PROTECTING YOUR RIGHT TO MEDICINES AND MEDICAL DEVICES
Thursday, 28 October 2021

  Chile Phiri Lungu, Zambia


  Organization: Zambia Medicines Regulatory Authority (ZAMRA).

   Regulatory Science Fellow (2020 Cohort)

 

Bio

I am a Pharmacist currently working at ZAMRA under the medicines Control Department as a Registration officer for Human Medicines. I have been working for ZAMRA since August 2017. My main duties include assessment of dossiers, assessment of additional information to dossiers, evaluation of amendments to dossiers as well as communicating with applicants based on findings in the dossier submissions. I also participate in preparing product assessment summaries and pre Medicine Committee Meetings. I previously worked as a District Pharmacist in the Northwestern part of Zambia where I was in charge of all the rural health facilities in the district. My job at district level involved Drug Supply and Management logistics.

Area of research interest

Registration requirements for complementary medicines in the Southern African Development Community (SADC) region

What do you hope to gain from the fellowship?

To acquire more knowledge and skill on how to critically evaluate a CTD dossier regardless of dosage formulation, hence contributing to the professional integrity of the organization, region and continent.
To gain more knowledge in assessment of bioequivalence component of dossier assessment.
The fellowship program will promote uniformity in dossier assessment across the region.
To be able to network with other fellows in the region with regards to new or latest assessment guidelines.
Actively contribute to projects both locally and in the region and to serve as a coordinator for new staff through skills transfer.
As an individual it will provide confidence be able to improve on communication skills with both the organization and applicants.
To become one of the best pharmaceutical regulators in both the organization, the region and the continent at large.

Regulatory mentor: Dr Burt Kroes, Medicines Evaluation Board, The Netherlands

Academic Mentor: Dr Tsitsi Monera – Penduka, University of Zimbabwe