Camilla Borrini has a master’s degree in biology from University of Florence-IT, and Post-grad master’s degree in management from 24ORE Business School-IT. She has worked in the medical device (IVD & Non|VD industry) for over the past 8 years with managerial positions in QA & RA. Her current role since 2018 is with Zimmer Biomet as the Program Manager for EU Medical Device Regulation.
Albert Maqolo is a Senior Analyst at the Medicines Control Authority of Zimbabwe in the Microbiology and Medical Devices Unit. He has more than 10 years of experience in the regulation of medical devices. He specialises in regulation and quality conformity assessments of medical devices and in-vitro diagnostics.
He is an experienced ISO 13485 factory auditor and ISO 17025 Quality Management System (QMS) auditor. He is also a member of the ISO/TC 157 technical committee (Non-systemic contraceptives and STI barrier prophylactics).
Albert has played a key role in ensuring that the public has access to quality, safe and effective medical devices through development and continuous improvement of regulatory processes.
He has worked with international and regional organisations such as the United Nations Population Fund (UNFPA), World Health Organisation (WHO) and African Medical Devices Regulatory Forum (AMDF) to further improve the quality of health commodities through development of international guidelines and processes for regulating medical devices. He holds a BSc Honours Degree in Biological Sciences and a Master of Business Administration degree.
Pharmacist with over 14 years’ of working experience in the Pharmaceutical industry and in the fields of Medical Devices, Food Supplements, Cosmetics and retail pharmacies.
Currently occupying the position of Head of Regulatory Affairs for North and West Africa and Pharmacovigilance deputy at Bausch & Lomb.
Previously worked at GlaxoSmithKline (GSK) and at a local Algerian pharmaceutical company.
Strong experience in New Marketing Authorizations Applications and post market activities for more than 20 African countries, as well as labeling and Regulatory Intelligence. In addition to involvement in Distribution, Quality Assurance and Pharmacovigilance.
Passionate about projects management and regulatory strategies.
EDUCATION
2010: University of Bordeaux (FRANCE) : Master’s Degree: Biomaterial & Medical devices & Bachelor’s Degree: Biochemistry
WORK EXPERIENCE:
Active member in local and regional Trade Associations (SNITEM, MECOMED, AMPDM).
Speaker at Dubai Pharmacy College via PRA Consultancy for Medical Device Regulation Masterclass MENA 2021 and 2022.
Mr. Batlegang Dallas Mosweu is a Manager Medical Devices, in the Department of Product Evaluation and Registration, at Botswana Medicines Regulatory Authority (BoMRA) in Gaborone, Botswana.
Batlegang joined BoMRA in December 2020, having worked as a Biomedical Engineer at the Ministry of Health since August 2003. In his current role, he is overseeing the development and implementation of Medical Devices Regulatory Framework. This involves but not limited to:
All these are achieved through continuous learning, stakeholder / shareholder consultations and stakeholder education on Medical Devices Regulation.
Batlegang holds a Degree in Biomedical Engineering from The University of Hartford in Connecticut, USA; Master’s in Project Management (specializing on Project economics and scheduling) from The University of Sidney in Australia; and various professional certificates in management and maintenance of specific medical devices, medical devices regulations, quality management system to medical devices etc.
Batlegang is a member of the Technical Working Groups aimed at harmonization of medical devices regulations and guidelines in the Region, Africa and for WHO working group on reviewing the GMRF for Medical devices including IVDs.
Dr. Placide Muhayimana is currently working as a diagnostics and medical devices registration specialist at Rwanda Food and drugs authority.
He has a few years’ experience in the assessment of medical devices including IVDs as well as in the assessment of human medicinal products and is Rwanda FDA focal person in WHO for IVDs collaborative registration procedure.
He owns several certifications namely in basic fundamentals of IVD medical devices regulations from the World Health Organization and Assessment of Technical Files for Blood Screening in Vitro Diagnostic Medical Devices from Paul Erlich Institute among others. As for his educational background he holds a pre-med certificate in science and Russian language from Taras shevchenko university, after which he pursued a degree in general medicine from Bogomolets medical university and graduated as a medical doctor.
Currently, he is pursuing a masters’ degree in science of public health at the University of Suffolk.
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory affairs. He has worked for multiple Medical Device company where he acquired 15 years of experience. Within his experience he had to develop Quality and Regulatory affairs departments, obtain CE marking for Medical Devices, register products all over the world, deal with audits as Management Representative.
He has now created Easy Medical Device to support Medical Device companies that need help to place compliant products in the Market. He also educates the Medical Device community through his Blog, Podcast and Youtube channel. By educating everyone, we prevent issues to happen.
His motto “Would I give this product to a member of my family”. This helps him to take decisions.
Has a PhD – Pharmacology from the University of Pretoria, MBL from SBL and project Management. Dr Mathibe has worked in both the pharmaceutical and medical device (IVD & Non|VD industry) for over the past 10 years with managerial positions in QA & RA. Her current role since April of this 2021 is with SAMPRA as the Senior Manager for Medical Device and Radiation control.
is the Head of Regulatory Affairs, Quality Assurance & Compliance for B. Braun Melsungen AG subsidiary in Kenya; having previously worked as hospital pharmacist and a tutor at Makerere University pharmacy school.
David a registered pharmacist holds a B. Pharm, MSc. Epidemiology & Biostatistics -Makerere University and MBA (Strategic Management) – Kenyatta University.
He is passionate about the Health Products & Technologies (HPT) regularization with a bias to the emerging markets where policies are being developed for consumer protection on the focal pillars of Safety, Efficacy & Quality.
Dr. David is proactively involved in several healthcare industry associations such as the Kenya Association of Pharmaceutical Industry (KAPI)- Chair of MDs & HPTs Committee as well as Medical Technology Industry Association of Kenya (MEDAK) – Chairperson.
Brenda Clare Kitimbo is a pharmacist with over a decade in regulatory undertakings. She has served with distinction as a Regulatory officer with Joint medical store a renown pharmaceutical distributor.
Prior to working at Joint Medical Store, Brenda worked as a general manager for a local production firm in Uganda. She has also served on the council of the pharmaceutical society of Uganda as an ex official council member and treasurer.
She has vast experience in pharmaceutical and medical devices supply chain management, Good manufacturing practices, quality management systems, submissions, strategies and agency interactions.
Brenda is a currently an assessor and inspector working at the Uganda National Drug Authority with present focus on medical devices.
She holds an M.S C. in Biotechnology innovation and Regulatory Sciences from Purdue-USA, an MBA from Makerere University -Uganda and Bachelors Degree in Pharmacy from University of Pune-India
