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)