Stakeholder Engagement

03 to o7 July 2022

ZAMBIA BENCHMARKING EXERCISE

Delegation from Botswana

·       Dr Parthasarathi Gurumurthy- Director Pharmacovigilance and Clinical Trials, BoMRA and BoCTRe Coordinator

·       Ms. Dorcas Mgadla – BoCTRe Deputy Coordinator

·       Ms. Tebogo Mokotedi – Clinical Trials and Research Manager, BoMRA

·       Dr Gontse Tshisimogo – Health Research & Development Committee Member

·       Ms. Matshediso Matome – Pharmacovigilance and Clinical Trials Acting Chairperson.

·       Ms. Vaida Munthali - Project officer BoCTRe, BoMRA

·       Mr. Oduetse Moaletsane- Project Associate, BoCTRe, BoMRA

·       Ms Tebogo Kelapile - Senior Research Officer II, Ministry of Health

SCHEDULE OF EVENTS

PURPOSE AND OBJECTIVES

• Purpose:

Learning activities related to

1. Regulation of clinical Trials –Processes and procedures
2. Ethical regulation of Clinical Trial research.

• Objectives:

1. To learn and acknowledge the Regulation Process experienced in Clinical Trials research in Zambia
2. To develop a comprehensive action plan to implement recommendations made in both the baseline assessment and benchmarking visit

LEARNT EXPERIENCES

·        Strong legal framework for the effective functioning of the organisation

·        Strong political will and budgetary commitments

·        Strong monitoring and evaluation

·        Finance and business development office

·        Resource mobilization and effective utilization of funds (Novelty

·        Registration and Accreditation of researchers

·        The hierarchy of the approval of protocols (Down upward approval of protocol) Linking objectives of NRHA to the strategies of MOH

·        Media partnership (health research journalism) for Dissemination

·        Translation of research knowledge into policy

·        Clearly defined mandate of NRHA 

·        Availability of online platform

·        Dissemination of research finding through various platforms

 13 to 17 June 2022

TANZANIA BENCHMARKING EXERCISE VISIT

Delegation from Botswana

1. Professor Parthasarathi Gurumurthy: Director, Pharmacovigilance & Clinical Trials and BoCTRe Project Coordinator

2. Ms Dorcas Mgadla: Principal Research Officer II & BoCTRe Deputy Project Coordinator

3. Ms Siphiwe Pako-Koboto: BoCTRe Project Officer

4. Ms Tebogo Mokotedi: Manager Clinical Trials and Research

5. Ms Mosetsana Modise: Research Officer II

6. Dr Gontse Tshisimogo: HRDC Member & Head of Non-Communicable Diseases Program

7. Ms Matshidiso Matome: Acting chairperson, Pharmacovigilance Advisory Committee (PVAC) & University of Botswana Lecturer

SCHEDULE OF EVENTS

PURPOSE AND OBJECTIVES

Purpose:

Learning activities related to

1. Regulation of clinical Trials –Processes and procedures
2. Ethical regulation of Clinical Trial research.

Objectives:

1. To learn and acknowledge the Regulation Process experienced in Clinical Trials research in Tanzania.
2. To develop a comprehensive action plan to implement recommendations made in both the baseline assessment and benchmarking visit

LEARNT EXPERIENCES

·       Legal Framework makes regulation effective.

·       Approval Certificates/Permits

·       Online Submission and review process through REIMS makes the review process efficient.

·       Commitment letters from the study sites of interest to avoid issuing an approval then the study doesn’t take place in that site. It should be part of the submission package.

·       IRBs have been delegated to give ethical clearance in their area. Though they don’t have oversight of the study

·       Trainings are done through projects hence there is an ongoing capacity building for the officers.

·       Plagiarism certificate is part of submission at the University IRB to sure authenticity of their work.

·       There is a linkage between Medicines Regulatory Authority and National Ethics Committee.

·       There is monitoring or visitations to the study sites, implementers, participants involved in the study and IRBs centers.

·       Availability of a database for research studies that have been translated to policy and practice

·       Standardized and regular dissemination of research results/findings

·       Permission to publish; Payment of protocol submission including for students; Submission of capacity building plan for all protocols with foreign investigators; Community Advisory Board

Pharmacovigilance and Clinical Trials department hosts delegates from Zambia and Tanzania

In a clinical trials, participants receive specific interventions according to the research plan or protocol created by the investigators. These actions may be medical products, such as drugs or devices, procedures or changes to patients behavior, such as diet. Clinical trials may compare a new medical approach to an ordinary one that is already available, to an effective substance that contains no active ingredients, or to no intervention.

Clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available. The Pharmacovigilance practitioners try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants as is the mandate carried out by Botswana Medicines Regulatory Authority (BoMRA).

When giving an update about clinical trials in Botswana, Director Pharmacovigilance and Clinical Trials at BoMRA, Dr Parthasarathi Gurumurthy indicated that through the Botswana Clinical Trial Regulation (BoCTRe) project, the NEC and NRA (BoMRA) intends to build capacity by focusing on internationally defined regulatory strengthening initiatives. The objective of this initiative is to build capacity of the NEC (Health Research and Development Committee), affiliated Institutional Review Boards (hospital based IRBs and University of Botswana), and NRA (BoMRA) to establish strong regulatory procedures. This is an essential foundation for conducting quality clinical trials in Botswana, he indicated. He also pointed out that  the Pharmacovigilance and Clinical trials Department (PV&CT) mandate is to ensure that a fully functional regulatory system is established by year 2023. In doing so BoMRA has gone into a partnership with the Ministry of Health and Wellness to spear head the BoCTRE project.

For his part, Dr Victor Chalwe of NHRA Zambia gave a brief overview about the Zambian National Health Research Ethics, he articulated the policies, statuses and guidelines related to clinical trials. He highlighted on special protocols reviewed by NHREB amongst their submissions - clinical trials involving medicines, vaccines or other biological products, new therapeutic regimes, as well as invasive diagnostic procedures.

When briefing delegates, Ms. Kissa Mbwana TMDA, Tanzania, explained the roles of Tanzanian Medicines Devices Authority which includes approving the conduct of clinical trials, inspections of trial sites, evaluating amendments, and evaluating serious adverse reactions and maintaining a registry of all clinical trials in the country. She also gave an overview of Clinical Trial process and oversight tools, good clinical practice compliance monitoring and inspection types. In conclusion, Mbwana would go on to highlight a key milestone which they are proud of, that is reaching the  World Health Organization maturity level 3 where their technical departments are a fully functional.

Closing the proceedings, Dr Sinah Selelo, Chief Regulatory Officer at BoMRA highlighted the need for collaborations across African Authorities. Dr. Selelo would gone on to acknowledged the presence of the technical team and also looking forward to learning a lot from them as they will be conducting more baseline assessment and seeking collaboration efforts.