Tuesday, November 14, 2023

Importance of Distinct Regulatory Frameworks for Medical Devices and Medicines 

Laird Treiber 
Senior Advisor 
Corporate Council on Africa (CCA)


Laird Treiber is a recognized leader and active consultant on international trade and investment issues.  He was previously a career member of the Senior Foreign Service in the State Department, where he worked as an Economic Officer for more than 30 years on the full range of international economic and commercial issues, with a specific focus on identifying and resolving trade and investment barriers.  Laird has extensive experience in promoting trade and investment ties with Africa, including successfully resolving AGOA related trade disputes and engaging U.S. companies on the opportunities presented by the African Continental Free Trade Agreement.  He worked most recently as the State Department’s Senior Liaison for Prosper Africa, the Administration’s program to promote trade and investment between the U.S. and Africa. 


Jackson Kiberenge
Tanzania Medicines and Medical Devices Authority (TMDA)


Steve Kipkoti 
Senior Regulatory Affairs Specialist 
Medtronic & MEDAK Chair 

Philana Mugyenyi
Director, Government Affairs & Market Access 
GE Healthcare 

Philana Mugyenyi is GE HealthCare’s Director of Government Affairs and Market Access (SSA), responsible for leading relations with governments, international organizations, authorities, and trade associations across the region. Philana represents GE HealthCare as a Director on the Board of the American Chamber of Commerce Kenya. Philana is a New York attorney-at-law and brings over 15 years’ experience in government and institutional affairs in Africa, working with corporates and the World Bank Group where she provided advisory on private sector development and governance.

Dr. Kenneth Otieno
Managing Director, Africa
Gradian Health Systems

As Managing Director for Africa, Kenneth Otieno, manages Gradian’s field service needs across the African continent. In this role, he works closely with Gradian’s network of biomedical technicians and engineers to support them with product training, service responses, and the technical understanding of Gradian’s products. Prior to joining Gradian, Kenneth spent eleven years at Joint Medical Stores (JMS), a medical device distribution company in Kampala, Uganda, as their senior biomedical service engineer. Through JMS’s work distributing Gradian’s UAM, Kenneth became one of the world’s experts on the installation, maintenance, and servicing of the UAM and now brings that expertise to all Gradian’s customers.


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

Private Sector Recommendations on How to Advance Regulatory Convergence and

Reliance for Medical Devices 

Dr. Kayenje Gakombe
Kenya Healthcare Federation


Dr. Kanyenje Gakombe is the current chairman of Kenya Healthcare Federation, Chief Executive Officer, Metropolitan Hospital. He is also a Director at MedSource Group Ltd, a founding member and past Vice Chair of KHF, the first healthcare governor in KEPSA, a past Member of the National Economic & Social Council (NESC) and Chairman of Kenya Association of Hospitals (KAH). Besides being involved in advocating for health to be prioritized as part of the Big 4 Agenda, he was also instrumental in the initiation and development of the Standard Service Agreement and Claim Form between Association of Kenya Insurers, and Kenya Association of Hospitals which was adopted in October 2006. 

Thomas Kisimbi
Project Leader
Boston Consulting Group (BCG)

With over 17 years of experience covering all aspects of Global Health, Thomas Kisimbi is a PPL at Boston Consulting Group (BCG), where I apply my expertise in global and public health, universal health coverage, primary healthcare, and community health systems to solve complex challenges and create social impact. He holds an MA in International Development & Policy from the University of Chicago, an MBA from MIT, an MPA from Harvard Kennedy School, and undergraduate degrees from the University of Pennsylvania. He has served as Senior Advisor to Cabinet Ministers in multiple governments to advance their ambitious strategic health plans. In Kenya, he was Senior Advisor to the Cabinet Secretary for Health working with with the Office of the President on Universal Health Coverage advancing to the President's Big 4 Agenda.


Steve Kipkoti 
Senior Regulatory Affairs Specialist 
Medtronic & MEDAK Chair 

Dr. Christopher Odero
Regulatory Policies and Intelligence Manager

As Roche Diagnostics' Regulatory Policy and Intelligence Manager in Africa, I collaborate with stakeholders and regulators worldwide to influence and refine regulatory practices for medical devices and diagnostics across the continent. My primary mission involves facilitating the adoption of international standards and best practices through reliance and recognition mechanisms, as well as promoting regulatory harmonization and convergence. I've also gained experience working with international organizations, supporting policy and access initiatives in Africa. My greatest satisfaction comes from contributing to initiatives that ensure life-saving interventions reach those who need them most, particularly in Africa.

Maxwell Okello
American Chamber of Commerce, Kenya

Maxwell Okello is an accomplished trusted advisor and well-rounded professional with compelling success working at a senior executive level. He is the current Chief Executive Officer of the American Chamber of Commerce (AmCham) Kenya, a business network organisation that is at the intersection of public policy and the private sector - focused on creating economic opportunity and transforming lives through two-way trade & investment between Kenya and USA. Maxwell embodies a unique combination of experience as startup founder, management consultant and nonprofit leader, enabling intimate understanding of multiple perspectives, exposure to a broad array of challenges and the ability to creatively solve complex problems across business contexts. He has deep experience building mutually reinforced networks to catalyze business growth, with the ability to bridge public-private sector perspectives.

Boniface Orang'i
Head of Operations and Customer Service 

An experienced business leader who is passionate about inspiring great talent, creating a performance culture and creatively aligning talent with culture to ultimately deliver on business strategy. Boniface has a wealth of leadership expertise in P&L leadership, driving operational excellence, a firm grasp of global business dynamics and doing business across Africa. He has a proven record of driving action oriented, impactful engagement across all levels of an organisation and thriving in a matrixed multinational, multi-cultural environment. Boniface is currently the Head of Operations & Customer Service for East Africa at Philips.

Joseph Rieras 
The United States Food and Drug Administration

Mr. Joseph Rieras is the Director of FDA’s Office of Trade and Global Partnerships.  Mr. Rieras oversees FDA participation in international trade negotiations involving regulatory matters. He also manages FDA participation in multilateral negotiations at the World Health Organization.  Prior to joining FDA, Mr. Rieras served as an Associate General Counsel at the Office of the U.S. Trade Representative, in Washington, DC.  Mr. Rieras also served in Geneva, Switzerland as a Legal Advisor to the U.S. Mission to the World Trade Organization.  Before entering public service, Mr. Rieras was an international trade lawyer at a major law firm.



Paulyne Wairimu
Pharmacy and Poisons Board Kenya