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.

Regulatory Affairs Professional with over 20 years of experience in the innovative pharmaceutical industry. Leading Regulatory Affairs teams Croatia & Bosnia and Herzegovina at Merck Sharp & Dohme. Prior joining industry spent 8 years in academic settings at the Department of Pharmacology, Medical Faculty, University of Zagreb, Croatia. By profession, I am a pharmacist, and I have also completed post-graduate studies in the field of Natural Sciences. As Regulatory Affairs professional I feel privileged to contribute to bringing innovative medicines to patients and to follow the product throughout life cycle. As Regulatory Affairs Policy Manager I am excited to be actively engaged in the development of new pharmaceutical regulation.

Maja Lovrek Romcevic graduated from Faculty of Pharmacy&Biochemistry, Zagreb. After her internship in a community pharmacy, she joined HALMED working in the field of regulatory affairs, PV and clinical trials. From 2010-2012 she worked as a regulatory affairs manager in an international CRO, after which she rejoined HALMED as the Head of Medicines Authorisation Division. She is responsible for the marketing authorisations procedures, including validation of applications, regulatory support and assessment of quality, safety and efficacy for national, MRP/DCP and CP procedures, as well as scientific advice.

Sara is currently Senior Manager, Scientific Programmes at DIA. In the EMEA region, she is responsible for engaging with external stakeholders and advancing the scientific content strategy by creating opportunities to integrate scientific and regulatory changes of interest in DIA initiatives. Additionally, she is responsible for the regional patient engagement and learning design initiatives, being the liason for the Middle East and SEE regions. Previously, she was Public Health Promotion Projects Manager at the Portuguese Pharmaceutical Society. Sara is a Master of Pharmacy since 2015 and a Soft skills Trainer since 2012, having delivered over 300h of Training internationally primarily focused on creating impactful interactions.

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.

Employed in HALMED since 2007, responsibilities included: assessment of Quality documentation for MA / Renewals / Variations for Human Medicines; Batch Release for Human Biologicals; participation in drafting secondary legislation and internal SOPs in the field of Medicines to ensure approximation with the EU legislation & international guidelines. Since 2015, primary responsibility is the assessment of validity of applications for Variations for Human Medicines and giving regulatory support and advice for Variation application, in national and MRP/DCP procedures. Jan 2021 - July 2022: Resident Twinning Advisor in EU Twinning Project "Support to the Institute for Medicines and Medical Devices of Montenegro"

Sabina joined the Croatian Agency for Medicinal Products and Medical Devices (HALMED) in 2006, where she currently holds the position of Principal Regulatory Advisor. Her main responsibilities include coordination and overseeing regulatory procedures within the MRP/DCP in HALMED. She has been Croatian representative to the Coordination Group for Mutual Recognition and Decentralised Procedures – human (CMDh) since the accession of Croatia to the EU, as well as representative to the NtA. She is also a member of several WG within the CMDh. She is a pharmacist with a postgraduate speciality study in clinical pharmacy.

Susanne Winterscheid is biologist and started at the BfArM in the variation section after a few years of employment in pharmaceutical industry. Since 2005 she was heading the Project Management of a licensing division at BfArM. Since 2008 she is Chair of the Joint CMD working party for variations. In November 2011 she has become the German member of the CMDh. Since June 2015 she is Head of Licensing Division 3 at BfArM.

I have a degree in Pharmacy from University of Tirana and a PhD in Pharmaceutical Sciences from the University of Medicine of Tirana, Albania. I am employed, since august 2006, as a specialist in the Department of Marketing Authorization and Regulatory Affairs at the National Agency for Medicines and Medical Devices in Albania. As a member of groups in charge of compilation of different Laws and Regulations for Drugs and Pharmaceutical service, I have collaborated with key actors in the pharmaceutical field and I have a very good knowledge of the legislation frame and the Healthcare system in Albania. In paralel,I have been involved in teaching activity in the University of Tirana

Currently working as a Senior review officer for registration applications of Human medicines in Kosovo Medicines Agency. Part of crucial commissions for updating legislation, internal guidelines and applications. With a degree in Pharmacy from Tirana University , MBA from Staffordshire University and specializing in Drug control and research in University of Pristina.

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.

B.Sc. molecular biology, University of Zagreb, Faculty of Science, Division of Biology. univ. mag. pharm., University of Zagreb, Faculty of Pharmacy and Biochemistry (Postgraduate Specialist Studies). Employed in Agency for Medicinal Products and Medical Devices (HALMED) since 2012, responsibilities include: assessment of validity of marketing authorisation applications, variations and renewals for human medicines; assessment of validity of applications for upgrade of marketing authorisation documentation prior EU accession. Primary responsibility since 2014, are the assessment of validity of variation applications and giving advices and regulatory support for administrative, quality and safety variations in national and MRP/DCP procedures.

Currently, Adviser for evaluation of the documents in the procedure of registration of human medicines and medical devices, Macedonian Agency for medicines and medical devuces (MALMED). Education: 2019- current - University “St Kiril and Metodij” Skopje, Faculty of Pharmaceutical Sciences, Specialist degree on Clinical Pharmacy 2010-2017 - University “St Kiril and Metodij” Skopje, Faculty of Pharmaceutical Sciences, Master of Science on Clinical biochemistry 2001-2007 - University “St Kiril and Metodij” Skopje, Faculty of Pharmaceutical Sciences, Bachelor of Science

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.

Lejla Rizvanbegovic – Taletovic is a pharmacist graduated from Faculty of Pharmacy, UNSA and completed a Specialization in Pharmacoeconomics & Pharmaceutical legislation from Faculty of Pharmacy UNBG. After completing her internship in community pharmacy, she joined Bosnalijek working in both International and National Regulatory Affairs Departments. Lejla joined Sanofi (affiliate Bosnia) in 2006 appointed as a Regulatory Affairs Head. In addition to regulatory role, occasionally she also held variety of appointed function like PV and quality assurance.

Since 2009, Biljana has served at Bosnia and Herzegovina's Agency for Medicinal Products and Medical Devices, currently as Deputy Director overseeing human medicinal products. Her role spans marketing authorization, policy drafting, EU regulatory alignment, price regulation, product information dissemination, shortage monitoring, and advertising oversight. Additionally, she's an external expert for CEP issuance and serves as the IPA project contact with the European Medicines Agency since 2018. Biljana, a pharmacist and Medicinal Chemistry professor, brings extensive expertise to her multifaceted role.

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.

Amra has graduated from the Faculty of pharmacy at Sarajevo University. She has 13 years of experience in regulatory affairs. She is currently working as a regulatory affairs manager in Novartis leading regulatory affairs department in Bosnia-Herzegovina. She is attending the Master of Science in Regulatory Affairs and Health Policy program at Massachusetts College of Pharmacy and Health Sciences.

Name: Milena Ljeskovic Adress: Jelene Cetkovic 6, Podgorica, Montenegro Nationality:Montenegrin Date of birth:15st August 1978 Principal areas of expertise: Assessment of documentation for human medicines, Wholesale Auditor WORK EXPERIENCE: 2009 - PRESENT Agency for medicines and medical devices Montenegro Marketing Authorisation Department Position: Head Main activities and responsibilities:Assessment of documentation for human medicines, Wholesale Auditor 2006 - 2009: Z.U apoteka “DHL” Zivka Davidovica, Beograd Private pharmacy Pharmacist

Dr Bojan Trkulja, Managing Director of Association of Innovative Drug Manufacturers, INOVIA. Graduated at Belgrade’s Medical Faculty in 1998. Between 1999-2010 worked for F. Hoffmann – La Roche in Belgrade on various positions including Medical and Product Management, Compliance and Market Access. Since December 2010 leading INOVIA cross-functional teams on Market Access, Medical, Compliance, Regulatory Affairs, Pharmacovigilance and Finance. Member of several Ministry of Health and National Health Insurance Fund-led Working Groups, as well as European Federation of Pharmaceutical Industry and Associations’ (EFPIA) Task Force for Central and Eastern Europe.

Mirjana Ipsha-Koceva, graduated from Faculty of Medicine in the University of Sts Cyril and Methodius in Skopje, North Macedonia. She has more than 15 years of experience in Regulatory affairs. From 2011 she is working in MSD on the position of senior specialist for regulatory affairs ensuring maintenance of product lyfe cycle on local level following local regulations and responsible for timely submission of MA applications, variations and renewals. Also acts as country PV person responsible ensuring compliance to PV requirements. She is representative within the Farmabrend Nova RA group and involved in direct communication with the Drug Agency representatives and other regulators on proper implementation of regulatory guidelines.

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.

Prior to Sanofi, she has worked with national governments and international organisations such as the World Bank and the Organisation for Economic Co-operation and Development (OECD). At Sanofi, Winona works in advancing regulatory science and policy issues internally and externally and has recently published articles on paediatric orphan medicine development in Europe, dynamic electronic labeling, and the use of real-world data in regulatory decision-making. Winona holds a BA in Social Sciences with a major in Economics and Political Science from the University of the Philippines and an MA in International Economic Policy from Sciences Po Paris, France.

Gordon is a pharmacist with 20 years of experience in the field of global regulatory affairs, with a special focus on biological products/vaccines. He has worked for a number of companies, including Roche, Novartis, Chiron and Leo Laboratoratories and has hands-on experience in formulating regulatory strategies; leading interactions with major Health Authorities; authoring and reviewing regulatory submissions (including MAAs, BLAs, PIPs, CTAs, INDs,scientific advice and post-approval changes). In his current position, Gordon is accountable for the preparation of CMC regulatory strategies and submissions to enable the introduction of technology innovations into the Roche manufacturing and quality control network.