Full Name and Surname, Country: Linda G. Mudyiwenyama, Zimbabwe
Organisation: Medicines Control Authority of Zimbabwe
Regulatory Science Fellow (2019 Cohort)
I am a holder of a Bachelor of Pharmacy (honors) and studying towards a Master in Regulatory Sciences. I also hold a Professional Diploma in Procurement and Supply Chain and an Executive certificate in Monitoring and Evaluation.
Currently, I am a Senior Regulatory Officer in the Evaluations and Registration Division at the Medicines Control Authority of Zimbabwe. My responsibilities include assessment of the quality, preclinical, clinical and labelling documentation of human medicines for the purposes of pre-marketing authorization. I am also involved in training and mentoring of junior officers as well as managing the Quality Management System of the Division.
In addition, I have actively participated in collaborative dossier assessment meetings with other Southern African National Medicines Regulatory Agencies (ZAZIBONA).
Area of research interest
My current area of research interest is global regulatory trends and practices in marketing approvals of advanced pharmaceutical products and therapies and efforts already made towards collaboration and harmonization with respect to issuance of marketing authorisations for these products.
The application of technology has widely spread to the pharmaceutical industry resulting in the development of technology-based pharmaceutical products. These products, because of their complexity and requirements for extensive and deep scientific knowledge have posed new challenges to regulation of pharmaceuticals and I believe it is worth exploring into the current trends and practices in regulation of these products.
What do you hope to gain from the fellowship?
By being a fellow, I believe I will be exposed to invaluable professional networks and new friendships that will even continue beyond the fellowship duration. I also believe that I will grow my leadership skills and these will be important and helpful as I move towards the next step in my career path.
The international exposure and hands-on research experience that I will get will nurture my competencies and make me aware of international practices.
My organisation will benefit from an officer with sharpened professional skills and findings from my work will assist the region and perhaps the continent in developing regulatory systems for advanced pharmaceutical products.
Last Updated: 24 May 2019