AGENDA
Please see list of confirmed speakers below.
8:45 am
Attendee Arrival & Check-in
9:30 am - 9:40 am
Opening Remarks
USTDA
9:40 am- 11:00 am
Panel One | Importance of Distinct Regulatory Frameworks for Medical Devices and Medicines
Moderator:
Mr. Laird Treiber, Senior Advisor, Corporate Council on Africa (CCA)
Speakers:
Mr. Jackson Kiberenge, Tanzania Medicines, and Medical Devices Authority (TMDA)
Mr. Steve Kipkoti, Senior Regulatory Affairs Specialist, Medtronic & MEDAK Chair
Ms. Philana Mugyenyi, Director, Government Affairs & Market Access, GE Healthcare
Dr. Kenneth Otieno, MD, Africa, Gradian Health Systems
Mr. Laurent Patern Tshimpaka K. Regulatory Affairs HOD, Congolese Pharmaceutical Regulatory Authority (ACOREP)
11:00 am - 11:20 am
Coffee Break
11:20 am – 12:00 pm
Device Demos (Medtronic)
12:00 pm - 1:45 pm
Closing Session - Private Sector Recommendations on How to Advance Regulatory Convergence and Reliance for Medical Devices
Moderator:
Dr. Kanyenje Gakombe, Chair, Kenya Healthcare Federation
Lead Respondents:
Mr. Thomas Kisimbi, Project Leader, Boston Consulting Group (BCG)
Mr. Steve Kipkoti, Senior Regulatory Affairs Specialist, Medtronic & MEDAK Chair
Dr. Christopher Odero, Regulatory Policies and Intelligence, Roche
Mr. Maxwell Okello, CEO, AmCham Kenya
Mr. Boniface Orang'i, Head of Operations & Customer Service, East Africa, Philips
Mr. Joseph Rieras, Director, U.S. Food and Drug Administration (FDA)
Ms. Paulyne Wairimu, Medical Devices and IVD sections, Pharmacy and Poisons Board Kenya (PPB)
1:35 pm – 2:35 pm
Closing Networking Lunch
CONFIRMED U.S. & AFRICAN GOVERNMENT REGULATORS
- Mr. Joseph Rieras, Director, U.S. Food and Drug Administration (FDA)
- Mr. Tshimpaka Kalala Laurent Pattern, Head of Registration Division, Congolese Pharmaceutical Regulatory Authority (ACOREP)
- Mr. Douglas Shaffer, Director, The U.S. Food and Drug Administration (FDA)
- Mr. Salvator Sindayigaya, Pharmacist, Director of Human Medicines, The Burundian Regulatory Authority for Medicines for Human Use and Food (ABREMA)
- Mr. Makomani Siyanga, Director General, Zambia Medicines Regulatory Authority (ZAMRA)
- Dr. Fred Siyoi, CEO, Pharmacy and Poisons Board Kenya (PPB)
CONFIRMED SPEAKERS
Moderator:
Mr. Laird Treiber, Senior Advisor, Corporate Council on Africa (CCA)
Speakers:
Mr. Jackson Kiberenge, Tanzania Medicines, and Medical Devices Authority (TMDA)
Mr. Steve Kipkoti, Senior Regulatory Affairs Specialist, Medtronic & MEDAK Chair
Ms. Philana Mugyenyi, Director, Government Affairs & Market Access, GE Healthcare
Dr. Kenneth Otieno, MD, Africa, Gradian Health Systems
Mr. Laurent Patern Tshimpaka K. Regulatory Affairs HOD, Congolese Pharmaceutical Regulatory Authority (ACOREP)
Moderator:
Dr. Kanyenje Gakombe, Chair, Kenya Healthcare Federation
Lead Respondents:
Mr. Thomas Kisimbi, Project Leader, Boston Consulting Group (BCG)
Mr. Steve Kipkoti, Senior Regulatory Affairs Specialist, Medtronic & MEDAK Chair
Dr. Christopher Odero, Regulatory Policies and Intelligence, Roche
Mr. Maxwell Okello, CEO, AmCham Kenya
Mr. Boniface Orang'i, Head of Operations & Customer Service, East Africa, Philips
Mr. Joseph Rieras, Director, U.S. Food and Drug Administration (FDA)
Ms. Paulyne Wairimu, Medical Devices and IVD sections, Pharmacy and Poisons Board Kenya (PPB)