Please see list of confirmed speakers below.

7:30 am

Attendee Arrival & Check-in

8:00 am – 8:20 am

Opening Ceremony

Ms. Heather Lanigan, Regional Director for Sub-Saharan Africa, U.S. Trade and Development (USTDA)

8:20 am – 9:35 am

Lessons Learned from EAC Harmonization Implementation – Where to Next?

The EAC region has made great progress in implementing regulatory harmonization in the region. Insights will be shared on the journey from inception to now as well as lessons learned for other regions in Africa and beyond as well as the role and contribution of various stakeholder groups.


9:35 am – 10:00 am

Coffee break

10:00 am – 11:15 am

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

Harmonized policies and guidelines are in place in many of the regions in Africa. However, the fact that national legislation for the regulation of medicines already exists cannot be ignored. Countries will have to develop national implementation plans to enable their transition to harmonized regulatory policies and guidelines. These approaches will differ from country to country. This session will explore practical approaches and best practices to transitioning to harmonization.

11:30 am - 1:00 pm


1:00 pm - 2:30 pm

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

The myriad of discussions and research on regulatory convergence and reliance models have focused predominantly on high level policies that need to be implemented to create the foundation for harmonization. However, operationalizing harmonization could prove challenging and complex. This session will focus on regulator and private sector perspectives on some of the progresses and challenges in implementation, including examining Subregional harmonization implementation – progresses and challenges (discussion between the private and public sectors on best practices).

3:00 pm – 4:30 pm

Networking Reception


  • 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. Jackson Kiberenge, Tanzania Medicines, and Medical Devices Authority (TMDA)
  • Dr. Rebecca Manani, National Quality Control Laboratory Kenya (NQCL)
  • Mr. Maxwell Marx, Senior Policy and External Relations Affairs, PEPFAR
  • Dr. Meshack Odenyo, Senior Advisor Regulatory Systems Strengthening Vaccine Manufacturing (STA RSS-VM), USAID
  • 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)


  • Ms. Angeline Achoka, Senior Regulatory Affairs Manage, AstraZeneca
  • Dr. Sara Agak, Operations Director and Company Pharmacist, Laborex Kenya Limited
  • Ms. Hala Abu Ghazalah, Head of Regulatory Sciences, Africa Middle East, Russia, Turkey and CauCAR, Pfizer
  • Dr. Kanyenje Gakombe, Chair, Kenya Healthcare Federation
  • Mr. Vinod Guptan, CEO, MedSource Group
  • Dr. John Mwangi, Head of Regulatory Affairs, Bayer
  • Mr. James Nyamosi, Associate Partner, Workforce Productivity Centre
  • Dr. Winnie, Ng'ang'a-Mwangi, Chairperson,Kenya Association of Pharmaceutical Industry (KAPI)
  • Mr. Victor Ogalo, Deputy Chief Executive Officer, Competitiveness & Operations, Kenya Private Sector Alliance (KEPSA)
  • Mr. Johnpaul Omollo, Senior Policy and Advocacy Officer, PATH
  • Mr. Evans Sagwa, Director Eastern & Southern Africa, U.S. Pharmacopeia (USP)