Goodluck Gotora

Experienced regulatory scientist with a Master of Science in Epidemiology and over 12 years of expertise in medicines, medical devices, and vaccines. Actively involved in promoting public health by ensuring the safety, efficacy, and quality of regulated products. Proficient in drafting and finalizing regulations and guidelines, with a proven record of reviewing clinical trial applications and other health research protocols to ensure compliance with local and international standards.

Over 12 years of experience as a Regulatory Scientist at TMDA, I have successfully:

• Reviewed numerous clinical trial applications to ensure compliance with regulatory standards and ethical guidelines.
• 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.
• Designed and implemented active surveillance programs to monitor the safety of medicines and vaccines.

• Date of Birth: 04/03/80
• Marital Status: Married

• Field Epidemiology and Laboratory Training Programs, 12/11/11, Dar es Salaam
• 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
• 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.
• 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 Drug Authority.
• Participated in WHO AVAREF Clinical Trial Joint Review Meeting for KLUJ 56 With Coartem® in the treatment of Uncomplicated Plasmodium Falciparum Malaria From 14th To 15th December, Abidjan, Cote D’ivoire

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.

Participated in drafting and developing various Guidelines for medical devices including in vitro diagnostic devices

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.

Associate Professor Joel Manyahi, Senior Lecturer

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 77150

Dar es Salaam

Mobile: +255687569693

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

Dr.Kissa W. Mwamwitwa

Director of Medical Devices and Diagnostic Tanzania Medicines and Medical Devices Authority

P.O. Box 77150

Mobile: +255754387773

Email: kissa.mwamwitwa@tmda.go.tz