Mary has a Bsc in Pharmaceutical Sciences and Technology from Maseno University, and a post graduate Diploma in Public Health from Kenyatta University. She has extensive hands-on experience in the Pharma manufacturing industry and over 7 years of experience in regulatory affairs and Quality Assurance. She is the current Vice Chair for MEDAK(Medical Technology Industry Association of Kenya) and member of the regulatory and Trade committee. She has been with Cepheid since 2020 and currently holds the role of Senior Regulatory Affairs Specialist over East, West, and North Africa

 

Abdelrahman is a distinguished Regulatory Affairs Team Leader with a career spanning over 11 years, demonstrating excellence in diverse sectors such as medical devices, pharmaceuticals, nutraceuticals, and cosmetics. His exceptional track record extends beyond Egypt, encompassing a history of successful product registrations across global markets in Africa, GCC, and the LEVANT region.

 

His commitment to excellence is further underscored by his prestigious ISO 13485:2016 internal auditor certification and his leadership in spearheading intricate certification projects within the medical device sector.

 

He adeptly ensures organizational compliance while optimizing registration processes, consistently empowering 40+ manufacturers to expand their global presence and streamline their operations.

 

 

The attainment of an MBA degree has equipped Abdelrahman with a strategic mindset and a broader perspective, significantly enhancing his effectiveness as the Regulatory Affairs Team Leader.

Doctor Saida Foughalia Fridi, Deputy Director of Scientific Documentary Evaluation of Medical Devices at the National Agency for Pharmaceutical Products (ANPP), and former head of medical device  vigilance at the National Center for Pharmacovigilance and Material Vigilance (CNPM).

• Emmanuel Emori Armon is a pharmacist and a public health professional of twenty-three (23) years of experience in diverse areas of pharmaceutical regulatory affairs. The foremost thirteen (13) years of his career in NAFDAC was in the Investigation and Enforcement Directorate, where he headed the Cybercrime and Miscellaneous Offences (CMO) Unit charged with the responsibility of  strengthening and re-positioning the Directorate’s Activities against the forgery of NAFDAC documents and cyber-related activities on substandard and falsified medicines; coordinating the Directorate’s participation in Operation Opson V and investigating public complaints and post-surveillance activities to ensure that registered products meet prescribed registration standards post-registration.

   

  He has also been in the Drug Registration and Regulatory Affairs Directorate, where he has been involved in regulatory activities geared towards ensuring access to safe and quality medicines namely:

  • Development of the first controlled medicines regulation gazette. This document prescribed the mandatory context for importers, manufacturers, and regulators.
  • Member of the Technical Working Group (TWG) that worked with United States Agency for International Development (USAID) and United States Pharmacopeia (USP) to develop NAFDAC monitoring and evaluation plan for pharmaceuticals.
  • Member of NAFDAC Technical Working Group on AFCFTA. The TWG was mandated to work with the country’s NAC-AFCFTA on inputs on the implementation plan of the Trade agreement, decisions on the Rules of Origin and workstreams meetings
  • Participated in the review and update of the NAFDAC 5+5 validity policy list and Agency Ceiling List of imported pharmaceuticals. These are 2 critical policies implemented to enhance local manufacturing of Pharmaceuticals.
  • Represented the Agency at the 2022 UNITAID Industrial engagement “access to health innovation” forum in South Africa. UNITAID is a global health organization engaged in funding innovation solutions to prevent, diagnose, and treat diseases more quickly, affordable and effectively, in low- and middle-income countries.

   

  Presently, Emmanuel is a Deputy-Director and is in charge of the registration of Biologics, Vaccines and Medical Devices in NAFDAC, undertaking the following:

  • Reviewing submissions including dossiers to support registrations of vaccines, biologics and medical devices licencing.
  • Issuing permits for registration samples.
  • Licencing and issuing marketing authorizations
  • Reviewing submission for post-approval variation
  • Issuing approval for post approval variations.

  He is also a WHO-trained in-vitro diagnostic device dossier assessor and NAFDAC’s focal person for WHO Collaborative registration Procedure for medical devices

   

• Cohen has over 25 years’ experience in laboratory testing and research, specializing in IVDs and clinical trials.

Executive Officer – SALDA – since August 2019

• Liaising with members and other stakeholders as needed relating to the MedTech Industry with emphasis on IVDs

Offers support in laboratory management, accreditation and oversight of  clinical trial laboratories

Monitoring , assessing and auditing of clinical trial and laboratory  processes

Training, lecturing, coaching and mentoring of clinical trial staff / pharmaceutical sciences students

 

She has previously held senior positions in the fields of laboratory medicine and clinical trials

Education

She obtained her Bachelor degree in Laboratory Management (Pretoria), Masters in Operations

Management (Johannesburg) and MBA (Australia)