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).

Hany Gamal, a qualified pharmacist and MBA graduate, currently appointed as the Regional Head of Regulatory Affairs Department at Boehringer Ingelheim Middle East, Turkey and Africa; services a very diversified region known for its turbulent yet very promising business environment. With expertise that range over 28 years in the industry within the Commercial, Marketing and Regulatory Affairs functions; he has excelled in the ability to create and use every opportunity to improve the life of patients. In his area of focus, he advocates that the welfare of patients will only be established through a robust and transparent collaboration between the countries’ regulatory authorities and the industry.

Alastair has worked in various roles in pharmaceutical product development, before moving into regulatory publishing at a major clinical research organisation. He then headed the International Regulatory Operations function at SmithKline Beecham and GSK, and as Director of Publishing, he led the UK based publishing team, working on the implementation of eCTD in the company. Alastair is now Director, Submission Standards at GSK, responsible for ensuring that GSK’s strategy with respect to electronic submissions and IDMP is aligned with external requirements. He is a member of the EFPIA IDMP Sub Group and active on several European projects, such as eAF and DADI. Alastair has a BSc (Hons) in Applied Chemistry from Aston University in B'ham.

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.

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.

Tomas Salmonson, M.Sc., PhD, brings outstanding experience and expertise from a long career in the regulation of medicines both on a national and European level to his new role. A pharmacist by training, he is currently senior scientific advisor at the Swedish Medical Products Agency in Uppsala, Sweden. He has been a member of the Committee for Medicinal Products for Human Use (CHMP) for more than 12 years. In 2012, Dr Salmonson was elected chair of the CHMP; he was Vice chair of the CHMP from 2007 till 2012. Tomas has been DIA Advisory Council of Europe Member during 1996-2002 and a speaker in over 20 DIA Events.

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.

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.

Frank holds a BA in History and MA and PhD in Economics. Professor of Business at the Columbia University Graduate School of Business; a Research Associate of the National Bureau of Economic Research; and a member of the CESifo Research Network. Previously taught at Harvard University and other universities. Has served as an expert for the Federal Trade Commission, the U.S. Dept. of Justice, and state Attorneys General. He has worked for several U.S. government agencies. He has been awarded research fellowships, grants, and contracts by several institutes and public organizations, and has also served as a consultant to private organization. He is an affiliate of the economics consulting firm Analysis Group.

She leads the GS1 Healthcare Global Public Policy Work Team, which has the mission to interact with decision makers globally and to provide strategic leadership on the use of GS1 standards in the healthcare sector to enhance patient safety and supply chain efficiencies worldwide.In the pharmaceutical sector, she was leading the APEC Trace and Trace Work Group of the Roadmap for Global Medical Product Integrity and Supply Chain Security. In the area of Medical Devices, she manages the GS1 Global Unique Device Identification (UDI) project. She represents GS1 as Liaison Member to the Asian Harmonisation Working Party (AHWP). A lawyer by training, based in Brussels, and works with her local GS1 colleagues in 112 countries across the world.

Dr. Amr Saad got his Ph.D. in Epidemiology from the University of Manchester in UK He was the Associate of the Egyptian Minister of Health and founder of the Egyptian Pharmaceutical vigilance Center (EPVC) and Founder of the Egyptian Pharmaceutical Vigilance Center. He is also the Head & Member of several regulatory committees, Lecturer of clinical pharmacy at Future University of Egypt (FUE), founding member in the Egyptian Clinical Pharmacy fellowship. Before that, he worked very hard to unify guidelines and performance across the Arab world in the field of Pharmacovigilance.

Professor Stuart Walker, BSC, PhD (London), MFPM, FRSC, FiBiol, FRCPath, is an independent Consultant in Pharmaceutical Medicine and Founder of both the Centre for Medicines Research (CMR) International and the Centre for Innovation in Regulatory Science (CIRS). UK

Pharmacist Ahlam Abdelaziz has joined the Jordan FDA team in 2009. She has a B.Sc degree in Pharmacy from the University of Jordan. Through the participation in different JFDA working committees dealing with the registration and re-registration, post-approval changes and bioequivalence studies evaluation, a distinguished knowledge has been achieved regarding different types of medicinal products including originator (chemical & biological), biosimilars, generics and sera & vaccines. She is currently the head of Sera & Vaccines and New Drugs Unit in the Drug Registration Department. Previously, she was the Head of Generics Unit. Ahlam represented JFDA in number of conferences and meetings nationally and globally.

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.

Frank Montgomery was awarded his PhD in Synthetic Organic Chemistry at Imperial College London and completed Post Doctoral studies at Ohio State University. He then moved to Ciba Central Research in Discovery Chemistry then to AstraZeneca Process R&D. Frank led the Process R&D team for AstraZeneca’s project in the FDA’s CMC pilot program for implementation of ICH Q8, leading subsequent consultations with PMDA, EMA & Health Canada. Frank moved from a technical role to Regulatory Affairs and is now Global Head Regulatory CMC for small and large molecules across AstraZeneca/Medimmune. He is a member of ICH Expert Working Group as EFPIA Expert for ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.

Dirk is leading the Serialization and Traceability program at Johnson & Johnson within the EMEA region since 2007. This encompasses implementation of Falsified Medicines Directive in Europe, Russian Track & Trace regulation as well as the ME requirements for product identification and traceability. Also preparation of supply for regulations outside EMEA region (US, South Korea, China, Brazil) falls within the scope. The program includes retrofitting of the internal and external packaging lines in EMEA, preparing internal and external distribution for handling serialized products, Enterprise IT capabilities, Master data and management of artwork conversion. He has worked 15 yrs. at Mars Inc. as supply chain professional.

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.

Head of Egyptian Drug Information Center (EDIC)-Central Administration for Pharmaceutical Affairs (CAPA)-Egyptian Ministry Of Health (MOH). Former Deputy Head of the Egyptian Pharmacovigilance Center (EPVC), Head of the Regional Pharmacovigilance Center in Cairo, Biocidal Vigilance Department EPVC- (CAPA); MOH, Specialist at Poliovirus Diagnosis Reference Laboratory to WHO; (EgyVac/VACSERA). Former Coordinator of the Higher Technical Committee of the Arab medicine at the League of Arab State. Memb. of ESPET. Participated in many technical and scientific committees (MOH). Representative/lecturer at many National and International scientific, professional seminars, workshops and meetings

Esteban has worked in both academia and industry in a range of roles including academic research, drug discovery, pharmacovigilance and regulatory policy. Before joining AbbVie, Esteban was Director of Regulatory Intelligence and Policy at Daiichi Sankyo Development Ltd, lead for Pharmacovigilance & Regulatory Affairs at the Association of the British Pharmaceutical Industry (ABPI) as well as working in pharmacovigilance for P&G Pharmaceuticals and drug discovery for Novartis. He holds a Biochemistry BSc from Warwick University, PhD in virology from University College London, and has worked as a postdoctoral researcher at Imperial College London

Manager of the Technical Office at Central Administration of Pharmaceutical Affairs (CAPA), Egyptian Drug Authority. Yasin was the rapporteur of the Drug Shortage Committee in 2013, executive member of the public pharmaceutical supply chain reform program from 2012 till 2014. He is the project manager of "Pharmaceutical Track and Trace" in Egypt. He led a joint WHO-World Bank medicines availability survey project in 2013 in the Egyptian market. He represented different Egyptian delegations across borders and media and press representative for pharmaceutical sector. Holds bachelors in Pharmacy, MBA from the University of Portland, Master's in Public Policy (MPP). He had a postgraduate certificate in "Pharmaceutical Policy Analysis".

Abdullah F. Al-Meshal is a pharmacist who graduated from king Saud university Saudi Arabia collage of pharmacy in 2002. He has 8 years expernice in health informatics field in different hospitals in Saudi Arabia before he moved in 2009 to Australia, Adelaide to study IT software engineering in Flinders University and graduate in 2011. After that he joined SFDA as Laboratories informatics department head and then assigned as director of drug informatics department which managing all drug sector electronic systems. one of his repsonsibilities now as managing track and trace project.

Profession: Director of the National E-Health Program & ICT Expert at the Ministry of Public Health (since 1997) and Lecturer at the Faculty of Public Health at the Lebanese University. Education: Master in Business Administration (MBAIP) - Health Management - Université Saint-Joseph – Université Paris I Pantheon Sorbonne; Bachelor of Science (BS) – Informatique de Gestion (MIS) - Université Saint-Joseph ; Project Management Professional Certificate (PMP) - Project Management Institute Pennsylvania, US. Awards: 2017: Golden Excellence Award – Best Government E-Services; 2016: Golden Excellence Award - Best Government Smart App.; 2015: E-Government Award – Best Government Website

Graduate of Jordan University of Science & Technology received her Master’s in pharmaceutical QA/QC from JUST. Worked as Regulatory affairs at Jordan Pharmaceutical manufacturing Company. In 2011 joined JFDA where she is now the head of the new & biological drugs division at registration department/drug directorate. She is currently a member of technical committee responsible for evaluation & Registration of originator drugs & Biological products. Head of PAC committee, responsible for evaluation & Approving PAC registered originator products. Responsible for the fast track registration project at JFDA. Today she is a pioneer in evaluation of registration files of medicinal products following the international Guidelines.

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.

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.