MS. NEREAH KISERA

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.

MR. LEONARD LAZARUS

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.

 

MR. EMMANUEL NKRUMAH

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. SANDRA LIGIA GONZÁLEZ AGUIRRE

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

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.

DR. LYDIA MINA

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

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.

MS. HELLA KHEMIRI GHORBEL

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

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

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.