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Laboratory

The unit is responsible for the analysis of medicines and related substances as well as medical devices placed on the market to determine their fitness for purpose and verify manufacturer claims on their quality, efficacy and safety. Timely testing and reporting of results as well as results validity are important outputs for a successful laboratory operation.

The laboratory will achieve this through implementation of a laboratory quality management system based on the principles of ISO 17025 and the WHO accreditation guidelines. Headed by a laboratory manager supervising fifteen (15) analysts across three sections of microbiology, physiochemistry and medical devices analysis the laboratory will inform key decisions on products marketing.

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Market Authorisation

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Pharmacovigilance

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems, generates knowledge to facilitate the rational use of medicines.

When a medicine is first marketed, there is limited information on adverse drug reactions (ADRs), especially in pediatrics, where medicines are less likely to have been extensively studied. Knowledge in drug safety is built up over time when more (in number, and more heterogeneous) patients are treated than were studied in the randomized controlled trials preceding the marketing of a medicine.

A well-organized system of pharmacovigilance is essential to ensure the safety of medicinal products. Before recommending the granting of a marketing authorization the BOMRA ensures that a system of pharmacovigilance is in place through scrutiny of the pharmacovigilance system, After granting an authorizations the Authority scrutinizes procedures, assesses safety reports and conducts pharmacovigilance inspections in order to:

  •  Regulate and provide drug information to the public and to coordinate and implement pharmacovigilance
  •  Receive, capture, analyses and recommend action on suspected adverse drug reactions reports
  •  Carry out post market surveillance on drugs
  •  Approve advertising and clinical trials of new, current and variant medicines and related medical products
  •  Train, mentor and help mentor health workers on Pharmacovigilance
  •  Develop thorough knowledge of medicines and flag up early warning signs of adverse effects of medicines
  •  Carry out and complete safety audits

Pharmaceutical companies and practitioners have specific obligations with regards to pharmacovigilance. BoMRA ensures patient safety by communicating with healthcare professionals and by monitoring the activity of Marketing Authorization in order to assess whether they are compliant with pharmacovigilance obligations.

Benefits and Risks of Medicines

Most people take medicines without suffering any unwanted side effects; however, all medicines can cause problems. For a medicine to be considered safe, its expected benefits should be greater than the risk of harmful reactions (side effects).

This is known as a positive Benefit-Risk balance. Information on the risks and safety of medicines often becomes known after the product is placed on the market (for more information visit our offices of contact BoMRA PV team on how we monitor the safety of medicines and therefore the Benefit-Risk balance may change throughout a product marketed life.

Risk Management Plan

Our PV has got a a Risk Management Plan in place, this is designed to identify, characterize, prevent, or minimize risks related to the medicinal products; to assess the effectiveness of those interventions; and to communicate those risks to health care professionals and patients.
Routine pharmacovigilance include includes the safety evaluations within clinical trials and the monitoring and reporting of spontaneous adverse events post-authorization. Routine risk management activities include ensuring that suitable warnings are in all product information and careful labelling/ packaging of the medicine.

Additional pharmacovigilance activities involve:

  • Active surveillance
  • Epidemiology studies
  • Further clinical studies
  • Drug utilization studies

Additional risk minimization measures Additional Risk Minimization Measures could include: educational materials about the medications and its indications (patient information brochures, visual aids, doctors' prescribing guides/checklists, pharmacist dispensing guides/checklists, direct healthcare professional communication letters), training programs (for patients, pharmacists or doctors) and restricting the use of the medicine for example by restricting access to prescription only.

Feedback: We kindly invite your anonymous feedback on your experience with BoMRA webpage. Feedback may be given through our online form.

ADR Reporting

A side effect means a response to a medicine in humans or animals, which is unwanted and unintended. It includes lack of efficacy and can occur at any dosage and can also result from overdose, misuse or abuse of a medicine.

Important Reporting Information

If possible, you should provide the following information when making your report:

  • Information on the person who has had the side effect (such as age and sex)
  • The description of the side effect
  • The dose and the name of the medicine suspected to have caused the side effect (brand
    name as well as active ingredient)
  • The batch number of the medicine (found on the packaging)
  • Any other medicines being taken around the same time (including non-prescription medicines, herbal remedies and contraceptives)
  • Any other health conditions that the person who experienced the side effect may have
What should be reported?
  • All side effects should be reported. Report any side effect of ANY medicines and/or vaccines, whether prescribed by a doctor or bought without a prescription
  • You can also report problems with; suspected pharmaceutical defect, lack of efficacy, counterfeits/fake medicines, medication errors etc
  • Report all suspected ADRs associated with drug-drug, drug-food or drug-food supplements (including herbal and complementary products) interactions
  • Report when there is a lack of efficacy or when suspected pharmaceutical defects are observed
How to Report Side Effects
  • Contact your healthcare provider e.g. doctor, nurse, pharmacist, vet etc
  • Your healthcare provider will fill out the ADR form and send it to BoMRA on your behalf
Contacts Details

Email: reportadr@bomra.co.bw
Tel: +267 373 1753 Fax: +267 318 6254
Toll Free: 0800 600 216

Postal Address

Botswana Medicines Regulatory Authority
Private Bag 2
Gaborone Station
Botswana

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FAQ
Does your scope of regulation include complementary medicines sold in the streets as herbal teas etc?

A.

Are people allowed to come to your office for consultation?

A.

Where can I find guidelines for nutraceutical products registration?

A.

Are receiving new dossiers yet?

A.

When are your revised fees have coming into effect?

A.

Has BoMRA started accepting new product applications for registration?

A

if I have license to run a general dealer, is it an offence to sell medical equipment like stethoscope, stethoscope, thermometers, disposable gloves, disposal face mask?

A

Kindly assist with the information necessary for one to register drugs with a company (manufacturer)which is not in Botswana and the requirements

A.

Does BoMRA have an official website?

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Where, how much does it cost to acquire a licence for a supplier of medicinal products and the requirements for one to obtain such licence

A.

Does BoMRA regulate operations of private laboratories (bio medical in particular) and if so what are the requirements...?

A.

I'm interested in formulating a skin care range ,how do I get a copy of the relevant standards on cosmetics?

A.

Are there employment opportunities?

A.

How do we as consumers download lists of registered medicines, supplements, etc and lists of those which are unregistered and not to be sold or advertised.

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Far too many people complain that effective medication available in neighbouring countries are not available in Botswana.. Don’t you think as BoMRA that this contributes to the spate of unregistered medication. If there are patients in need and ther

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Please provide links to products /brands which can and cannot be advertised, sold, marketed or distributed in Bo..

A.

Mandate

The Legal and Enforcement Unit, under the direction of the Legal and Corporate Counsel, is responsible for providing BoMRA with legal services and undertaking the enforcement of the MRSA and related legislation. The Unit further provides Board secretarial services to the Medicines Regulatory Board.

Legal

During the financial year 2018/19, the decision was taken to review and amend the MRSA and to draft subsidiary legislation, including the Medicines and Related Substances Regulations. The process to amend the MRSA was necessitated by the need to ensure that the provisions of the MRSA, which was promulgated in 2013, are aligned to current practices in the industry, meet the international medicines regulatory standards and adequately address the Authority’s mandate to regulate veterinary medicines.

Enforcement

The Legal and Enforcement Unit is responsible for ensuring compliance with the MRSA. In this regard, the Unit is mandated to investigate and enforce provisions of the MRSA. The Unit works in collaboration with other Law Enforcement Agencies in discharging its mandate including the Botswana Police Service and Botswana Unified Revenue Services.

Way Forward

The key strategic initiatives for the Legal and Enforcement Unit as outlined in the 2019 - 2024 Strategic plan are as follows:

  • Ensure Compliance to Legislation
  • Improve Corporate Governance with Effective Practices

The initiatives are aimed at ensuring that the appropriate resources and structures are in place and optimised to ensure adherence to the MRSA, in line with the Authority’s mandate. In addition, the Authority intends to put in place structures to ensure that the Board and the Authority maintain good corporate governance practices.

BoMRA Mascot Competition

Imports & Exports Habit Forming Drugs

In line with the International Narcotics Control Board (INCB) guidelines, BoMRA continues to facilitate the import/ export controls for habit-forming drugs (HFD’s) through issuance of Import and Export permits for narcotics and psychotropic drugs.

INCB is the United Nations office responsible for the control of narcotics and psychotropics medicines in international trade, that involves the movement of the products across borders and their use and consumptions in countries. Permits are issued against the INCB allocated quotas and a database on the consumption of these controlled medicines is kept and closely monitored to ensure that quotas are not exceeded.

The Authority is working on a new system of issuance of import permits which will be piloted on veterinary medicines imports and later rolled-out to human medicines by. It is anticipated that this system will improve the tracking and tracing of medicines as they are imported into the country and provide further information as to the quantities imported at any given time.

The system will initially be manual and when fully developed it will provide the necessary foundation upon which to build an electronic system as the Authority strives to improve efficiencies and enhance customer service. Through collaboration with Port Health in Ministry of Health & Wellness and the Botswana Unified Revenue Services the Authority has established presence at Port of entries to facilitate verification of incoming and outgoing consignments. It is anticipated that these relationships will be formalized and strengthened through MOU in the next financial year.

Interceptions and detention of noncompliant medicines at Sir Seretse Khama Airport and other border entry points have been reported and subsequently investigated and resolved. Such issues mainly relate to medicines imported without prescriptions and mis- labelled product packaging to name a few.

Way forward

Inspections and premises licensing are identified among core functions for the attainment of WHO maturity level three,
consequently, through the 2019-2024 corporate strategy, BoMRA is committed to strengthening inspections, licensing and import/export controls through the following strategic initiatives:

  •  Establishment and implementation of inspection and licensing processes, standards and structures
  •  Development and implementation of an inspection frameworks and associated programmes

These initiatives will be progressed during the strategic period to among other priorities ensure capacity building in medicine manufacturing site inspections which is critical to facilitate product registration.

Dr Stephen Ghanie
Dr Stephen Ghanie

Chief Executive Officer

Lydia Maleho PA to CEO
Lydia Moleho

PA to CEO

Dr Sinah Selelo

Chief Technical Advisor

Dr Parthasarathi Gurumurthy Director Post Marketing Surveillance and Clinical Trials
Dr Parthasarathi Gurumurthy

Director, Post Marketing Surveillance and Clinical Trials

Dr Seima Dijeng

Director, Inspections and Licensing

Harold Kuvenga Director Finance Admin
Harold Kuvenga

Director, Finance & Admin

Israel Kgosidiile Public Relations Manager
Israel Kgosidiile

Public Relations Manager

Zukiswa Raditladi

Quality Manager

 

Botswana Medicines Regulatory Authority (BoMRA) carries out inspections of premises to assess compliance with Good Manufacturing practices (GMP), Good Distribution Practices (GDP), Good pharmacy practices (GPP) along the medicines supply chain in line with requirements of the MRSA. The Department of Inspection and Licensing (DIL), in the first year of BoMRA’s operations began by developing procedures and guidelines to provide for a focused approach to inspections. Parallel to the mapping of processes and development of documentation, the BoMRA Inspectors continue to conduct countrywide inspections and subsequent licensing of new premises for both human and veterinary facilities. The inspections are carried out according to a planned annual schedule with the aim of inspecting every facility at least once annually.

HR Committee 3
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= Dr Gontle Moleelei
= Dr Modisa

Finance Audit and Risk committee 3
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Procurement tender committee 4
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Technical Committees

Registration committee (9)
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Pharmacovigilance committee (10)
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Licensing committee

Mamagement Team

Executive management
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Directors and managers, names and portfolios

Product Evaluation and Registration

Mandate

Product Evaluation & Registration department is responsible for protecting and promoting human and veterinary public health by ensuring that medicines (human, veterinary and complementary medicines) and other healthcare products registered/approved for use in Botswana are safe and effective for their intended use and that they meet established quality standards.

Registration Procedure

In order to register your product, you will be required to submit a full product dossier for evaluation to determine whether the medicine is safe, of good quality and efficacious. The dossier is first submitted for screening together with the applicable fee. Our assessors will screen the dossier to determine whether all the appropriate sections of the dossier have been submitted. This is not full assessment but checking for completeness of the submission. If there is outstanding information, communication will be sent and an updated dossier will be requested. After passing screening, applicants will be advised to pay application fees, submit samples of the product and an application form signed by the applicant. Please refer to our Service Standards for the timelines. After evaluation, you will receive a letter communicating any outstanding issues with a deadline to respond. Once all queries are addressed, the application is presented before the Registration Committee who will make a regulatory decision based on the provided quality, safety and efficacy data.

 

Zazibona collaborative process

BOMRA invites applicants to submit Expressions of Interest (EOIs) for evaluation of applications through the Zazibona collaborative process.

The Zazibona process is a collaboration between national medicines regulatory authorities (NMRAs) in Zambia, Zimbabwe, Botswana, Namibia, South Africa, Tanzania, Malawi, DRC, Mozambique and Malawi (active countries) as well as Eswatini, Angola, Seychelles and Madagascar (non-active).

The vision of the Zazibona process is:

  • A region in which good-quality medicines are available to all those who need them;
  • To significantly reduce time taken to grant marketing authorisation in the individual countries; and
  • Efficient utilisation of resources within regional national regulatory through work sharing.

The process’ objective is to promote a collaboration model to facilitate access to good-quality medicines through work-sharing in assessment of medicines and inspection of medicine manufacturing and testing facilities. Products that meet assessment criteria are then granted marketing authorisation in the participating countries, in which applications for registration would have been submitted. As and when agreed by the respective countries, variations to the products which have been registered under this collaboration may be handled through the same process.

The Zazibona collaboration does not represent the replacement of the need to submit applications for registration in participating countries in line with national requirements. However, as described in this document, in order to facilitate cooperation among Zazibona authorities, certain modifications are expected. Although there is close collaboration on assessments and inspections, final national registration decisions are the responsibility of individual participating authorities.

It is envisaged that manufacturers of needed medicines will benefit from accelerated registration processes, a single set of questions during the registration process and in principle harmonized registration decisions, which will facilitate easier review of any post-registration variations. Applications may be submitted by any person that qualifies to be an applicant in each participating country as per national requirements.

 

Scope of products

Any medicine meeting the criteria of being an essential medicine is invited for submission to be considered for registration via the Zazibona collaborative process. Special consideration may be given to medicines that are vital to effective treatment and to expanding treatment programmes, where there are currently limited options for health practitioners in the participating countries. This includes medicines identified for special regional programmes and initiatives.
Focus will however be on the 10 priority disease conditions identified by SADC reproductive health products.

Top conditions/diseases in SADC with an overall regional priority ranking

HIV/AIDS

1

Tuberculosis

2

Malaria

3

Acute respiratory infections

4

Diarrhoea

5

Diabetes

6

Pneumonia

7

Cardiovascular

8

Cancer

9

Obstetrics

10

Gastroenteritis & colic

10

Any other medicines that are important from a public health perspective may be considered on a case-by-case basis.

Other eligibility criteria

Medicines that are already registered in any participating country or other products jointly accepted by participating authorities are eligible for the collaborative process, provided there is an agreement between the participating countries.

Innovator products which have not been registered by SRAs may be accepted for the procedure.

To be eligible for the Zazibona collaborative process an application should have been lodged with at least to two (2) Zazibona participating countries.

Applications not eligibles

The invited generic products exclude those which have been prequalified by the World Health Organization (WHO) and/or registered by Stringent Regulatory Authorities (SRA), for which other accelerated registration mechanisms can be applied.

Applicants are encouraged to make pre-submission consultations on eligibility of their products with their respective national authorities.

Application submission process

As a condition for a medicines dossier to be included in the collaborative process an application should be submitted according to current Zazibona requirements which include an agreement to consent to information sharing among participating regulatory authorities. All participating countries shall treat the shared information as confidential in line with applicable national legislation and arrangements.

Potential applicants are further advised that Zazibona participating countries reserve the right to accept or refuse submissions to be considered for this collaboration. Each Zazibona authority retains the right to assess submitted data and organize site inspections to the extent they deem appropriate. Inclusion in the collaborative process may be affected by the available Zazibona capacity. Medicines that are not selected follow regular national registration procedures.

Applicants are encouraged to submit applications for inclusion in the Zazibona process at least 1 month before the meeting of assessors which considers applications received and assignment of rapporteurs. Early submissions facilitate the administrative screening of applications before the meeting of assessors. Assessment meeting dates are published on participating authority websites.

Documents to be submitted

  1. Covering letter, in English, expressing

    1.1. interest in participating in the Zazibona process and information, whether the product is already registered in any Zazibona participating country,

    1.2. confirmation/attestation that the information submitted in the product dossiers is "true and correct",

    1.3. confirmation/attestation that the same dossier and data have been submitted to all participating countries,

    1.4. consent to sharing of the product related information during registration and in the post-registration period among Zazibona participating authorities and with WHO staff and external experts, who support the process and are bound by a confidentiality undertaking; and

    1.5. commitment to apply for the same variations and post-registration changes in all Zazibona participating countries where the product is registered.

  2. Product dossier, in English, organized in CTD format for submitting product data and information. For the purpose of generic medicine registration, data demonstrating quality of raw materials (Active Pharmaceutical Ingredients and Excipients) and FPP are necessary, as well as demonstration of bioequivalence with an acceptable comparator. Details are specified in the relevant guidelines that reflect the harmonized SADC position. Paper and electronic copies of the dossier should be submitted as per national requirements.
  3. A product sample (for example a package of 100 tablets), for evaluation of product appearance, container material and labelling, as well as to enable, under exceptional circumstances, chemical and pharmaceutical analysis. Where sample labelling does not comply with national requirements or the proposed final labelling, mock-up labels demonstrating design of final labelling should be submitted.
  4.  A site master file, for each manufacturing site of the medicine, in the requisite format.
  5.  The national specific requirements include especially:

    I. Application fees

    II. Statutory forms to be completed and to accompany a specific national application

    III. Country specific labelling requirements

Further details on requirements for the Zazibona collaboration process, mechanisms of the Zazibona work-sharing and interactions with applicants are specified in other documents.

The Zazibona collaborative process is designed to achieve registration within a total time of 11 months, during which the applicant will have two windows of opportunity to respond to consolidated lists of regulatory assessment questions within a period of 60 days. Total regulatory time is therefore 210 days, which corresponds to regulatory deadlines of established regulatory authorities. Timelines for Zazibona process starts at the point of allocation of rapporteurship i.e. within 1 month of the submissions, followed by 10 weeks for initial assessment, 2 weeks for sharing assessment report, 8 weeks for the manufacturer/supplier or applicant to respond, and 2 weeks to process response. Products are only considered for 2 review cycles (for the responses) thereafter a final recommendation should be made. A country reserves the right to make a final determination on the submissions or request further information.

For Further information email nkago@bomra.co.bw and izimba@bomra.co.bw

Who Prequalification Of Medicines Programme

The Collaborative Registration Procedure (CRP) for WHO-prequalified products is one of the registration pathways that applicants can utilise when submitting applications for registration. The link below directs interested parties to the WHO website for more information on the procedure: https://extranet.who.int/prequal/content/collaborative-registration-faster-registration

For more information contact: olekuni@bomra.co.bw

Non-routine MA of products for Public Health Emergency- Emergency Assessment Pathway

BoMRA has provision for non-routine marketing authorisation (MA) of products availed in response to public health emergencies

To qualify for an Emergency Assessment Pathway (EAP), the use of the product must meet the following criteria:

  • The disease for which the product is intended has been declared by the WHO to be a Public Health Emergency of International Concern (PHEIC) and there is no licensed product for this disease.
  • The disease for which the product is intended has been declared by the Ministry of Health and Wellness to be a Public Health Emergency (PHE) and there is no licensed product for this disease.
  • The product is manufactured in compliance with current Good Manufacturing Practices (GMP).
  • The applicant attests that it intends to complete the development of the product. In the ideal situation, the remaining clinical trials and other requisite testing will already be underway at the time of the application.

Products meeting the criteria will be prioritised for assessment. Screening and assessment will be conducted simultaneously. The assessment will be conducted in accordance with the WHO Emergency Use Listing procedure and BoMRA registration guidelines

Applicants should consult BoMRA to confirm eligibility and for applicable fees/ payment arrangements for EAP products.

Please see the WHO Emergency Use Listing for further guidance  https://www.who.int/teams/regulation-prequalification/eul 

Governance Structure

The Medicines Regulatory Board (the Board), established under Section 6 of the MRSA, is the primary governing structure and is responsible for directing the affairs and operations of the Authority.

In accordance with the MRSA, the Board is mandated to supervise and control the administration and financial management of BoMRA and formulate policies for the purpose of providing guidance to BoMRA.

In carrying out its mandate the Board has the following duties and responsibilities, among others, as set out in the Board Charter.

  1. Providing leadership and direction to Management of BoMRA
  2. Overseeing the strategy, risk, performance and sustainability of BoMRA.
  3. Ensuring that the Authority’s ethics are managed effectively.
  4. Managing reputational risk and BoMRA’s relationship with Management, the Ministry of Health and Wellness and other 

In terms of Section 7 (1) of the MRSA, the Board shall consist of Members appointed by the Minister of Health and Wellness, after consultation with the Minister of Agricultural Development and Food Security, and elected from amongst persons with expertise in law, pharmaceutical industry, business management, medicine, pharmacy, veterinary medicine and two other areas as determined by the Minister.

The Chief Executive Officer, the Director of Health Services and the Director of Veterinary Services are ex-officio Members of the Board.

Members appointed by the Minister hold office for three years and are eligible for reappointment for no more than two consecutive terms.

Board of Directors
Dr Duncan Thela
Mr. Duncan Thela
Board Chairperson
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Mr. Duncan Thela - Board Chairperson

Mr. Duncan Thela has a Bachelor of Pharmacy, Nottingham University (UK) and MBA from the University of Botswana. He is the Managing Director of the Associated Fund Administrators Botswana (Pty) Ltd (AFA).

Mr. Thela is a well-rounded healthcare professional with a good understanding of the Botswana Healthcare System. From a regulatory perspective, Mr Duncan Thela served as a member of the Botswana Health Professions Council and is the former Chairman of the Botswana Drug Advisory Board. He is a member of the Human Resource Development Council – Health Sector Committee, Tourism, Health and Education Immigrants-Sector Specific Selection Board and member of the Business Botswana Health Sector Committee.

Dr Mbatshi Mazwiduma
Dr. Mbatshi Mazwiduma
Board Vice-Chairperson
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Dr. Mbatshi Mazwiduma - Board Vice-Chairperson

Dr. Mbatshi Mazwiduma is a veterinary surgeon. His professional experience spans over 16 years with footprints in Botswana, New Zealand and Australia. Dr Mazwiduma is the founder and Director of VETPRO, a veterinary centre that provides specialised services in Agri business consulting and veterinary services throughout Botswana. He is also a member of the Veterinary Council, and deputy chairman of Botswana Veterinary Association.

Dr Stephen Ghanie
Dr. Stephen Ghanie
BoMRA CEO
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Dr. Stephen Ghanie - BoMRA CEO

Dr. Stephen Ghanie is the Chief Executive Officer of BoMRA. A veterinarian by profession, Dr. Ghanie’s academic footprints include veterinary medicine, meat science, strategic management and general management. He has worked as a veterinary public health practitioner, occupied various executive positions at Botswana Meat Commission and became the first citizen country manager at Parmalat Botswana.

Ms Shameelah P Winston
Ms. Shameela Pholo-Winston
Board Member
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Ms. Shameela Pholo-Winston - Board Member

Ms. Shameela Pholo-Winston is a Human Resources Specialist and holds B.Soc.Sci (Hons) in Industrial & Organisational Psychology from Rhodes University. With more than 15 years’ experience, Ms. Pholo - Winston has successfully led transformation projects in private and public sector environments, cultivating organizational performance through alignment of strategy to organizational structures, policies and processes. Ms. Pholo - Winston served in the Human Resource Management field both as an executive and as a consultant in private practice. She continues to offer her services for the advancement of performance management in Botswana.

Dr Tiro Mampane
Dr. Tiroyaone Mampane
Board Member
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Dr. Tiroyaone Mampane - Board Member

Dr. Tiroyaone Mampane holds a MBChB (MEDUNSA) (GIPS) and Corporate Governance & Project Management Certificate (University of Pretoria). Dr. Mampane is the founder and President of Boitekanelo College, a specialized health education academy. He has been at the helm of the college for over 10 years in charge of its Strategic direction, compliance and adherence to the regulatory framework. He previously worked at Princess Marina hospital as a medical practitioner. Dr. Mampane recently completed an Entrepreneurship Development Programme with Stanford Business school sponsored by De Beers Group.

Mr Meshack Baoleki
Mr. Meshack Baoleki
Board Member
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Mr. Meshack Baoleki - Board Member

Mr. Meshack Baoleki holds an LLB from the University of Botswana, Post Graduate Certificate - Compliance Management, UCT and Graduate Certificate - Policy, Regulation & Management, WITS. He is the Managing Partner of Baoleki Attorneys - a transactional law firm specializing in corporate and commercial law. He has worked in the Telecommunications and Banking Industry, in charge of legal, compliance and regulatory affairs.

Dr Joyce Kgatlwane
Dr. Joyce Kgatlwane
Board Member
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Dr. Joyce Kgatlwane - Board Member

Dr. Joyce Kgatlwane is a pharmacist and an academic. Her career spans over 28 years, where she worked in various hospitals in Botswana. Dr. Kgatlwane previously worked for Botswana Harvard AIDS Institute Partnership, PEPFAR and her areas of research include medicines utilisation, antibiotics use, adherence to medicines, medication errors, adverse medicines reactions and reporting. She contributed to the curriculum review and development of the advancement at the Institute of Health Sciences and the University of Botswana respectively.She served as a member of the Pharmacy Board under the Botswana Health Professions Council. She is also a member of HIV Management Guidelines Committee, Palliative Care Advisory Committee, National Health Research Committee and one of the founders of the Medicine Utilisation Research in Africa. In the area of medicine regulation, Dr. Kgatlwane worked at the Drugs Regulatory Unit as part of internship and She received training on dossier evaluation. She also received training on pharmacovigilance. Dr. Kgatlwane obtained a Bachelor of Pharmacy from the University of Otago (New Zealand), PharmaD from the University of Florida (USA) and Masters of Public Health from the University of Texas School of Public Health (USA).

Dr Gaseitsiwe M Sento
Dr. Michael G. Sento
Board Member
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Dr. Michael G. Sento - Board Member

Dr. Michael Sento is a qualified veterinary surgeon with experience spanning over 21 years in private practice. Away from the surgery room, Dr Sento is a passionate small stock farmer and keen promoter of organic farming practices. He previously held a board membership of the Botswana Vet Council.

Dr Gontle Moleele
Dr. Gontle Moleele
Board Member
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Dr. Gontle Moleele - Board Member

Dr. Gontle Moleele is a practicing physician and endocrinologist, based at Bokamoso Private Hospital, where she is also the hospital Superintendent. She has sat on several boards including MRI Botswana and the University of Botswana School of Medicine Advisory Board. She currently chairs the Joint Medical and Surgical Board of the Botswana Health Professions Board.

Dr Lethugile Modisa
Dr. Letlhogile Modisa
Board Member
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Dr. Letlhogile Modisa - Board Member

Dr. Letlhogile Modisa is the Director of Veterinary Services in the Ministry of Agricultural Development and Food Security. He is the Vice President of the OIE regional Commission for Africa.

Mr Kagiso Balopi
Mr. Kagiso Balopi
Board Member
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Mr. Kagiso Balopi - Board Member

Mr. Kagiso Balopi holds a Bachelor of Accounting, University of Botswana, Management Development Program, University of Stellenbosch, and IIE, Pacific Institute. He is a Fellow Chartered Accountant (FCA) of the Botswana Institute of Chartered Accountants (BICA), a fellow member of the Association of Chartered Certified Accountants FCCA (UK), and a Certified Enterprise Risk Manager (CERM). His career spans over 16 years in Auditing, Accounting, and banking at various levels. He serves on the Boards of the Botswana Privatization Asset Holding (BPAH) and he is also a co-opted member of the Finance, Audit and Risk comittee for the Botswana Technology Research and Innovation (BITRI) He is also a member of the Institute of Directors Southern Africa (IODSA).

 

Mr. Duncan Thela
Mr. Duncan ThelaBoard Chairperson
Bachelor of Pharmacy, Nottigham (UK), MBA University of botswana