About MedDevREG AfriSummit

Effective regulatory frameworks, harmonized to international standards, are critical to expanding access to quality medical devices in low- and middle-income countries. A streamlined regulatory process across African nations would simplify this process for innovators seeking to bring medical devices to the African market, thereby increasing patient access to safe medical devices.

This two-day event provides a platform for discussion and collaboration for manufacturers and distributors to bring these life-changing devices to the continent.

MedDevReg AfriSummit will highlight the most important and relevant medical device regulations, through case studies, interactive presentations, and discussions. Attendees will learn which regulatory strategy is applicable for their products in which country in Africa.

WHY ATTEND

MEET NEW FACES

MORE THAN 150 PARTICIPANTS, among them your peers, advisers, clients and potential business partners

GET INSPIRED

A TWO-DAY PROGRAMME, filled with analysis, strategic ideas and exclusive new information from top speakers

INFORMATIVE PLATFORM

INTERACTIVE FORMATS, including industry leaders debates, interviews, discussions, analyses, Q&A, round tables and master-classes

2022 SPEAKERS

DR. NAJDET MEZIANI

Position: Head of Regulatory Affairs for North and West Africa and Pharmacovigilance deputy at Bausch & Lomb.
Categories: meddevreg 2022

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.

DR. NAJDET MEZIANI

Head of Regulatory Affairs for North and West Africa and Pharmacovigilance deputy at Bausch & Lomb.

AHMAD HACHAMI

Position: REGULATORY AFFAIRS SPECIALIST AT JOHNSON & JOHNSON MEDTECH
Categories: meddevreg 2022

EDUCATION

2010: University of Bordeaux (FRANCE) : Master’s Degree: Biomaterial & Medical devices & Bachelor’s Degree: Biochemistry

WORK EXPERIENCE:

  • 2009-2011: vigilance Evaluator at ANSM (French Heath Authority)
  • 2011-2018: Regulatory Affairs & Quality Engineer: BBRAUN MEDICAL, Siemens Healthiness, THALES AVS France
  • From 2018 : Responsible for all aspect of regulatory activities for Maghreb, Ghana, Mozambique, and French West Africa, at Johnson & Johnson MedTech

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.

AHMAD HACHAMI

REGULATORY AFFAIRS SPECIALIST AT JOHNSON & JOHNSON MEDTECH

MR. BATLEGANG DALLAS MOSWEU

Position: MANAGER MEDICAL DEVICES, DEPARTMENT OF PRODUCT EVALUATION AND REGISTRATION, AT BOTSWANA MEDICINES REGULATORY AUTHORITY (BOMRA) IN GABORONE – BOTSWANA
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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:

  • Establishment of medical devices regulatory function in a stepwise approach, following the WHO Global Model Regulatory Framework for Medical Devices including IVDs (GMRF).
  • Development and implementation of medical devices & IVDs regulatory strategy and roadmap.
  • Registration of medical devices including IVDs (for both human and animal) to ensure of their safety, quality, and effectiveness before coming into the market.
  • Listing of medical devices including IVDs.
  • Assessment of Covid-19 related medical devices including IVDs coming into the market through an exemption process.
  • Collaboration with other internal Departments in development and implementation of:
    • Licensing, Inspection and Enforcement plan for medical devices including IVDs.
    • Laboratory testing plan for medical devices including IVDs.
    • Clinical trials and research plan for medical devices including IVDs.
    • Post Market Surveillance and materiovigilance of medical devices plan including IVDs.
  • Ensure effective implementation of collaboration action plans for the established Strategic Partnerships and Collaborations.

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.

MR. BATLEGANG DALLAS MOSWEU

MANAGER MEDICAL DEVICES, DEPARTMENT OF PRODUCT EVALUATION AND REGISTRATION, AT BOTSWANA MEDICINES REGULATORY AUTHORITY (BOMRA) IN GABORONE – BOTSWANA

DR. PLACIDE MUHAYIMANA

Position: Diagnostics and Medical Devices Registration Specialist at Rwanda Food & Drugs Authority
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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.

DR. PLACIDE MUHAYIMANA

Diagnostics and Medical Devices Registration Specialist at Rwanda Food & Drugs Authority

MR. MONIR EL AZZOUZI

Position: CEO & Founder - Easy Medical Device
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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.

MR. MONIR EL AZZOUZI

CEO & Founder - Easy Medical Device

DR. DIMAKATSO T. MATHIBE

Position: SENIOR MANAGER MEDICAL DEVICE UNIT AT SAHPRA & CO-CHAIR OF AMDF
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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.

DR. DIMAKATSO T. MATHIBE

SENIOR MANAGER MEDICAL DEVICE UNIT AT SAHPRA & CO-CHAIR OF AMDF

DR. DAVID KARENYE

Position: Head of Regulatory Affairs, Quality Assurance & Compliance for B. Braun Melsungen AG subsidiary, Kenya
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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.

DR. DAVID KARENYE

Head of Regulatory Affairs, Quality Assurance & Compliance for B. Braun Melsungen AG subsidiary, Kenya

DR. BRENDA CLARE KITIMBO

Position: Assessor & Inspector working at the Uganda National Drug Authority
Categories: meddevreg 2022

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

DR. BRENDA CLARE KITIMBO

Assessor & Inspector working at the Uganda National Drug Authority

GET INVOLVED

EXHIBITION

If you an established provider in the pharmaceutical industry and would like to showcase yourself

BECOME A PARTNER

There are a number of ways to participate in the conference: If you an established provider in the pharmaceutical industry and would like to showcase yourself

BECOME A SPEAKER

If you are expert in the Pharma Regulatory Affairs field with a great story to tell then let us know and join the speakers panel

INTERESTED IN ATTENDING

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