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 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. Joerg received a PhD in biochemistry from the University of Hannover/Max-Planck-Institute of Biochemistry, Germany.

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.

Amira is the Global Regulatory Policy Director for Eastern 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 an industry network for Southeast Europe. 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.

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.

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.