Mahlodi Moropa

• Contributed to development of strategy, performance plan, annual performance plan and operation plans for the Unit and SAHPRA.
• Lead the planning of clinical preregistration unit's regulatory activities. Provided clear directions and priorities to teams.
• Streamlined workflows by identifying bottlenecks in existing systems and implementing appropriate solutions. Constantly reviewed internal processes to improvement opportunities to mitigate against the risk of developing backlogs.
• Timely reporting to SAHPRA Senior Management and Executive in terms of the clinical preregistration unit's bi-monthly, quarterly, annually and when required on performance/achievement including monitoring of the timelines.
• Analyses evaluation reports from subordinate staff and assumes accountability for work delegated to others (peers, team members, experts, etc.). Monitor staff accountability for agreed upon performance.
• Application of scientific principles, regulatory requirements, best practices and quality assurance to team leader reviews for clinical applications. Perform team leader review and/or adjudicate peer-reviewed reports and provide technical decision regarding applications.
• Execute and take accountability on regulatory decision regarding applications (on clinical aspect in terms of safety and efficacy) and signs approval or non-approval letters pertaining to respective applications.
• Applies knowledge of SAHPRA policies and procedures to identify and resolve complex issues and inconsistencies and make recommendations on initiatives, ensuring cohesive implementation of changes.
• Technical lead in the appeal processes for applicant that appeals the decisions of the organization.
• Identifies gaps in information and makes reasonable assumptions to continue analysis and or act. Identifies key issues and critically evaluates scientific information with minimal support.
• Monitor and review evaluation reports of various regulatory authorities where co-operative arrangements have been established.
• Establishes a priority review system to ensure that the clinical preregistration evaluation unit attain the prescribed timelines.
• Regularly analyzed the clinical preregistration tracker for performance tracking and guide the evaluator coordinator on management of applications.
• Developed and implemented strategies to manage priority application to ensure that the unit responds to public health emergencies and responds to security of supply of Medicines.
• Collaborated with cross-functional teams within SAHPRA (Health Product Authorization, Pharmaceutical Preregistration unit, names and scheduling unit, Inspectorate, Pharmacovigilance) in ensuring that registered is in accordance regulatory guidelines.
• Preparing reports to be submitted to relevant technical committee for their information, discussion, review and/or recommendation to the relevant advisory committee in accordance with prescribed legal requirements and standard operating procedures of SAHPRA.
• Managed and motivated employees to be productive and engaged in work.
• Accomplished multiple tasks within established timeframes.
• Enhanced customer satisfaction by resolving disputes promptly, maintaining open lines of communication, and ensuring high-quality service delivery.
• Attended and lead clinical preregistration matter in management meetings, policy meetings, registration committee meetings and any other relevant SAHPRA meetings.
• Developed or managed the development or implementation and maintenance of regulations, guidelines, policies, and procedures pertaining to regulation of orthodox medicines to ensure alignment with international and national protocols, legislations, and other legal requirements.
• Manage and monitors financial risks at Clinical Preregistration Unit. Continuously looks for new opportunities to obtain and save funds.
• Assesses, manages, and monitors financial risks that could deter revenue generation within the unit. Continuously looks for new opportunities to increase revenue generation within the unit.
• Lead the QMS audit, internal audit and any other regulatory audits (e.g. SABS, WHO GBT, etc) for the clinical preregistration unit.

• Managed and motivated employees to be productive and engaged in work.
• Accomplished multiple tasks within established timeframes.
• Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground.
• Maximized performance by monitoring daily activities and mentoring team members.
• Trained newly appointed staff members
• Streamlined workflows by identifying bottlenecks in existing systems and implementing appropriate solutions.
• Created or modified and coordinated operational structures (e.g. processes, systems, structures, roles, metrics) to support strategic objectives and for driving sustainable results.
• Application of scientific principles, regulatory requirements, best practices and quality assurance to team leader reviews for clinical applications.
• Perform team leader review and/or adjudicate peer-reviewed reports and provide technical decision regarding applications.
• Execute and take accountability on regulatory decision regarding applications (on clinical aspect in terms of safety and efficacy) and signs approval or non-approval letters pertaining to respective applications.
• Review and approve professional information and patient information leaflet and ensuring that they represent the clinical data submitted, reviewed, and ensuring compliance with regulatory requirements.
• Provide technical advice, regulatory guidance, and support to all stakeholders, to ensure that regulatory requirements are adhered to.
• Analyses and timeously respond to queries/complaints from the Manager, Senior Manager, other Programmes, the Legal Unit and the Chief Regulatory Officer's Office and external stakeholders.

• Responsible for the accurate and timeous assessment of new applications and responses received in terms of their quality, safety and efficacy as per the defined processes.
• Prepared comprehensive reports for various purposes (e.g., regulatory submissions, advisory committees, internal communication).
• Streamlined registration processes by implementing efficient digital systems and reducing paperwork.
• Improved customer satisfaction with timely and accurate registration services, addressing inquiries professionally.
• Prepared technical documents/reports for Advisory Clinical Committee (ACC) and Registration Committee meetings.
• Attended ACC and Registration Committee meetings.
• Execution of the ACC recommendations and Registration Committee resolutions to the applicants.
• Provide technical advice and information to all stakeholders.
• Attend to queries from the Senior Manager, other Programs, committee members, the legal unit and the Chief Regulatory Officer.
• Performed technical screening and allocated clinical submissions to evaluators and clinical committee members according to their areas of expertise.
• Train new technical staff on evaluation of clinical applications, PI, PIL, and all the other activities in the unit.
• Managing the admin staff and all their activities in the unit to ensure the smooth running of the unit.
• Review processes in the unit.
• Deputized whenever the unit manager is not available.

Deputy Chairperson of Clinical Peer-review subcommittee:

December 2015 until March 2019

• Peer review both preregistration and post-registration documents for the Peer-review Committee meetings.
• Support the Chairperson regarding the Peer-review Committee meetings.
• Manage the Peer-review Committee meetings when the Chairperson is not available.
• Draft and amend policy guidelines as required by the Clinical Committee.
• Schedule Policy meetings.
• Present the Peer-review Committee minutes at the Clinical Committee meetings for ratification.

• Preparing comprehensive reports for various purposes (e.g., regulatory submissions, advisory committees, internal communication)
• Managed high volume of prescriptions daily while maintaining excellent customer service and attention to detail.
• Developed strong relationships with healthcare providers to optimize patient care and medication adherence.
• Educated patients about possible drug interactions and gave special administration instructions.
• Collaborated with pharmacy team members to develop and implement strategies for continuous improvement in quality of care.
• Monitored & Dispensed Chronic Prescriptions to Clinics.
• Control & Issue medication to Wards and monthly statistics
• Assisted with receiving Pharmaceutical and Surgical Stocks from Polokwane Depot
• Stock control in the Pharmacy store using PDSX system.
• Supervise Repacking and Compounding of Pharmaceuticals and monthly statistics.
• Prepared chronic medication and deliver them at the Clinic in Bela Bela
• Stock control in the Clinics around Bela Bela
• Implemented medication therapy management programs, resulting in improved patient adherence to prescribed medications.
• Enhanced patient understanding of medication usage and potential side effects with clear, empathetic communication.
• Managed drug and supply inventories.
• Performed technical processes required to dispense medications to patients.
• Provided consultations and answered inquiries from patients, healthcare professionals and physicians regarding drugs, potential side effects, and specified use.

• Contributed to a positive work environment through effective teamwork and collaboration with pharmacy staff members.
• Utilized strong communication skills to educate patients on proper medication usage, potential side effects, and drug interactions.
• Good pharmacy practice
• Evaluating prescription and dispensing prescription to out patients & in patients
• Control, Monitor & Dispensing Chronic Prescriptions to Clinics.
• Control & Issue medication to Wards.
• Receive weekly Pharmaceutical Stocks
• Stock control in the Pharmacy store
• Supervise Repacking and Compounding of Pharmaceuticals.
• Attended the Masakhane Clinics (HIV/AIDS)
• Educated patients on possible drug interactions, potential side effects, and optimal methods of administration.
• Prepared packaging and labels for prescriptions, verifying accuracy of dosage, side effects, interactions, and refill instructions.
• Reduced medication errors by diligently verifying prescriptions for accuracy before dispensing to patients.
• Developed strong relationships with healthcare providers to facilitate timely prescription refills when needed.
• Assisted other pharmacy staff with drug inventory, purchasing and receiving.