HIITI SILLO
Mr Hiiti Sillo is the Unit Head, Regulation and Safety within the WHO Department of Regulation and Prequalification. In this role, he coordinates WHO strategies for strengthening national and regional regulatory systems as well as promoting regulatory harmonization, networking, convergence, work-sharing and reliance including through the implementation of WHO Listed Authorities Initiative. He was previously the Team Lead, Regulatory Systems Strengthening, Regulation and Safety Unit, WHO.
Before joining WHO in January 2018, he was the Director General of the former Tanzania Food and Drugs Authority (TFDA), now the TMDA. In this capacity, he was also one of the pioneers for the design and launch of the African Medicines Regulatory Harmonization (AMRH) Initiative, providing a strong foundation for the establishment and operationalization of the African Medicines Agency (AMA).
Mr Sillo is a Pharmacist and holds an MSc in Medicines Control and Pharmaceutical Services.
MARIE VALENTIN
Pharmacist specialized in drug product regulation with over 22 years of experience in regulatory affairs and product development, acquired both in the private and public sectors.
Since September 2023, Marie is the Team Lead for the Facilitated Product Introduction Team supporting the Member States by implementing various approaches and mechanisms, including collaborative procedures, reliance approaches, and joint activities at the national, regional, and international levels to facilitate and accelerate the introduction of priority medical products in countries. She previously worked in the WHO Regulatory Convergence and Networks Team towards convergence, harmonization, reliance and system strengthening activities, supporting different regional regulatory networks and regulatory systems strengthening. She was actively involved in the finalization of the WHO documents on Good Regulatory Practices and Good Reliance Practices
Before joining WHO in May 2019, Marie worked for 9 years at the European Medicines Agency in London as a Regulatory Affairs Officer where she was in charge of providing regulatory and procedural advice in relation to the development, evaluation and surveillance of medicinal products in the European Union as well as new EU legislation implementation. Before that, she worked in the pharmaceutical industry, contract research organization and consultancies in the United Kingdom, Spain and France.
AGNES KIJO
Mrs. Agnes Sitta Kijo, is a pharmacist, with a Master of Science (MSc) in Pharmaceutical Technology. She has over 23 years of experience in regulation of medicines and medical devices including in vitro diagnostics.
As a Technical Officer, at the Facilitated Products Introduction (FPI) Team in WHO-HQ, Geneva, Switzerland, she is responsible for the Collaborative Registration Procedure for in vitro diagnostics and other facilitated regulatory pathways activities. She also provides technical support related to regulation of medical devices globally and serves as member of the AMRH Joint Secretariat through the African Medical Devices Forum (AMDF) which oversees matters related to regulation of medical devices in Africa.
Before joining WHO in March 2020, she worked as regulator for 19 years and held different technical, advisory and leadership roles which allows her to provide sound and relevant guidance/advice to regulators and regional harmonization initiatives globally.
MARIANA ROLDÃO SANTOS
Mariana Roldao Santos is a Pharmacist, holding a Doctor of Pharmacy Degree (PharmD) as well as a Master in Pharmaceutical Regulation, both from the University of Coimbra, Portugal. She has also obtained other Postgraduate Diplomas and courses in Global Health Diplomacy from the Graduate Institute in Geneva, Pharmaceutical Policy from the University of Utrecht and Pharmaceutical Industry Management from the Católica Lisbon - School of Business & Economics.
Besides her scientific and regulatory academic background, Mariana spent the last 10 years building professional expertise in the areas of global access to quality-assured medicines and regulatory systems for medical products, both at the European and International levels. After experiences in hospitals and pharmacies in USA and Portugal, Mariana joined the field of regulation of medical products, first at the Obelis s.a. in Brussels for medical devices regulation (an EU Regulatory Centre and EU authorised representative) and later joining the field of medicines regulation at the European Medicines Agency (EMA) in London, in the Chief Policy Adviser Division and in the International Affairs Department. Later, she joined the Access to Medicine Foundation (ATMF) in Amsterdam, working with the ATMF Director of Strategy to enhance the impact of the Foundation and its activities.
Before joining WHO, Mariana also worked at the United Nations Development Programme (UNDP) in Ukraine as Pharmaceutical Specialist, to strengthen the Ukrainian healthcare system and support the development of capacities on the pharmaceutical regulatory area.
Mariana is now working at WHO Headquarters in Geneva for 5 years, firstly in the Regulatory Systems Strengthening team as Scientist and moving later on to the Facilitated Product Introduction Team as Technical Officer. Currently in the Facilitated product Introduction team at WHO, she is responsible for the facilitated regulatory/registration pathways activities and collaborative mechanisms for medicines and vaccines.
RAYANA BOU HAKA
Dr Rayana Bou Haka is the WHO Representative for WHO country office in the State of Qatar since June 2022. Dr Bou Haka joined WHO in 2000 and she had occupied several senior level positions in WHO at HQ, in the Eastern Mediterranean Regional Office/ World Health Organization in Cairo and in Djibouti and Pakistan.
As Manager CCU before joining WHO Qatar her work focused on supporting WHO country offices including the strategic planning processes in countries. As the desk officer for Qatar based in Cairo from 2017-2022 she oversaw the WHO collaborative programs with Qatar, liaising with technical units in the regional office and in headquarters. The WHO office in Qatar was established in August 2022.
Prior to joining WHO, Dr Bou Haka worked as a Consultant to Ministry of Public Health (MOPH) Lebanon in the Primary Health Care Pilot Project part of the World Bank funded project for Health Sector Rehabilitation project (HSRP) June 1998-August 2000.
With Medical doctor degree (1987) , Specialty diploma in Pediatrics (1991) and Masters in Public Health (1992), she has clinical and managerial experience as the Emergency Unit Physician, American University of Beirut Medical Center (AUBMC) –Beirut from 1991-1997 .
VICTORIA PALMI
Victoria Palmi, Senior International Affairs officer, has over 20 years of experience at the European Medicines Agency (EMA). Currently, she supports international collaboration programs as part of her role in the International Affairs office. Previously, Victoria worked as Product Lead in different therapeutic areas within the Evaluation of Medicines department. During this time, she led initiatives that accelerated assessment and early access to critical medications.
Victoria earned her degree in Pharmacy from the University of Valencia in Spain and René Descartes-Paris in France. She has also obtained additional qualifications in Methodology of Clinical Trials, European Regulatory affairs, and Advanced Therapies.
CHERISE SCOTT
Dr Cherise Scott (Senior Strategy Manager a.i. – Unitaid) is a global health specialist with over 15 years of experience developing and advancing innovations and products for neglected diseases. Dr. Scott’s career spans preclinical to market introduction for medicines and vaccines. Her current work encompasses identifying and supporting interventions to overcome access barriers to innovative treatment, diagnosis, and prevention tools for major diseases in low- and middle-income countries with a particular focus on the areas of tuberculosis, HCV, long-acting technologies, innovative delivery forms for paediatric treatment, regulatory and intellectual property
LAWRENCE NZUMBU
Lawrence, a pharmacist graduated with Bachelor of Pharmacy degree from University of Nairobi, Kenya in 2000 and MSc. Pharmaceutical Technology, Kings College London in 2009. He worked as a hospital pharmacist for six years and a quality assessor and a GMP inspector with Pharmacy and Poisons Board, Kenya (NMRA) for eight years. He joined WHO Prequalification of Medicines Team in 2011 as Temporary Technical advisor and later in 2014 as Technical Officer. He is currently a senior quality assessor for medicines dossiers submitted for prequalification and focal point for prequalified products CRP, Requalification, QMS and ePQS IT project in the Medicines team.
ALEX JUMA ISMAIL
Mr. Alex Juma Ismail is a Programme Officer at AUDA-NEPAD, working under the Medicines Regulatory Harmonization (AMRH) initiative, specializing in regulatory systems strengthening and harmonization. He is focused on supporting the operationalization of the African Medicines Agency (AMA), particularly in the formation and strengthening of continental technical committees that lead medical products regulatory activities in Africa. Mr. Ismail has more than 9 years of experience in the medical and pharmaceutical industries. He is a pharmacist by training and has previously worked for both private pharmaceutical companies and governmental regulatory bodies In East and Southern Africa. He was also actively engaged in the regional economic communities’ medicines regulatory harmonization programmes for EAC and SADC whereas he served as the focal person and regional technical officer respectively.
MURRAY LUMPKIN
Dr Murray Lumpkin became Deputy Director – Integrated Development (Regulatory Affairs) and Lead for Global Regulatory Systems Initiatives at the Bill and Melinda Gates Foundation in 2014. He leads the Foundation's strategic initiatives around global regulatory systems optimization working with the World Health Organization and other multinational organizations, continental and regional regulatory harmonization initiatives, and national regulatory authorities. These initiatives are focused on making more efficient and effective the regulatory processes through which products must pass to be developed, authorized, and marketed/procured in less resourced countries.
He retired from the US FDA in 2014 after 24 years of service. There he was Deputy Commissioner for International Programs and was responsible for policy development and operations of the FDA’s international activities. Under his leadership, FDA’s foreign posts were established, and FDA’s confidentiality arrangements and harmonization activities with foreign counterpart agencies were designed and implemented. From 1993-2000, he was the Deputy Center Director (Review Management) of FDA’s CDER and was responsible for all of CDER’s clinical trials oversight and initial marketing authorisation and post-marketing changes activities, and for CDER’s public advisory committees. From 1989-1993, he was the Director of CDER’s Division of Anti-infective Drug Products.
He is an MD with post-graduate training in pediatrics and pediatric infectious diseases at Mayo Clinic. As a Fulbright Scholar, he completed an MSc in medical parasitology at the London School of Hygiene and Tropical Medicine and his certification in tropical medicine and hygiene.
JANIS BERNAT
Janis leads cross-functional activities in regulatory science and international health policy for IFPMA, while partnering with policy experts and stakeholders to strengthen the pharmaceutical regulatory environment. She is responsible for guiding the organization’s regulatory team to successfully deliver its policy objectives and advocate for improved regulatory system strengthening.
Prior to joining IFPMA,Janis worked in quality assurance and regulatory compliance fora US-based multinational company that specializes in supplying custom value-added food products to a world leading food service and retail food brand.
Janis holds a Master of Science in Communication-Public Relations and a Bachelor of Science in Agriculture-Food Science
JOSEPH KABATENDE
Dr Joseph Kabatende, is a Technical Officer, Health Products and Regulatory Systems strengthening Specialist, responsible for strengthening regulatory systems in countries of the African Region, with a focus on countries in Eastern and Southern Africa.
Dr Kabatende is a pharmacist and holds a Master’s Degree in Pharmacy from the University of the Western Cape, Republic of South Africa, and a PhD in Medical Science (Clinical Pharmacology) degree from Karolinska University Hospital, Stockholm, Sweden.
Previously, Joseph worked as head of inspectorate and later as the Head of Pharmaceutical Services in the Ministry of Health, Kigali Rwanda (2000-2018). He spearheaded the designing and drafting of pharmaceutical sector policies, the law establishing Rwanda Food and Drugs Authority and actively participated in the drafting and finalization of the Africa model law on medical products regulation and its domestication in Rwanda. He was the national focal person on matters related to the AMA’s Treaty drafting and ratification processes.
From 2018 – 2022, Dr. Joseph was the Head of the Food and Drugs Assessment and Registration Department at Rwanda FDA.
During Covid-19 pandemic, Dr. Joseph was nominated to be part of the national vaccines manufacturing task force team to engage with BioNTech and other key partners for the establishment of the mRNA vaccines manufacturing facility in Rwanda. He played a key technical role in the drafting and finalization of the Rwanda BID for hosting AMA.
KERRINE OTTLEY
Kerrine Ottley is a Registered Pharmacist with a BSc in Pharmacy, and a Certificate in Regulatory Affairs (Medical Devices and Pharmaceuticals). As the Technical Officer at Caribbean Regulatory System (CRS) her responsibilities include:
Review medicine and vaccine dossiers, as per verification procedures based on regulatory reliance, and prepare related assessment reports.
Review post-approval changes, periodic safety update reports and risk management plans submitted to CRS for recommended medicines and vaccines.
Assist in developing procedures, tools, and templates for CRS operations, with reference to international guidance and standards.
Assist to maintain the CRS’ system of documentation, through updating of trackers, and filing of submissions and reports in the electronic system.
SÉRGIO CAVALHEIRO FILHO
Sérgio works with different IFPMA regulatory workstreams in the development of technical policy documents and implementation of related advocacy activities for regulatory system strengthening, manufacturing quality, and regulatory reliance. He also spearheaded IFPMA’s contribution toward the establishment of the Fight the Fakes Alliance.
Before joining IFPMA, Sérgio worked on late-stage drug formulation and development, and as a community pharmacist in Portugal.
Sérgio holds a Diploma in Advanced Studies in Management of Clinical Trials from the University of Geneva and a Master in Pharmaceutical Sciences from the University of Coimbra, Portugal.
SUSIE BRANIFF
Dr Susie Braniff is a Scientist in the Prequalification IVD Assessment Team at the World Health Organization. Prior to joining WHO in 2019, Susie was the Team Lead of the IVD Evaluations department at the National Reference Laboratory in Melbourne, Australia. This role encompassed product dossier review and laboratory performance evaluation of HIV and HCV diagnostics for the Australian Therapeutic Goods Administration and the WHO Prequalification program. While at NRL Susie was also a training facilitator for laboratory capacity strengthening and has worked with National Health Laboratories in many countries in the Asian region to support accreditation to ISO standards.
SUZETTE KOX
Suzette Kox is the first Secretary General of the International Generic and Biosimilar Medicines Association. She was nominated in January 2019, after 17 years in various functions at Medicines for Europe. Adopting a patient centric approach, IGBA works to improve patients’ access to quality-assured, safe and cost-effective medicines by promoting competition and enabling innovation in the pharmaceutical sector and sustainable economic contributions for all stakeholders. Before joining the generic medicines industry in 1992, Suzette followed a hospital and retail pharmacy career. Along with a degree in pharmacy (Paris), she holds a postgraduate diploma in anatomy-pathology (Cochin Port Royal, Paris).
VIVIANE ROBBRECHT
My name is Viviane Robbrecht and I am an Associate Director Regulatory Affairs for Johnson & Johnson. I am based in Belgium and I have spent my entire professional life in regulatory affairs. The last 19 years of my career I have taken up different regulatory roles in our Company, gaining expertise on registrations in African countries in the most recent years. Working with WHO FPI has become an integral part of my job. I graduated from the University of Antwerp with a Master’s degree in Biology and from the University of Hasselt with a Master’s degree in Applied Statistics.
RUTENDO T KADZUNGE
Rutendo Kadzunge is a Regulatory Officer in the Evaluations and Registrations (EVR) Division with the Medicines Control Authority of Zimbabwe (MCAZ). She joined the Authority in 2019 and has experience in the assessment of quality information of applications for registration of human allopathic medicines as well as BCS-based and additional strength bio-waiver applications and bioequivalence study data. Rutendo also evaluates applications for non-safety-related post-approval changes to registered products. Over the years, she has participated in several trainings and workshops offered by the World Health Organisation (WHO), CDER Small Business and Industrial Assistance, GHPP-PharmTrain project (BfArM), and AUDA-NEPAD Agency RCORE in Medicines Evaluation and Registration. She has a background in biotechnology and holds a certificate of competence from the University of Witwatersrand in collaboration with Pharmacometrics Africa in the assessment of clinical data. She is currently a biosimilar fellow with the GHPP-PharmTrain 2 project and the WHO-CRP focal person for Zimbabwe.
AMÉLIE DARMON
Dr. Amélie Darmon, a distinguished professional with a Ph.D. from the Institut Pasteur, Paris, specializes in health sciences, particularly Mycobacterium tuberculosis drug resistance. With a decade of experience, she's an expert in quality assurance for pharmaceuticals and Medical Devices, including In Vitro Diagnostic Devices. Since 2016, she's contributed to the Global Fund, initially as a Quality Assurance Specialist that included the management of the Expert Review Panel (ERP) process to improve access to essential medicines in LMICs for HIV, TB, and malaria. In June 2023, Dr. Darmon transitioned to a new role, focusing on policy and governance matters for global health access.
AZRI NASRUDDIN
Mr Azri Nasruddin graduated with a Bachelor of Pharmacy from the International Islamic University Malaysia and a Master in Medical Statistics from the Science University of Malaysia.
He started his career in 2008 as a regulatory pharmacist in the post-marketing department until 2018 and gained valuable experience and expertise in post-marketing activities.
Since 2018, he has been placed in the New Drug Product Section and is involved in evaluating new chemical entities for marketing authorization. He has been involved as the lead evaluator from NPRA in the ASEAN Joint Assessment (JA) collaboration.
LAURENT TSHIMPAKA KALALA
Dr Laurent Patern Tshimpaka Kalala is a pharmacist.
He has been worked as regulatory since 2005 with DRC-NRA.
He has been trained in GMP, Assessment in CTD format, Assessment of Clinical trials, GDP, and Benchmarking. He has conducted several GMP audit in China, India, Egypt, Malaysia and Pakistan.
Member of Zazibona Technical Working Group on drafting Guidelines of labeling & excipients;
WHO -CRP process focal person & Zazibona process focal person;
He is currently the head of Division of Registration at ACOREP (Congolese Pharmaceutical Regulatory Authority
KAREN LOFT
Dr Karen Loft is an organic chemist by training obtaining her PhD from the University of Melbourne, Australia. Karen has over 10 years’ experience at the Therapeutic Goods Administration in evaluation roles, predominantly pharmaceutical chemistry. In her 13 years at the TGA she has been a Principal Evaluator responsible for managing and training evaluation teams and, making decisions on new medicine approvals and variations. She has gained substantial experience in using reliance and recognition in the TGA’s assessments from these roles.
Karen now works in the TGA’s Regulatory Strengthening Program providing technical and regulatory strengthening assistance on a wide variety of matters including application management, risk-based decision making and reliance.
ALI ARALE ABDULLAHI
Dr Arale is a pharmacist and has a Master in Biotechnology, Innovation, and Regulatory Sciences.
He has over 20 years of experience in the Pharmaceutical industry including regulation of health products and technologies, Supply Chain, Quality assurance, and Quality control.
He is currently Ag. Chief Principal Regulatory Officer, Product Evaluation and Registration Department of Pharmacy and Poisons Board, and a focal person for WHO Collaborative Registration Procedures of the Board.
He is a quality assessor at the Pharmacy Board in Kenya, with good experience in dossier review, product information, post-approval changes/variations, and Good Manufacturing Practice (GMP) auditing/inspection for pharmaceutical products.
Additionally, Arale is an assessor at the EACMRH joint assessment process, he is passionate about improving access to essential quality, safe, and effective medicines and biologics, and medical devices primarily to the low- and middle-income countries (LMICs) in the East and Horn of Africa for better health outcomes.
LAURENCE DESCOURVIERES
Laurence Descourvieres is the Regulatory Affairs EMEA Associate Director at Abbott Rapid Diagnostics. She is a Doctor in Pharmacy (Lyon) and Masters in Regulatory Affairs (Paris XI).
She has over 15 years of experience in Regulatory Affairs; Pharmaceutical and IVD - GSK, Amgen, Chugai and Abbott since 2013 and Regional role for Africa, APAC, LATAM, Middle East, Russia, CIS and EU.
Key personal facts & Hobbies:
Lived in London and Singapore, now based in Switzerland. A Nature & travel lover. Rowing and cross country skiing.
SANDHYA VIJAY JADHAV
A Pharmacist from Pune University, Maharashtra, INDIA, with 21 years of total experience.
Currently working as a General Manager with M/s. Macleods Pharmaceuticals Limited, Mumbai since last 17 years in the department of Drug Regulatory Affairs
Responsible for Registration in WHO-PQ, APAC (Asean Pacific Region) and Institutional Business and various procurement Agencies like, UNICEF, Global Fund, Global Drug facility, IDA, UNFPA, CHAI Etc.
Current job responsibilities includes:
Submission of FPP, Technical Registration Dossiers, along with the satisfactory responses against Agencies queries towards registering the same in WHOPQ and APAC, Tender submission in different procurement Agencies (Technical Part).
Life Cycle Management of approved products, submission of Variations & Notifications.
Requalification or Renewal of the approved products.
Responsible for the providing technical support from initial stage of product development till Product Commercialization.
Technical support to Manufacturing Units and Business Development team.
Product Quality and Regulatory Compliances.
GIULIA DI PERSIO
Giulia Di Persio is a Global Regulatory Affairs Director for Viiv Healthcare.
She joined Viiv Healthcare in 2021 after spending several years in Johnson & Johnson and GSK working in Regulatory Affairs and supporting European regional development programmes first and global development programmes lately.
Giulia graduated in Environmental Toxicology from the University of Rome “La Sapienza” and holds a master’s degree in Pharmacy
GUDULA SABINA MPANDA
Ms. Gudula Sabina Mpanda is a Pharmacist (Bpharm) with Msc. Biotechnology Innovations and Regulatory Sciences of Purdue University USA. She is a Senior Medical Devices Officer under the Directorate of Medical Devices and In Vitro Diagnostics Control and works as an assessor for Medical Devices and IVDs product dossiers. She has 15 years’ experience in medical products regulations at TMDA on areas such as medicines dossiers assessment, manufacturing facility audits for medical devices (ISO 13485) and GMP for medicines, PMS and Vigilance of medical products. Furthermore, she serves as quality assurance and risk management coordinator for TMDA Medical Devices regulatory systems.
NAIRA ROMANOVA
Naira Romanova is the Head of Medicine Registration and Pharmacovigilance departments at scientific centre of drug and medical technology expertise after academician Emil Gabrielyan MoH Armenia(NMRA).
SAKENI HADEBE
Sakeni Hadebe has a Master of Science in Public Health and a Bachelor of Pharmacy
He is currently the Registration Officer-Human Medicines and WHO focal point person at Zambia Medicines Regulatory Authority
Work Experience: 10 years
Description:
Successfully completed Masters Science in Public Health of the University of Zambia and looked at Challenges of regulatory requirements on medicines registration in Zambia-Perception of locally based pharmaceutical companies.
Responsibilities:
Assessing of applications for registration of Human medicines for both quality part, non-clinical, clinical and bioavailability/Bioequivalence applications submitted in accordance with applicable WHO, ICH, FDA EU guidelines.
Focal point person for WHO-CRP
Corroborate with WHO PQTm team in the assessment of Human medicines
Participate in routine evaluating sessions under ZAZIBONA collaborative procedure in full CTD format. Actual evaluation and presenting the reports
Preparing technical committee summaries for products recommended for registration
Participate in ongoing regulatory meetings and updates to ensure that only current regulatory practices are implemented.
STEPHANIE CROFT
Stephanie Croft is a Chemist with a M.Sc. degree in Pharmaceutical Sciences. She currently working with WHO as a Technical Officer in the Inspection Services Group of the consolidated WHO Prequalification Team for Medicines, Vaccines, Devices and Diagnostics and Vector Control products.
Experienced in GMP, GCP, GLP and ISO 13485 Regulatory Inspections with over 8 Years of onsite inspections at the international level. With Health Canada’s Bureau of Pharmaceutical Sciences, was an assessor of the quality of generic medicines.
Has conducted over 100 inspections in 35 countries such as India, China and France and is currently responsible for the planning of inspections for her team.
NYASHA MAREGERE
Nyasha L. Maregere is a pharmacist currently working as a consultant in the Facilitated Product Introduction Team within the Regulation and Safety Unit in WHO Headquarters, providing technical support in the implementation of regulatory reliance and facilitated product introduction mechanisms such as the Collaborative Registration Procedure for medicines and vaccines.
Nyasha has over 11 years of experience in the pharmaceutical field, specifically in medicines regulation and international development, having previously worked at the Medicines Control Authority of Zimbabwe, as a medicines assessor; at the Botswana Medicines
Regulatory Authority as a Manager for human medicines registration and at GIZ SADC/Botswana as a Technical Advisor.
Nyasha holds a Bachelor of Pharmacy (Honours) and a Master of Clinical Pharmacology, from the University of Zimbabwe.
ANN OTTOSEN
Ann E. Ottosen, Senior Manager, Vaccine Centre, UNICEF Supply Division. Joined UNICEF in 2007, and has managed different product portfolios across the years from the new vaccines portfolio initially and was engaged in the development of the first Advance Market Commitment to secure early access to Pneumococcal vaccines, roll out of rotavirus vaccine; accepted the challenge to lead the Polio team for procurement and supply in 2014 across the global switch from tOPV to bOPV across 155 countries and introduction of IPV in 126 countries; adding Ebola and Malaria vaccines to the portfolio as they became available. Was in Sept 2020 tasked to build a team and lead UNICEF’s procurement and supply management of COVID-19 vaccines during pandemic. Before joining UNICEF, Ann worked for more than a decade with a government owned vaccine manufacturer, holding the last post as Director of Global Sales and Vaccine Procurement.
CHARLES PRESTON
Charlie Preston is a public health physician with experience in regulatory systems strengthening and access to quality medicines in low-and-middle-income countries. His career spans the US Food and Drug Administration, the World Health Organization/Pan American Health Organization (WHO/PAHO), and now the Bill and Melinda Gates Foundation. He is currently a senior program officer working across the foundation’s regulatory team, with a focus on major grants to WHO for regulation and prequalification, and the development of strategy and grants to address substandard and falsified medicines in Africa. He holds an MD from the University of Pennsylvania, an MPH from Johns Hopkins, and completed a preventive medicine residency at Johns Hopkins.
BEATRICE AYIM
A pharmacist and a drug regulatory officer with the Drugs and Nutraceuticals department of the Food and Drugs Authority, Ghana.
A proficient dossier assessor who is knowledgeable in both the quality and clinical aspects of medicines regulation.
JONATHAN UVIASE
Jonathan Uviase is a Chief Regulatory Officer and quality assessor for biologics at NAFDAC's Biologics, Vaccines and Medical Devices Registration Division. He has a Bachelor of Pharmacy degree from Ahmadu Bello University Zaria, Nigeria, and a master's degree in public health from University of Ilorin, Nigeria. He has worked as a community pharmacist with Osbud-K Pharmacy Limited and as a senior officer and medical detailer for reproductive health products with Society for Family Health. He joined NAFDAC in 2012 as a Senior Regulatory officer and was promoted to Chief Regulatory office in January 2022.
NTSETSELELE KAGO
Ntsetselele Kago is a Pharmacist with experience in Regulatory affairs specifically assessment or evaluation of the quality, safety, and efficacy data of applications for registration of medicines. She has experience in Regulatory affairs at national and international level. Her current scope of work includes registration of human medicines to ensure that they are safe, efficacious and of good quality. Prior to her Regulatory work, she has worked in government facilities in the Pharmaceutical sector.
For more than 12 years, she has served as a medicines regulator in Botswana. She started regulatory work under the Ministry of Health as a Principal Pharmacist until she joined the Botswana Medicines Regulatory Authority (BOMRA) in 2018 during its inception as a Dossier Assessor under the Human Medicines Unit. In March 2022 she became a Manager for the Human Medicines unit at BOMRA the position she holds till today.
Ntsetselele holds a Diploma in Pharmacy, a Bachelor’s Degree in Pharmacy from Rhodes University in South Africa, and an MSc in Pharmacy Administration and Policy Regulation from the University of Western Cape, South Africa.
SUNDAY KISOMA
Sunday Kisoma is a pharmacist who currently works as a Consultant at the Facilitated Product Introduction (FPI) Team at WHO Headquarters. In this role he supports the work facilitated product introduction which is established to facilitate the timely introduction of quality assured, safe and efficacious medical products in the Member States. Specifically, he supports the Collaborative Registration Procedure (CRP) of WHO Prequalified medicines, vaccines and IVDs as well as Joint Assessments in regional economic communities (RECs).
He previously worked as a regulator in Tanzania, where he held various positions at the Tanzania Medicines and Medical Devices Authority (TMDA), specifically as an assessor of human and veterinary medicines, Manager for Quality and Risk Management (QMS) and until recent where he worked as the Manager for Medical Devices and Diagnostics Control. Between 2013 – 2021 he served as a Temporary Adviser to the WHO Prequalification of medicines team, where he worked as an Assessor of quality of finished pharmaceutical products (FPPs) applied for WHO prequalification.
Sunday holds a Bachelor of Pharmacy (BPharm) and Master of Public Health (MPH) degrees from Muhimbili University of Health and Allied Sciences, Tanzania. He also holds a Master of Science (Msc) degree in Pharmacy Policy and Regulation from University of the Western Cape (UWC), South Africa. Mr. Kisoma also holds a Postgraduate Diploma in Industrial Pharmacy from Purdue University, USA.
ANA RITA NOGUEIRA
Ana Rita is a Consultant in the WHO Facilitated Product Introduction Team (FPI) at WHO Headquarters.
Before joining WHO, Ana Rita spent several years in the private sector, specifically in products market analysis, project planning and management and budgeting. She also worked in regulatory framework of cosmetics, medical devices, and chemical products, with regards to compliance to EU and international markets requirements.
During her career she worked as a Public Health Professor and in several research centers (CICbioGUNE in Spain, INSERM in France and in MBL, UK).
Ana Rita is a Biologist by training and she holds a PhD in Molecular Biology, specialized in HIV inhibitors, from University of Algarve. She was part of the MIT Portugal Program where she attended courses on bioengineering of biomedical devices. She also holds a Master in Economy and Management of Resources from Nova School of Science and Technology and currently pursuing a Master in Pharmacy with a specialization in Drug and Medication Management.
DORINA PIRGARI
Dorina Pirgari – pharmacist by training is a technical officer from the Access to Medicines and Health Product Team (AMP) within the Division of Country Health Policies and Systems (CSP) in WHO EURO. In this capacity, she is responsible for the implementation of the WHO strategies for strengthening and capacity-building for the national regulatory authorities in EURO MS, she worked on the same subject with the Immunization team as a consultant responsible for vaccine regulation and provided country support on the same subject in VietNam WHO country office.
Before joining WHO in August 2015 she was responsible for regulatory strategy and policy of the Medicines and Medical Devices Agency (MMDA). Dorina started her carrier as a GMP/GDP/GPP inspector in the same agency.
SANDRA LIGIA GONZÁLEZ
Sandra Ligia has hold diverse management and directive positions at Regulatory Affairs, Sales, Marketing, Business Development and R&D for various countries in Latin America and Turkey. Her experience covers from public institutions such as the National Institute of Nutrition in Mexico, to Global Companies such as Baxter, Danone and Johnson & Johnson Medical Devices where she held a Regulatory Affairs Senior Manager Position for Colombia and Mexico; she led the Regulatory Affairs Committee at AMID (Mexican Association of Innovative Medical Devices Industry) in 2016 and 2017. She acted as Chair of AdvaMed’s Latin American Regulatory Affairs work since 2017 and is currently serving as Executive Secretary Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector, which unifies its 18 largest industry bodies in the Western Hemisphere and she also leads the Tier 2 Component of the Medical Device Regulatory Convergence, COVID-19 Project (MDRC), under the USAID – ANSI Standards Alliance initiative, which encompasses work with various countries in Latin America, Africa and Asia.
Sandra holds a bachelor’s Degree in Nutrition and Food Science and a Diploma on Product/Brand Management, both by Universidad Iberoamericana and a Diploma on Enterprise Top Management by IPADE (Instituto Panamericano de Alta Dirección de Empresas).
