Sensitization of National and Regional Stakeholders for advocating Regulatory Controls for Medical Devices and in vitro diagnostics

Sensitization of National and Regional Stakeholders for advocating Regulatory Controls for Medical Devices and in vitro diagnostics

 

9-10 February 2021

Time (GMT)

Agenda

Time		Sessions	Responsibility
From	To
		Opening Session Moderator	WHO AFRO
		Day 1
11.00	11.15	Welcome and opening remarks	Petra Doerr, WHO/REG
11.15	11.30	Introductions and objectives	Samvel Azyatan, WHO/REG
11.30	11.45	AMDF – Roles and responsibilities	Paulyne Wairimu (AMDF)
11.45	12.00	ASLM perspective on a need for collaboration between NRAs and national laboratories.	Anafi Mataka (ASLM)
12.00	12.20	Principles for Regulation of medical devices including in vitro diagnostic medical devices based on WHO GMRF	Agnes Kijo (WHO)
12.20	12.35	AMDF Survey results	Paulyne Wairimu (AMDF)
12.35	13.00	Overview of WHO prequalification (Focus on Performance evaluation)	Sussie Branif (WHO-PQ)
13.00	13.10	BREAK
13.10	13.25	Regional overview on regulation of medical devices and in vitro diagnostics– where are we and future plans	WHO AFRO
13.25	13.45	Introduction to WHO reliance concept and facilitated regulatory pathways	Marie Valentine WHO/REG
13.45	14.00	Discussion	ALL
		Day 2
11.00	11.30	Regulation of medical devices during emergencies Emergency assessment and Use listing procedure: the case of COVID-19	Willy Urassa, WHO Consultant
11.30	12.00	Countries experience in the collaboration between NRAs and Laboratories in regulation of medical devices including IVDs	TBD
12.00	13.00	Approaches in country coordination in the regulation of medical devices including in vitro diagnostics (Discussion on scenarios and approaches)	Paul Tanui (AUDA-NEPAD)
13.00	13.30	Summary of recommendations and action points.	Agnes Kijo/Willy Urassa, WHO Consultant
13.30	13.40	Closing Remarks	WHO/ASLM/AUDA-NEPAD