SANDRA LIGIA GONZÁLEZ AGUIRRE

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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).

MS. RANA CHALHOUB

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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.

LYDIA MINA

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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

MS. SHIMAA SALAH

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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.

HELLA KHEMIRI GHORBEL

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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.

Ms. Lea Attallah

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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.

MR. CHRISTIAN NATALIS KAPINGA

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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.

Ms. Camilla Borrini, MSc

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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.

MR. ALBERT MAQOLO

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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.

DR. NAJDET MEZIANI

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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.