Monday, November 13, 2023 

Lessons Learned from EAC Harmonization Implementation – Where to Next? 

Dr. Douglas Shaffer 
Associate Director​
The United States Food and Drug Administration


Dr. Douglas Shaffer is Associate Director in the Office of Global Policy and Strategy (OGPS) at the U.S. FDA. He leads OGPS global health/strategic initiatives and serves as Senior Advisor on global policy matters, including equitable access to quality medical products.  Doug has over 20 years of experience in Africa and lived in East Africa almost two decades.  Previous positions include Chief Medical Officer at the Office of the U.S. Global AIDS Coordinator and Health Diplomacy, Director of U.S. Centers for Disease Control and Prevention-Rwanda, and Clinical Trials Unit Principal Investigator of the National Institutes of Health AIDS Clinical Trials Group.

Angeline Achoka
Senior Regulatory Affairs Manager 
Astra Zeneca 

Angeline Achoka is a  Quality Assurance Manager, Operations and Regulatory Affairs Head with 14+ years of extensive experience and significant executive leadership accomplishments in operations management, quality assurance, human resource and cross-functional team management. She has hands-on leadership skills in increasing efficiency, improving infrastructure, and establishing effective business practices for staffing, operations and client service satisfaction. Ms. Achoka possesses outstanding leadership expertise in all facets of operations including training, operational planning, and inventory control while ensuring compliance with corporate policies and procedures. 

Hala Abu Ghazalah
Head of Regulatory Sciences, Africa, Middle East,
Russia, Turkey, and CauCAR

Hala has over 25 years of experience in Regulatory Affairs, External Affairs and Commercial having supported several regions and several multi-national companies with increasing roles and responsibilities and several leadership roles. Pharmacist by education, licensed in both UAE and Canada. 


Jackson Kiberenge
Tanzania Medicines and Medical Devices Authority (TMDA)


Dr. Winnie Ng'ang'a-Mwangi
Kenya Association of Pharmaceutical Industry (KAPI) 

A highly motivated thought leader in the Healthcare industry with 15+ years’ experience in Regulatory Science, Government Affairs, Global Health, Market Access, Advocacy and Policy and product and program development for Health Products and technologies including medical devices and IVDs. Dr. Ng'ang'a-Mwangi has heightened private sector industry voice in Africa by building and strengthening relationships with senior stakeholders in government agencies, multilateral organizations such as African Union (AU), GIZ, IFC, WHO,diplomatic corps, regional trade associations and elected as industry Trade Association Chairperson.


Salvator Sindayigagya
Director of Human Medicines 
The Burundian Regulatory Authority for Medicines for Human Use and Food (ABREMA) 



Dr. Fred Siyoi 
Pharmacy and Poisons Board 


From Policies & Guidelines to Practice & Implementation - what will it take for countries
to transition to harmonization? 

Dr. Evans Sagwa 
Director, Eastern & Southern Africa
U.S. Pharmacopeia


Dr. Evans L. Sagwa, (BPharm, MBA, MPH, PhD) is a pharmaceutical management expert and public health practitioner with over 20 years’ experience in strengthening pharmaceutical and health systems; including, pharmaceutical policy and regulation. Dr Sagwa currently leads USAID’s Promoting the Quality of Medicines Plus (PQM+) program in Eastern and Southern Africa, based in Nairobi. Previously, he was the Regional Technical Strategy Lead for the USAID Medicines Technologies and Pharmaceutical Services (MTaPS) program, for Eastern, Central and Southern Africa. He’s supported programs in Kenya, Rwanda, Ethiopia, Tanzania, Uganda, South Sudan, Democratic Republic of Congo, Madagascar, Mozambique, Lesotho, Eswatini and Namibia.

Dr. Sara Agak
Operations Director and Company Pharmacist 
Laborex Kenya Limited 

Sara Agak is a Pharmacist by profession, currently working as the Operations Director and Company Pharmacist at Laborex Kenya Limited - a leading importer and distributor of medicines and medical devices. Previously, Sara worked in various private hospitals as a Pharmacist in various capacities. She graduated from Nelson Mandela Metropolitan University (South Africa) with a BPharm (Hons) and is currently doing an MBA and a Masters in Health Systems Management. Sara is passionate about health and healthcare and strongly believes in bringing quality medicines closer to the people. She also strongly believes in empowering the younger generation through mentorship and coaching. Her objective is to see more Pharmacy practitioners take on leadership roles in the management of health systems.


Laurent Patern Tshimpaka K. 
Regulatory Affairs HOD
Congolese Pharmaceutical Regulatory Authority (ACOREP)



Dr. Rebecca Manani 
Head, Client Services and Director's Representative 
National Quality Control Laboratory Kenya (NQCL)


James Nyamosi
Associate Partner 
Workforce Productivity Centre 

James is a workforce strategy expert with over 18 years experience in global health and management consulting. He is currently an Associate Partner at Workforce Productivity Centre. He provides advisory services to government, private sector, bilateral, and multilateral institutionsJames has experience in strengthening National Regulatory Authorities (NRAs) in sub-Saharan Africa with an interest in workforce development. He has supported NRAs to adopt WHO global competency framework for regulators of medical products. He holds a master’s degree in HRM and is currently writing his PhD thesis on modelling health workforce productivity in the public sector.



Makomani Siyanga
Acting Director-General
Zambia Medicines Regulatory Authority



Private Sector Recommendations on How to Advance Regulatory Convergence and Reliance for Medicines

Johnpaul Omollo
Senior Policy and Advocacy Officer 


Johnpaul Omollo is a versatile, analytical and hard-working Public Health Professional with practical hands-on approach,excellent negotiation and problem solving skills and swiftly identifies the root of any problem and develops an effective solution. Proven ability to manage and complete projects to the highest standard, with a meticulous attention to detail and within agreed deadlines.



Vinod Guptan
MedSource Group 

Vinod Guptan is Chief Executive Officer of MedSource, a Kenyan group purchasing organization for medicines, medical products and technologies, wholly owned by Management Sciences for Health. Vinod has over 30 years of experience in the pharmaceutical industry, having led operations, sales, marketing, strategic planning and distribution for companies across Africa, Latin America, the Middle East and Southeast Asia. Before joining MedSource, Vinod was General Manager – Sales & Marketing of Surgipharm, a Kenyan distributor of pharmaceutical, vaccines, surgical, medical equipment and over-the-counter products. Vinod has been involved in several successful start-ups throughout his career, including re-launching Abacus Pharma in Kenya to strengthen its production capability of IV fluid and branded generic products in East Africa.




Juliet Konje
Senior Programme Manager, Africa Partnerships & Growth 
U.S. Pharmacopeial Convention

Juliet Konje, a seasoned pharmacist with over a decade of experience in Africa's pharmaceutical landscape, with expertise in Manufacturing, Quality Assurance, Regulatory Compliance, and Project Management. She currently is the Senior Manager for Africa Partnerships & Collaborations at US Pharmacopeia. Her background includes senior roles at Marie Stopes International, GlaxoSmithKline, and Dawa Life Sciences. She has made significant contributions as a Board member of National Quality Control Laboratory, Federation of Kenya Pharmaceutical Manufacturers and served in various technical health committees. Juliet holds a Bachelor of Pharmacy, MBA, and further qualifications in Leadership and Management in Health.






Maxwell Marx 
Senior Policy and External Relations Affairs 




Dr. John Mwangi
Head of Regulatory Affairs 

John currently works at Bayer as Head of Regulatory Affairs responsible for East & West Central Africa Region based in Kenya, responsible for Pharmaceuticals and Consumer Health divisions and doubling up as Regulatory Policy & Intelligence Lead for EEMEA Region. He has previously held different roles in Pharmacovigilance and Quality Control within the Pharmaceutical Industry. He has been an active member of several industry associations including KAPI (Kenya Association of Pharmaceutical Industry) where he has served as member since 2013 including as past executive secretary and continues to serve in in various committees within KAPI and as Board Member. 




Dr. Meshack Oiro Odenyo
Senior Advisor Regulatory Systems Strengthening Vaccine Manufacturing (STA RSS-VM)

Dr. Meshack Oiro Odenyo is an accomplished pharmaceutical professional consultant from Nairobi, Kenya, with a rich 16-year career focused on the delivery of quality-assured, affordable, and safe medical products and services. In his previous role as a Senior Technical Advisor for Regulatory Systems Strengthening in Vaccine Manufacturing at MSH MTaPS Program-USAID, he provided critical technical assistance to government ministries and national regulatory authorities to strengthen pharmaceutical systems. These included procurement, supply chain, information, regulatory systems, and the management of medical health products and technologies, with a focus on Registration, Supply Chain, Clinical Trials, and Pharmacovigilance/ Post-market surveillance. 




Victor Ogalo 
Deputy CEO, Competitiveness and Operations
Kenya Private Sector Alliance (KEPSA)

Victor Ogalo is an Economist and Policy Entrepreneur with over 15 years of professional work experience, currently serving as the Deputy Chief Executive Officer, in charge of Competitiveness and Operations at KEPSA. Prior to that, Ogalo was Head of Policy Research Analysis & Public-Private Dialogues at the KEPSA from 2017 to 2021. In these roles, he has led thought leadership development on public policy, legislative and regulatory issues affecting businesses in Kenya and within East Africa. He was instrumental in the planning and organization of Presidential Roundtable, Speaker’s Roundtable, Ministerial Stakeholder Forums and the EAC Regional Forums targeting reforms to improve the local and regional business environment, competitiveness, and national development agenda. Ogalo began his career in the Ministry of Planning and National Development before joining CUTS International as Trade and Development Officer and Regional Coordinator for the EAC-EU Economic Partnership Agreements between 2006 and 2012.