Asst. Prof. Dalia Abouhussein, QA General Manager at the Egyptian Drug Authority, holds a Master’s and PhD in Pharmaceutics from Cairo University and has over 23 years of regulatory experience. Starting her career at NODCAR, she has served on committees for stability studies, CTD quality files, clinical trials, and pricing. She is a member of WHO’s TAG-WLA, the AMRH Steering Committee, and the AMQF QMS subcommittee. Since 2022, she has supported WHO’s Regulatory System Strengthening (RSS) team and joined the International Pharmacopoeia consultant roster in 2023. Dalia has published 17 peer-reviewed articles.

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.

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.

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.

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.

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.

Angelika Joos is a trained pharmacist. She is responsible for Regulatory Policy issues within MSD's Global Regulatory Affairs and Clinical Safety department. This role includes identifying regulatory policy priorities that align with MSD’s business priorities, leading cross-functional networks to define policy positions, and informing MSD’s regulatory strategy development. Angelika represents MSD in the IFPMA Regulatory Science Committee and is one of IFPMA's delegates to the ICH Management Committee. She is also involved in international policy activities though efpia as well as BIO and PhRMA international Committees. She served on the DIA Board of Directors from 2013-2020.

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.

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.

Amira is the Global Regulatory Policy Director for Europe, Middle East, and Africa at MSD. With over 15 years in Regulatory Science and Policy, she’s a thought leader in reliance, work sharing, and regional harmonization. She’s built a network to advance regulatory science in the region. She chairs the EFPIA Middle East Regulatory Network (MERN) and is an active member of several trade associations including IFPMA ,PhRMA, and Southeast Europe industry network. She regularly presents at DIA conferences and has contributed to publications on regulatory topics. She holds a bachelor’s degree in Pharmacy and Biotechnology from the German University in Cairo.

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 IREG, member of EFPIA Middle East network and several IFPMA expert groups.

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.

Nevena Miletic is a pharmacist, with postgraduate studies in parmacoeconomics, Reg Affairs and QA, with more than 18 years of experience in pharma industry. Currently she works in Global Regulatory Policy at F. Hoffmann-La Roche and for the last five years, she is co-chairing IFPMA Africa Regulatory Network and CPP Network. She is also a member of IFPMA Regulatory Science and Africa Engagement Committees, DIA MEA Advisory Board, EFPIA ERAO PI WG, IATF etc., being involved in numerous projects with regulators and cross-industry collaborative platforms (e.g. Pre-ICDRA, ICDRA, IMI, SCoMRA etc.). Nevena is a strong advocate for regulatory convergence and harmonisation, with main interest in innovative approaches in drug development and review.

+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.

May is working at Merck Group as the Regional Regulatory Affairs Manager for the Middle East, Africa, Turkey, Russia, and CIS (MEAR) region. With over 14 years of experience in the pharmaceutical sector, she has held progressively senior roles in R&D and Regulatory Affairs with a diverse experience within EU and International Markets. She is leading strategic regulatory initiatives, regulatory intelligence, and advocacy efforts in MEAR region, and chairs the EFPIA MERN Safety Label Updates Optimization Taskforce. May holds a bachelor's degree in pharmaceutical sciences from Cairo University.

Over 20 years of experience in regulatory operations across multiple regions including EU and GCC. 14 years of eCTD experience including eCTD implementation in multiple markets. Chair of EFPIA MERN eCTD Task Force. Currently leading submissions portfolio for Turkiye and CauCAR markets. 

Luther Gwaza holds a Bachelor of Pharmacy (honours), a Master of Philosophy (MPhil) in pharmacology, and a PhD in Pharmaceutical Policy and Regulation. He is currently a Technical Officer in the Regulatory Systems Strengthening (RSS) Team in the World Health Organization (WHO), Geneva. His responsibilities include all aspects related to the Collaborative Registration Procedure and other facilitated registration mechanisms. Previously, he worked as a consultant regulatory officer for the national medicines regulatory authority (NRA) in Zimbabwe. He has consulted for various international organizations such on systems strengthening, harmonization, collaboration and cooperation in medicines regulation in Africa and Asia.

Virginie Hivert joined EURORDIS in 2014 as Therapeutic Development Director.Virginie is responsible for following the development of orphan drugs as an observer on the Committee for Orphan Medicinal Products at the European Medicines Agency.She coordinates the group of high-level EURORDIS representatives/volunteers who sit on the various scientific committees/working parties at the EMA, known as the Therapeutic Action Group (TAG).

Sondos Moshtohry, Head of the Administration for Cooperation with International Organizations, Office of the Chairman of the Egyptian Drug Authority (EDA). EDA, Egypt’s ICH Coordinator, IPRP Management Committee Member. Dr. Moshtohry has over a decade of experience in Regulatory and Public Affairs, representing Egypt internationally and leading projects in regulatory harmonization and market access. She is EDA, Egypt's IMDRF Representative, ICCR Observer, and a former Team Lead at the Central Administration of Pharmaceutical Policies. She holds a Master’s in International Development and Policy from AUC, a Bachelor’s in Pharmaceutical Sciences from Ain Shams University, and is a Microsoft Certified Educator.

Hebatallah Ibrahim Abdel-Salam, General Manager of Biological Products and Head of Marketing Authorization at EDA, holds a bachelor’s in pharmaceutical science and an MBA in project management. She is an external evaluator at the African Union Development Agency-NEPAD and represents EDA in the AMRH Technical Committee, chairing its Vaccines Oversight Subcommittee. A former head of Post-Approval Changes, she contributed to WHO COVID-19 vaccine assessments, biosimilar registration updates, and reliance pathways for biological products.

Assmaa Yousry is a pharmacist and the Quality Assurance Unit Manager at the Central Administration of Pharmaceutical Policies and Market Access (PPMA), Egyptian Drug Authority (EDA). She collaborates with the Pharmaceutical Information Systems Administration (PIS) to support EDA's digitalization and regulatory business analysis. With over 20 years of experience in Regulatory Affairs across various product categories, including Human, Biologicals, and Dietary Supplements, she also brings 10+ years of quality assurance expertise, bolstered by a TQM Diploma from the American University in Cairo (AUC).

Shereen Abdelgawad is the Head of the Central Administration of Pharmaceutical Care at the Egyptian Drug Authority (EDA), with over 15 years of experience in pharmaceutical regulatory affairs and public policy. She holds master's degrees in Pharmaceutics & Industrial Pharmacy and Public Policy. Shereen focuses on improving pharmaceutical care practices, patient safety, and policies. She has spearheaded initiatives like e-labeling for accessible medical information and leads key committees on antimicrobial rational use and national guidelines. Her strategic leadership continues to drive advancements in pharmaceutical care and regulatory policy.

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.

Chimwemwe Chamdimba heads the African Medicines Regulatory Harmonization Initiative at AUDA-NEPAD. She manages the AMRH Programme, supports AMA operationalization, and drives policy reforms connecting regulatory strengthening to local medical product manufacturing. A health policy expert, she leads reforms, harmonization, and partner coordination, contributing to vital continental policies including the AU Model Law on Medical Product Regulation; the Treaty for the establishment of the African Medicines Agency (AMA); and the AU Private Sector Engagement in Health Framework.

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.

Neil McAuslane is Director of the Centre for Innovation in Regulatory Science (CIRS, previously CMR International) and works in the area of regulatory and HTA strategy and R&D performance. Prior to joining CMR International in 1988, Neil completed his PhD degree in Clinical Pharmacology from the University of Edinburgh and an MSc from Surrey University in Toxicology.

Dr Ibrahim Tlili is an industrial Pharmacist holding a Doctor of Pharmacy and a Master degrees in Oncology from the University of the Mediterranean in Marseille, France. Ibrahim have 12 years of experience in Regulatory Affairs, started his career in the French Health Authority before moving to pharmaceutical industry in local, regional and global roles in France, Switzerland and the United Arab Emirates in different companies such as Sanofi, AbbVie, Bayer and is currently working with MSD in Zurich, Switzerland.

Dr.Hamza Benisa currently is the Head of Items Registration,in Ministry of Health libya. He is an assistant lecturer at Faculty of pharmacy, Elmirgib University2015-2019,Farmer head of regulatory affairs section in MOH2016-2017, member of medical waste committee, member of High committee of medical gases.

Dr. Sara Magdy, PhD, is Head of Technical Support Administration at the General Administration of Biological Products, EDA/BIO-INN. She leads regulatory development and collaborates on harmonizing guidelines. As EDA's Topic Lead, she contributes to the ICH Expert Working Group updating the M4Q(R2) guideline. Previously, she headed the Marketing Authorization Department at Egypt's National Organization for Research and Control of Biologicals, overseeing the technical assessment of biological product applications.

Dr. Maha Mohammed holds a BSc. Pharm. 2009, Master in Pharmacology, and toxicology Azhar University. 2018. She is the General Manager of Pharmaceutical Vigilance– Egyptian Drug Authority (EDA). Previously, she was a team leader of Cairo regional pharmacovigilance centre & Senior PV specialist. Maha Mohammed is has fourteen years of experience working in regulatory authority. Dr Maha specializes in pharmacovigilance and is responsible of Supervising the Egyptian Pharmceutical Vigilance Center, including ICSRs management unit, Signal detection unit, emerging safety issues unit, follow up unit and PRBER Unit, PV system, PV inspections ..etc.

Muhanad H. Alharbi is currently working as head of data capture section at the National Pharmacovigilance Center, in the Saudi Food and Drug Authority (SFDA) since 2019. He awarded his master degree in pharmacology from Aston University UK. He is the project manager of pharmacovigilance regional offices. He also has trained in several courses in drug safety and pharmacovigilance and he has participated in a number of pharmacovigilance activities.

Fabio is Head of the International Regulatory Policy group at Roche. He has over 18 years’ experience of working within Global Regulatory Affairs. Fabio started his regulatory career at Cyton Biosciences Ltd., and then joined Chiron Vaccines as Senior Regulatory Affairs Manager. He joined Roche in 2005 where he led the Global Regulatory activities for biologics, before joining the Biologic Strategy Team as Global Biosimilar Regulatory Franchise Head. He has contributed and managed global regulatory projects and has engaged in a variety of interactions with Health Authorities globally. He represents Roche in various EFPIA, IFPMA and EBE-biotech working groups. He is currently Vice-chair of the EBE Biotherapeutics Working group.

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.

Sarah Ibrahim is the Associate Director for Stakeholder and Global Engagement in the OGD/ CDER at the U.S. Food and Drug Administration (FDA). Dr. Ibrahim develops OGD strategies to address identified and emerging regulatory challenges in relation to the international nature of the generic drug industry. She established OGD’s current global affairs program, the generic drug cluster which is the first generic drug forum that involves the word leading regulatory agencies. In collaboration with other CDER and FDA offices, she supports stakeholder engagement concerning issues related to globalization of the generic pharmaceutical supply and harmonization of regulatory approaches for generic drugs.

Mariem Kadri is a Doctor in pharmacy  . A Team lead in the National Agency for Medicines and Health Products . She is in charge  mainly  of clinical trials. Mariem is the focal point regarding the function :  clinical trial supervision in the GBT of WHO . She is working on the different agency projects like digitalization and e-CTD implementation

Rania Shousha specializes in clinical studies regulation at the Egyptian Regulatory Authority, with over 7 years of experience. She oversees clinical trial protocols, participant safety, and data integrity, ensuring compliance with regulatory standards. She also advises pharmaceutical companies on study design, data collection, and analysis. Rania earned a Master's in Clinical Pharmacy with honors from the University of Tanta and completed a clinical pharmacy residency at a government hospital. She is currently pursuing a PhD in Pharmacology and Toxicology at Cairo University.Rania represents the Egyptian Drug Authority (EDA) at the International Council for Harmonization (ICH) as a member of the ICH M15 Expert Working Group.

Head of drug registration department in Pharmaceutical and Herbal Medicines Registration and Control Administration, Ministry of Health, Kuwait. She is responsible of registration and approval of pharmaceutical products including human medicines, herbal medicines, veterinary medicines and medical devices. In addition to monitoring pharmacovigilance activities in Kuwait, she is a member of Kuwait Pharmaceutical Association and member of GCC Central Registration Committee and participated in setting the GCC Guidelines for Drug Registration as well as Stability, Bioequivalence and PIL GCC guidelines and others. She is assigned as Kuwait focal point with the League of Arab states in the field of Pharmacy and drugs.