Instructors

Muhammed Afolabi is a Global Health scientist and a Clinical Associate Professor at the London School of Hygiene & Tropical Medicine. He obtained a medical degree from the University of Ibadan; a master’s degree in Public Health from Obafemi Awolowo University, both in Nigeria and a PhD from the London School of Hygiene & Tropical Medicine, UK. He underwent specialist training that led to the award of the postgraduate fellowship of the West African College of Physicians in Family Medicine. He is also a Fellow of the Faculty of Public Health of the Royal Colleges of Physicians of the UK and Higher Education Academy.

Muhammed research antecedents were in the evaluation of vaccines related to the control and prevention of Ebola, HIV and malaria across several African countries. He led the Ebola paediatric vaccine trials in Sierra Leone, findings of which contributed to the approval of the novel two-dose Ebola vaccine regimen (ZABDENO/MVABEA) by the European Medicines Agency and World Health Organisation for the first time in children. 

Muhammed Afolabi is currently working on a prestigious UK Research and Innovation (UKRI) fellowship that focuses on investigating the effectiveness of integrating the vertical control programmes for malaria and neglected tropical diseases among a high-risk paediatric population. This adventurous project will hopefully lead to the implementation of an increasingly recognised WHO strategy of an integrated, non-disease specific approach to elimination of malaria and neglected tropical diseases, which could help to achieve the Sustainable Development Goal 3 by 2030.

Muhammed serves on several high profile committees including the WHO Strategic Advisory Group of Experts (SAGE) Working Group on COVID-19 vaccines and Nuffield Council on Bioethics.

Marieme Ba is the Founder and Managing Director of Pharmalys, a Contract Research Organisation (CRO) originally set up in the United Kingdom in 2008 and subsequently established in Senegal in 2012.

Marieme received both her master’s degree in biochemistry and postgraduate diploma in immunology and haematology from the University of Paris 7 Jussieu. She also holds a business school diploma from Institut Supérieur de Gestion of Paris.

Marieme set up the clinical research departments of a German pharmaceutical company in France and in the UK. Today, with over 25 years of experience implementing clinical trials in Europe and in Sub-Saharan Africa, Marieme is capitalising on her strong scientist and entrepreneur background to give back to the African health research community by setting up the Pharmalys Academy of Clinical research Excellence, PACE.

Sokhna Beye has a Bachelor’s degree in General Sciences from Missouri State University, (China Branch), certificate in Financial Markets, Child-Safeguarding, Psychology, TESOL/TEFL.

She is the current Office Administrator at Pharmalys, in charge of facilitating CRA monitoring trips, filings, tracking absences along with other administrative tasks.

Sokhna has several years of experience in the Admin field, Insurance, Banking and teaching from multiple institutions.

Sokhna works in English and French.

Simone Chimeura is a Global Clinical Project Manager with over 20 years’ experience in clinical research, working across all industries (Big Pharma, CRO and sites), in all major regions, encompassing US and Canada; Latin America and Europe, as well as in non-core/traditional countries like Asiapac – Japan, China, South Korea, Malaysia, Thailand, Australia, Singapore; and both East and West Africa.

Simone has worked across all phases of clinical trials from Phase I – IV including observational non-interventional studies and has a broad therapeutic area experience having worked in Oncology, Cardiovascular, Neurosciences, Infectious Diseases, Gastro-intestinal, Respiratory and Immunology.

She also specialises in unblinded project management, training and coaching/mentoring of junior staff.

Simone is an enthusiastic, proactive and self-motivated individual with a strong determination for success. She is a team player who works well on own initiative, hard working with very good communication, leadership, project management, negotiation and presentation skills.

Kitty has a Master of Science in Business Administration (MScBA) in Management of Change, obtained at the Erasmus University Rotterdam School of Management, The Netherlands. 

She is a CTI trained Co-Active Coach (Coaches Training Institute).  

Kitty has broad working experience in strategic Human Resources Management (HRM) with multinational companies as well as start-ups, improving employee performance, career growth & development, employee experience, employee well-being & retention.

She helps companies to empower people, continuously working at the optimal intersection of business consultancy, skills training & coaching. She designs solutions that impact both organizational structure & culture, aligned with the company & employee needs.

Kitty works in English, Spanish & Dutch. 

 

UK and Ireland based CRA, who has worked in Pharmalys for over 2 years.

Funke Erejuwa has a postgraduate degree (PGcert) in Cancer Biology and an undergraduate degree (BSc) in Biomedical Science.

Funke has worked within the Clinical Research Industry for 6 years; 3.5 years served as a CRA and 2.5 years as a Data Manager.
Experience working within a variety of organisations including; CRO’s, Sponsor, Academia.

Funke has worked on phase I-III clinical trials in a number of therapeutic areas including; Oncology, Cardiology, Infectious Diseases, Haematology, Immunology and Hepatology.

Bernard Fritzell, MD has been an independent consultant in vaccinology and vaccine development at BFL conseils SAS since 2012. Current member of the IABS human vaccine group, and TBVI clinical development team, former member of WHO PDVAC committee, WHO TB vaccines R&D group and the French Scientific Council on Covid-19 vaccines and the Scientific Committee of the French National Agency for Scientific Research (ANRS) on Covid-19.

Over more than 35 years, Dr Fritzell has gained experience in the direction of vaccine clinical trial programmes. Dr Fritzell held the position of Vice President, International Scientific & Clinical Affairs for Wyeth/Pfizer Vaccines, based in Paris France (1999-2011), Vice President, Clinical Research and Medical Affairs for Chiron Vaccines (1996-1999) and Director of Clinical Research for Vaccines at Pasteur-Mérieux Sérums et Vaccins (1993-1996).

Dr Fritzell has directed all phases of vaccine development, with programs set-up across Africa, Asia, Europe and the USA. They have included research into new adjuvants, paediatric and adult combination vaccines, Pneumococcal conjugate, Haemophilus influenzae type b conjugate, Meningococcal conjugate and serogroup B vaccine, Typhoid fever, Influenza, Hepatitis B and Hepatitis A, Varicella and Zoster, Measles, Rabies, Dengue and Japanese Encephalitis vaccines.

From 1996 to 2010, Dr Fritzell has been Chairman of the clinical working group of the European Vaccines Manufacturers (EVM).

Katharina Hartmann has over 30 years of experience in vaccine and drug safety.

Formerly Global Head Vaccine Pharmacovigilance for the Vaccine Business Unit of Takeda, she has also held executive positions at the Swiss Drug Monitoring Center SANZ, Crucell (Switzerland), the former Berna Biotech AG / Swiss Vaccine and Serum Institute and was a Senior Lecturer for pharmacovigilance / pharmaco-epidemiology (Master level) at ETH Switzerland. Katharina Hartmann is currently an independent consultant for pharmacovigilance / pharmacoepidemiology.

Edem is a doctor in pharmacy. He also holds a Master in Business Administration and a Master’s degree in quality management at the Cheikh Anta Diop University, Dakar, Senegal.

Edem has been working for Pharmalys as a Clinical Research Associate (CRA).
For the past 5 years, he has been assigned to studies related to various therapeutic areas, from phases I to IV. He is comfortable with electronic systems such as Clinical Trial Management System (CTMS), Electronic Data
Capture (EDC), electronic Trial Master File (eTMF), and Interactive Web Response System (IWRS).

Edem is experienced in monitoring African study sites in accordance with Good Clinical Practices (GCP) guidelines, Sponsor’s Standard Operating Procedures (SOP) and applicable regulatory requirements.

Ethixpert.org.za/ceo

Francis Kombe is a Public Health practitioner and bioethicist, with a passion in Research Integrity. He has a wealth of experience working in international health research institutions, where he has held various leadership positions. 

Francis Kombe holds an MSocSc (research ethics) from the University of KwaZulu-Natal (UKZN), South Africa; Master of Public Health (MPH) and Postgraduate Diploma in Public Health (PGDPH) from London School of Hygiene and Tropical Medicine-UK (LSHTM) and is currently pursuing a Wellcome Trust funded PhD in Bioethics at UKZN. 

He has published widely in the field of community engagement, frontline staff, research integrity, fair study benefits and informed consent, among others. 

Affiliation:  Faculty of Tropical Medicine, Mahidol University

Saranath is a medical doctor by training and currently works as an epidemiologist. Her main interest in research is clinical trial and population-based study on tropical diseases, including malaria, tuberculosis, and dengue. Saranath is also interested and has expertise in data management in clinical research. She has over 12 years’ experience in the field.

Saranath holds a PhD in Epidemiology for the University of Maryland, Baltimore. She is an Associate Professor of Epidemiology and is currently the head of Department of Tropical Hygiene, and the deputy director of the center of excellence for Biomedical and Public Health Informatics (BIOPHICS), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.

Victorine Mensah obtained her BSc in applied biology from Institute of Health Careers of Rabat, Morocco, in 2003.

She started working in the clinical trials field as a Lab Scientist in 2008, first at “Institut Pasteur de Dakar” where she was involved in a Hepatitis B therapeutic vaccine evaluation study; and in 2010, in the department of Parasitology at Cheikh Anta Diop University of Dakar (UCAD), Senegal.

She soon progressed to a Scientific Officer position on Malaria vectored vaccine trials; having extensive hands-on training in immunology and molecular biology at the Jenner Institute’s laboratories in Oxford University, UK. She was also involved in study site coordination, protocol submission, project management activities and contributed to results dissemination with peer reviewed publications of her work.

Victorine joined Pharmalys in 2016 as an international clinical research associate. She worked on vaccines and drugs, phase 1 to 3 interventional clinical trials, mainly for infectious diseases. Victorine was promoted in January 2021, to the Clinical Project Manager role.

Robert Ndege is a medical doctor and research scientist from the Ifakara Health Institute (IHI) in Tanzania, with over 7 years of experience in the field of HIV and tuberculosis. He is a physician with a specialization in infectious diseases and is currently pursuing a PhD in epidemiology and public health, with a focus on tackling unsolved issues of the dual epidemic of HIV and TB. 

Apart from research and patient management, Dr. Robert Ndege is also involved in the development and implementation of HIV policies and guidelines within his country. His interests lie in infectious disease epidemiology, diagnostics and implementational science.

Holder of a Bachelor of Science in Biology and a Master of sciences in Medical Entomology from the University Cheikh Anta Diop in Dakar, Senegal, Assane Ndiaye has more than five years of experience as a Clinical Research Associate (CRA). 

His expertise mainly consists of haematology and vaccine trials. At Pharmalys, he has deepened his knowledge of the clinical trial process while improving his training capacity through GCP training sessions for African ethics and regulatory authorities. He continues to develop his skill set through the mentorship of junior CRAs. 

As a CRA Manager, Assane’s responsibilities include (i) leading and supervising a team of CRAs and CTAs to ensure high quality of work, (ii) constant monitoring of CRAs’ performance to identify topics or processes that need to be improved through training and (iii) involvement in new CRAs’ recruitment and onboarding.

Djibril Ndiaye holds a Baccalaureate degree in Electrotechnical Sciences and Techniques from Lycée Technique de Thiès, and a Bachelor’s degree in Development and Application Administration at the University Alioune Diop. Djibril is currently pursuing a Master’s degree in Statistics and Business Intelligence at the University Alioune Diop.

Djibril is a five-year experienced IT Manager with expertise in various areas of intervention, including conception, study and development, system administration and data analysis. He possesses a strong skill set that encompasses databases such as MySQL and SQL Server, development languages like PHP and Python, and system information components such as system architecture, business process mapping, database administration, Windows Server administration, electronic document management systems, and data analysis tools, to name but a few.

Additionally, Djibril is a member of the prestigious organization Jeune Chambre Internationale, demonstrating his commitment to personal and professional development.

Djibril works in English and French.

Mbaye Ndiaye is a Senior Clinical Project Manager at Pharmalys since July 2020. He was graduated with a Master in Public Health and Human Nutrition at Paris VI, and obtained Certificates in Clinical Research and Tropical Medicine. He is certified Clinical Research Professional (CCRP), member of the American Society of Clinical Research Associates (SoCRA) and a MBA Candidate at Concordia University.

Mbaye started working as a Clinical Research Associate in 2010 in Paris, France, before moving to Canada in 2015 where he held several positions including Clinical Project Coordinator, Clinical Research Lead/Supervisor and Clinical Project Manager, within private and public Clinical Research Organizations.

Mbaye has a strong international experience in project management and monitoring, in various therapeutic areas. 

Supporting CRCs, CRAs and CTAs early on in their careers is another of Mbaye’s priorities, and to date, he has mentored more than 25 clinical research professionals.

 

Aissatou holds a Bachelor degree in biology and a clinical research associate and study coordinator Inter-University Diploma. She has a strong knowledge of the drug development process, ICH-GCP principles, and regulatory requirements of west African and European countries.

Aissatou joined Pharmalys as a clinical research associate. She has more than 3 years experience in conducting clinical trial related tasks from site set up to site close out, along with site monitoring activities (setting up, maintaining, and quality assurance of trial documentation, tracking study status, follow ups, etc.). She has been involved in studies related to various therapeutic areas, from Phase II to IV, in Europe and Africa.

Eric is a physician, research scientist at Centre de Recherche en Santé de Nouna (CRSN)/National Institute of Public Health (NIPH) in Burkina Faso. He is specialized in tropical medicine, vaccinology, and clinical research with over one decade experience in clinical research.

Eric is an alumnus of WHO-TDR Clinical Research career development and the Africa London Nagasaki (ALN) fellowships and holds a post-graduate diploma in Research and Development of products to meet public health needs.

Eric’s Research interest focuses on clinical development of drugs and vaccines, innovative health interventions designing, implementation and evaluation.

Eric’s current PhD project, conducted within the African Contributions to Global Health (AfriCon) project at Swiss TPH, addresses clinical trials efficiency improvement by learning from tropical diseases drug development in Africa.

Ms. Kamila Novak holds an MSc in molecular genetics. 

She has been involved in clinical research since 1995, having worked in various positions in pharma and CROs. 

Since 2010, she has been independent and incorporated her company several years later. Her business activities include auditing, consulting for QMS establishment and process improvements, medical writing, and training. 

Kamila is a certified Lead Auditor for five ISO standards and a certified auditor for two more. She chairs the DIA Clinical Research Community and the SQA Beyond Compliance Specialty Section, leads DIA Working Groups on System Validation and Data Interoperability, serves as a mentor at the SQA and the DIA, is a member of the European Medical Writers’ Association (EMWA), the Continuing Professional Development (CPD) UK, the Association for GXP Excellence, and other professional societies. She publishes articles, speaks at webinars and conferences.

Marianne holds a Master’s Degree in Social and Organizational Psychology (State University of Leiden, The Netherlands) as well as a postgraduate degree in Business Administration and Organizational Strategy (Erasmus University, Rotterdam). 

She is certified in communication and personal effectiveness methodologies, such as Transactional Analysis, DISC, Transformational Coaching, Competency Focused Interviewing (STAR) and Problem Solving Techniques (Root Cause Investigator). 

Marianne is an international consultant and trainer with over 20 years’ experience and provides consultancy, training and coaching services to national companies and multinationals. 

She is a senior adjunct professor at EADA Business School in Barcelona since 2008 and specialized in topics on Human Behavior within Organizations.

Marianne works all over Europe in English, Spanish and Dutch. 

She as well is the founder of Yellow | Soft Skills for Tech.

 

Nana Tawiah has over 25 years of experience in regulatory quality standards GXP (GLP, GCPv, GCP and GCLP) and business quality management systems such as, ISO 9001, ISO 15189 and ISO 14155.

He is passionate about quality management systems and
particularly for continuous improvement.

He has managed, implemented and delivered training in quality standards and Quality Management Systems in Europe, USA and Africa.

Dr. Retha Visagie is heading the Unisa Research Integrity Office, fulfilling several national and international leadership roles. She is a NonExecutive Director and the EthiXPERT Board of Directors’ Chairperson. She is a founding member and the co-chair of the Executive Committee of the SARIMA Northern Regions Community of Practice for Research Ethics and Integrity. She contributed to formulating the SARIMA/SANBIO Southern African Development Community guidelines for research ethics and integrity in 2021. Retha is also a Globethics.net Global Pool of Ethics Experts member.

She received the 2018 DST/SARIMA Award for Professional Excellence in Research Management. The International Professional Recognition Council awarded her Senior Research Management Professional status in 2022.

She has been active in research support strategy planning, policy creation, and establishing research integrity support systems for the past nine years. She is recognized as a thought leader in research ethics and integrity governance. She has co-authored several international scholarly articles and book chapters on social science research ethics. She is a co-editor of a Springer book on research ethics in Africa. Since 2016, she has trained over 3,000 academics, research administrators, and members of research ethics committees. Her research niche has recently broadened to include Indigenisation of research management.

Simonetta Viviani is an independent scientific advisor who has collaborations with vaccine manufacturing companies, academia and other institutions operating in the field of vaccine research & development, epidemiology and global health. 

She received a Medicine and Surgery Degree from Siena University, Italy, and postgraduate degrees in Public Health and Laboratory. She holds a two-year postgraduate training in Field Epidemiology from the CDC, Atlanta, USA, and the Istituto Superiore di Sanità, Rome, Italy.

From 2005 to 2010 she was director of Vaccine Development at the Meningitis Vaccine Project (MVP) a partnership between WHO and the Program for Appropriate Technology in Health (PATH), with goal to eliminate epidemic meningitis sub-Saharan Africa. 

Dr. Viviani has worked in several public health and epidemiology projects in Italy, Zimbabwe, The Gambia, Brazil and Guinea Bissau. Her experience in vaccine development includes pediatric vaccines, Hib, pertussis, measles, influenza, HIV, dengue, meningitis, hepatitis B, leptospirosis, polio, SARS-Cov2 vaccines. She has published in these fields.

ORCID: https://orcid.org/0000-0002-3652-5082