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His Excellency Dr. Amin Hussain Al Amiri is the Asst. Undersecretary of Public Health Policy & Licensing Sector in UAE Ministry of Health & Prevention
Dr. Al Amiri got his Ph.D. and Ms. C. in Medical Science in 2003 from Faculty of Medicine; Aberdeen University in Scotland; UK.
He is responsible for the following departments at MOHAP:• Drug Dept.
• Empowerment & Health Compliance Dept.
• Organization, Licenses& Advertisement Dept.
• Public Health Policies Dept.
Mrs Nisreen Nassr is an Omani Senior specialist pharmacist, holding a Master degree in pharmaceutical Sciences. Her research was focused on Drug Discovery. In October 2015, she was appointed as the head of registration of Pharma products in the MOH, Oman. She is a member and secretary of the Technical registration and Pricing committee in MOH Oman, Bioequivalence committee and the National committee of Pharmacovigilance. Her responsibilities include policy development regulatory affairs and capacity building.
Prior to this role and since 2002, Mrs. Nisreen handled various tasks as she was the Section of Controlled Medicines, GMP inspector, registration applications reviewer, and handled pricing. In 2007, she effectively contributed in the with WHO/HAI survey on medicines prices availability and affordability.
An experienced professional with in depth knowledge in different regulatory fields related to product regulations that include Medical devices , pharmaceuticals, Biologicals , herbal products, nutritional products, medicated cosmetics and other related product classes (FMCG), A member of multiple technical and policy making teams on a national & regional scale ,most of these teams are joint groups with different authorities from all across the UAE/ GCC like ESMA/HAAD/DHA/ DM / GCC Health Council. Has a wide experience in different areas as regulatory affairs / market access / regulatory compliance and government affairs in the GCC & MENA regions.
Wesal holds a Bachelor of Science in Pharmacy from the University of Jordan, MSc.in Pharmaceutical Sciences from the Applied Science Private University, has completed a professional Diploma in Supply Chain Management. Assigned as Director General Technical Assistant / Jordan Food & Drug Administration in Jan 2021 , and as Drug directorate director from July 2017 until Jan 2021, assigned as Chairman and Vice-Chairman of several committees at JFDA ,She worked as head of drug registration department in the period 2012-2017, through her participation as a member in the Technical Committees, she contributed to the development and establishment of regulations and instructions for drug registration and review process, she was a member in faculty of pharmacy council in several universities in Jordan , she participates regularly in regional and international workshops and conferences (as speaker and trainer).
I hold a PhD in Biochemistry from Imperial College, London and have over 25 years of experience working with biological products in bio-pharmaceutical (CELLTRION, POLUS, ABBVIE), consultancy (PAREXEL), regulatory (MHRA), manufacturing (PROMETIC BIOSCIENCES, LONZA) and academic (ROYAL POSTGRADUATE MEDICAL SCHOOL, IMPERIAL COLLEGE) environments.
In my current role at CELLTRION, I have responsibility for the global regulatory strategy to support our extensive (more than 20) biosimilar monoclonal antibody pipeline. I am presently a member of the Medicines for Europe Biosimilars Sector Group.
At POLUS, I was responsible for the development of an extensive microbial derived biosimilar pipeline with oversight of over 60 scientists and professionals across R&D and regulatory affairs.
At ABBVIE, I was initially part of the Biologic Strategic Development Group, a global team who informed on biosimilar policy and development activities before moving into a European Regulatory Policy and Intelligence role for a variety of other policy areas. Whilst at ABBVIE, I was Chair of IFPMA BioT Working Group and a member of EUROPABIO and EFPIA working groups.
At PAREXEL, I was the European Practice lead for all Regulatory/CMC issues related to biological products, especially biosimilars and predominantly worked with CELLTRION supporting their biosimilar pipeline and the approval of the first monoclonal antibody biosimilar (infliximab, REMSIMATM), in Europe.
At the MHRA, I was a Senior Quality Assessor in the Biologicals Unit reviewing CMC data for all types of biological products and was a Regular contributor to both UK and CHMP scientific advices as well as being a member of various CHMP guideline groups and working parties.
At PROMETIC BIOSCIENCES, I coordinated all Bioprocessing/Technical Support activities relating to affinity chromatography adsorbent development.
At LONZA, my role was a Senior Purification Scientist developing downstream purification processes for monoclonal antibodies for multiple clients and supporting transfer from bench to commercial scale.