Abebe Alamneh Kassahun is a dedicated professional with a strong background in the field of medicine regulatory affairs. He holds a Bachelor’s degree in Pharmacy and a Master’s degree in Medicine Regulatory Affairs from Addis Ababa University.

Currently, Abebe serves as a Medicine Registration Expert at the Ethiopian Food and Drug Authority (EFDA), where he plays a crucial role in ensuring the safety, efficacy, and quality of pharmaceutical products in Ethiopia. With his expertise, he actively contributes to the regulatory processes involved in the registration and approval of medicines, ensuring compliance with national and international standards.

In addition to his role at EFDA, Abebe also holds the esteemed position of Vice Chairman at the East African Regulatory Affairs Professionals Association (EARAPA). As the Vice Chairman, he demonstrates exemplary leadership skills and actively participates in shaping the regulatory landscape within the East African region. Abebe collaborates with fellow professionals to develop harmonized regulatory frameworks, facilitate information exchange, and promote best practices in medicine regulation.

Miriam Boles is the head of central administration of medical devices in the Egyptian drug authority. She holds a bachelor degree of pharmaceutical sciences from an established Egyptian university and a master degree in business administration from Arab Academy for Science, Technology & Maritime Transport, (AASTMT), where she specialized in supply chain.

Miriam worked for two decades in various positions in medical device regulatory governmental sector. Prior to her current role, Miriam began her career as medical devices registration reviewer, then senior reviewer, afterwards , director of medical devices unit.

From November 2020, Miriam became the head of central administration of medical devices.

Her goals in this role are to develop and implement strategic plans for premarket regulations of medical devices and IVDs in pursuit of EDA’s mission and vision of providing safe, and effective medical devices.

The most significant achievements that took place under her leadership :

• Enhancing the localization of many medical devices and equipment.
• Establishing an online platform (MeDevice) for automating administrative
• workand electronic archiving.
• Issuing guidelines to regulate all procedures related to premarket approvals, unique device identification and labelling requirements.
• Developing a procedure to regulate the import and circulation of laboratory and diagnostic reagents for the first time in the Arab Republic of Egypt.
• Unique device identification(UDI) was applied to all medical devices that are circulated in the local market .

Miriam Boles is an experienced hard worker driven by passion. She takes pride in providing the best possible achievements. She believes in team work, power of positivity, motivation by task, and interested in data analysis, problem solving beside her sustainable passion to be kept updated with medical devices and IVDs regulations all over the world.

Dr. Noha El-Hariri is the General director of the general administration of medical devises registration -Egyptian drug authority (EDA) since 2020 and until now.

In 2003 She had bachelor of clinical pharmacy with excellent grade with honor.

In 2019 She had  her 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.

On 2019 the EDA was established and she was chosen among the cadres who were transferred from the ministry of health to join EDA and she was selected to be the general manager of general administration of medical device registration.

Dr. Rania obtained her bachelor’s degree in pharmaceutical sciences from the Faculty of Pharmacy at Cairo University in 2005. During her undergraduate studies, she engaged in part-time work and summer internships at various pharmaceutical firms, factories, and pharmacies. Following her graduation, she fulfilled her mandatory government service with distinction, serving as a Validation Specialist from July 2006 to March 2007 and later as a Quality Auditor from March 2007 to March 2009.

Her journey continued in 2009 when she transitioned to the Central Administration of Pharmaceutical Affairs (CAPA). This organization, a pivotal entity under the Egyptian Ministry of Health, oversees a wide array of regulatory functions, including registration, pricing, inspection, importation, and licensing of all medical products. Dr. Rania commenced her role as a Medical Device Custom Release Specialist, with responsibilities that encompassed evaluating importation approvals, liaising with global notified bodies for quality verification, and collaborating with other departments to update importation guidelines.

Impressed by her organizational prowess, fluency in English, and remarkable presentation skills, her immediate supervisor recognized her talents. As a result, she was entrusted with the role of Rapporteur for the Specialized Committee on Importing Supplies and Medical Devices, as well as the responsibility of overseeing various scientific committees.

In her present capacity, Dr. Rania’s responsibilities are wide-ranging and crucial. She meticulously examines applications for import approvals, establishes trading regulations, approves importation plans, and leads specialized scientific committees. Her role involves interactions with high-level officials, including CAPA’s Director and the Assistant to the Minister of Health for Pharmaceutical Affairs, where she contributes to policy updates and registration rules for medical devices. Collaborating with the medical device pharmacovigilance department, she ensures post-marketing safety and efficacy through surveys and clinical questionnaires.

Dr. Rania’s achievements extend beyond the workplace. She has been selected to contribute to the formulation of Egyptian guidelines for medical devices, as well as to participate in the development of clinical trials protocols. Her dedication led her to represent her workplace in international events, such as the Arab Transfusion Medical Course and the First Arab Conference for Food, Drug, and Medical Devices.

Evidently, Dr. Rania is deeply committed to advancing healthcare policies. Her engagements with governmental bodies, parliament members, and international organizations like WHO demonstrate her role in shaping rules and regulations for medical device registration in Egypt. Notably, she anticipated a critical shortage of medical devices following currency devaluation and advocated for emergency measures to mitigate potential health crises.

Her pursuit of continuous improvement is evident through her participation in various programs, including Project Management, International Visitor Leadership, Total Quality Management, and ISO standards for medical devices. Now, in her mid-thirties, Dr. Rania holds a senior leadership position at CAPA, where she adeptly navigates her dual roles in pharmaceutical and civil service functions.

Outside of her professional commitments, Dr. Rania’s humanitarian spirit shines through her involvement in charity and social affairs. She dedicates her time and resources to support those in need and works passionately to empower women—an endeavor she holds close to her heart.

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).

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.

Richard is a pharmacist with 26 years’ experience starting off his career in hospital pharmacy in the public sector.  He has spent the last 19 years in the regulatory profession in various capacities.  He is currently the Director-General at the Medicines Control Authority of Zimbabwe.

Ofentse Ramokgopa is a pharmacist by profession who obtained her qualification from Nelson Mandela Metropolitan University, she is currently in pursuit of a master’s degree in pharmaceutical affairs at the university of the Witwatersrand with her research focus on advanced drug development. Her first exposure to medical devices was through community service at the former Medicines control Council (MCC) which is now The South Africa Health Products Regulatory Authority (SAHPRA).  Her experience includes wholesale, distribution, and warehousing. She currently holds a position as a medical device technical officer responsible for Licensing and Compliance at SAHPRA.

Ms Khanyisile Nkuku is a Medical Device & IVD Registration Officer, she holds a Bachelor of Pharmacy degree from the University of Witwatersrand. She is currently completing her Master’s in pharmacy administration & Policy Regulations. She has experience and Knowledge in medical device registration, clinical trials regulation, law enforcement, licensing, post marketing surveillance, reliance, and good regulatory practice.

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.

Ms. Kesego Moalosi is a goal-oriented professional with a background in medical devices. She holds a bachelor’s degree in biomedical and electrical Engineering from Carleton University, Canada, and a master’s degree in project management from Sunderland University as well as a RAPS Certificate on Medical Devices Regulatory Affairs.

Ms. Kesego gained her experience in medical devices on her previous roles where she served as a Biomedical Engineer at a government hospital in Botswana where she was mandated with servicing, repairing, and carrying out routine maintenance of major and minor medical equipment. She has also served as a Medical Devices Capital Equipment Supervisor for two years in a private sector in which one of her roles was setting up, conducting, and overseeing maintenance plans and maintenance programs of all capital equipment supplied by the company.

Currently Ms. Kesego holds a Medical Devices Regulatory Officer position at Botswana Medicines Regulatory Authority (BoMRA), where she plays a major role in ensuring safety, qualify and efficacy of medical devices. In her current role, she is involved in implementation of Medical Devices Regulatory Framework through assessment of medical devices (both human and animal) registration applications as well as through collaborating with other internal Departments in development and implementation of: Licensing, Inspection and Post Market Surveillance plan for medical devices including IVDs.

Frank N Laban is a Pharmacist at the Zambia Medicines Regulatory Authority with 15 years of experience as a regulator in the area of medicines and medical devices regulation.

Currently Frank N Laban is the Principal Registration Officer overseeing marketing authorization activities around Allied Substances and Human Medicines in Zambia.

Frank holds a holder of a BPharm and is a candidate in Ms Pharmacy Administration and Policy

My professional experience spans over a decade, during which I have held Technical and Management Positions. Notably, I served as the National Reference Laboratory Division Manager at Rwanda Biomedical Center, where I held senior positions. In this role, I was responsible for overseeing diagnostics and management of reference laboratory division and medical device performance evaluation procedures, providing technical reports to the Ministry of Health, and guiding diagnostic algorithm decisions for equipment and IVDs in the country. My areas of expertise include Research, Training, Mentorship, supervision, diagnostics, Field epidemiology, and public health mostly touching the big three diseases such as HIV, TB, Malaria and other blood borne pathogens including regulatory procedure for medical devices per world health organization guidelines. I have published scholarly articles on these topics with over 35 Publications in PubMed and Medline and google scholar.

In June 2021, I joined Rwanda Food and Drugs Authority as the Medical Device and IVDs Assessment and Registration Analyst. In this role, I’m responsible for various tasks, registering medical devices and IVDs, developing and validating regulations, guidelines, and SOPs for full assessment, abridged, reliance, and recognition pathways, including developing strategies to quickly register devices on market in Rwanda. Additionally, I actively participate in various technical committees, including the clinical trial safety committee, Peer review committee for cosmetics and household chemicals, and the committee for good manufacturing practice at Rwanda FDA.

• 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)

• 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

   

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.

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.

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.

Hamoud holds a bachelor’s degree in Pharmaceutical Technology from Jiangnan University, supplemented by a Diploma in Chinese Language from the same esteemed institution. He is a highly proficient Regulatory Affairs leader with specialized expertise in Pharmaceutical and Medical Device product Registration within the Saudi Arabian market.

Hamoud’s exceptional leadership skills and effective time management abilities have enabled him to successfully navigate the complexities of regulatory affairs. He is not only skilled in managing regulatory processes but also adept at leading and mentoring cross-functional teams.

Managing relationships with 400+ manufacturers across both KSA and the UAE, Hamoud’s exceptional leadership and organizational skills have empowered him to seamlessly oversee diverse product categories, including Sterile, Non-Sterile IVD, Medium Risk, and High-Risk items. His profound understanding of the stringent regulations and standards set forth by SFDA is complemented by a demonstrated ability to navigate complex regulatory landscapes.

Presently, Ms. Shaimaa Salah occupies the role of Associate Director for the Middle East & North Africa Clusters at Alcon. Armed with an extensive background exceeding 15 years in the field of regulatory affairs, Ms. Salah’s professional trajectory spans both the private and governmental sectors, with a focused dedication to generics and innovative products within local and regional contexts.

Her expertise extends across the pharmaceutical and medical device landscape, with specific proficiencies encompassing regulatory compliance, supply chain management, pricing strategies, and market access. Possessing remarkable interpersonal capabilities, including adeptness in presentation, communication, and analytical thinking, Ms. Salah showcases an innate creative flair and a steadfast commitment to continuous learning and innovative practices. Problem-solving is a hallmark skill, complemented by her adeptness in conducting skillful negotiations and cultivating positive relationships with Local Health Authorities. Her journey in the realm of regulatory affairs commenced with a role as a regulator in the Ministry of Health in Egypt, subsequently advancing to lead the planning and importation department within the Egyptian drug authority (EDA).

Having completed her education at the Faculty of Pharmacy at Cairo University, Ms. Salah pursued further academic achievements, obtaining an MBA with a specialization in supply chain management from AAST. Notably, she recently secured certification as a lean six sigma green belt. In her current capacity, Ms. Salah shoulders the responsibility of formulating meticulous regulatory strategies, pivotal in guiding the introduction of new products, facilitating geographical expansion, overseeing licensing procedures, and adeptly managing potential regulatory risks to ensure a steadfast commitment to compliance.

She is deeply committed to utilizing her expertise and collaborating with various stakeholders to champion the field of regulatory science and to drive positive change in the healthcare ecosystem to ensure patients have access to safe and innovative products.

In her current position, she collaborates closely with various external stakeholders, including the World Health Organization (WHO), the Global Harmonization Working Party (GHWP), the Medical Device Regulatory Capacity Building (MDRC) project team, Mecomed, and national regulatory authorities.

Together, they drive the convergence, reliance, and adoption of international best practices, ultimately accelerating patient access to innovative healthcare products. Through these efforts, they aim to improve patient health outcomes and alleviate the burden on the healthcare ecosystem.

Her area of expertise is in medical devices and in vitro diagnostics (IVDs), with a specific focus on regulatory policy and capacity building for regulatory professionals.

Prior to her current role, she served as the Regional Regulatory Affairs Manager for the Middle East and Africa, leading significant projects such as MDR/IVDR and Brexit. In this position, she ensured compliance with regulatory requirements and provided strategic guidance to cross-functional teams to bring innovative products to market.

Senior Regulatory Affairs Manager at GE HealthCare and based in Casablanca. Salma is responsible for the Regulatory Affairs activities and leading the relationship with Healthcare’s regulators in French speaking Africa and Northeast Africa.

Salma joined GE HealthCare in 2011 as RA leader in France. Since then, she has held a variety of roles with increasing responsibility in Regulatory Affairs for different GE HealthCare portfolio and regions.

Salma holds a master’s degree in quality and healthcare products from the Pharmaceutical University “Châtenay Malabry” in France.

Loshnee has a BSc in Biochemistry and Microbiology from the University of KwaZulu Natal, a National Diploma in Biomedical Technology from the Cape Peninsula University of Technology as well as a Post Graduate degree in Business Management. She has extensive, hands on laboratory experience and has worked in the Medical Device and IVD industry for over 15 years with managerial positions in both Quality Assurance, Compliance and Regulatory Affairs. She has been with Cepheid since 2019 and currently holds the role of Senior Manager, International Regulatory Affairs for Middle East and Africa.

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

Dario Belluomini is Manager International Affairs at MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices, and digital health.

In this position, he manages and coordinates project and working groups addressing market access, trade policy initiatives and international regulatory matters in the medical technologies sector, with a primary focus on the countries outside of Europe.

He is experienced in representing the organization before multiple institutional stakeholders as well as engaging with third country authorities and international fora (e.g., IMDRF, GMTA). Earlier in his career, he coordinated market trackers and ad hoc market intelligence projects in the medical technologies sector. He holds a Master’s Degree in International Trade from the University of Antwerp (Belgium).

Mohamad has been working in the field of medical devices and pharmaceuticals for more than 14 years. He has been on both sides of the supply chain, distributor and manufacturer, and has an experience in different fields such as orders management, business support & regulatory affairs.

Mohamad works with CooperSurgical, a leading manufacturer of IVF products, and since 2021 he is occupying the role of Regulatory Affairs Manager for Middle East, Turkey and Africa. He holds an MBA degree and a master’s degree in Law.

He graduated from the Faculty of Pharmacy in 2008, then he joined the marketing, sales and Business administration diploma at the American University in Cairo and the Naval Academy as well.

He started his career in the Egyptian Drug Authority (formerly the Ministry of Health and Population) in 2013 and worked gradually until he reached the Head of Digital Transformation in EDA.

His big focus was managing the track and trace project in Egypt from 2018 until 2020 adding to that he managed to transform the registration to be automatically and having company profile for each entity registering in EDA then he decided to move to GS1 Egypt, where he is responsible for helping in implementing the GS1 standards in the healthcare sector and continuing to manage track and trace and other projects such as the UDI project for medical supplies, which was implemented in Egypt in 2021-2022 and other projects related to the health care sector in Egypt.

Avanthi is the Associate Director-Regulatory and Quality at Alcon Laboratories South Africa across a portfolio of medical devices and pharmaceuticals. Prior roles involved various Regulatory and Quality responsibilities in Sub-Saharan Africa.

She is a member of the Board, past Chair and Vice Chairperson of SAMED, and an Associate Executive Member of the Industrial Pharmacy Section of FIP (since 2008).

Avanthi is a registered pharmacist, with a Master’s degree in Health Economics and Pharmacoeconomics.

She has worked in both the private and public sectors of South Africa covering the retail, hospital, academic and industry sectors, and in Singapore.

Avanthi has a particular interest in access to healthcare in Africa, specifically focusing on the regulatory mechanisms that enable these processes.

Dr. Lydia Mina’s impressive regulatory experience is complemented by her strong commercial background in the Middle East region. During her tenure at Merck Sharp & Dhome, she held the pivotal role of overseeing regulatory submissions for Specialty products, including Oncology, Antibiotics, and HIV products, specifically for the Gulf Region.

Transitioning to Reckitt Benckiser, Dr. Mina assumed the position of Regulatory Lead for Pharma & Health Care products throughout the Middle East Region, showcasing her expertise in navigating regulatory intricacies across various domains.

Her career continued to ascend as she joined Abbott as the Regulatory Affairs Regional Manager, where she played a crucial role in facilitating the transition to IVDR & MDR within the AMTI region (Africa Middle East Turkey & India), and eventually extended her influence to the UK & METAP regions.

Beyond her regulatory prowess, Dr. Mina also demonstrated her versatility by serving as the Sales Manager for the Psychiatry & Neurology unit at Janssen Cilag, Egypt, a subsidiary of Johnson & Johnson Pharma companies, and later expanding her responsibilities to include the gastro business unit.

She is an esteemed member of the Regulatory Affairs Professional Society (RAPS) in the USA and holds a Diploma in e-CTD Masterclass from eXtedo E-Regulatory Affairs. Dr. Lydia Mina’s dedication to professional development is evident through her certifications from the Saudi Council for Health Specialists and the European Pharma Consultant group, specifically in the field of Regulatory affairs for Saudi FDA.

In addition to her extensive professional achievements, Dr. Mina has pursued higher education, earning an MBA from Warnbough College in the UK. She also holds a Diploma in Marketing & Salesmanship from the American University in Cairo and graduated with a Bachelor of Pharmacy & Science from Alexandria University. Her diverse educational background further enhances her multifaceted expertise in the field.

With over 18 years of experience in regulatory access and market intelligence healthcare industry, I successfully assisted different MAHs, manufactures and companies in developing innovative strategies for entering new markets, focusing on all different market access perspective such as BD, regulatory, pricing and vigilance considerations.

Through my career in different healthcare stakeholders of which Shocair Group (Arab Drugstore, Arab Medical and scientific Alliance and Amsterdam Medical and scientific Alliance )which I served for more than 15 years which id Shocair group, I successfully established and managed different operational departments such as supply chain, quality compliance, in addition to regulatory and intelligence department, which gave me enrichment exposure to registration experience in different regions and from different perspectives. Moreover, I was part of the teams responsible for revision of different JFDA regulations, member in drug owner association, in addition to my active participation as a keynote speaker at numerous healthcare industry events, I regularly provide updates on the latest trends in regulatory affairs. Additionally, I serve as a business coach and trainer, helping companies unlock the potential of their employees through technical training and personalized coaching.

As for my qualification; by educations I`m a pharmacist with two master degrees; Public Health and MBA which both supported my remarkable achievements in different scopes. Moreover, through continuous education and commitment to unremitting learning I gained different professional certifications in different regulatory access and market intelligence fields such as quality pharmacovigilance auditing (International Colleague of London),  Professional GCC Regulatory Affairs Certificate (Dubai Pharmacy College), Certified Innovation Associate (GIMI), and Vocational Diploma in Regulatory Affairs of Pharmaceutical Products &Market Authorization (University of Jordan)

Recently, I`m working as a Regulatory Access and Market intelligence Strategist and Consultant through which I help companies to strategies their regulatory access in different countries with thorough market assessment. Support different MAHs in their regulatory projects within the region through creating innovative solution when coming to challenges faced with authority or other stakeholders. Furthermore, I create and implement effective business coaching plan for companies that positively reflected in their team achievements and increased quality of their work deliverables.

Senior Regulatory & Quality professional with more than 20 years’ experience in multinational environment and emerging regulations including leading, planning and implementing strategies, policies & procedures for the Regulatory Affairs & Quality Assurance department for  Boston Scientific. Solid experience in working with Health Authorities throughout the Middle East, Africa and rest of emerging markets. One of founding and active member of Mecomed since 2007 currently acting as Chair of the regulatory committee.

In his current job role, he is responsible for all aspects of regulatory activities for Maghreb, Ghana, Mozambique, and French West Africa.

Prior to his current job role, Mr. Ahmad has worked at BBraun Medical, Siemens Healthiness, Thales AVS France till 2018, and from 2011 he began at ANSM (French Health Authority), as a vigilance evaluator.

He is an active member in local and regional Trade Associations (SNITEM, MECOMED, AMPDM).

In addition, he is a speaker at Dubai Pharmacy College & PRA Consultancy’s Medical Device Regulation Masterclass MENA in the year of 2021 and 2022.

Charle Leibbrandt is a partner of VECTOR Life Science. He is responsible for overall business development and the strategic growth of products and markets. He gained his experience in the electrical and Automotive arena where he fulfilled the role of managing director in South Africa and Zambia.

A pharmacist with 14+ years of regulatory experience on both Local and Regional levels. Combining both Governmental and Pharmaceuticals companies experience.

Majda Mghimimi is Moroccan based in Casablanca. She is a Senior Regulatory Affairs Specialist for North Africa and French-speaking Africa at Medtronic.

She holds a master’s degree in Marketing and Immunology. She has prior experiences in diverse departments: Regulatory Affairs, Quality Control, Compliance and Customer Relationship Management, with other renowned multinational l compagnies operating in the Pharmaceutical and Medical Devices field (Roche – Fresenius – 3M).

As a scientist, leading relationships with healthcare regulators and various internal and external stakeholders, our mission is to facilitate patient access to appropriate and better Health products and Medical Devices, making regulation our ally in overcoming environmental challenges.

A pharmacist by graduation, with 17+ years of Regulatory experience on Local, Regional and Global levels.

Fatma has a proven track of record in regulatory strategy setting and advocacy activities combining the Governmental, Pharmaceutical, and Medical device companies experience.

Kent Briggs is the Managing Director at VECTOR Life Sciences. He began working with eSubmissions in 2002 and eCTDs when they were first implemented in 2003. He has provided industry workshops in the US, Canada, Europe, South Africa, India and Australia and has performed application compilation training with both big and small pharmaceutical companies around the world. In addition to performing evaluator training at over 20 health authorities, Kent has authored the eCTD specifications for 4 regions including the soon to be released specifications for ECOWAS. Since 2014, Kent has focused on the CTD in Africa and supporting the harmonization efforts through regional and continental activities.

VECTOR Life Sciences is a service provider for the African regulatory market with a key focus on the implementation and usage of electronic systems to improve regulatory efficiency. VECTOR supports customers in their transition from paper based methods to electronic processes by streamlining their regulatory operations and making their use of data more effective