Unité des laboratoires de biologie médicale – Ministère de la santé de Tunisie

Pharmacien de la santé – depuis avril 2019

• Contrôle technique à l’importation des DMDIV
• Réactovigilance et surveillance du marché
• Gestion des dossiers de création, de transfert et de fermeture des laboratoires privés de biologie médicale

MedicaSud

Directeur médical – janvier à avril 2019

OPALIA RECORDATI industries

Délégué médical – juin 2017 à octobre 2018

Novopharm SARL

Emmanuel Nkrumah is the Director for the Medical Device, Cosmetics and Household Chemicals Directorate at the Food and Drugs Authority (FDA), Ghana. He has been a regulatory officer for eighteen years with immense experience in Food, Drugs, Medical devices, Cosmetics and Household chemicals regulation.

Emmanuel holds a Bachelor’s degree in Biological Sciences from the Kwame Nkrumah University of Science and Technology, Kumasi and a Master’s degree in Pharmaceutical Sciences from the University of Greenwich, United Kingdom.

Emmanuel is a member of the Food and Drugs Authority’s GMP inspection team (as a GMP Lead inspector) and a member of the Drugs Product Registration Committee of the Food and Drugs Authority.

He is also a member of the Technical Committee (National committee) responsible for drafting standards for the Cosmetics and Household chemicals industry at the Ghana Standards Authority, and also the Ghana Society of Dermatology.

Emmanuel has a strong background in the regulation of medical devices, cosmetics and household chemicals in Ghana, and has been involved in the drafting of a number of policies for the regulation of the medical devices, cosmetics and household chemical industry in Ghana; and has represented Ghana on the international stage having delivered a presentation including Cosmetic Regulation in West Africa.

• ISO13485 Auditor/ Lead auditor-Freelancer

Medpoint LLC-USA

• ISO13485 Auditor/ Lead auditor-Freelancer TD File reviewer –MDD93/42/EEC

Under Qualification MDR2017/745 and MDSAP

DQS MED-Notified Body N°0297

• ISO 13485 Auditor-Freelancer

Rina certification – Italian Notified body

• Project manager

Sartorius Stedim Bioprocess -Tunisia

Medical device manufacturer: bags for parenteral nutrition injection and transfer lines

Company under ISO13485-Products under CE mark MDD 93/42/EEC

• Quality Director and regulatory affairs- medical device industry

Epsilon Orthopedics (Tunisia)/ Smart Spine (France)

Medical device manufacturer: implantable intersomatic cages; metallic osteosynthesis

screws and plates

Company under ISO13485-Products under CE mark MDD 93/42/EEC

Michelle completed her PhD (Molecular Medicine) through the University of the Witwatersrand in 2013, exploring in vitro HIV-1 drug resistance phenotyping, genotyping and novel virological failure detection tools for clinical patient management. Her research was performed at Virco Lab, Inc (now Janssen Diagnostics) in Belgium and at the NHLS in Johannesburg. Michelle put into practice her PhD acquired skills at partner laboratories in Zimbabwe (Newlands Clinic; Harare) and Uganda (JCRC; Kampala, Fort Portal, Mbale). Post-PhD, she spent much of her career in the molecular research and diagnostics environment and related quality systems at the NHLS, focusing on HIV drug resistance and haematological malignancies. She was actively involved with the development of education programmes and training of haematopathology registrars, intern medical scientists, and medical technologists. As a project manager, Michelle carried out the design and implementation of an NHLS dashboard to enable the monitoring of performance indices of the Department of Health’s HIV programme. She is a registered medical scientist with the Health Professions Council of South Africa and currently serves as an examiner for intern medical scientist portfolios.

Having joined Diagnostech (research and IVD distributor company) in 2015, Michelle strives to enhance the use of state-of-the-art technologies to drive the highest level of quality research and diagnostics in Africa. She has a personal interest in translational research focusing on the medical diagnostics environment. Within the IVD regulatory context, she’s currently an executive member of the Southern Africa Laboratory Diagnostics Association (SALDA), a member of the SAMED regulatory committee, and the Management Representative for Quality and Technical Director at Diagnostech.

Depuis Septembre               Pharmacien de la santé publique/ Unité                 

2015                  de la Pharmacie et du Médicament

(Décembre 2019)                   Chef de service de la commercialisation des produits pharmaceutiques et para pharmaceutiques à la sous-direction de l’industrie des produits pharmaceutiques et para pharmaceutiques et du contrôle de leur commercialisation

(Depuis Février 2017)            En charge du Contrôle Technique à l’Importation (CTI)

• Gestion et réponse aux courriers (émanant du BO du Ministère/ électroniques) relatifs aux dispositifs médicaux et aux produits parapharmaceutiques
• Evaluation administrative des dossiers d’enregistrement de dispositifs médicaux soumis au Contrôle Technique à l’Importation
• Evaluation de la recevabilité et gestion des dossiers de demande de commercialisation de produits frontières, de laits infantiles et des produits apparentés et de filtres d’hémodialyse
• Etude et validation des demandes déposées à la DPM concernant le dédouanement de matières premières, de dons et d’échantillons de dispositifs médicaux et de produits para pharmaceutiques, concernant les Privilèges fiscaux et concernant l’export des produits mentionnés ci dessus
• Réception des usagers pour répondre à leurs questions, suivre et résoudre les problèmes qu’ils rencontrent
• Préparation et suivi des travaux du Comité Technique de classification des produits frontières, de la Commission Nationale Pour la Promotion de l’Alimentation du Nourrisson et de l’Enfant et du Comité Technique d’Agrément des Filtres d’hémodialyse
• Préparation et suivi des travaux des réunions de la DPM concernant tout sujet relatif au CTI, aux Dispositifs médicaux et aux produits para pharmaceutiques
• Gestion des réclamations liées aux dispositifs médicaux et aux produits parapharmaceutiques
• Rédaction des notes destinées au Ministre et des avis destinés aux usagers
• Contribution à l’élaboration et à la révision des textes juridiques liés au CTI, aux Dispositifs médicaux et aux produits para pharmaceutiques
• Représentation de la DPM dans les réunions interministérielles et au sein du Ministère concernant tout sujet relatif au CTI, aux Dispositifs médicaux et aux produits para pharmaceutiques
• Contribution à la rédaction et à l’amélioration des procédures de travail
• Organisation et gestion de l’équipe du service du CTI

(Sep 2015- Jan 2017)  Pharmacien Evaluateur Médicament/CTI

• Evaluation de la partie administrative des dossiers de demande d’AMM
• Traitement et suivi des réclamations relatives à la qualité, l’efficacité et la pharmacovigilance des médicaments
• Traitement des commandes fermes
• Gestion des dossiers de produits frontières (entre médicaments et autres statuts)
• Contribution à l’élaboration et à l’amélioration des procédures
• Représentation de la DPM dans les réunions

   Novembre 2011-                Pharmacien Responsable Affaires

      Août 2015           Réglementaires/ Société Tradisco – 

(Laboratoires pharmaceutiques Reckitt   Benckiser)

• Préparation, suivi et dépôt des dossiers de nouveaux médicaments (importés) en vu d’obtention d’AMM
• Préparation, dépôt et suivi des dossiers de demande du CTI auprès de la Direction de la Qualité et de la Protection du Consommateur (Ministère du Commerce), de la DPM et de Direction de l’Hygiène du Milieu et de la Protection de l’Environnement (Ministère de la Santé) en vu d’obtention de l’Autorisation de Mise à la Consommation
• Contribution à la mise en œuvre de la stratégie technico-réglementaire de l’entreprise
• Contribution à la gestion des Ressources Humaines

Avr 2011- Sep 2011        Pharmacien Assistant/ Pharmacie

Déc 2009 – Juin 2010     Catégorie A   

• Dispensation des médicaments
• Traitement des bulletins de soins
• Réalisation des préparations magistrales et officinales
• Conseil officinal
• Gestion du stock

        Responsabilités assurées

Emploi fonctionnel

Chef de service de la commercialisation des produits pharmaceutiques et para pharmaceutiques à la sous-direction de l’industrie des produits pharmaceutiques et para pharmaceutiques et du contrôle de leur commercialisation depuis Décembre 2019.

Membre d’une commission

1. Membre du Comité technique multisectoriel pour l’étude des dossiers d’importation de masques à usage unique suite à l’alerte Interpole depuis Janvier 2021.
2. Membre du Groupe de travail chargé de la création d’une centrale d’achat de dispositifs médicaux stériles à usage unique en 2020.
3. Membre de la Commission d’élaboration du projet de décret relatif aux dispositifs médicaux (depuis 2017) au sein de l’ANCSEP.
4. Membre de la Commission d’élaboration du projet de décret relatif aux compléments alimentaires (2015/ 2016/ 2019) au sein de l’ANCSEP.
5. Membre de la Commission d’élaboration du projet de décret relatif aux produits cosmétiques (en 2016) au sein de l’ANCSEP.
6. Membre du Comité Technique de Classification des Produits Frontières en tant que Coordinatrice (depuis 2017).
7. Membre de la Commission Nationale pour la Promotion de l’Alimentation du Nourrisson et de l’Enfant en tant que Coordinatrice (depuis 2016).
8. Membre du Comité Technique d’Agrément des filtres d’hémodialyse en tant que Coordinatrice (depuis 2016).

Divers

Qualités:

Sociable, organisée, rigoureuse, patiente, esprit d’équipe.

Langues : Arabe (Maternelle)/ Français (Principale)/ Anglais (Excellent)/ Allemand (Scolaire).

Hobbies:   Lecture/ Cinéma

Neville is a Global Project Manager, Import Export Specialist, Africa Region at Oximio, responsibilities include the coordination and completion of all projects on time, within budget and to the client requirements. This involves overseeing all aspects of projects, monitoring and summarising progress of project and ensuring the reports are prepared key stakeholders of the business regarding status of project.

Oximio, previously known as the SMO Group, has a rapidly expanding GxP storage and services network focused on Eastern Europe, the Middle East and Africa. Along with the two facilities in serving the sub-Saharan region, Oximio also operates through a partner depot in Egypt in Africa.

Oximio in Kenya runs a Customs Bonded depot, and serves as a gateway to East, Central and West Africa. This enables cost-effective solutions and quick turnaround times in the region and substantially improves patient access to medicine, particularly in difficult to reach areas and marginalised populations.

Neville’s background

Neville entered the Clinical Supply Chain market in 2014 working for various carrier in the clinical trial sector and continues to build and maintain mutually beneficial relationships with local and international sponsors, manufacturers, and other key stakeholders including regulators and Research Organisations.

Robyn is a qualified Medical Technologist specialising in infectious diseases. She has worked in microbiology clinical laboratories for 8 years before entering the commercial environment. Robyn was a director of Bioweb Pty Ltd diagnostics company importing and exporting diagnostics reagents to laboratories and blood banks into Africa for 17 years.

She is a member of the Southern African Diagnostics Trade Association and held the post of Executive Officer between 2015 until 2018. During this time, she participated in the following SALDA and SAMED committees and activities:

Portfolio of activity:

-SAHPRA Legislation and Regulations

-MD and IVD Licence Applications

-Regulatory Educational Forums for Member Companies

-Laboratory Medicines Group

-NHLS HTA

-Point of Care

-SAMED Board (2015 – 2017)

-Medical Device Code of Ethical Marketing and Business Practice

-Health Economics and Reimbursement

-SALDA/SAMED Regulatory Committee

-Association governance and company membership management

It is in this role as Executive Officer of SALDA Robyn has been able to interact with several industry stakeholders which has given her valuable insight into the future path of the In Vitro diagnostic industry and the many challenges ahead.

Robyn was appointed as Regulatory Manager for Abbott Diagnostics Division in Oct 2018 which will allows her insight into the regulatory environment across the African Continent.

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.

Personal Interests and Fun Facts

Originally born and raised in Egypt, currently live in Dubai

Outside of work spend most hours in:  time with family & friends, practicing sports (Swimming, Basketball), have a walk, jogging, eat good food, love to travel!

Professional Background (13 yrs RA/QA Pharmaceutical& Medical Devices)

• GSK (~8 yrs)
  Held multiple roles as microbiologist, raw material analyst (Quality Control), Quality Assurance, Change Control management, Risk management, Auditing, QMS, CAPA management, Complaints, Root cause Analysis.
• Astellas Pharma, Pfizer Consumer Healthcare (~3 yrs)
  – Regulatory Affairs associate MENA
• Hillrom (2 yrs)

-RAQA Specialist MEATI

Education

• German University in Cairo
  – S. Pharmacy and Biotechnology double major
• RAPS Online University

-Regulatory Affairs Certificate: Medical Devices and

Pharmaceuticals (dual)

Dr. Noha El Hariri is the general manager of the general medical device registration administration-Egyptian drug authority (EDA).

She had Bachelor of Clinical Pharmacy year 2003 with excellent grade with honor.
She had MBA (Master of Business Administration in health economics) with grade excellent with honor.

She worked in the central administration for pharmaceutical affairs since 2004 as inspector
In 2011 she left the inspection department and joined the medical device department since 2011.

In 2013 she became head of variation department in medical devices unit.
In 2020 she became general manager of registration department.

• 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)

Rob is Regional Director, sub-Saharan Africa at Oximio, which includes operations in South Africa and the newly opened facility in Kenya. Both are licensed pharmaceutical distribution warehouses, specialising in global clinical trial supply procurement, comparator sourcing, repackaging, storage and distribution.

​

Oximio, previously known as the SMO Group, has a rapidly expanding GxP storage and services network focused on Eastern Europe, the Middle East and Africa. Along with the two facilities in serving the sub-Saharan region, Oximio also operates through a partner depot in Egypt in Africa.

Oximio in Kenya runs a Customs Bonded depot, and serves as a gateway to East, Central and West Africa. This enables cost-effective solutions and quick turnaround times in the region and substantially improves patient access to medicine, particularly in difficult to reach areas and marginalised populations.

Rob’s background

Rob entered the Clinical Supply Chain market in 2002 and continues to build and maintain mutually beneficial relationships with local and international sponsors, manufacturers, and other key stakeholders including regulators and Research Organisations.

As a leader, team player and brand ambassador, and through Oximio clients, Rob is focussed on attracting a wider range of research into sub-Saharan Africa.

Fadoua Khadiri, Docteur en pharmacie, lauréate de la Faculté de Médecine et de Pharmacie de Rabat, Maroc en 2008.

Elle travaille actuellement et depuis Janvier 2019, au Centre Marocain de Pharmacovigilance. En plus des activités de la Pharmacovigilance et de la Vaccinovigilance et depuis 2020, elle s’occupe des activités relatives à la Matériovigilance, à savoir le traitement des notifications et la gestion de la base de données Marocaine des incidents liés au dispositifs médicaux.

Elle a participé dans des programmes de formation des professionnels de santé en matière de Pharmacovigilance.

Elle a commencé son exercice dans la fonction publique comme pharmacien hospitalier, elle a exercé en tant que pharmacienne responsable de la gestion de la pharmacie hospitalière. Elle a une expérience de 9 ans dans la gestion des médicaments et des dispositifs médicaux au niveaux des hôpitaux. Elle a travaillé également dans la gestion et la préparation des médicaments cytotoxiques utilisés en Oncologie en milieu hospitalier.

Ms. Bulliard has over 25 years’ experience in real-world evidence studies, patient registries, safety surveillance programs, and other specialized real-world programs. She has an extensive global portfolio, specializing in medical device & diagnostics studies.

Ms. Bulliard works with medtech companies around the world to design & deliver solutions that translate evolving methodological real-world research standards and real-world data generation methods into feasible operational delivery strategies to meet the needs of regulators, payers, providers & patients.

A subject matter expert in RWE medical device, diagnostic and digital health studies with a robust knowledge of the current and evolving clinical, regulatory, scientific and commercial medtech landscape, she seeks to generate product value by leveraging the most effective, innovative and compelling strategies within the marketplace.

Ms. Bulliard is a member of IQVIA’s MedTech Center of Excellence representing the domain of real-world evidence.

She has previously held senior positions in the field of post market safety and real-world research in medical device and biotech companies.

Education

She has obtained her Bachelor of Science in Nursing, BScN, RN, from Dr Steevens Hospital  / Trinity College Dublin Ireland, with a P. Grad. Dip in Critical Care ICU Dublin, Ireland and Lausanne, Switzerland.

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.

An Industrial Pharmacist of 30 years. Started her career at Adcock Ingram (pre – Sterling Winthrop) in production of Panado tablets and Syrup before moving to Smith & Nephew in 1992, which became BSNmedical (2001), National Bio-products (20004) as Pharmacist Plant Manager (ampoules / Vials ) followed by own Consulting business 2005.

At Smith & Nephew, Introduced to medical devices such as burns creams, wound dressings, bandages and plasters and the new quality management system, at the time, ISO9001 and moving to ISO 13485 in 2000.

Worked in Production, Quality Assurance, Regulatory affairs, Validation and Laboratory Management of a chemistry, microbiology and textile laboratory.

In 2005, the consultancy business started providing;

• Consultation on quality management systems (ISO9001/22001/13495) regulatory requirements, product licensing, company registration for medicines and medical devices
• Training in-house or public venue on the development, implementation and maintenance of a quality managements system (ISO13485), good manufacturing practices and internal auditing for conformity assessment certification and
• Documentation requirements for risk assessment (ISO 14971), procedures, clinical evaluation, technical file and declaration of conformity

A member of PSSA, SAAPHI, SAHFE, SAMED , MDPG (Chairperson 2019) MDMSA (chairperson 2021),  and is a committee member of the SAMED Regulatory and Procurement committees and the SABS Technical committees for textiles and medical devices

She is a qualified pharmacist with a Bachelor of Pharmacy from Rhodes University and has worked extensively in the healthcare industry.  She has spent the majority of her career in health risk management / managed care.

Susan began her career serving as a dispensing pharmacist in public as well as private sector but later progressed to the Managed Care industry where she managed several portfolios. Her positions included the Executive Manager: Medicines Risk & Electronic Benefit Management and Specialist: Business Modelling & Coordination.

Her notable achievements was on the public and private partnership initiatives in enabling access to care. She consulted for a number of segments within the healthcare industry whereby she facilitated the streamlining of access to primary healthcare and development of technologies to support maternal and child care.

Currently, Susan is heading up the Health Policy Unit where she is responsible for the development of strategies for enabling access to pharmaceutical, technological and medical procedures. One of her ambitions is finding sustainable solutions in building reimbursement models to facilitate the funding of specialised medicines in South Africa.

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

He gained experience in regulation of both medicines, medical Devices, and invitro diagnostics specifically on Evaluation of dossiers for acquiring MA, conducting inspection of premises, conducting post marketing surveillance and vigilance, and conducting GMP inspection and quality audit against ISO 13485.

Christian has previously Worked as Supply Chain Advisor for PEPFAR HIV/AIDS Project at Bugando Medical Centre- A hospital in Eastern Northen part of Tanzania.

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.

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.

Sandra Ligia has hold diverse management and directive positions at Regulatory Affairs, Sales, Marketing, Business Development and R&D for various countries in Latin America and Turkey.

Her experience covers from public institutions such as the National Institute of Nutrition in Mexico, to Global Companies such as Baxter, Danone and Johnson & Johnson Medical Devices where she held a Regulatory Affairs Senior Manager Position for Colombia and Mexico; she led the Regulatory Affairs Committee at AMID (Mexican Association of Innovative Medical Devices Industry) in 2016 and 2017.

She acted as Chair of AdvaMed’s Latin American Regulatory Affairs work since 2017 and is currently serving as Executive Secretary Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector, which unifies its 18 largest industry bodies in the Western Hemisphere and Lead of the Tier 2 Component of the Medical Device Regulatory Convergence, COVID-19 Project (MDRC).

Sandra has participated as a Faculty Member and speaker for several international events organized by the Regulatory Affairs Professionals Society (RAPS), International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and COFEPRIS/PAHO.

Sandra holds a bachelor’s Degree in Nutrition and Food Science and a Diploma on Product/Brand Management, both by Universidad Iberoamericana and a Diploma on Enterprise Top Management by IPADE (Instituto Panamericano de Alta Dirección de Empresas).

Rana Chalhoub is an experienced Regulatory Affairs Professional with a demonstrated history of working in leading multinational medical devices companies such as Medtronic, Johnson & Johnson and Hospira Pfizer. During her career, Rana has managed to take over regulatory roles of increased responsibilities with an extended area coverage where she has built extensive knowledge of the regulations across MEA region. Rana holds a Laboratory Sciences degree along with a Regulatory Affairs Certification (RAC) from RAPS, along with a certificate in “Regulation: Theory, Strategy & Practice” from London School of Economics & Political Sciences (LSE).

In her current role as Regulatory Affairs Director at Mecomed, Rana is responsible for managing Regulatory Affairs-related responsibilities in MECOMED, the Medical Technology Association in Middle East and Africa, and works closely with Mecomed RA and executive teams on advancing Medical Technology regulations in the region.

She acts as the link between MECOMED members and external stakeholders such as Ministry of Health officials and Regulatory agencies with special emphasis on the prioritization of the RA needs of the MedTech industry.

Salma Salim is an experienced Regulatory Affairs expert specialized in medical devices. She has worked for multiple medical devices companies for more than 12 years. During her career Salma has covered all the regulatory aspects in several regions: Europe, USA, Japan, China, Middle East and Africa. Salma is graduated from the Pharmaceutical School of Châtenay-Malabry (Paris XI – France) where she had her master’s degree in “Quality and Health products”.

In her current role as Senior Regulatory Affairs Program Manager at GE Healthcare, Salma is responsible for building RA strategy in Africa and covering all the regulatory aspects (Products registrations, Matereovigilance, Regulatory Intelligence…). She is also continuously interacting with the ministry of health representatives in the regulated countries within the region.

She is a RAPS (Regulatory Affairs Professional Society) member in USA and has a Diploma in e-CTD Master class by eXtedo E-Regulatory Affairs. Ms. Lydia is certified from Saudi council for Health Specialists & European Pharma Consultant group for Regulatory profession in Saudi FDA. In addition to her educational background, she has an MBA from Warnbough college, UK and a Diploma in Marketing & Salesmanship from American University in Cairo as well as a Bachelor of Pharmacy & Science, Alexandria University

She’s a pharmacist with +15 years of experience in regulatory affairs in both private and governmental sector, generics & Innovative products on local and regional basis.

She’s experienced in fields of pharmaceutical &Medical Device industry (e.g. Regulatory compliance, supply chain, pricing and market access), with strong interpersonal skills reflecting presentation, communication, and analytical thinking with creative ability coupled with eagerness to learning and innovation, with high approach for problem solving, Conducting skillful negotiations, and establishing good relationships with Local Health Authorities.

Ms. Shimaa started her regulatory career as regulator in MOH in Egypt, currently it is EDA Egyptian drug authority in Egypt as she was occupied the position of planning & importation department head before I joined Alcon in 2011.

I’m graduated from faculty of pharmacy Cairo University and holding MBA from AAST in supply chain management.

In her current role in Alcon, she’s responsible for setting regulatory strategies for new product introduction, geo-expansion, licensing, as well as RA risk mitigation and regulatory compliance.

Nereah Kisera is a Senior Technical Advisor for the regulatory systems improvement portfolio of the Medicines, Technologies and Pharmaceutical Services (MTaPS) initiative of the Medicines Sciences for Health (MSH). She supports country programmes in the development and implementation legislation, guidelines, quality management systems, and information management systems to enhance the regulatory frameworks within the African continent. She also provides technical guidance for the continent-wide implementation of regulatory system harmonization initiatives. She is an experienced pharmacist with over 10 years’ experience in public health research the conduct of clinical trials in in Africa. Nereah holds a Bachelor of Pharmacy form the University of Nairobi in Kenya and A Master of Vaccinology and Pharmaceutical Clinical Development form the University of Siena in Italy.

She Co-founder of the first Tunisian CRO, Senior project and regulatory affairs manager, with more than 15 years’ experience in clinical trials field.

Ms. Hella has worked on phase I to IV clinical trials in different therapeutic areas, in pharma-industry and medical devices, across Europe, Middle East & Africa region.

She has a demonstrated history of professional work with multinational sponsors in addition to other clinical services vendors.

At 1MED she Oversees the medical device evaluation and food supplements clinical trials projects in Mena, including daily Interactions with Medical devices manufacturers about MDR and IVDR as well as Team training and support.

Corporate Female too passionate about QARA Commercial and Medical Care with almost 9 years of high-tech experience, including a strong record in quality management systems, and registration projects for all risks of medical devices, IVDs/ biologics, and robotics.

I share best practices in PMPs, M&As, Corporate Strategic Thinking, Business Compliance, and Trade Compliance. This has allowed me to interact with counterparts in US/Americas, APAC, and EMEA. We have built together initiatives and delivered solutions across multiple areas, for efficient marketing strategies and processes effectiveness.

I continue to support Global DEI and the EMEA Leadership with the excellence delivery of culture growth and business transformation. This comes at the same time with my EMBA Program at ESCP Business School where I get the chance not just to explore and meet more than 15 cultures in at least 10 different new countries, but also to expand my creativity from the day-to-day usual tasks. This was pretty obvious having developed dashboard channels for the EMEA EM and Developed Markets for BREXIT, MDR, Demand Plans, and GTMM while assessing the risks in a user-friendly readiness.

Because of this dedication, I received more than 10 awards for being customer focused and for performing beyond expectations. Other significant professional achievements are being listed in the 2021 Med-Tech Women Advocates and moderating in regional events like the 2021 GCC Summit and the upcoming 2022 Afri Summit.

#dreambigger is my personal mantra. This has pushed me to never give up and continue innovating. One of the recent projects is the design of E-Touch, a multi-disciplinary polyclinic focused on both onsite services and omni services. I support the BOD creating new channels and exclusive strategies.

While I keep now focusing on my corporate lifestyle and writing my book, my other favorite times are for cycling, swimming, and reading over coffee. Besides life spirituality, I read about data analytics, brain functionality, and entrepreneurship/consulting.

Leonard has been involved in clinical trial logistics for the past 30 years.  He has been serving as the Service Provider representative on the SACRA since 2014 Executive Committee. Over the past 30 years he has attended investigator meetings.

He has managed and controlled large clinical trials and assisted CRO’S in setting up complex clinical studies globally with TAT from 6 hours to 24 hours temperature controlled.

Leonard has done presentations to companies on handling, shipping and storage of clinical trial medication and blood samples.  He has assisted with documentation required for shipping medication and samples.

He has assisted with the required packaging and temperature monitoring devices and ensured that all regulations are met for shipping of samples / medication. He visits investigators / CRA’s and advises them on shipping requirements / packing / handling.  He facilitated 5-day training for Pathogenic Avian flu testing for WHO /CDC and, Webinars on Logistic and Regulatory challenges in Africa for Clinical Trials.

Leonard works with various regulatory boarders to bridge the gap with regulations with permits approvals for the Clinical Trial and Pharma Industry. He is an approved Trainer / Facilitator for IATA 6.2. Clinical storage Drug facility set up (Writing Site Master file /Sops) which is approved by Pharmacy Council / DOH.

His other duties include Setting up complex trials in Africa. Leonard is involved in business development on the African continent in the industry.

Leonard is an Independent Management Consultant / Import and Export specialist.

Leonard has really demonstrated his willingness to support researchers in South Africa and abroad

over many years. Recently he demonstrated tremendous commitment to the country’s COVID-19

response by ensuring that essential vaccines made it safely to their destinations.

Leonard Managed and facilitated the Covid 19 Vaccine rollout on the Sisonke Study. He was critical in

assisting us with the districts around the Covid-19 vaccine; without his leadership and hands on management of this process the successful execution of Sisonke would not have been possible.

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.

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:

• 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.

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.

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.