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.
Eng. 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.
Dr. Donia Al Bastaki
Ph. Donia Al Bastaki is the Head of Drug Registration Department with more than 16 years working experience in the pharmaceutical field, her area of expertise is regulatory affairs and pharmacovigilance where she contributed to the development of drug regulatory framework in Kuwait and GCC.
Being the Head of Drug Registration Department she is responsible of registration and approval of pharmaceutical products including human medicines , herbal medicines , veterinary medicines ,health products as well as medical devices .In addition to monitoring pharmacovigilance activities in Kuwait.
Ph. Donia Al Bastaki is a Senior GMP inspector and an ISO lead auditor , where she inspected several international, regional and local pharmaceutical and medical devices manufacturing companies.
Member of GHC Central Drug Registration Committee since year 2007 till 2018 and contributed to setting the GCC Guidelines for Drug Registration as well as Stability, Bioequivalence and PIL GCC guidelines and others.
Currently she is a member of Medical Devices GHC Registration Committee.
Member of the International Society of Pharmacovigilance and Kuwait deputy focal point for Uppsala Monitoring Center /WHO Collaborating Center for International Drug Monitoring.
She was assigned as Kuwait focal point with the League of Arab states in the field of Pharmacy and drugs and participated in the development of the Arab common Bioequivalence Guidelines.
Dr. Mohammed Majrashi
PhD in Biomedical Engineering, University of Strathclyde, Glasgow -UK
Bioengineering, University of Strathclyde, Glasgow-UK
Biomedical Technology Engineering, King Saudi University, Riyadh –
15 Years Experience at Saudi FDA
Medical Devices Regulatory Affairs
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
Essam M. AlMohandis
Worked at King Faisal Specialist Hospital and Research Center in Riyadh (engineer / supervisor / chief engineer) for more than 12 years in which he received multiples over-seas technical training at various international foreign factories , administrative courses , participated in a number of local committees and founded with a number of engineers in the hospital the an innovative purchasing system for high medical technology in what is known as Grantee Price Per Reportable Result –GPPRR, which contributed to saving substantial coast were applied at that time in 1997 AD. Then the team worked on publishing the new system for purchasing in the Ministry of Health-MOH, the National Guard, Ministry of Defense hospitals and other hospitals. Essam joined Saudi Food and Drug Authority – SFDA 2007 (Component authority) as one of the founders (a director then an executive director) for nearly 12 years, during which he Chaired working Group 1 – AWHP for 9 years continuously also a chair /member for number of relevant regional and local committees, during his carrier has received many specialized technical courses in the field of medical devices as well as many advanced leadership courses. Essam contributed to the establishment first of its kind in the region the National Center for Medical Devices Reporting Center (this center proudly was supporting GCC, AHWP economy members) also contributed in the establishment of the Center for Post Marketing Follow-up Studies.
Finally Essam devoted to private work in this important vital field as a CEO of a group of companies working in the field of medical devices importation, distribution and manufacture as well as Ubiquitous ecosystems.
Dr Aseel Al-Sagarat is an accomplished Healthcare Automation expert, PharmD with more than twelve years’ experience in delivering and managing large scale, complex, multi-million projects from medical devices launching and strategy development in cathlabs and interventional radiology suites to MedTech solutions implementing healthcare transformation projects across Turkey and the middle east.
Dr Aseel is currently leading BD Medical Supply Management Dispensing portfolio in Eastern Europe, Middle East and Africa. Working closely with governmental key opinion leaders and healthcare executives across EMA, translating strategies into viable Medtech solutions, with clear quantifiable outcomes and meaningful ROI. Prior to BD, she worked in various marketing, clinical and consulting capacities in top fortune 500 companies in the U.S, Belgium and Jordan including Abbott Vascular, St Jude Medical and J&J.
Dr Al-Sagarat is a licensed PharmD, certified in pharmacy informatics by ASHP. Her mission is to advance the world of health through improving healthcare awareness and working with healthcare providers to improve their clinical, operational and financial outcomes by leveraging innovative medical technologies and optimized workflows and processes. Of note, Dr Aseel is active in voluntary contributions as a founder of JPSA, a member of FIP and Alumni of AIESEC. She is very involved in women empowerment with regional contributions on that front and is dedicated to the continual pursuit of raising awareness.
Eng. Omar Mohamed
ENG. OMAR ISMAEEL a medical equipment engineer awarded with the bachelor’s degree in mechatronics engineering from AMA University. worked in the medical field since 2012 as a bio-medical service technician and then in 2015 got promoted into a bio-medical service engineer in one of the biggest governmental hospital. worked with NHRA as a health inspector & medical equipment engineer since March 2016. got the medical devices – Quality management systems Auditor/lead auditor (ISO 13485: 2016) certificate from BSI in 2019. Currently managing the Permit to use project, which is considered as the first of its kind in the region where it aiming to prevent unauthorized personal to use medical devices.
Health technology expert with 19 years of experience in technology planning, implementation, support, education management and eager to learn more co-founder of the safe care initiative; a health technology safety network and social entrepreneurship to help unregulated medical device market in Arabic speaking countries.
Monir El Azzouzi
Monir El Azzouzi is a Medical Device Expert specialised in Quality and Regulatory affairs. He has worked for multiple Medical Device company where he acquired 15 years of experience. Within his experience he had to develop Quality and Regulatory affairs departments, obtain CE marking for Medical Devices, register products all over the world, deal with audits as Management Representative.
He has now created Easy Medical Device to support Medical Device companies that need help to place compliant products in the Market. He also educate the Medical Device community through his Blog, Podcast and Youtube channel. By educating everyone, we prevent issues to happen.
His motto “Would I give this product to a member of my family”. This helps him to take decisions.
Dr. Wolfgang Ecker
Hon(FH) Prof. of University of Applied Sciences Technikum Vienna and Medical Technology Upper Austria
Graduated at Medical Faculty of University of Vienna, 4 years of medical education at Viennese hospitals
More than 30 years serving the Austrian Health Ministry and various expert groups of the European Union for medical devices
Member of EU delegation to the Global Harmonization Task Force (GHTF) in Study Group 5 “Clinical Evidence”
Member of the EU Council Working Party on Medical Devices which drafted the new EU Regulations on medical devices and IVDs.
Giving lectures at Universities of applied sciences and medical technology clusters and author of books on the new EU regulations.
Eng. Wesam Abdelzaher
Eng. Wesam Mamdouh Abdelzaher Medical Equipment Engineer in the National Health Regulatory Authority (NHRA) in Kingdom of Bahrain since 2017. graduated from faculty of engineering -Cairo University 2006, worked in Dar Al Fouad Hospital in Egypt as a bio medical engineer, holds a Medical Devices – Quality Management Systems Auditor/Lead Auditor (ISO 13485:2016) certificate from BSI in 2019.
Eng. Mohamed Aman
Eng. MOHAMED AMAN is currently working as Acting Head of Waste Management Section at the Supreme Council for Environment (SCE), Kingdom of Bahrain. He has been working in the Waste Management Section since 2004. His educational qualifications include Bachelor’s Degree in Chemical Engineering and MBA from AMA University.
The Supreme Council for Environment in Bahrain is a government entity responsible for the development and compliance of Bahrain’s future strategy for the environment and sustainable development as well as following up on the implementation of this strategy with relevant ministries, organizations and institutions. One of the key mandate is implementation of the strategy on managing municipal, industrial and healthcare waste.
Eng. AMAN is a member of National Committee of Complementary and Alternative Medicine and is involved in preparation of revised hazardous waste and healthcare waste management regulations. He is also the National Focal Point of the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and Their Disposal and is the member of Implementation and Compliance Committee in the Basel Convention.
Sanjay is called to the Singapore Bar and practised as an advocate and solicitor in a local Big Four firm prior to his move in-house to be a general manager.
Holds experience in the medical device industry having worked at the Health Sciences Authority (HSA) for almost a decade. His work experience at HSA covered both pre-market and post-market and included:
(1) being a Unit Head of the Therapeutic Medical Device Evaluation Unit
(2) submissions for high-risk medical devices to the Medical Device Advisory Committee
(3) being part of the team that developed and obtained ministerial assent for the ASEAN Medical Device Directive
(4) conducting GDPMDS witnessed assessment audits
(5) post-market review of medical device related adverse events and field safety corrective actions (FSCA)
(6) participating in enforcement operations against counterfeit and unregistered medical devices
(7) testifying as an expert witness in a Coroner’s Inquiry.
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, and is currently pursuing a program certification in “Regulation: Theory, Strategy & Practice” from London School of Economics & Political Sciences (LSE).
In her current role as Regulatory Affairs Manager at Mecomed, Rana is responsible for managing Regulatory Affairs-related responsibilities in MECOMED, and works closely with Mecomed RA and executive teams on advancing Medical Device 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 coordination and prioritization of the RA needs of the MedTech industry.
Dr. Bassil Akra
Dr. Bassil Akra is the CEO and co-owner of QUNIQUE GmbH, a medical device and in-vitro diagnostic consultancy company, located in Germany and Switzerland. He spent the last decade as a subject matter expert at the biggest notified body in Europe and represented locally and the globally the notified body association in the various European discussion. Dr. Akra was the Vice President for strategic business development at the Global Medical Health Services of TÜV SÜD Product Service GmbH in Germany. He has long experience in leadership, business management, research, development, quality management and regulatory approval of medical devices, combination devices and ATMP products. Dr. Akra played an essential role during the implementation of the medical device regulation (MDR 2017/745) in Europe and was involved in the drafting of the several European guidance documents (e.g. MEDDEV, MDCG, etc.). He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR) and their impact on the EU healthcare system.
Ahmed Al Shareef
A visionary, highly organized, and accomplished executive offering extensive background in the healthcare sector. Al Shareef, carries more than 24 years of experience covering functions like service, sales, management, external affair management, and entrepreneurship. Working with Multinational corporates like GE Healthcare, Unilever along with an extensive knowledge of SFDA where he served as a member of the launching team in Saudi Arabia.
Al Shareef, joined Bio-Standards as MD and contributed in its successful expansion to cover other relevant departments under SFDA like Food, Cosmetics, Health & Herbal products, OTC products, Pesticides, and Veterinary, besides being the experts in the Medical Device sector.
In general Al Shareef has managed to play a major role in advocacy and lobbying, partnerships, policy formulation, political strategy and brand protection for their ever-growing client portfolio.
Dr. Mazin Gadir is a Director at IQVIA Payer Provider Government Management Consultancy. He is also an external Advisor at The Executive Office for Organizational Transformation, Dubai Health Authority with responsibility for Health strategy development, implementation, execution and Transformation. Prior to that, Dr Mazin Gadir led Healthcare Strategy Transformation and Digital Health Innovation at PricewaterhouseCoopers PwC Middle East, Abu Dhabi Healthcare Services Co. SEHA, Cerner UK and ME accumulating 19+ years of experience in the field of Healthcare, innovation and transformation. As a management consultant, he accumulated a depth of experience covering
Faten Arzouni, has a general MBA from Preston University, Bachelor degree in Biochemistry & a Geology certificate from the University of Quebec in Montreal.
She has 15 years of experience in the Pharma industry – Middle East region covering innovative, generic, OTC and Medical device products.
Faten has started her pharmaceutical career with the Novartis group ME regional office based in the United Arab Emirates, Dubai since 2004; where she occupied different roles and responsibilities within the Medical and Regulatory department for innovative and generic products.
She then expanded her pharmaceutical knowledge to include the OTC portfolio within the Middle East, Africa and Turkey region at Boehringer Ingelheim from 2012-2016.
Currently Faten is occupying the role of Head Regulatory Affairs Middle East at Alcon since 2016 with main focus on the Medical device portfolio with extended responsibilities to cover strategical projects for the Emerging Growth Markets – EGM.
Zahra Mansoor is the Global Brand Protection Manager for Johnson & Johnson (Middle East, Africa & Pakistan) supporting Medical Devices, Pharmaceuticals and Consumer Health products.
In her role, Zahra is responsible to combat illicit trade activities such as counterfeiting, tampering as well as parallel trade for all J&J’s products to ensure patient and consumer safety. She is responsible to partner with Health Authorities, Law Enforcement Agencies as well as key institutions to address illicit trade issues within the industry.
Prior joining Johnson & Johnson, Zahra was in GE Corporate covering regional responsibilities.
Zahra has a double major degree in Finance & Management from the American University in Dubai.
Dr Neil Ebenezer
Dr Neil Ebenezer has joined the Department for International Trade as a Medical Technologist Specialist. His role includes developing and implementing the global strategy for medical technologies across inward investment and exports.
Neil has a broad scientific knowledge with a degree in Biotechnology from Dublin City University. He initially worked on plant biotechnology before obtaining a PhD from the Institute of Ophthalmology (UCL), working there for over 13 years on the genetics of ocular diseases. Neil subsequently held various posts within the civil service, including; the Department of Health where he contributed to Blood Safety and Genetics policy; was the Head of New and Emerging Technologies at the Medicines & Healthcare Products Regulatory Agency (MHRA) and the Head of Science and Innovation at the Department of Transport.
More recently, Neil was the Director of Research, Policy and Innovation at the charity Fight for Sight. He is a Fellow of the Royal Society of Medicine and a Member of the Institution of Engineering and Technology.
Dr. Helen Erwood
Helen has been leading teams in the Pharma / Medical Devices industries for over 30 years and continues to spread her fascination and enthusiasm for regulatory affairs with colleagues and clients globally. After senior roles with AstraZeneca, Sanofi and GSK, in both Rx and Consumer products, Helen founded ESPL in 2000 and currently leads a team of regulatory experts based across the EEA, and within North America, Australia and Japan on a broad range of different regulatory projects. Helen’s interests in the regulatory arena include the challenges of the borderlines between medicines, devices, drug-device combinations, PPE and consumer products. Helen regularly lectures within companies, for TOPRA and for other professional organisations on medical device and medicinal requirements, including the design and development of medical devices. Helen is based in Scotland, has a doctorate in Medical Microbiology and in her spare time is a social documentary film-maker.
Project manager and commissioner of waste incineration plants for hospitals, laboratories, oil industry.
Various missions accomplished in Europe, Africa and countries of the Middle East.
Currently in charge of the Bahrain Medical Waste Treatment Plant.
Gert is an expert in European regulations based on 18 years hands-on working in the field, as auditor, product reviewer, regulatory specialist, Head of notified body and strategic consultant.
He has been leading the Notified Bodies in Brussels for many years, and has strongly supported the regulatory debate with the EU Commission, EU Parliament and the EU Council of Ministers.
He combines strong experience in quality, compliance and regulations with a pragmatic, result driven approach at both operational and strategic level.
From his PhD in Biomaterial Sciences, and PostDocs in controlled release of drugs and gene therapy, he has dealt as technical reviewer and consultantwith a large range of devices mostly in the non-active device area.
For his contributions to the regulatory profession he has been awarded as Fellow of RAPS.
Gert is president-elect of RAPS, and serves as board member of RAPS Europe.
Stephanie’s competencies and experience are briefly detailed below:
Expert advice on the interpretation of the Medical Device Directives and US Quality Regulations (21 CRF 820.30) pertaining to medical devices in regard to items such as regulatory pathways, classification.
Lead Auditor, with hands‐on approach to device quality issue management with emphasis on technical analysis, problem solving, and CAPA creation of manufacturing and distribution sites for Medical Devices
Creating, implementing, monitoring and maintaining Quality Management Systems according to ISO 13485/9001 standards and QSR 21 CFR Part 820 (CE Marking, Quality Manual, Surveillance Auditing, Internal Audits, Document Management/Master Control)
Post Market Surveillance and international complaint/vigilance management under ISO 13485 and QSR: CRF Parts 820.100, 198 and 803.
Project Planning & Management & Deployment. Lean and effective task coordination to accomplish projects with timeliness and creativity.
Experienced in developing and managing quality metrics and scorecards (KPIs) for management
Strategy development and implementation in QA/RA project management at all levels.
Manage the regulatory submission planning to ensure that all business requirements are met, by building strong relations with stakeholders to determine regulatory requirements.
Managed and participated in many strategic projects within SFDA
10 years’ experience in MD regulations both premarket & post-market
Master degree in Health services administration
Waste Management and Incineration of Hazardous Waste
Dr. Mohamed Hani
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 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 ad government affairs in the GCC & MENA region
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