EDASPIRE II

EDASPIRE II Biographies

Biographies

Prof. Dr. Tamer M. Essam

Chairman Of the Egyptian Drug Authority

Prof. Dr. Tamer Essam, Chairman of Egyptian Drug Authority Since January 2020.

He Acted as The Deputy Minister of Pharmaceutical Affairs – Ministry of Health and Population During the Period Of 2018- Early 2020, And Before That He Was the Head of Central Administration for Pharmaceutical Affairs (Capa) During the Period Of 2015-2016. He is Also a Professor of Microbiology and Immunology, Additionally He Acted as A Lead Assessor and A Member of The Supreme Committee of The Egyptian Accreditation Council - Ministry of Trade and Industry, Member of The Arabic Accreditation Council (Arac), Member of The Technical Committee for The Egyptian Standards for Cosmetics -Egyptian Organization for Standardization (Eos) And A Reviewer in Many Scientific Journals. He Has Been Graduated from Faculty of Pharmacy, Cairo University at The Year 2002, And Got His PhD from Lund University, Sweden in The Field of Biotechnology at The Year 2006. He Was the Director of The Biotechnology Centre, Faculty of Pharmacy, Cairo University and The Founder of The Biotechnology and Life Sciences Department, Faculty of Postgraduate Studies for Advanced Sciences, Beni-Suef University.

Prof. Dr. Aiman S. El-Khatib

Vice President of The Egyptian Drug Authority

He Is Currently the Vice President of The Egyptian Drug Authority. He Is a Professor of Pharmacology and Toxicology in The Faculty of Pharmacy, Cairo University Since May 2002. He Held Several Leadership Positions in Cairo University Including Vice President for Graduate Studies and Research Affairs, Dean of Faculty of Pharmacy, Vice Dean for Education and Students Affairs as Well as For Community Service and Environment Development. Additionally, He Held the Post of Assistant Minister of Health and Population for Pharmaceutical Affairs. His Primary Research Area of Interest Is Investigation of Pharmacological Actions of Natural Products. He Published Numerous Articles in International Journals. His Awards Include Cairo University Scientific Research Fosterage in Field of Theoretical and Applied Biological Sciences In 2004, Silver and Gold Medal of Merit from Egyptian Syndicate of Pharmacists In 2004 And 2005.

Dr. Rasha Ziada

Egyptian Drug Authority Chairman's Assistant for Technical Development and Capability Building Affairs

Rasha Ziada is the Eda Chairman's Assistant for Technical Development and Capability Building Affairs which responsible for preparation and implementation of training programs to raise the efficiency of workers in the field of work of the Authority, both inside and outside the Authority
She Graduate from Bachelor of Pharmacy Cairo University and Professional Master of Health Economics - Cairo University and Clinical Pharmacy Diploma - Ain Shams University
She Held Multiple Positions as Head of Central Administration for Pharmaceutical Affairs – Ministry of Health and Population, General Manager for Planning and Pharmaceutical Policy, Head of Pricing Department

Dr. Radwa Elmoneer

Head of Central Administration of Pharmaceutical Policies and Market Access and Supervisor of Central Administration of Chairman Office 

Radwa Elmoneer is the head of the central administration of pharmaceutical policies and market access, which is responsible for ensuring accessibility, reliable availability, and continued supply of medicinal products; as well as, promoting the international competitiveness of the national products. besides, she is, currently, supervising the central administration of chairman office; including technical offices, governance and decision support units, public relations and international cooperation. in addition to having strong academic background in pharmaceutical sciences, business analytics and management, pharmaceutical policies as well as regulatory affairs. academically, Dr. Elmoneer holds a bachelor of pharmaceutical sciences from the university of ain shams (2007) and a master's in business administration from the university of Akron, Ohio, USA (2013), where she studied business administration and management. she earned a professional diploma in research methods and their applications in guiding and evaluating policies and programs from the American university in Cairo (2018). she also completed a further master’s in public policy with a concentration on social and environmental policies from the American university in Cairo (2019). during her professional journey, Radwa participated in several strategic initiatives serving the pharmaceutical sector and our community as well. besides, she held key positions in the ministry of health and populations; Dr. Elmoneer is a senior professional with more than 10 years of experience in pharmaceutical regulatory affairs and public policy; she was a senior pricing specialist, a technical team leader in the technical office of the assistant minister for the pharmaceutical affairs, and lately the head of the technical bureau of deputy minister of health for pharmaceuticals.

Dr Medhat Al-Ghobashy

Director of Drug Control Laboratories

Professor of Analytical Chemistry, Faculty of Pharmacy, Cairo University is the leader of the Bioanalysis Research Group. He has a solid background in the field of bio similarity assessment, biomolecular characterization, analysis of biotherapeutics and pharmaceuticals in biological fluids. Dr Al-Ghobashy is currently the director of Drug Control Laboratories at the Egyptian Drug Authority (EDA). He has been the Chemistry discipline lead at School of Pharmacy, Newgiza University. Dr Al-Ghobashy served as a “Titular Member” at the Analytical Chemistry Division of the International Union of Pure & Applied Chemistry (IUPAC) after being the “National Representative” for two years in the same division.

Prof. Dr. Hanan Amin Rizk

Head of Central Administration of Pharmaceutical Products

Professor of Pharmacology and Toxicology. Head of Central Administration of Pharmaceutical Products – Egyptian Drug Authority. Head of Technical Committee for drug control – Egyptian drug Authority. Former head of general directorate of registration – Ministry of Health. Former head of registration department – National Organization of Drug Control and Research (NODCAR). Former member in assessment committee of Egyptian guidelines for registration of herbal medicines. Former member in Assessment committee of antivirus C quality module. Former member in variation committee for pharmaceutical products.

Dr.Miriam Boles Kostandy

Head of Central Administration of Medical Devices

Miriam boles kostandy is head of central administration of medical devices  which responsible for evaluating and registering medical supplies and devices, and diagnostic and laboratory reagents produced locally or imported, and issuing approvals for their circulation after ensuring that they comply with the necessary technical requirements approved by the authority; this ensures verification of its quality, efficacy and safety, release of medical devices and their spare parts, sterile and non-sterile medical supplies, laboratory reagents, and dental supplies and equipment, in this role she develop and implement strategic plan of medical device and ivd premarket regulation  upgrading  to advance EDA mission and vision of providing safe , and effective medical devices. She graduated from a bachelor degree of pharmacy from Ain Shams university and of business administration from aastmt, where she studied supply chain. Miriam worked for nearly 2 decades in various capacities in medical device regulatory governmental sector. She worked first as medical device registration reviewer, then senior reviewer, director of medical device unit, then Miriam from November 2020 worked as head of central administration of medical devices. She believes in team work, power of positivity, motivation by task, and interested in medical device and ivd regulation all over the world, data analysis, problem solving 

Dr. Engy Elhosary

Head of Central Administration of Biologicals, Innovative Products & Clinical Studies

Head of the central administration of for biologicals, innovative products & clinical studies which is responsible for evaluating and registering the biological and innovative products after ensuring the safety, quality and efficacy of those locally produced and imported products, before they are traded and put on the local or foreign market; this is during the stages of registration of these preparations, as well as the stages after their registration, evaluation of protocols and periodic follow-up of all clinical studies related to biological and pharmaceutical preparations that are conducted in the Arab republic of Egypt and evaluation of their results, as well as evaluation of clinical studies and clinical presentations prior to application, providing technical support to companies to complete the registration procedures for these preparations in accordance with local and international rules.

Engy Elhosary is a who expert since 2018 & a former who rotational prequalification inspector with international & local experience in gmp inspections, she facilitated & participated in many who bench-marking missions for nras & workshops, participated in drafting new Egyptian plasma collection law & regulation as well as EDA regulations for plasma collection & fractionation, in addition to, having strong academic background in pharmaceutical sciences, inspection as well as regulatory affairs. academically, she graduates from faculty of pharmacy, ain shams university in 2002 and hold master in business administration in 2018 from Arab academy for science technology & maritime transport with major: supply chain, she has been a regulator in Egyptian nra since 19 years, starting as an inspector, then specialized in inspection of biological products and finally became a head of ca in EDA on July 2021.

Dr. Shereen Abdel Gawad

Head of Central Administration for The Pharmaceutical Care (Cap. Care)

Shereen Abdel Gawad Is The Head Of The Central Administration For The Pharmaceutical Care (Cap. Care) Which Is Responsible For Follow-up pharmacovigilance before and after marketing of medical products and supplies, Pharmaceutical education and spreading community awareness of the safe and rational use of medical preparations and supplies, and reporting the adverse effects related to their use, Reviewing and approving the rules for reviewing and publishing permits for marketing, advertising and awareness materials for preparations and supplies that are subject to the authority's control., Supervising and participating in setting work practice standards in the field of clinical information systems, developing their strategies, and selecting the best practices to integrate them into the current systems, as well as all clinical practices and practices of pharmacy. She Was Certified in Drug Regulation Through School of Pharmacy, Temple University - USA. She Is Pursuing Her Master of Public Policy at The American University of Cairo.bShe Held Multiple Positions at Central Administration of Pharmaceutical Affairs (Capa), Exploring Diverse Experiences in Pharmaceutical Regulatory Affairs.

Dr. Yasin M Ragaey Afify

Head Of Central Administration of Operations

Dr. Yasin M Ragaey Afify the Head Of Central Administration Of Operations which Responsible For Issuing licenses for various types of pharmaceutical facilities, and the authority is specialized in issuing technical licenses for operation and ensuring that the requirements of good manufacturing are implemented without the rest of the licensing procedures for pharmaceuticals and pharmaceutical crises ,Follow-up and control of all pharmaceutical facilities from the beginning of production, manufacturing and import to the different channels of distribution and reaching the patient in pharmaceutical facilities, and to ensure that they comply with the practices of manufacturing, transportation, and cold storage, Inspecting the different pharmaceutical facilities in the various governorates - in coordination with the concerned authorities - in order to verify the safety of pharmaceutical performance and compliance with the required requirements. he Graduate BSc Pharmacy, Ain Shams University and holds Master of Business Administration University of Portland USA 2012, master of public policy American University in Cairo 2016, in addition Post Graduate Certificate in Pharmaceutical Policy Analysis, Utrecht 2017. He Held Multiple Positions as Supervisor For The Pharmaceutical Care Sector In Egyptian Drug Authority, Assistant Head Of Central Administration Of Pharmaceutical Affairs For Follow Up And Investment Support ,Vice Chief Executive Officer For Business Development And Regulatory Sector In One Of The Pharmaceutical Companies, Lead For The Taskforce Of The Biological And Oncology Products Localization ,Head Of Pharmaceutical Supply Chain Unit, Head Of Pharmaceutical Track And Trace Unit Head Of Technical Office For The Assistant Minister Of Health For Pharmaceutical Affairs And Head Of Central Administration Of Pharmaceutical Affairs.

Dr. Gehan Tohamy

General Manager of stability Study Directorate

Gehan Tohamy general manager of stability study directorate at the Egyptian drug authority (EDA) which is responsible for evaluation of stability study, inspect on stability centre ,she had been graduated since 2001, faculty of pharmacy Cairo university, she join the central administration of pharmaceutical affairs (CAPA) at 2002, she held several positions in CAPA and the registration department, she was responsible for the review of the registration dossier for the pharmaceutical products, biological, veterinary products, dietary supplement & cosmetics. at 2007, she was assigned to establish the stability department at the Egyptian health authority since its early start till she became at 2021, the general manager of stability study directorate at the Egyptian drug authority (EDA)

Dr. Noha El-Hariri

General Director of the General Administration of Medical Devices Registration

Noha is the general director of the general administration of medical devices registration which responsible for evaluating and registering medical supplies and devices, and diagnostic and laboratory reagents produced locally or imported, and issuing approvals. She graduates from bachelor of clinical pharmacy with excellent grade with honor in year 2003 and hold master in business administration (MBA)in health economics specialty with grade excellent with honor. In year 2004 she worked as the central administration of pharmaceutical affairs inspector, then in 2011 she joined the medical devices registration department, in 2013 she became head of variation department, in 2020 she became director of medical device registration department.

Dr Rania Soliman

General Director of General Administration of Medical Devices Marketing Authorization

She Graduate From Pharmaceutical Sciences From Faculty Of Pharmacy, Cairo University In 2005 and hold-Master Degree Of Global Public Health Policy (American University Of Cairo (Auc) ,Clinical Scholar, Egypt Clinical Scholars Research Training Program (Harvard Medical School),Project Management Program (Pmp) (American Chamber Of Commerce ,Total Quality Management (Tqm) (National Institute For Micro Small And Medium Enterprises Nimsme–India) (January2016),Leadership Fellowship (International Visitor Leadership Program) (Ivlp) (USA), she Held Multiple Positions as Validation Specialist ,Quality Auditor , That Was Before Moving To The Central Administration Of Pharmaceutical Affairs (Capa), Now Egyptian Drug Authority Eda In 2009

Dr Heba Essam

General Manager of General Administration of Cosmetic Product Registration

Heba Essam Is the General Manager of General Administration of Cosmetic Product Registration at Eda from August 2021 till Date Who Works for The Progress and Improvement of Cosmetic Registration Process. She Has Thirteen-Year Experience of Working in Cosmetic Registration Department. She Started Her Journey By Working As Pharmacist At Cosmetic Products Registration Department From Non-Reference Countries At Capa From August 2008 To 2014, Then, She Worked As Head Of Cosmetic Products Registration Department From Nonreference Countries At Capa From 2014 To November 2019, After That, She Worked As Head Of Cosmetic Products Registration Department From Reference Countries At Capa From December 2019 To July 2021,All These Experiences Gave Here The Knowledge And The Ability To Master Cosmetic Products Registration Processes. She Has Also Excellent Communication & Presentation Skills, Ability to Set & Achieve Goals, Cooperative Attitude, Handling Problems and Issues, Creation and Development. She Graduated from The University of Helwan with A Bachelor's Degree in Pharmacy In 2006 With Excellent Grade. She Was a Member in the Team Working for The Notification System as She Was Responsible for The Part Concerning the Cosmetic Product Registration.

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