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.

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.

Currently working for Biogen as the Regional Regulatory Lead for Middle East, Africa, Central Eastern Europe, Russia, Israel & Turkey, Rachelle has extensive experience in global regulatory filings and strategy in the International Markets. Combining a passion for science and innovation with the desire to enable better healthcare for patients across the globe, Rachelle has focused her career to date on the emerging markets. Prior to Biogen, Rachelle worked for Takeda and Allergan in their Emerging Markets Regulatory departments covering all geographic regions. Rachelle is also a member of the EFPIA MERN, Russia and Turkey networks.

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.

Sylvie has been engaged in regulatory policy activities for 20 years, through positions in Brussels trade associations, including EFPIA. She joined MSD as Director Global Regulatory Policy in June 2015, where she is now Global CMC Policy Director. Sylvie’s expertise and knowledge of the European pharmaceutical environment serves to drive regulatory policy activities in the areas of CMC and Quality in the EU and globally. Sylvie also co-leads the IFPMA Manufacturing & Quality Group policy activities. Sylvie holds a Maîtrise in Biochemistry from the University of Bordeaux II and a Diploma from the University of Kent at Canterbury.

Adèle El Choueiry, MSc is currently the Head of Regulatory Affairs for Levant Region in Novartis. She started her career in quality control then moved to regulatory affairs and thus bringing 14 years of expertise in different fields and positions in the Pharma industry. Prior to her current role, Adèle was Regional regulatory affairs Senior Manager for Near East, Maghreb and Africa in J&J. In addition, leveraging on her expertise and connections, Adèle is the Chairperson of the Lebanon Regulatory Working Group (LRWG).

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.

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.

ALWOHAIBI holds a bachelor degree in Pharmacy and an MBA. Started his profession in 2001 as in-patient Pharmacist. Then a Medical Application Analyst. Then he joined Saudi Food and Drug Authority in 2007. He held different departments, and currently as the Executive Director of Regulatory Affairs directorate leading four departments (Products licensing, Pricing and Pharmacoeconomics, Standard settings and Narcotics). ALWOHAIBI led the Drug eSubmission and RMS system projects.

Sarah Al-Maqseed holds a bachelor degree in Pharmacy, Liverpool John Moores University, 1999 and an MBA, Kingston University, 2008. She joined Kuwait MOH and started her profession in 1999 as junior pharmacist, then pharmacist, then became senior pharmacist. Currently Laboratory Superintend.

Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She joined MSD in 2017 to lead regulatory policy efforts ex-US for innovation that leads to better treatment for patients globally. Since 2020 this scope has expanded, as Ginny now leads the talented and experienced Global Regulatory Policy and Intelligence team for MSD. Her work has regularly focused on policy shocks that challenge innovation and access to novel therapies for patients, including global and industry-wide policy work on BREXIT, COVID-19 and now the R&D impacts of the Inflation Reduction Act.

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.

Noha has 13 years of experience in public health and public policy and joined MSD in 2016 as the Policy and Communication Director for the Egypt Cluster covering Egypt, Libya, Sudan and Yemen. Prior to joining MSD, Noha was the Government Affairs Manager for Abbvie in Egypt, following the separation of Abbott into two publicly traded companies: Abbott & Abbvie. She began her career in 2006 in the World Health Organization, in the Regional Office for the Eastern Mediterranean in Cairo. She worked in the department of communicable diseases control, focusing on the HIV/AIDS programs in the 22 countries of the Region. Noha graduated from the Faculty of Dentistry in Alexandria, Egypt in 2004 and holds a BA degree of Dental Medicine and Surgery.

Hadir holds B.Sc. Clinical pharmacy, a Certificate in Executive Management from Harvard School of Public Health USA and Clinical Pharmacy Diploma from Cambridge Regional College UK. She has 19 years experience at the Egyptian Pharmaceutical Authority. On 2009 she was assigned to be a co-founder of The Egyptian Pharmacovigilance Center (EPVC) and the national pharmacovigilance system On 2016 she has been promoted to be the Head of EPVC with a mission to strengthen Pharmacovigilance practice in Egypt. She is also a member in National PV committee and Non-reference medicinal products evaluation Committee. She is a principal contributor in issuing the “Good Pharmacovigilance Practice guidelines in Arab Countries” (GVP-Arab)

Julie Rihani is a young mother of two beautiful children. She has a Master’s degree in education and has been teaching for 17 years, currently working at the American Community School in Amman as a teacher as well as an assistant Activities Director. Julie is a firm believer that positivity, laughter and faith are the key to a happy soul.

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.

Previously served as Senior Vice President and Managing Director for DIA Europe, Middle East, and Africa (EMEA) in addition to corporate international public affairs and as consultant for Amgen, Merck KGaA, and Biogen, working across market access, government affairs, public affairs, health policy, corporate communications, and patient advocacy to bring medicines to patients. Mr. Bols has held board positions for Europabio, the European Confederation of Pharmaceutical Entrepreneurs, and other associations, and chaired various regulatory and access working groups within the European Federation of Pharmaceutical Industries and Associations. Mr. Bols earned his post-graduate degree in European Law from the University of Amsterdam.

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.

Mathieu Boudes, PhD, joined the European Patients’ Forum (EPF) in 2018 as coordinator of the PARADIGM project, a public-private partnership financed by the Innovative Medicines Initiative and co-led by EPF and EFPIA (European Federation of Pharmaceutical Industries and Associations). Strong of 34 partners (patient organisations, pharmaceutical / biotech companies, regulators, HTA bodies and academic teams), PARADIGM (for Patients Active in Research and Dialogues for an Improved Generation of Medicines) will strengthen the understanding of stakeholders’ needs, the systems-readiness, ensure maximum synergies with other initiatives and develop an inventive and workable sustainability roadmap.

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.

Ansgar Hebborn is Roche Pharma's Head of Access Policy Affairs Europe. He represents Roche in relevant industry associations e.g. in Brussels as the chair of EFPIA’s European HTA Working Group. During the past few years, he has taken an active role as advisor and stakeholder representative in various HTA collaboration networks e.g. EU HTA Network, EUnetHTA and the HTAi Policy Forum Committee, and also has been involved in the foundation of other initiatives in this field e.g. the Green Park Collaborative, the HTAi Asia Policy Forum and SwissHTA. In an earlier role as health economist and outcomes research specialist for Roche in the US, he has gathered extensive experience with real world data research.

I joined MSD Europe, Inc in 1998 as Desktop Support in the Corporate IT organization. After having hold several IT Support and Administration functions for the EMEA region, I joined the MRL Division in the Regulatory Affairs Operations group. I there developed expertise in eCTD, Nees and paper format for the EMEA region as well as eSubmission processes. I’m currently leading the Publishing Team supporting all publishing activities and acting as SME for all the Regulatory Affairs groups within the EMEA region. I have recently been part of the PSUR Repository Advisory group and I’m now part of the PSUR Repository Maintenance group and the Gateway Maintenance group.

Mrs Lindström is the Chair of the ICH Assembly. She is working as a Senior Expert in the Directorate General for Health and Food Safety (DG SANTE) in the European Commission where she is in charge of international relations in the field of pharmaceuticals. Mrs Lindström has over 20 years experience in the European Commission, including over 10 years in the field of pharmaceuticals. She holds a Master of Laws degree from the University of Helsinki, Finland.

+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.

Dr S Pal has a Masters in Pharmacy with a PhD in Pharmacology. Been with WHO for nearly 2 decades, and leads the Medicines Safety Programme in WHO, to support pharmacovigilance activities in low and middle income countries and in priority programmes such as HIV, TB, malaria. WHO representative in platforms such as ICH, CIOMS, ICMRA, and a Deputy Board Member of the Uppsala Monitoring Centre, Sweden.

Anna-Eva Ampelas is Head of Unit for Medical Products: quality, safety, innovation in Unit B4 in DG SANTE, European Commission. In this capacity, she manages files on medicinal products (falsified medicines, clinical trials, shortages, GMP etc); Health Technology Assessments (HTA) and substances of human origin (blood, tissues and cells, organs). She has more than ten years of experience working on health policy and legislation in the European Commission. Before joining the Unit for Medical Products, Anna-Eva headed the unit dealing with tobacco control and global health. She was Health Counsellor at the Permanent Representation of Sweden 2002-2006 before joining the European Commission. She has a Master of Laws from Uppsala University.

Gracy holds a Ph.D. in Molecular Oncology from King’s College Hospital, an M.Sc. in Biomedical Research from King’s College. She did her postdoctoral training at Oxford (UK) and at MIT (USA). Gracy brings broad experience in clinical research, medical affairs and health outcomes within the pharmaceutical industry. She currently works as a Regulatory Policy Lead at Roche Pharmaceuticals, focusing on RWD Policy.

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.

Dr. Reem Al-Essa has a PhD in Pharmaceutical Regulations and an EU2P MSc in PV and Pharmacoepidemiology,with a long and diversified experience in both government and private sectors in Kuwait.She started her career in Kuwait Ministry of Health, Drug and Food Control, Pharmaceutical and Herbal Medicines Registration and Control Administration. She then moved from there to work at a community pharmacy in the private sector. She decided to move back to MOH to work in the Drug Inspection Administration carrying out the role of pharmacy licensing and inspection in addition to her role as a PV focal point in Kuwait.

Bachelor degree pharmacy from Oman Medical Collage in 2011. worked at the royal hospital for 3 years in outpatient, inpatient, and chemotherapy preparation unit. 3 years of experience in Drug Regulatory Authority.

PhD in Regulatory Affairs from Cardiff University, United Kingdom, 2014. He joined Ministry of Health-Oman in 1998. His current position is the Director General of pharmaceutical Affairs and Drug Control. A member of the GCC Central Registration Committee, and actively involved in many other GCC committees and working groups for the drafting of the GCC pharmaceutical regulations and policies. Dr Al-Rubaie was instrumental in forming the Pharmaceutical society in Oman and chaired it from 2010-2011.

Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including technology, processes, and relevant aspects of Pharmacovigilance Legislation. He is now accountable for Patient Safety Monitoring across medicines, vaccines, devices, defects and blood products. Phil was responsible delivery of MHRA systems for COVID-19 vaccine surveillance and their integration into the healthcare system. For several years he has led international projects to develop and deliver tools for global pharmacovigilance.

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.

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.

20 years working in pharmacovigilance, of which 12 have been as a director of pharmacovigilance for the affiliates at MSD. In his current role, Sean provides pharmacovigilance support to primarily the Eastern Europe, Middle East and Africa regions. Sean supports the local offices during inspections, in the development of local PSMF’s at MSD, which are legislatively required or requested pre-inspection. Responsible for Pharmacovigilance activities such as PV Intelligence and Operational activities within the International PV organization. Sean is a chairperson of two EFPIA PV working groups, (Africa and the Middle East).