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).

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.

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.

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.

Dr Lembit Rägo was a Professor of Clinical Pharmacology and Director General of the Estonian State Agency of Medicines until joining WHO Geneva in 1999. When retiring WHO in 2016 Dr Rägo served as the Head of the WHO’s Unit, Regulation of Medicines and Other Health Technologies (RHT), which covered norms and standards, safety, prequalification and regulatory strengthening for medicines, vaccines and diagnostics. 2000-2016 he served also as WHO observer to the ICH Steering Committee, ICH GCG and MedDRA MB, IPRF and ICMRA. Since 2016 he works as a Secretary-General of Council for International Organizations of Medical Sciences (CIOMS). Under his leadership CIOMS joined ICH as an observer in 2016 and increased its number of working groups.

Joerg joined BI as Global Head of RegOps in 2012. Previously he worked at Astellas, Wyeth and Merck. He studied Pharmacy in Bonn. He has been a member of ICH M2 and M8 since 2010 and joined the EFPIA Telematics Working Group in 2009 and is currently chair of the EFPIA eCTD Focus Group.

Sean is a Senior Biologicals Assessor at the Irish health authority, HPRA, where he reviews CMC data for new product applications, scientific advices, clinical trials, and variations for mAbs, recombinant proteins, vaccines, and cell & gene therapies. Sean is chair of the Biologicals Working Party (BWP) at EMA and regulatory chair the ICH Quality Discussion Group. He has helped draft several guidelines such as the EMA toolbox guidance for PRIME products, the EMA reflection paper on statistical methodology, and the EMA-FDA Q&A on regulatory flexibilities. As a member of the ICMRA collaborative assessment group, Sean helped establish the first pilot programme for multi-agency assessment of post-approval CMC changes.

Dr. Nasr is responsible for the development and the execution of CMC regulatory strategy at GSK. Prior to joining GSK, he spent over 22 yrs at FDA and established and led the Office of New Drug Quality Assessment (ONDQA). Dr. Nasr was instrumental in the development of QbD concept and several ICH guidelines and continues to play a leading role in global regulatory harmonization. Dr. Nasr is currently the rapporteur of ICH Q12

Florence Roizard is Associate Vice President in Regulatory Affairs International at Merck Sharp & Dohme, responsible for Europe, Middle East and Africa. She has more than 25 years of experience within the pharmaceutical industry.

Besides his academic position, Dr. Ahmad serves as a consultant primarily to drug regulatory agencies in LMICs to whom he provides training/capacity building services. From 1998-2013, he was a safety reviewer at the U.S. FDA, and an active member of their training office which promoted excellence in advanced scientific education, and assisted reviewers to maintain a high level of competency in regulatory and scientific knowledge by organizing seminars; courses; workshops; and training sessions.

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

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.