Kevin Wangokho

• Provided support in implementing policies, rules, and regulations on clinical trial strategies of medical products and health technologies for control in human subjects.
• Implemented clinical trial guidelines, standards, infrastructure, tools, and procedures.
• Provided support in conducting the activities of the Expert Committee of Clinical Trials (ECCT).
• Participated in the maintenance of clinical trials database taking place in Kenya.
• Conducted screening of applications to conduct clinical trials or bio-equivalence studies in Kenya.
• Provided support in preparation of emerging trends in the control of clinical trials.
• Provided support in the implementation Quality Management System within the division.
• Providing support in the implementation of divisional strategic plan, work plan and budgets.
• Providing support in internal controls within the division.
• Providing support in the aggregation of comments from Expert Committee of clinical trials members and secretariat comments for submission to the Principal Investigator of the study to be addressed before approval.
• Providing support in screening of annual renewal request applications.
• Providing support in preparation of list of safety reports for evaluation.
• Preparing a list of protocol deviations/violations per study site for risk assessment.
• Participating in review of minor protocol amendments.
• Achieving targets set by the principal regulatory officer clinical trials.
• Providing support in preparation of annual work plans, budget, quarter and annual reports for the division.

• Trained and sensitized about 200 healthcare professionals on pharmacovigilance and safety reporting.
• Received, recorded, and reported about 400 Individual Case Safety Reports (ICSRs), Periodic Safety Update Reports / Periodic Benefit Risk Evaluation Reports (PSURs/PBRERs), and any other safety reports from healthcare professionals and the public
• Reviewed safety reports received at the Pharmacovigilance Center for completeness, giving feedback and performing safety data cleaning, verification, and uploading of data to the Vigiflow.
• Assisted Technical Officers in the unit to conduct investigations regarding the safety of drugs, including follow-ups, review of ICSRs, and collecting samples of medications or other materials involved in the investigation.
• Participated and supported the conduct of active and passive Pharmacovigilance studies that monitor the safety of HPTs such as the CEM-Covid-19 Vaccines Study
• Compiled and prepared minutes, reports and other documents related to safety reports as directed by Senior Regulatory Officers within the unit.

• Reviewed prescriptions and rationally dispensed medicines to patients ensuring the promotion of proper patient care
• Counselled patients on medicines and medicines use.
• Managed the supply chain and inventory of drugs within the pharmacy to ensure no stock-outs.
• Maintained proper documentation within the pharmacy.

The Centers for Disease Control and Prevention(CDC)-Atlanta Georgia in collaboration with the University of Nairobi and the Ministry of Health conducted a Monitor and Prevention Antimicrobial Resistance (MAP-AMR) project at the Kenyatta National Hospital (KNH). The aim was to detect and control Candida auris (an antifungal species) in the specialized units of the hospital such as the ICU, HDU, Renal Unit, Newborn Unit, Paediatric Specialised Unit, and Burns Unit. My duties included:

• Consented to patients to inform them of the study and their willingness to be involved in the study
• Carried out participants' or guardians' interviews on their past hospitalization history
• Extracted medical information from the participant's medical record files
• Coordinated sample removals from participants
• Fed the information from the interviews, medical records, and samples into the online application tool.

• The Pharmacy and Poisons Board (PPB) with the support from World Health Organization (WHO) and the Ministry of Health-Kenya, carried out a study on the Level of Antimicrobial Consumption (AMC) in Kenya from 2016 to 2021. The main aim was to establish the country's annual antimicrobial consumption (2016-2021) from the data collected from the import permits and the local manufacturers. My duties included;
• Preparation of the project Standard Operating Procedures(SOPs)
• Screening for antimicrobials from the import permits to get the data needed
• Data cleaning to ensure conformity to the drug master file register
• Data analysis using the WHO AMC GLASS methodology tool and Pivotal Tables
• Interpretation and discussion of the findings for the Final Report Writing

As a pharmacist intern, I rotated through hospital pharmacy, primary care pharmacy, community pharmacy, and industry pharmacy. Working under my supervisors, my duties included;

• Interpreting, processing, dispensing, and documenting prescription orders in the pharmacy.
• Offering proper counselling to the patients about medicines and medicine use.
• Extemporaneous preparations of creams, ointments, and specific paediatric formulations.
• Receiving order and issuance of medicines to various pharmacy departments using the S11 issue vouchers.
• Balancing the bin cards stocks after issuance of medicines to various departments.
• Monitoring the temperature and humidity of the bulk store to ensure the values are within acceptable ranges, especially for the refrigerated products.
• Participating in quality control (QC)tests of various substances according to cGMP.
• Participating in manufacturing both solid and liquid dosage forms according to cGMP.

During my undergraduate attachment, I rotated through hospital pharmacy, community pharmacy, and industry. During this period, I appreciated various aspects including;

• Rational prescription and dispensing process.
• The importance of patient counselling and patient education.
• Good Manufacturing Practices.
• Quality Control/ Quality Assurance practices.
• Inventory management.