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.

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.

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.