GCC REGULATORY AFFAIRS
PHARMA SUMMIT 2021 | VIRTUAL

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.

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, REMSIMA^TM), 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.