Sara is currently Senior Manager, Scientific Programmes at DIA. In the EMEA region, she is responsible for engaging with external stakeholders and advancing the scientific content strategy by creating opportunities to integrate scientific and regulatory changes of interest in DIA initiatives. Additionally, she is responsible for the regional patient engagement and learning design initiatives, being the liason for the Middle East and SEE regions. Previously, she was Public Health Promotion Projects Manager at the Portuguese Pharmaceutical Society. Sara is a Master of Pharmacy since 2015 and a Soft skills Trainer since 2012, having delivered over 300h of Training internationally primarily focused on creating impactful interactions.

Bandar is Chief Pharmacist at the Executive Department of Regulatory Affairs in Saudi FDA since October 2018. Before this, he was in charge of clinical assessment at SFDA, working as Director of Risk-Benefit Assessment Department from Jan 2015 - Oct 2018. He joined Saudi FDA in 2005 as a pharmacist and worked on the establishment of the Pharmacovigilance Center, later working as a Clinical Assessor, at the National Drug Information Center at SFDA 2009-2015. He got his Master’s degree in clinical pharmacy from Curtin University, Western Australia in 2009. His bachelor’s from King Saud university in 2004.

Amira is the Global Regulatory Policy Director for Europe, Middle East, and Africa at MSD, with over 14 years of experience in regulatory science and policy. She is recognized as a thought leader in reliance, work sharing, and regional harmonization. Amira has built a strong network of colleagues to enhance regulatory practices in the region. She chairs the EFPIA Middle East Regulatory Network and actively participates in various trade associations, including the EMA Reliance focus group, IFPMA and PhRMA networks. She has been a regular speaker and session leader at conferences and has numerous publications on regulatory topics. Amira holds a Bachelor's degree in Pharmacy and Biotechnology from the German University in Cairo.

Fadilla has over 12 years of experience in Pharma Industry transitioning from Sales, to Global Policy and Intelligence till reaching Regional Regulatory Affairs. She is the Vice Chair of EFPIA Middle East Regulatory Network (MERN) since end 2021 and an active member in PhRMA Gulf Regulatory Affairs Working Group (RAWG). She holds bachelor’s degree of Pharmacy from the Lebanese International University & MBA degree from the American University of Science & Technology in Lebanon.

Holder of Pharmacy diploma, and Master in EU and International Regulation and Healthcare Laws. Currently heading the regulatory department for MENA region in Novartis. She has 15 years’ experience and expertise in the European and Emergent markets regulations; worked for various MNCs. Inas is an active member in the EFPIA Middle East Regulatory Network group, and of the Programme Committee of the MERC and DIA Middle East since 2008. She has participated as a speaker in several international and regional conferences. Inas is a member in the MEA Regulatory Working Group, under the PhARMA association umbrella. Her focus and interest is the healthcare reforms and legislations to accelerate patient access to innovative medicines.

Catherine is a Medical Doctor holding an MBBS degree followed by several Post graduate Diplomas and trainings in Reg. Affairs, PV, Clinical Research, Compliance, Medical Aff., and Reg. Policy, with 20 years of experience in these fields and in different countries and clusters within the region. Currently she is leading EEMEA Regulatory Affairs and Pharmacovigilance operation in over 70 countries in Eastern Europe, Middle East and Africa at Organon. She is an active member in several Policy Advisory Committees for DIA and previously EFPIA Regulatory Networks in the Middle East region, as well in Pharma Executive Committee. She is a strong advocate to Health Care reforms that aim at enhancing regulatory environment and access to innovation.

Amani Mansour is currently the Head of Regulatory Affairs, Gulf cluster in Pfizer. She has over 12 years of experience in Regulatory Affairs (RA) across the pharmaceutical industry and governmental sector. She joined Pfizer in 2011 and handled different roles within the regulatory team in Pfizer. She is also an active member within the Gulf trade association and is currently the RAWG Co-Chair for the past 2 years. Before joining Pfizer, Amani worked with the Ministry of Agriculture in Lebanon as Regulatory Affairs specialist. Amani graduated from faculty of science in Saint Joseph University in Lebanon and holds 2 Master’s degree in Food Chemistry & Agro-economics.

Previous work experience in as a registration officer at Egypt Health Authority, a regulatory officer for MUP. In 1992, moved to multinational German company (Madaus / Rotta pharm) as medical representative, growing into different functions and added responsibilities until becoming Deputy General Manager. In 1999, Manager of Regulatory & Corporate affairs and QPPV for Egypt, Sudan & Libya at Eli –Lilly. In 2013 joined the newly established research-based company Abbvie to a patient centric team. Also simultaneously the Chair for Regulatory working group of pharma association in Egypt. Member of organizing committee of MERC 2015 & 2017 and 2019.

Head of Regulatory Science, Africa & Middle East, at Pfizer with 25 years’ experience in Regulatory Affairs, External Affairs, and Marketing, supporting various healthcare categories. Pharmacist by education, licensed in UAE, Jordan, and Canada. Was appointed recently as Chair for PhRMA Middle East & Africa Regulatory Working Group.

Waleed is currently working as vaccines efficacy and safety evaluation lead at the Saudi food and drug authority. Waleed holds a bachelor degree in Pharmaceutical Science from King Saud University and a Master’s degree in science of medicine-clinical epidemiology from the University of Sidney with over 10 years of experience at SFDA, strong clinical knowledge in evaluation of efficacy and safety of medicinal products.

Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global convergence of regulatory requirements and has been engaged in many international conferences, workshops and meetings with regulators from various emerging markets around the world over the last decade. Currently, she is the Vice Chair of the EFPIA International Regulatory Expert group, member of EFPIA Middle East network and several IFPMA expert groups.

Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 24 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration, convergence and harmonization, as well as regulatory capacity building and facilitation of products introduction in the countries. Dr Azatyan has also led various projects aiming at development of national regulatory systems, as well as the development and implementation of the concept of reliance in regulation of medical products. Dr Azatyan is currently leading the Regulatory Convergence and Networks Team at the WHO's Headquarters in Geneva, Switzerland.

Shahinaz, a pharmacist with over 20 years in pharmacy and the pharmaceutical industry, is a Pharmacovigilance Consultant and Lead Auditor across the EMEA region. She began as a clinical pharmacist at Cairo University Medical School and advanced to an internal auditor role. Transitioning to the pharmaceutical industry, she worked in Regulatory Affairs before specializing in Pharmacovigilance as a regional QPPV and later as a PVQA Lead Auditor. Shahinaz is active in the ISOP Special Interest Group, contributing to global pharmacovigilance certifications, and frequently speaks at international conferences on patient and drug safety

Isabelle has joined Merck KGaA since 2005 where she has held growing managerial roles in RA and RA CMC as Head of Department. She currently is Head of International Global Regulatory & Scientific policy at Merck and as such actively engaged in international regulatory policy as member of IFPMA since 2014, representative at ICH TrSC, EFPIA and PhRMA ICH WG. Prior to joining Merck, she has worked for several Companies in areas of small and large molecules including in Clinical Development for Servier Laboratories, and assumed various manufacturing site managerial responsibilities within Sanofi GMP QA & RA. Isabelle holds a MSc and a Pharm. D from Lyon (France) coupled with an MBA from Paris (EAP) High Business School.

Bachelor of Pharmacy – Faculty of Pharmacy – Cairo University, MBA Maastricht school University-The Netherlands. Extensive knowledge and experience in Pharma industry and Health sector, regulatory affairs, governmental affairs for 23 years. 10 years working with Ministry of Health in Egypt. Also as a government official working with various HA, Ministries e.g. ministry of foreign affairs, associations across different countries in ME, Africa. Heading regulatory operations in Egypt, Libya, SAU, year 2015- MSD. In 2016 until date Heading Gulf region Regulatory operations -MSD Gulf. Local Chair for the Regulatory Working group in Gulf Region. An active member in Regulatory working group for Pharma Middle East & Africa.

Dalia Fouad, head of regulatory and policy at Sanofi, is a seasoned professional with over 15 years of expertise in pharmaceutical regulation and policy development. With a strong background in Pharmacy, she has demonstrated exceptional leadership, strategic thinking, and a deep understanding of regulatory frameworks. Dalia has successfully driven regulatory compliance, shaped impactful policies, and fostered collaboration to enhance access to medications. Her visionary approach and commitment to ethical standards have been instrumental in advocating patient-centric healthcare solutions and steering Sanofi toward regulatory excellence and improved health outcomes worldwide.

Dr. Mohammed Serve as Head of signal detection section at Saudi food and drug authority. In this role, he has several initiatives to enhance the drug safety regulation in the kingdom of Saudi Arabia. In 2008 Dr. Fouda received his bachelor’s degree in pharmaceutical sciences from king Saud university he also awarded his doctor of pharmacy degree in 2014 from Massachusetts College of Pharmacy and Health Sciences University. Dr. Fouda is currently a member of several international reference groups.

Wija Oortwijn studied health sciences and holds a PhD in Medicine. Since 1993, she has been involved in the development of HTA & health system strengthening around the world, including Abu Dhabi. Currently, she is affiliated at Radboud University Medical Centre in the Netherlands. She is working with Ministries of Health, the European Commission, World Bank, and WHO on institutionalizing HTA mechanisms for legitimate coverage decision making and capacity building in HTA. She is the President of HTAi, the international Society for HTA, as well as associate editor of the International Journal of Technology Assessment in Health Care.

Marco Rafael, a PharmD graduate from the University of Coimbra, transitioned from consulting to the pharmaceutical industry, building an international career in the UK and Switzerland. Over nine years, he held key roles at Teva, Roche, Biogen, and Alexion, complemented by an MBA from EPFL and specialization in Health Policy at the London School of Economics. As Regulatory Policy Leader at Roche’s Global Headquarters in Basel, Marco develops policies driving medical innovation, leads strategic foresight initiatives, and contributes to EFPIA’s Clinical Research Expert Group, Clinical Trial Strategy, and other global regulatory networks.

Stephan works in Quality External Affairs at Amgen on Operations/CMC since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. He represents Amgen in EFPIA MQEG and represents EFPIA on GMPs/inspections, in ICH training and ICH-QDG and before on ICHQ9, ICH Q-IWG and ICHQ7-IWG. In PDA he was at the board and chaired RAQAB.

Patricia is a Pharm D from 'Universite Saint Joseph', Beirut with 21 years of experience mainly in regulatory affairs. She is currently heading the Regulatory Affairs of Merck (Healthcare Sector) in the MEAR region (Middle East, Africa, Turkey, Russia & CIS countries), handling a diverse team of RA professionals. Since the beginning of her RA Career, Patricia has been an active contributing member in the industry via IFPMA/EFPIA/PhRMA. During the last 2 years; she acted as Regional Coordinator of the PhRMA MEA RA Group enabling, with the support of esteemed peers, the design and implementation of multiple capability building programs for key Authorities, contributing to re-shaped policies/regulations; enhancing medicines access to patients.

Rabia Sucu, President of HTAi 2023-2025, is a Senior Principal Technical Advisor at MSH, leading the HTA and Market Access Cluster. She advises the USAID-funded SAFEMed project, supporting the Ukrainian government in priority setting, HTA institutionalization, reimbursement, pricing, verification, and bioequivalence. Formerly Director of ANHTA, a professor, national clinical quality coordinator, and member of various committees, she has published over 150 articles, delivered 300 presentations, and edited 8 books.

Dr.Fawaz Alharbi is currently working as director of drug safety and risk management department in drug sector at SFDA. Dr.Alharbi holds bachelor degree in pharmaceutical sciences from King Saud University, master of science in clinical pharmacology with distinction from University of Glasgow in the UK, and master and PhD degree in pharmacoepidemiology from Utrecht University in the Netherlands. Dr.Alharbi is one of the co-founders of the National Pharmacovigilance Centre (NPC) that officially launched in March 2009. His research interests are in fields of pharmacoepidemiology and pharmacovigilance.

Sarah is a doctor of pharmacy and currently serves as Regulatory Policy Lead at Roche since 2019. She is responsible for supporting the development of the global regulatory environment for clinical trial globalization, and contributing to regulatory policy advocacy efforts. She also coordinates global Advanced Therapy Medicinal Products (ATMPs) regulatory policy advocacy initiatives at Roche.

Ms. Asmaa Fouad Ismail is currently General Manager of the Biological Products General Administration, the Central Administration of Biological and Innovative Products and Clinical Trials at EDA managing marketing authorization, lot release and laboratory evaluation, and analysis of biological products. Ms. Fouad is also delegate of EDA in ICH & IPRP since December,2021. She is also a member of the Emergency Committee at EDA and has participated in the formulation of many national guidelines in Egypt. She worked in the COVID-19 Vaccines Global Review team with the WHO. She has 20 years of biological products regulatory experience.

Dr Adel Alharf serves as Vice President for Drug Sector at the Saudi Food and Drug Authority (SFDA).In this role, he is responsible for the strategic and tactical oversight of Drug Sector’s activities including licensing of medicines, products evaluation, safety of cosmetics, pharmacovigilance, and drug availability. He joined the SFDA in 2004 and was among first team responsible for the establishment of most of Drug Sector’s Departments and regulations (Pharmacovigilance, Licensing, Inspection, and Drug Evaluation). Adel received his master’s degree from King’s College London in pharmacology and his PhD in Medicine and Therapeutics from the University of Glasgow.

Mr. Yahya I. Al-Nujaym is the Director for the Standards Directorate at the Saudi Food & Drug Authority. Prior to this, Mr. Al-Nujaym was in the Quality Assurance for Drug Sector at SFDA for four years. In addition to his previous experiences in projects and strategic planning, Mr. Yahya has worked with WHO on several projects related to guidelines and standards. Mr. Al-Nujaym holds a Masters degree in Business Administration from Thompson Rivers University Kamloops, BC Canada and a Post-baccalaureate Diploma in Marketing from the same university. Mr. Al-Nujaym holds a Bachelors degree in Pharmaceutical Sciences from King Saud University, Saudi Arabia.

Manal Almutairi, MSc, BCPS. is a Scientific Evaluation Expert and a clinical lead in benign hematology, cardiovascular, gastroenterology, respiratory and infectious in the efficacy and safety department at Saudi food and drug authority (SFDA). Ms. Almutairi received her bachelor's degree in pharmaceutical science and her master's degree in clinical pharmacy from king Saud University in Saudi Arabia. She is bored-certified pharmacotherapy specialist. She done a great contribution in improving the clinical evaluation process at SFDA, also, she represents the SFDA in different international organization. Ms. Almutairi interested in assessing blood products particularly hemophilia treatments, biosimilars, and ATMPs clinical development program.

-Professor of Pharmacology and Toxicology. -Head of Central Administration of Pharmaceutical Products - Egyptian Drug Authority (EDA). -Former head of general directorate of registration - Ministry of Health (MOH). -Former head of registration department - National Organization of Drug Control and Research (NODCAR). -Head of Technical Committee for Drug Control - Egyptian Drug Authority (EDA). -National communication point with UN agencies for Tech Access Partnership in joint effort to scale up local production of life-saving health technologies for COVID-19. -Contributed in issuing of Egyptian Herbal Monograph, EDA. -Former member in CTD committee - NODCAR. -Focal Point of Egyptian Drug Authority Associate Membership in ICMRA.

Professor John CW Lim is founding Executive Director of the Duke-NUS Centre of Regulatory Excellence (CoRE), inaugural Chairman of the Consortium for Clinical Research & Innovation Singapore, Senior Advisor at Singapore’s Ministry of Health (MOH), and Policy Core Lead at the SingHealth Duke-NUS Global Health Institute. Formerly Chief Executive Officer of Singapore’s Health Sciences Authority and Deputy Director of Medical Services in MOH, Professor Lim has also held other senior positions in Singapore’s Health and Education ministries.

Victoria Palmi, Senior International Affairs officer, has over 20 years of experience at the European Medicines Agency (EMA). She supports international collaboration programs and reliance as part of her role in the International Affairs office. Previously, Victoria worked as Product Lead in different therapeutic areas within the Evaluation of Medicines department. During this time, she led initiatives that accelerated assessment and early access to priority medications.

Dr. Raed Al Swayed is leading the Pharmaceutical & Biotechnology sector at National Industrial Development Center. With more than 27 years’ experience in Pharma Industry in lifecycle, manufacturing and value chain management of local & regional markets multi channels, Dr. Raed held several senior positions in Multinational and local Pharma Industry with diverse cross-functional experience supporting patients’ access and health solutions. Dr. Raed holds Pharmaceutical Science bachelor’s from King Saud University with progressive certification from Tulane university, Advanced Leadership and Finance international programs from Oxford Business center, in addition to several prestigious global awards in localization & patient support programs.

Mr. Abdullah H. AL-Hatareshah is a Clinical pharmacist; He is appointed as the Executive Director for Regulatory Affairs at the Saudi Food and Drug Authority (SFDA). Prior to this, Mr. AL-Hatareshah was the Director of the Product Licensing Department and Director of the Clinical Trial Department. Mr. AL-Hatareshah is active member with ICH, he started as a member of ICH expert working group (E17 EWG) since 2014 and now he is ICH Assembly member and IPRP committee member. He was a member of the National Committee of Bio Ethics. Mr. AL-Hatareshah has diversified experience in clinical trial regulation, evaluation, and drug regulatory affairs processes.

Sarah Aljahili, PharmD, is a Senior Scientific Evaluation Specialist in the Efficacy and Safety Directorate at Saudi Food and Drug Authority (SFDA). Mrs. Aljahili holds a doctor of pharmacy (PharmD) from king Saud University and currently pursuing a Master’s of Public Health degree at Alfaisal University in Saudi Arabia. Mrs. Aljahili has almost 5 years of experience at SFDA, her experience focused on evaluating clinical studies during the drug registration cycle in Saudi Arabia.

Abdullatif has been the head of Pharmacovigilance inspection in the Saudi food and drug authority (SFDA) since 2018; He completed a Bachelor of pharmaceutical science from King Saud University (KSU). He received his master's degree in Public Health from the University of New South Wales in Australia. Abdullatif started his career in the SFDA as a pharmacist in 2006, starting as an awareness and communication specialist and then supervisor. After that, he moved to the Medication errors department and established this department by working on Medication error guidelines. He started his career in the national pharmacovigilance center until he became the head of pharmacovigilance.

After qualifying as a pharmacist, Meindert worked in a hospital in the Netherlands and held positions in health outcomes and sales in the pharmaceutical industry. He completed an MSc in Health Policy Planning and Financing at the London School of Hygiene and Tropical Medicine and the London School of Economics and Political Sciences and briefly worked for the King’s Fund before starting at NICE in 2004. Meindert is currently on the board of directors for the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), 2017 to 2020.

A pharmacist with regulatory experience over 19 years at national and international level. A WHO Consultant supporting WHO Regulatory Systems Strengthening Team in NRA benchmarking and building regulatory capacities of NRAs, A Member in WHO Technical Advisory Group TAG on Local Production and Technology Transfer of Health Products, which act as an advisory body to the WHO Local Production and Assistance Unit. A United Nations Experts for GMP Inspections as well as a Former Rotational Prequalification Inspector in WHO PQ Inspection Team.

Global Director for Public, Private Partnerships at Novo Nordisk, Global Medical Affaris. Former Director of Data Analytics Centre at the Danish Medicines Agency and co-chair of HMA / EMA Big Data Steering Group. 20 years for life science experience in academia and industry. Been leading EU framework programme workpackages, IMI and TransCelerate Biopharma workstreams in the past. Currently active in development of FHIR for clinical research and use of AI/ML in life science.

Connie Langer is a Senior Director at Pfizer who leads a team that monitors and advises on regulatory changes and impacts. She collaborates with experts to communicate Pfizer's feedback and position to health authorities on regulations and guidance documents. She also has experience implementing science- and risk-based approaches and recommending strategic regulatory options to achieve product approvals globally. She is a member of the ISPE PQLI® ICH Q12 Working Team and chair of the IQ ICH Q12 Working Group. She holds BS in Chemical Engineering and an MS in Chemical Oceanography both from the University of Connecticut, and a Drug Development Certificate from Temple University.

Mr Hiiti Sillo is the Unit Head, Regulation and Safety within the WHO Department of Regulation and Prequalification. In this role, he coordinates WHO strategies for strengthening national and regional regulatory systems for medical products, including promoting regulatory harmonization, convergence, networking, work-sharing and reliance. He was previously the Team Lead, Regulatory Systems Strengthening within the Regulation and Safety Unit of WHO. Before joining WHO in January 2018, he was the Director General of the Tanzania Food and Drugs Authority (TFDA), now the Tanzania Medicines and Medical Devices Authority (TMDA). Mr Sillo is a Pharmacist and holds an MSc in Pharmaceutical Services and Medicines Control.

Chih Tzer is a pharmacist and graduated from the University of Otago, New Zealand. He is a Senior Regulatory Specialist at Singapore’s Health Sciences Authority and has been working in area of pharmacovigilance for the past 16 years. His area of work and interest involves the post market management of therapeutic product defects and regulatory communications. Prior to joining the Health Science Authority, Chih Tzer has experience as a pharmacist in both the hospital and retail pharmacy sector.

Ph. Shabana started her PV career in National Pharmacovigilance center in Sultanate of Oman in 2019. She monitors & investigates adverse effect or side effect related to the drugs. She also analyses the reported medication errors from different health facilities. She was a Member of National Pharmacy Licensing Exam Committee in 2020. She is a Member of Oman Pharmaceutical Society Scientific Committee. She is an established member of Pharmacovigilance Technical Joint Committee. In 2022 she assigned by WHO as a member of expert working group for identification of medicinal product committee.

Dr. Nabil A. Alhakamy (Pharm.D. M.S., Ph.D. ) is Associate Professor at the Department of Pharmaceutics at King Abdulaziz University. He is the chairman of the board of directors and the founder of the Saudi Scientific Society of Pharma Industries, being the founder and CEO of Al-Teriaq Pharma, Jeddah Valley. He is the chairman of the Pharmaceutical Department, Vice Dean of the Faculty of Pharmacy for graduate studies and scientific research, founder and director of the Center of Excellence for Drug Research and Pharmaceutical Industries. He is the general supervisor of KSU Transformation Office. He has received many national and international awards, and he serves on the editorial advisory board for several peer-reviewed journals.

Naser aljaser is the head of risk management section in the Saudi food and drug authority (SFDA), He completed a Bachelor of pharmaceutical science from king Saud University (KSU). He received his master degree in clinical epidemiology from university of Western Australia. He received a postgraduate certificate in pharmacoepidemiology and pharmacovigilance from London school of hygiene and tropical medicine in the United Kingdom. Naser started his career in the SFDA as pharmacist in 2008, He involved in the implementation and enhancement of pharmacovigilance guideline. He has participated in a number of pharmacovigilance activities such as drug safety review, drug risk management and communication.

Mohammad Alowairdhi is currently working as the Pricing and Pharmacoeconomics Director at the Saudi Food and Drug Authority (SFDA). Alowairdhi holds a bachelor degree in pharmaceutical sciences, a master degree in health outcomes and socioeconomics sciences, and a master degree in business administration. He started working for the SFDA since 2011. Alowairdhi is a member of several national and international committees and societies. Alowairdhi worked on several projects related to health policy, pharmaceutical regulations, pharmaceutical pricing, and economic evaluations.

Alsayyari is Executive Director of Quality Evaluation of Medicines, Saudi Food and Drug Authority (SFDA). He received his Ph.D. in Bioprocess Engineering from Wageningen University, Netherlands. His expertise comprises biomanufacturing and Quality by Design. He has more than 15 years of experience as a biological medicinal products evaluator, including Gene and Cell therapy. He is the head of the scientific advance therapy medicinal products committee within SFDA and an active member of the IPRP-Cell therapy working group and IPRP Gene. therapy working group at ICH.

Merck Serono (Regulatory Manager Oncology): Therapeutic Cancer Vaccines*** National Institutes of Health, USA: Development of B- and T-cell vaccines; Viral-Like Particles*** Food and Drug Administration, CBER: Assay development; Quality control of viral vaccines

BSc in pharmacy from university of Jordan in 2007 and MSc in pharmaceutical Science from University of Jordan in 2012. I have 10 years experiences in quality control department, I worked in Jordanian Pharmaceutical Manufacturing Company from 2008 till 2018 , held a position of Raw material Section Head. Since 2018 till now , I am a pharmacist in registration department , generic unit in JFDA. I am a member in a committee for evaluation of post approval changes for Generic drugs. And in a committee for assessment and evaluation the registration dossier of generic drugs. I was a member in Bio equivalence committee.

Mr. Hamel spent his last 23 years working with the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) at Health Canada as Senior Evaluator and Division Manager. He is currently Associate Director with BRDD. Mr. Hamel was involved with reviewing the CMC information pertaining to CTAs, NDSs and Post-Marketing changes associated with Biotherapeutics and represented Health Canada on the WHO drafting group in charge of developing the WHO Guidelines on procedures and data requirements for changes to approved biotherapeutic products. Mr. Hamel is also a member of the ICH M4Q EWG and ICH Q12 IWG and leads its implementation in Canada. He is pleased to share his experience with the ICH Q12 pilot program in Canada.

Dr. Hashan is currently the Deputy of General Director at The Gulf Health Council. He started his professional experience in 1994 as Deputy Director 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. In 2006, he was appointed as Executive Director of Licensing Department in the Drug Sector - Saudi Food & Drug Authority (SFDA). He has been a member of various Committees and projects in the field of Pharmaceutical Regulations. His areas of interest include Pharmaceutical Regulation, Policy, Management, Quality Use of Medicines, Pricing and Pharmacoeconomics.

Mohei has over 8+ years’ experience in Conducting, Managing and Monitoring Clinical Trials through CROs and Pharmaceutical industries in the MENA region. He is currently Medical Operations and Evidence Generation Specialist at AbbVie Saudi Arabia. He is fully engaged with all clinical trial management phases from Site Selection to Initiation, Monitoring and Close out. He worked in different therapeutic indications on early phase multinational clinical trials. He holds a bachelor’s degree in pharmaceutical sciences and a diploma in Total Quality Management for Healthcare.

+20 years’ of experience working in both the public & private sector of Regulatory Affairs (RA). Her career started at the MHRA - the UK RA & then moved into UK & EU regulatory strategy roles at both AZ & then Pfizer. In each of these roles she gained valuable experience across multidisciplinary aspects of RA ranging from Strategy, Labelling, CMC, Submissions, Artwork to Clinical Trials. In 2009, Ronnie moved into Labeling, managing diverse roles within Global & Regional functions at Pfizer. Ronnie’s responsibilities have included projects spanning labeling activities across EUCANZ, EME, AfME, Canada &LATAM. Currently a key focus for Ronnie is internally & externally leading on the topics of health literacy and ePI across LATAM, AFME, EU.

At WHO, Marie works as the Team lead for the Facilitated Product Introduction Team supporting the Member States by implementing various approaches and mechanisms, including collaborative procedures, reliance approaches, and joint activities at the national, regional, and international level to facilitate and accelerate the introduction of priority medical products in countries. Before joining the WHO in May 2019, Marie worked for 9 years at the European Medicines Agency in London as a Regulatory Affairs Officer. Before that, she worked in the pharmaceutical industry, contract research organization and consultancies in the United Kingdom, Spain and France.

Dr. Al Awadh is Acting Director of Innovative Medicines in Saudi Food Drug Authority. He has worked in a number of roles in the Regulatory Affairs and Products Quality Evaluation for more than 12 years. Dr. Al Awadh hold his PhD in Pharmaceutics and he has many researchers focused on Novel drug delivery system, Nanotechnology, Cell based delivery system and Drug Targeting to cancer cell. In addition, he is a member of Pharmaceutical Quality Knowledge Management System in ICMRA.

Nouf Al-Fadel is a Drug Safety Section Head at Saudi Food and Drug Authority . In this role, Al-Fadel is responsible for promoting and developing the post marketing monitoring of drug safety in Saudi Arabia. Al-Fadel has a master degree in clinical pharmacy from King Saud University in Saudi Arabia. She is a member in several local and international committees. Moreover, she has publications related to pharmacovigilance and drug safety.

Dr. Ashraf Algrain is an experienced, results-driven, and transformational leader. In 2020, Algrain earned his Bachelor degree in Pharmaceutical Science from King Saud University. Algrain has over 20 years of experience in different fields in the pharma industry & regulatory agency. Agrain is a member of several national committees related to the healthcare sector. In July 2020, he was appointed as the Healthcare & Pharma Director at the Local Content and Government Procurement Authority (LCGPA).

Almadani Ohoud is Head of Real World Evidence Section at the Saudi Food and Drug Authority (SFDA). In this role, she is leading her team to generate real-world evidence researches by RWD analysis, addressing the use and prospective advantages or adverse event of a medical product.

Head of Yemeni National Pharmacovigilance Center Hariri, born in 1959, and holds PhD in Clinical Pharmacy since 1987. He worked as a clinical pharmacist in Al-Gomhoria Teaching Hospital for 3 years, then worked in drug control and inspection for 24 years. He also worked in drug registration for 3 years. Dr. Fadhel is currently working as the Director of the National Center for Vigilance and Medication Safety in the Republic of Yemen (Aden).

Joerg has 20 years of extensive experience in the pharmaceutical industry within different functions in the quality field for development and commercial products. He serves as Global Quality Manager in Roche Pharma Global Technical Operations overseeing Roche’s global in-country testing activities. Joerg has been a contributing member in the industry via IFPMA/EFPIA. As global Policy Lead, he co-/authored several publications and industry positions on in-country testing and Advanced Therapy Medicinal Products (ATMPs) and functions as scientific reviewer for several journals. He is engaged as conference speaker and in numerous workshops/capability buildings with regulators from around the globe.

Peter Pitts is President and co-founder of the Center for Medicine in the Public Interest. Prior to founding CMPI, Pitts was a Senior Fellow for healthcare studies at the Pacific Research Institute. Peter was FDA’s Associate Commissioner for External Relations, serving as senior communications and policy adviser to the Commissioner. He supervised FDA's Office of Public Affairs, Office of the Ombudsman, Office of Special Health Issues, Office of Executive Secretariat, and Advisory Committee Oversight and Management. He served on the agency’s obesity working group and counterfeit drug taskforce.

Aline Silva holds a Ph.D. in Sciences and Health Technologies, a master's degree in Public Health, and a B.Sc. (Pharm). Postdoctoral studies in Patient-Oriented Research, Consensus Methods, and Long-Term Care. Steering Committee member of the HTAi Patient and Citizen Involvement Interest Group and co-leader of the HTAi-PCIG project "Stakeholders' Perspectives of Impact of Patient Involvement in HTA." She also acts as an independent patient advocate and patient partner at the Patient Voices Network.

Fatimah Al Hussain is currently working as the Head of Pharmacoeconomics Section within the Pricing and Pharmacoeconomics Directorate at the Saudi Food and Drug Authority (SFDA). Fatimah holds a bachelor degree in pharmaceutical science, a master degree in clinical pharmacy. She is also an active member in several internal and external scientific committees related to drug regulation and pricing. Fatimah has more than 11 years of experience as a hospital, clinical, Pharmacoeconomics, and regulatory affairs pharmacist.

Dr. Khalid Al-Kinani is currently the Chair of the Department of Pharmaceutics at College of Pharmacy, University of Baghdad. He is also a former Head of Biologics and Biosimilars Registration Committee at the Iraqi Ministry of Health (MoH). He earned his Ph.D. in pharmaceutics (Pharmaceutical Biotechnology track) from the University of Kansas, School of Pharmacy, USA in 2017. Before that he earned a Bachelor degree and Master degree in pharmacy from the University of Baghdad, College of Pharmacy in 2004 and 2010, respectively. He also works as a consultant for the WHO Regional Office for the Eastern Mediterranean (EMRO) on several projects.

Mr Fahad Alnuaim is the Deputy Minister for Sector Investment Development. Mr. Alnuaim is Private Equity investment professional, with experience in a variety of PE strategies and direct investment project globally and locally, corporate finance and investment banking, Equity Capital Markets, M&As, Portfolio and Wealth management and advisory. Mr. AlNuaim holds a bachelor's degree and MBA in Finance and multiple executive educations from Harvard Business School & University of Chicago.

Mr. Mohammed Alturki received an EMBA from the college of business and a bachelor's degree from the college of pharmacy at King Saud University. Mr. Alturki worked in Prince Sultan Military Medical City (PSMMC) for a number of years, where he led several projects, including the Automated Dispensing Cabinet and other projects related to drug automation and informatics. Mr. Alturki is currently working in the Saudi Food and Drug Authority (SFDA), where he is the Head of the Drug Tracking Department, foreseeing the RSD project planning and implementation.

Prof. Tamer Essam, Chairman of Egyptian Drug Authority .Pharmacist and University Professor, with 20+ years' experience in Pharmaceutical Field, Quality and Accreditation, Research and Academia.Acted as Deputy Minister of Pharmaceutical Affairs – Egyptian MoHP, Lead and Technical Advisor in Microbiological and Biotechnological Q.C, Member of Supreme Committee of Egyptian Accreditation Council, Arabic Accreditation Council, and Technical Committee for Egyptian Standards for Cosmetics, Director of Biotechnology Centre - Faculty of Pharmacy, Cairo University.Holds PhD in Biotechnology from Lund University, Sweden Founded Biotechnology and Life Sciences Department, Faculty of Postgraduate studies for Advanced Sciences, Beni-Suef University.

Pharmacist graduated from Nihon University in Japan with 3 years of clinical experiences. Holder of a Master's degree in pharmacology from the University of Paris 5 René Descartes, and an Inter-University Diploma (DIU) in pharmaco-epidemiology and pharmacovigilance from the University of Bordeaux Segalen. Since 2019, Technical Officer in pharmacovigilance (PVG) team at WHO headquarters and serves as a technical focal person of the Programme for International Drug Monitoring (PIDM).

Eman has worked in multiple pharmaceutical companies, from local Egyptian companies to Gilead’s agent in Cairo then joined Allergan as Egypt LSO in March 2016. She was selected to Regional PV Lead for TMEA region in March 2017 and in May 2021 she was appointed as the Lead of the Middle East & Africa PV hub. She has a vast experience in delivering trainings to pharmaceutical companies in Egypt. Since 2022, she became a member of the advisory board of this GCC PV Trainings. She also has multiple lectures in the annual PV course arranged by PRA and the Dubai Pharmacy College. Eman is now the Middle East & Africa MEA Hub Lead in Abbvie and a member of ISoP, ISoP Middle East Chapter and the Country Representative in United Arab Emirates.

Dr Yacine Hadjiat is Global Head of Biogen Digital Health Solutions. Throughout his career, he has covered several senior leadership positions in the life science industry as well as clinical practice and academic medical research in Europe, the US, and Asia. He is also currently part of the French Health Institute (INSERM) in a public health research program. Yacine also holds non-executive positions as advisor for governmental, as well as HealthTech incubators. He is the author of several scientific publications in both clinical research and tech and serves as Chief Editor of Digital Health In Pain management Journal.

Kowid Ho has been working at F. Hoffmann-La Roche Ltd.’s Global Pharma Technical (CMC) Regulatory Policy in Basel, Switzerland for >10 years. He was previously a quality assessor for biological products at Agence nationale de sécurité du médicament et des produits santé (ANSM, formely AFSSaPS) for 13 years. He has authored many European assessment reports and scientific advices on biotech, vaccines, blood and advanced therapy products, and has participated to several product related inspections. He was a member of European Medicines Agency (EMA) Biologics Working Party (BWP), Biosimilar Working Party (BMWP), and PAT/QbD team.

Melly Lin is working at F. Hoffmann-La Roche Ltd. as CMC Regulatory Policy Lead. She is responsible for identifying policy priorities and supporting regulatory policy advocacy efforts for South East Europe, Central Asia and Egypt. She has over 20 years of experience in Regulatory Affairs, within that 13 years in CMC Regulatory Policy. She joined Roche China in 2004. There she held different positions with increasing experience and responsibility in regulatory filing. She took the responsibility as China Policy Lead from 2011 to 2019. She is now taking an active role in the middle east region by leading the EFPIA MERN LCM team. She is also chairing an industry network for South East Europe.

Rodrigo Palacios is an Executive Director in Regulatory Policy at Roche. He is responsible for advancing global policy on data and technology in the regulatory domain. These topics include Cloud Submissions, Data Standardisation (e.g. IDMP), structured data submissions, eCTD and Regulatory Information Management. Rodrigo represents Roche in EFPIA and PhRMA Regulatory Technology expert groups and acts as PhRMA's deputy topic lead in the ICH M4Q R2 Expert Working Group. He has over 25 years of experience in data and technology strategy, Information Technology management, software development and consulting.

Rich Rolke holds a master degree in organic chemistry along with an master degree in business administration and is a master black belt in six sigma. He currently serves as CMC Associate Vice President in the Pharmaceutical Post-Approval Products team within Global Regulatory Affairs & Clinical Safety – CMC in MSD Pharmaceuticals Pvt. Ltd., since 2017. He currently is accountable for multiple small molecule CMC teams within the organization supporting a large portfolio of Products. Prior to joining MSD, Rich led a large post-approval CMC team Pfizer.  Rich was certified as a Six Sigma Black Belt and has led a variety of process improvement initiatives.

Sami Al Sager is the VP for Operations Sector at the Saudi Food & Drug Authority, which is responsible for establishment licensing and inspection activities, since 2018. Before that, he was the VP for Drug Affairs at the SFDA. He is passionate about improving the regulatory environment for drugs and food, having +20 years experience aligning systems with business and regulatory requirements and policies. Alsager holds a Bachelor in Pharmaceutical Sciences and a MBA in Health and Hospital Administration from King Saud Univ. In addition, Alsager is a member in the Board of Directors of the Saudi General Authority for Foreign Trade, of the Saudi Export Development Authority and of the Saudi Accreditation Center.

Dr.AlGhamdi is Health Care Strategy and Clinical Research Consultant has a wide experience in different areas of Clinical Research and Medical Education with interest and expertise Clinical Trial Management and early detection of cancer Research.Dr. AlGhamdi completed his B.Sc. at King Abdulaziz University, College of Medicine & Allied Sciences in Jeddah, KSA. He has high Diploma in the Clinical Cellular Sciences at The Johns Hopkins Hospital USA and a PhD in Molecular Pathology at University of Nottingham, UK.Currently, Dr. Al Ghamdi is working at King Fahad Medical City (KFMC), Riyadh Second Health Cluster (R2) as Director of applied clinical Research administration as well as director of Strategy planning and development administration.

Yazeed Alkhinzan is currently working as a Senior Pricing and Pharmacoeconomics Specialist within the Pricing and Pharmacoeconomics Directorate at the Saudi Food and Drug Authority (SFDA). He holds a bachelor degree in pharmaceutical science, and completed his education with a master degree in international Health Technology Assessment (HTA), pricing, and reimbursement in 2023. Yazeed has almost 5 years of experience at SFDA, these experiences was shaped in biological products’ regulations and pharmaceutical pricing and pharmacoeconomics. Yazeed is also a member in several committees.

Stephanie Croft is a Chemist by training and currently working with WHO as a Technical Officer in the Inspection Services Group of the consolidated WHO Prequalification Team for Medicines, Vaccines, Devices and Diagnostics and Vector Control products.Experienced in GMP, GCP, GLP and ISO Regulatory Inspections with over 8 Years of onsite inspections at the international level. With Health Canada’s Bureau of Pharmaceutical Sciences, was an assessor of the quality of generic medicines. Has conducted over 100 inspections in 35 countries such as India, China and France.

Mr. Naser O. Aldosri is the Scientific Assessment Expert at the Vaccines and Blood Products Department at Biological Products Directorate at the Saudi Food & Drug Authority. He has more than 16 years of experience as a biological products quality assessor, especially in vaccines. Mr. Aldosri holds a Master degree in Biotechnology from University of Wollongong in Australia and a Bachelor degree in Pharmaceutical Sciences from King Saud University, Saudi Arabia.

Tim is responsible for managing a team of Global Delivery Managers who support regulatory submissions around the world. He is experienced in regulatory systems strategy and implementation and helping to define a roadmap for systems and data management, and is also the chair of the EFPIA eCTD Sub-Group where new & upcoming regulatory guidelines relating to eCTD and other telematics initiatives are discussed.

Prof. Aljedai earned his Doctorate Degree (PharmD) from the Univ of Health Sciences and Pharmacy in St. Louis, MO, USA, followed by an MBA. He is board certified as Pharmacotherapy Specialist (BCPS), Board Certified as Transplant Pharmacotherapy Specialist (BCTxP), beside several Fellowships. He works currently as the Assistant Deputy Minister for Therapeutic Affairs at the Ministry of Health of Saudi Arabia. He is the founding President of the Saudi Clinical Ph. Society (SSCP). He is a Professor at Al-Faisal Univ, Schools of Medicine and Pharmacy and the editor-in-chief of the Saudi Journal of Clinical Pharmacy.

Eleonora is Principal at IQVIA Middle East and Africa and she is responsible for Management Consulting and Financial Institution Consulting in Middle East and Africa focusing on advising clients in their strategic decisions in Healthcare and Life Sciences. Eleonora has 17+ years of strategy consulting experience, specializing in Healthcare and Life Sciences. Prior to IQVIA, Eleonora worked 6 years with the EY-Parthenon EMEIA Life Sciences Center of Excellence focused on strategy, commercial excellence and market access. She managed and delivered strategic projects for innovator and generic pharmaceutical companies in Europe and Middle East.

Thierry Gastineau is Global Quality Head of Innovation, Culture and Engagement at SANOFI vaccines. He has 35 years of experience in the Pharmaceutical Industry, mainly in World Wide Regulatory Affairs and Quality activities. He is a member of multiple associations and working groups, in particular the following ones: • Vaccines Europe: Co-leader of CMC/Quality Core Team and LCM working group • IFPMA: Leader of the Vaccines Head of Quality group and of the working group on Post Approval Changes • Leader of the CMC/GMDP Covid-19 joint Vaccines Europe / IFPMA Task Force By education, he is Pharmacist and he holds a post graduate in molecular biology

Dr Rana is an experienced pharmacist with more than 15 years of experience in Regulatory affairs, holding a master degree in pharmaceutical quality assurance. She joined JFDA in 2008 and held various positions, including head of new drugs registration section, head of biological and vaccine registration section. She was the Project lead for the installation of the eCTD system at JFDA and collaborated in the preparation and review of the “Guidance for Registration of Biosimilars in Jordan” from May 2015. Currently, Dr Rana is the head of Clinical Studies Department at JFDA, a member of the Clinical studies and of the national stem cells committee and the MOH clinical trials and access to innovation committee.

Mr. Babiker has more than 25 years of experience in different fields of pharmacy practice including hospital, community and clinical pharmacy, drug information, patient safety, quality and risk management. By training, he is a pharmacist with an additional Master program from Queens University Belfast in the UK. His research interests are in the areas of patient safety and pharmacy practice. Mr. Babiker has worked as drug information pharmacist at Hamad Medical Corporation, the principal health institute in Qatar. Through his work for the Ministry of Public Health, especially the Community Pharmacies Steering Group and as vaccine registration supervisor, he also has experience with the development of policies.

David has been involved with providing input to R&D from a patient perspective for more than 20 years. He has played an active role in the European Patients’ Academy on Therapeutic Innovation (EUPATI), and currently co-leads their external Advisory Committee. He is a past co-chair of the Patient and Consumer Working Party at the European Medicines Agency.Currently, is involved with Swissmedic’s Patients and Consumer Working Group, and he is a member of the PFMD Executive Committee, of the Zurich Cantonal Ethics Committee and the Impact Council for Gilde Healthcare. As a past member of the DIA Regional Advisory Council for EMEA, he was awarded the Outstanding Contribution to Global Health award in 2019.

Álmath is Head of Europe Regulatory Policy at AbbVie. Álmath dually qualified as a pharmacist and a barrister-at-law with a PhD from Trinity College Dublin and postgraduate qualifications in statistics and pharmaceutical medicine. Álmath has extensive experience in regulation and policy having held management and assessment roles at the Irish HPRA (2007-2019) and at EMA's PRAC (Vice Chair 2012-2018). Álmath was called to the Bar of Ireland in 2018 and practiced in Commercial Law prior to joining AbbVie in 2020. At EFPIA, Álmath chairs the Integrated Evidence Generation Working Group. She has prior experience in various global initiatives including at ICH. She is a member of the DIA Regional Advisory Council.