pharmacometrics and who want to apply quantitative approaches to benefit drug development and clinical practice in Africa to consider applying.” Colin Pillai, Ph.D., CEO of Pharmacometrics Africa and CEO of CP+ Associates The fellowship program is accepting applications now. To learn more or apply, please visit the application site. The application phase will close on 15 October 2022. “We are looking forward to welcoming the second cohort of fellows and are excited to continue advancing our goal of expanding scientific and leadership

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