Goodluck Boaz Gotora

A highly experienced regulatory scientist and medical doctor with over 12 years at the Tanzania Medicines and Medical Devices Authority (TMDA), specializing in pharmacovigilance and clinical trial oversight. Expert in ensuring medical product safety through robust signal detection, comprehensive benefit-risk assessment, and the evaluation of Risk Management Plans (RMPs) and PSURs. Proven track record in strengthening African regulatory systems through capacity-building initiatives with the Rwanda FDA and in Uganda. Currently serving on key national and continental expert bodies, including Tanzania's Vigilance Technical Committee and the African Vaccine Regulatory Forum (AVAREF) Expert Working Group. I bring to the committee of AU-PRAC a decade plus of competency, experience, knowledge, understanding of African Regulatory Environment, and serving in similar committees.

• Date of Birth: 03/04/80
• Gender: Male
• Nationality: Tanzanian by Birth
• Marital Status: Married

· Drafted various TMDA pharmacovigilance bulletin

· Contributed to the development of various guidelines and regulations related to clinical trials and pharmacovigilance.

· Conducted GCP inspections of ongoing clinical trials to assess compliance and identify areas for improvement.

· Conducted pharmacovigilance inspections

· Conducted various sensitization to health workers on Tanzania pharmacovigilance regulations

· Designed and implemented active surveillance programs to monitor the safety of medicines and vaccines.

· Participated in establishment of post market surveillance regulations of the medical devices including in vitro diagnostics

· Drafted and reviewed the guideline for vigilance of medical devices including in vitro diagnostic devices

· Reviewed the applications for marketing authorization for medical devices

· Conducted audits of quality management systems for medical device manufacturing facilities, serving as the lead auditor for more than 40 facilities overseas.

· Participated in drafting and publishing manuscripts on pharmacovigilance and clinical trial activities

· Provided technical assistance to other countries: Facilitated overseas training on good clinical practice (GCP) in Uganda and acted as a lead auditor for clinical trials in support of the Rwanda FDA's capacity building efforts.

· Adam Fimbo, Yonah H. Mwalwisi, Kissa Mwamwitwa, Damas Matiko, Elirehema Mfinanga, Johnson Lyimo, Amon Sabasaba, Seth Missago, Elias Bukundi, Goodluck Gotora, Dorice Respick, Alex Nkayamba, Emmanuel Masunga, Rajabu Hussein Mnkugwe, Peter P. Kunambi, Castory Munishi, Christine Chiedza Musanhu, Omary M. S. Minzi & Eulambius M. Mlugu. Incidence and determinants of adverse events in individuals with HIV commencing Dolutegravir-based antiretroviral therapy mainland Tanzania, https://doi.org/10.1038/s41598-023-51144-7

· Lessons from enriching Tanzania's clinical research ethics clinical trials oversight and pharmacovigilance through the ASCEND project Adam Fimbo,Yona H. Mwalwisi,Damas Matiko, Eulambius M. Mlugu,Emmanuel Masunga Gedi,Ndekya M. Oriyo,Blandina T. Mmbaga,Nyanda E. Ntinginya,Wilber Sabiiti,Ruby Mcharo,Ame Masemo,Sunzy M. Chambiri,Bora Lichanda,Mayassa Ally,Burhani Simai,Eliangiringa Kaale,Rajabu hussein Mnkugwe, Peter P. Kunambi, Castory Munishi,Goodluck B. Gotora & Kissa Mwamwitwa

· Factors influencing availability and prescription of anti-malaria drugs among health facilities in Iringa Region,2011 as part of my dissertation work.

· A Co-investigator of the EDCTP-funded project titled “Moving Tanzania's Clinical Research Ethics and Medicines Regulatory Capacity to the next level: Fostering Medicine Quality, Safety and GCP Clinical Trials” (ASCEND)

· Bottlenecks in compliance to HIV reporting systems: Evaluation of data recording and reporting in HIV and AIDS interventions to strengthen HIV information systems in Dar es Salaam, Mwanza, Shinyanga, Mtwara regions, 2012; Research Assistant.

· Cholera outbreak investigation in Masasi District, Mtwara Region, January 2012: A case-control study; Co-Investigator.

· Cholera outbreak investigation in Kigoma rural district, June 2011: A case- control study; Principal Investigator.

· Evaluation of Sentinel Surveillance of Malaria at Mpwapwa District Hospital, January 2011.

· Working in M&E at NMCP as part of field attachment in fulfilling Master of Science in Applied Epidemiology, January 2011- May 2011.

· Working with Mtwara RHMT as part of field attachment in matters related to public health issues and epidemiology issues and assisting in the analysis of hospital data.

· Participated in Scientific Advice meeting via MAGHP a collaborative Scientific Advice procedure Swissmedic is collaborating with several other targeted NRAs and the WHOfor malaria program (Riamet/Coartem infants and neonates

· Appointed as a member of the AVAREF Working Group on the Development of Guidelines for Human Challenge Studies (2024).

· Appointed as a member of the AVAREF Clinical Trial and Digital Pilot Project Group (2025), contributing to regional regulatory harmonization and innovation in clinical research oversight

· Current Member of National Ethics Committee for Health Research since 2020 to date

· Appointed by the National Institute for Medical Research as a Member of the IREC Accreditation Team, October 2024.

· Appointed as a Representative to the Regional Task Force under the Strengthening Ethics and Responsible Conduct of Clinical Trials in East and Sub-Saharan Africa (SERCEA) Project, September 26, 2024

Field Epidemiology and Laboratory Training Programs, 12/11/11, Dar es Salaam

Attended scientific communication skills and presentation, 10/01/11, Dar es Salaam

Attended the two weeks training programme at the World Health Organization (WHO) on Prequalification of Diagnostics Programme in WHO Pilot Project on strengthening regulatory capacity of diagnostics and Post Marketing Surveillance in Tanzania, March 2013, Geneva.

Attended 5th Advanced Course on Diagnostic (ACDx), Les Pensie'res, Veyrier-du-Lac, (France).

Attended the 6th 2014 HPFB International Regulatory Forum, which was held October 6– 10, Ottawa, Canada.

Attended Who Prequalification of In Vitro Diagnostics: Joint Assessment Meeting,Held in Crown Plaza Hotel, Geneva Switzerland from 5-9 October, 2015

Attended PEPFAR Fellowship to learn the laws and principles undertaken on regulation of HIV assay tests and blood donor screening tests at USA FDA, Silver Spring, from 15 June- 14septembar, 2015.

Participated in the ‘' World Health Organization (WHO) workshop on Prequalification of In vitro Diagnostics (IVDs) for national regulatory authorities, Cape Town International Convention Centre, Cape Town, South Africa, from 4 -8 December, 2016.

WHO/ITM Training Workshop Dossier Assessment of Malaria Rapid Diagnostics Tests ITM Antwerp, Belgium,5-7 July 2017.

Rotational inspector for three months for WHO Prequalification team specific to manufacturers of In vitro diagnostic, from 1 June,2017-30, August, 2017 at WHO HQ, Geneva, Switzerland,

Attended 6th Annual meeting on WHO Registration Procedure (CRP) which was held in Nairobi from 15th to 18th October, 2018.

Attended 4th WHO Global Forum on Medical Devices, Visakhaptnam, India 13-15 December, 2018.

Attended 3rd Regional Centre of Regulatory Excellence Fellowship Programme for Clinical trial held in Ghana for period of one month from August to September, 2019.

Attended e-blended training on the causality assessment of Anti-Tuberculosis drugs in October 2019, Dar es Salaam, conducted by the PAVIA project.

Attended virtually on PMDA-ATC Pediatric Review Webinar 2020 offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC), which held from September 28 to October 1, 2020.

Attended training on assessing periodic safety update reports (PSURs) and Risk Management Plans (RMPs) for medicines and vaccines. The training was conducted in June 2021 in the Morogoro region of Tanzania through the PAVIA project.

Attended training for 4th Proforma Pharmacovigilance Training 2022: Qualified Person for Pharmacovigilance) QPPV) TOT Training was held virtually for 6 days in January 2022

Attended Tanzania National Immunization Technical Advisory Groups workshop held in Zanzibar from 17th to 26th January, 2022 discussed on current preparedness use of nopv-2 and understanding of current situation of Polio responses and provide recommendation on the use of nopv2 vaccine in the country.

Attended the virtual training on the assessment of Pre-Clinical Data and First-in- Human Clinical Trial Applications conducted from, 28th February 2022 to Friday, 4th March 2022 conducted by CEPI in collaboration with GHANA FDA.

Attended 2-days a dissemination forum for a neglected tropical disease research held from 3rd to 4th August 2022, at CEEMI Conference Hall, NIMR Headquarters, Dar es salaam conducted by NIMR through a project known as TAKeOFF

Facilitated and attended workshop for assessment of periodic safety update reports and risk management plan held at Nursing and Midwifery Centre (TNMC) Hall, Kibaha from 1st to 5th August, 2022 Pwani, funded by WHO

Attended Vaccines safety surveillance in COVID-19 vaccination training on investigation and causality assessment of AEFI conducted by World Health Organization in collaboration by TMDA from 15-16th August, 2022 at Oceanic Bay Hotel, Bagamoyo.

Attended Workshop for Implementation of the African Vaccine Regulatory Forum (AVAREF) Guide for Safety Monitoring of Clinical Trials 30th -31st August, 2022, Kigali, Rwanda conducted by World Health Organization (WHO).

Attended Advanced RCORE Clinical Trial Regulatory Fellowship Programme In Accra, Ghana for two weeks from November 28- December, 09, 2022

Attended in the IABS conference on controlled human challenges studies from 22nd-24th May, 2023 in Mombasa, Kenya

Facilitated a Good Clinical Practice (GCP) inspection training program for Rwandan FDA inspectors from June 5-17, 2023 in Kigali, Rwanda

Facilitated a training workshop on AVAREF clinical trial assessment tools in Kampala, Uganda, from September 26-29, 2023. The workshop was organized by the Uganda National Council for Science and Technology and the National DrugAuthority.

Participated in WHO AVAREF Clinical Trial Joint Review Meeting for KLUJ 56 WithCoartem® in the treatment of Uncomplicated Plasmodium Falciparum MalariaFrom 14th To 15th December, 2023  Abidjan, Cote D'ivoire

Attended WHO implementation Workshop on considerations in developing regulatory framework for human cells and tissues and for advanced therapy medicinal products, 14-16 May, 2024, Muscat, Oman

Facilitated training on Refresher Program for Reviewers on the Conduct of Thorough Ethics Review of Health Research Protocols, currently ongoing at Edema Conference Centre, Morogoro from 2nd to 3rd July 2024

Participated in a meeting on establishment of open access and e-learning Good research regulatory practice plaforms held in Morogoro, Tanzania from 26-27 August, 2024 coordinated by Tanzania Commission for Sciences and Technology (COSTECH)

Attended the meeting in Kigali from July 29 to 31 July, 2025 for Trial Regulation and Clinical Trial Ethics Optimization (TRACE) Project

Dr. Joel Manyahi

Associate professor

Muhimbili University of Health and Allied Sciences

Department of Microbiology and Immunology

P.O. Box 65001,

Dar es Salaam, Tanzania

Mobile: +255 712 51709,

E-mail: manyahijoel@yahoo.com

Dr. Adam Mitangu Fimbo

Director general

Tanzania Medicines and Medical Devices Authority

P.O. Box 1253

Dodoma

Mobile: +255 687 569 693

Email: adamfimbo@gmail.com, adam.fimbo@tmda.go.tz

Dr. Dan Maeda

Senior lecturer

Department of Molecular Biology and Biotechnology

University of Dar es Salaam.

Mobile: +255 756 217 824

Email: maed.daniel@udsm.ac.tz