The Medical Device Regulatory Convergence (MDRC) Project held a training workshop on Good Regulatory Practices & Technical Competencies in Nairobi Kenya from 22 to 24 August 2023 together with the Pharmacy and Poisons Board (PPB) & the regulated sector. The aim of the workshop was to build joint knowledge about Good Regulatory Practices (GRP) to strengthen the medical device regulatory sector in Kenya.
Agenda
Day 1 – 22 August 2023
Recording
Presentations
Overview of regulation of Medical Devices and IVDs – Paulyne Wairimu – Pharmacy and Poisons Board (PPB), Kenya
Overview of Medical Device Convergence Project – Prof. David Wangombe – MDRC
The WHO Global Model Regulatory Framework for Medical Devices Including IVDs – Agnes Sitta Kijo – World Health Organization (WHO)
Introduction and Overview on Good Regulatory Practices (GRPs) – Marina Carvalho (Ph.D.) – MDRC
Good Regulatory Practices in the Regulation of Medical Products – Maureen Njeri – Advocate, Kenya
Guideline for development, review and approval of regulatory instruments – Kibet Kisorio – Pharmacy and Poisons Board (PPB), Kenya
Implementation of good regulatory practices, foundational principles and applications in FDA rulemaking – Kristan Callahan – U.S. Food and Drug Administration (USFDA) – United States
Implementation of a quality management system for the regulatory processes of a national regulatory authority – Nancy Collazo-Braier, PhD (USFDA)
Day 2 – 23 August 2023
Recording
Presentations
Overview of Medical Devices – Fatemeh Razjouyan – Medtronic
IVDs – Overview – Steve Kipkoti/Asmaa Aswad – Roche
Risk Classification of IVDs – Rama Sethuraman – Health Sciences Authority (HSA), Singapore
Risk Classification Rama of medical devices – Rama Sethuraman – Health Sciences Authority, Singapore
Risk Classification of Medical Devices and IVDs – Domestic Regulation PPB Guidelines – Solomon Koech – Pharmacy and Poisons Board (PPB), Kenya
Day 3 – 24 August 2023
Recording
Presentations
International Standards, Their Role in the Regulation of Medical Devices – Amanda Benedict – Advancing Safety in Health Technology – Association for the Advancement of Medical Instrumentation (AAMI)
Role of Harmonized Standards in Promoting Manufacture and Trade of Medical Devices and Equipment in Africa – Reuben Gisore – African Organization for Standardization (ARSO)
Reliance applied to Medical Devices & IVDs – International References and Experience of National Regulatory Authorities – New Regulation on GRelP – Sunday Kisoma – WHO
Reliance applied to Medical Devices & IVDs – International References and Experience of National Regulatory Authorities, Wong Woei Jiuang – Health Sciences Authority (HSA), Singapore
Reliance applied to Medical Devices & IVDs International References and Experiences of National Regulatory Authorities, John Jamieson – Therapeutic Goods Administration (TGA), Australia
Reliance applied to Medical Devices & IVDs – International References and Experience of National Regulatory Authorities – MDSAP – Augusto Geyer – Brazilian National Health Regulatory Agency (ANVISA)
Reliance applied to Medical Devices & IVDs – International References and Experience of National Regulatory Authorities, Augusto Geyer (ANVISA)
International Standards Practical Application by National Regulatory Authorities and Manufacturers – US FDA, S-CAP – Scott Colburn/Terry Woods – USFDA
International Standards Practical Application by National Regulatory Authorities and Manufacturers – Local Manufacturer – Roneek R. Vora – Revital, Kenya
Kenya standards and conformity assessment for medical devices – Lucy Ikonya – Kenya Bureau of Standards (KEBS)
Practical application of international standards – Jeff Eggleston – Medtronic
