Appointed by His majesty the King, as the Chief Executive Officer of the National Health Regularity Authority in the Kingdom of Bahrain, a member of the supreme Council for health in Bahrain, and a member in Academic accreditation Committee of the supreme council for Higher Education.
Dr. Al-Jalahema was holding the position of Assistant Undersecretary for Primary Care and Public Health until 2015. She was a member of the Executive Board of The Health Ministers’ Council for GCC States until 2016.
In 2000 she was awarded the Academic Excellence and Honours Diploma of health care management from the Royal College of Surgeons in Ireland, and in 2009 she was awarded by Her Highness Shaikha Sabika Bent Ebrahim Al-Khalifa the Princess of Bahrain and Chairperson of Woman Supreme council the award of National Woman day Celebration, the award is presented to women leaders in health. In December 2011 she was awarded an honouree medal of efficiency by his majesty the king of Bahrain.
In June 2011 she is awarded by the regional office for eastern Mediterranean of the WHO the Anti-tobacco award of the region.
Dr. Amin Hussain Alamiri
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:
Empowerment & Health Compliance Dept.
Organization, Licenses& Advertisement Dept.
Public Health Policies Dept.
Nada Ghassan Alsayegh
I have a bachelor degree in biomedical engineering at the Ajman University of Science and Technology a Master degree in health care quality and safety management at RCSI with a 10 years’ experience in medical devices field starting from servicing moving towards hospital management and joined NHRA in 2015 as a consultant/advisor of engineering safety handling medical device regulation in the kingdom of bahrain, qualified as an ISO 13485 auditor and a Member in GSO/TC11 committee, AHWP , GCC central registration committee , a voting member in ISO/TC 121 ,210, 106, 150 ,170, 194,198, and the head of national medical device standards committee
Strategist, Technology Transfer, Innovations, World Health Organization (WHO) Medical Devices Expert, an Associate professor of Electrical and Computer Engineering at King Abdulaziz University, Jeddah, Saudi Arabia. Seeking To contribute in promoting and building the echo system innovation and technology transfer and play a role in localization of best practices in technology innovation, management and commercialization of ideas. Received his Phd in Electrical and Computer Engineering from the University of Pittsburgh, USA, MSc in the same field from the University of Michigan, Ann Arbor and BSc from King Abdulaziz University in Jeddah.
Dr Nazeeh is a member in Medical Devices committee as well as the Scientific Council for Dental and Medical Technology at the Saudi Commission for Health Specialties. He is also a founder and a board member in Rofaida Women Health Society. He held many positions, The vice executive president for Saudi Food and Drugs authority, consultant for deputy minister of health, consultant with King Abdulaziz foundation for giftedness, WHO, and many other public and private entities.
His areas of expertise includes strategy, Instrumentation, signal and image processing, biomedical applications, innovation, technology transfer, and entrepreneurship. He holds tow patents for medical devices from the US patent office, published multiple papers in peer reviewed Journals and co-authored a textbook “Electrical Engineering Measurement Technologies”, authored a novel “scholarship journey between easternizing and westernizing. Delivered dozens of local and international speeches, webinar in technology, innovation, research , biomedical engineering, localization, and entrepreneurship. He also has a blog “Be the change you would like to see” where he writes blogs in his areas of expertise
Dr. Hajed Hashan
Dr. Hajed Hashan graduated with a bachelor’s degree in pharmacy from King Saud University, Saudi Arabia in 1994. He continued his higher education in 1997 and got a master’s degree in Pharmaceutical Services & Medicines Control from University of Bradford, United Kingdome in 1998. He got his PhD in 2005 from University of Wails, United Kingdom. His thesis was “Evaluation of The Review Process for Marketing Pharmaceutical Products in The Gulf States and its Impact on Patients’ Access to Medicines”.
Dr. Hashan started his professional experience in 1994 as a pharmacist of Medicine Directorate at the General Directorate of Medical Supplies- Ministry of Health. In 1999, he was assigned as the Director of Pharmaceutical Affairs in the General Directorate of Medical Licenses & Pharmaceutical Affairs. After that, he held the position of the Executive Director of Licensing Department in the Drug Sector- Saudi Food & Drug Authority (SFDA). Currently, He is the Deputy of General Director in Gulf Health Council (GHC).
Dr. Hashan is a member in various professional Committees and participated in many projects in the field of pharmaceutical Regulations such as:
Head of Committee responsible for Revising Pharmaceutical Pricing Guidelines
Member in Herbal & Health Products Registration Committee
Member in Pharmaceutical Products pricing Committee
Member in Saudi Pharmaceutical Association
Member in the Scientific Council for Pharmacy in the Saudi Commission for Health Specialties.
Participated in Setting the 1st and 2nd Strategic Plans of the Drug Sector in the SFDA
Participated in setting the Current Regulatory Framework for Drug Approvals
Participating in setting in national drug policy
Directed the central registration department of gulf health council.
Supervised both pharmaceutical, medical devices registration committees.
Supervised the improvements of medical devices evaluation project in GCC countries.
His areas of interest include pharmaceutical regulation, policy, management, quality use of medicines, Pharmaceutical Pricing and Pharmacoeconomics.
Eng Faiza AlZadjali
Director of medical device control at MOH oman since 2016
Worked in Ministry of Health Oman in various posts for a total of 19 years covering assessment and procurement of Medical Technologies, their contract, upgrades and replacements. Worked in different hospitals as head of engineering depts.
MSc Graduate in Maintenance Engineering and Asset Management from University of Manchester 2014 and Bsc from Bradford University in Medical Engineering year 2000.
A seasoned CTO, Advisor and International speaker, with experience in Blockchain, Cyber Security, AI, IoT, 5G, Cloud Computing, Disaster Recovery, Bigdata, & Managed Services. Jorge is professional advisor in several innovative startups using disruptive technologies with focus on generating business value.
He created the powerful framework A6 of security: Assess, Assess, Apply, Administer, Awareness & Agility. Jorge is a regular speaker at international conferences.
Jorge is action and results oriented with passion to deliver a results… “Cyber Security is a continuous skilled process”
Theresa has over 30 years’ experience working in both the Pharmaceutical and Medical Device industries and has been involved in the development of many commercially available medicinal and medical device products.
Theresa has over 12 years Notified Body experience, initially at BSI as a technical expert for devices with ancillary medicinal substance and she held the position of Head of Notified Body at the UK NB LRQA until January 2019.
Her core area of technical expertise is in the combination product area and Theresa now works as a consultant to the Pharmaceutical and Medical device sectors supporting Companies in meeting regulatory requirements. Theresa is a frequently invited speaker on the medical device legislation and combination products.
Rami Habbal, Chief Executive Officer for GS1 UAE, is an accomplished executive with over 20 years of experience in supply chain and operational management. He is responsible for building long-term industry relationships through strategic and meaningful collaboration and is widely recognized as a major influencer in the expansion of GS1’s footprint and adoption of GS1 standards in the Middle East region.
Prior to joining GS1, Rami held several positions at various companies across multiple countries.
An accomplished public speaker, Rami is often invited to speak at industry events and gives advice as part of government public policy consultations.
Deborah leads on a number of strategic initiatives within the scientific advice programme across both the pharmaceutical and medtech areas. These have included development of the medtech early assessment tool (META) and the programme’s medtech offer. She’s also involved in the development work around artifical intelligence and digital health technologies.
She holds an honours degree and a clinical diploma in pharmacy. Deborah joined Cambridgeshire Primary Care Trust in 2005. She was responsible for developing a series of combined clinical and commissioning roles within the PCT and NHS Cambridgeshire CCG. She produced papers and lead on the economic evaluation, assessment and prioritisation of new drugs and therapies for both the local health economy and regionally. She ran the area prescribing committee. She was lead pharmacist for both the Anglia Cancer Network and for the public health network associated with Cambridgeshire PCT.
Following this Deborah worked in a hospital foundation trust to optimise their economic evaluation and implementation of drugs and devices. She has an MSc in Economic Evaluation in Healthcare from City University, London.
Jack Wong is a senior regulatory expert in Asia with extensive leadership experience in multinational medical device companies, pharmaceuticals companies and Notified Body. He has broad regulatory expertise of different regulatory system in device, drug, nutritional, consumer healthcare and biological products.
In his most recent position, Jack was Associate Vice President Regulatory Affairs, APAC Middle East and Africa at Allergan. He was part of the regional leadership team to deliver US$3500 million revenue. There were several achievements including award from regional management on getting product launch 9 months earlier for a dermal filler project in China. Jack also won award on a project on saving 20% Product Launch time.
Before joining Allergan, Jack was Head, Regulatory Affairs APAC at Baxter. There, he responsible for regulatory affairs and support Commercial QA in Asia Pacific including Japan. A project was initiated by him to align all product launches processes which saving 20% overall product launch time.
Previously, Jack also leading regulatory roles in US based, European based and Japan based companies with good understanding of different cultures and needs. One important milestones of his career is the Vice President Regulatory Affairs role in British Standard Institute, where he worked as reviewer role so that companies can get approval of their products and manufacturing sites.
Jack founded Asia Regulatory Professional Association to enhance regulatory professionals in 2010 with over 4600 members. He developed the First Asia Regulatory Affairs Certificate course since 2007 with over 2800 students in industry, government, and universities. Jack is also the author of Handbook of Medical Device Regulatory Affairs in Asia, 2nd edition which was used as textbook in 9 universities in Asia.
Jack acquired Six Sigma Black Belt certified by IASSC. He also Qualified Auditor of ISO 13485, Japanese Regulations for Medical Devices and ISO 9000 Lead Auditor by BSI (British Standards Institution (BSI). Jack earned Bachelor of Science (2nd Upper Hons) in Pharmacy, University of Brighton, UK
Dr. Toni Kennet Jorgensen
Dr. Jorgensen been working in the medical device area for more than 20 years, working for companies such as Medtronic, J&J, Straumann and Liva Nova in the area of Quality Assurance, Regulatory Affairs and Clinical Affairs. He currently is the founder and CEO of a consulting firm, MDRAC (Medical Device Regulatory Affairs Consulting) providing support for mainly smaller medical device company, all the way from strategy to implementation and maintenance of certification and medical device registrations world wide.
Eng. Shatha AlSaleh
Ee Bin Liew
Ee Bin Liew is the Group Executive Director of Access-2-Healthcare, a global commercialization and market access consulting company that physically executes end-to-end market entry and product launch activities to help overcome various challenges faced by medical technology companies globally – specifically in areas of healthcare business due diligence, commercialization solutions from concept to market, and market access activities such as regulatory, quality & trade compliance. Access-2-Healthcare currently 5 years old, is present in 10 countries, with a team of 25.
Ee Bin spent 16 years in several large medical device multinational companies, spanning from production line management, design and development, quality and regulatory, commercial operations across the Asia Pacific region, and now lends his experience and energy to the MedTech SMEs around the world.
Rita Peeters is since June 2016, Senior Director Regulatory Affairs Policy EMEA at Johnson & Johnson. In May 2011, she came back to JnJ as the Head of Regulatory Affairs for the Medical Devices & Diagnostics Marketing Operation companies in EMEA. Prior to joining J&J, she was Director of Clinical Research, Cardiac Rhythm Disease Management at Medtronic.
She started her career at the research department of Terumo Europe. During the following years, she was responsible for Clinical Affairs, Regulatory Affairs, Quality Affairs and Process Excellence at CR Bard, and later, for the Electrophysiology division of Johnson & Johnson – Biosense Webster. Before joining Medtronic, she was Director Health Economics and Medical Affairs for the Sorin Group CRDM division in Paris.
Rita graduated as a Pharmacist from the Catholic University of Leuven and obtained also a degree in Industrial Pharmacy. She holds a Ph.D. in Pharmaceutical Sciences, a MBA from EHSAL European University College Brussels and a post-graduate in Health Economics from the University of York, UK.
Stuart co-founded the UK based IVDeology Ltd in 2018 providing expert quality and regulatory support to the IVD industry drawing on his experience within regulatory at Novartis Near Patient Testing and ThermoFisher Scientific. IVDeology Ltd have had successes with providing IVD quality and consultancy including ISO13485:2016, Risk Management and EU IVD Submissions, and are well establsihed in providing CPD certified training on the EU IVD Regulation and Quality Management Systems
Reem El Sayed is the Regulatory Affairs Director for GE Healthcare Eastern Growth Markets, driving regulatory strategy and compliance to regulations, providing regulatory support for products assigned to the region throughout their product lifecycle. She is also responsible to strategically partner with the healthcare regulators to address company issues with industry and influence new and existing regulations in the region. In this role, she leads the formation and execution of Regulatory strategy within EGM Region also represents GE Healthcare in various internal and external forums with regional regulatory bodies, health authorities.
Prior to joining GE Healthcare, Reem led Regulatory Affairs at Sandoz where she served as the Head of RA team in the Middle East.
Reem holds a Bachelor degree of Pharmacy from Jordan University.
Mirette Abskharoun, since Jan 2018, she is the Associate Director Regulatory Affairs for Middle East at Johnson & Johnson Medical Device company.
In July 2011, she Joined as the Regulatory Affairs for Gulf & Levant at JnJ the Medical Devices. She moved with her family from Egypt to United Arab Emirates, based in Dubai.
Prior to joining J&J, she was Regulatory Affairs at Egypt Ministry of Health working for Medical device registration departement at CAPA (now EDA-Egyptian Drug Authority).
She started her career at the Regulatory Affaris field to ensure Medical device safety and efficacy before placing the product on the Egyptian market, learning EU/US and other GHTF Medical device regulation for product compliance.
Mirette was graduated as a Pharmacist from the Cairo University of Egypt.
She was Enrolled in Global Regulatory Affairs Certificate Course at Northeastern University’s College of Professional, USA
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