Andrej Gracner holds the position Associate Director of Regulatory Submissions Management at Pliva Hrvatska d.o.o (part of Teva group). In this role, he oversees global submission teams suporting Europe, Africa and Asia Pacific. With over 20 years of experience in Regulatory Affairs, he has spent the last decade specializing in Global Regulatory Operations/Submission Management. As publishing expert, he actively contributed to the implementation of new systems, streamlining processes and provided training related to publishing and submission managment. Additionally, he is a member of EFPIA eCTD Sub-Group.

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.

Petar Mas is a physician, specialist in clinical pharmacology. He has been working at HALMED in Pharmacovigilance department since 2015 where he currently holds position of Principal coordinator for safety assessment. He is also Croatian member of Pharmacovigilance Risk Assessment Committee (PRAC) at EMA. His main responsibilities are related to coordination of assessment in EU centralized procedures.

Experienced student with a demonstrated history of working in the non-profit organization management industry. Skilled in Team Motivation, Health Advocacy, Communication, Supervisory Skills, and Teamwork. Aiming to become a strong business development professional with a Master of Pharmacy - MPharm focused in research, pharmaceuticals industry, regulatory affairs and health advocacy - from University of Mostar - Faculty of Pharmacy.

Nick is a Policy Advisor for Regulatory Strategy at EFPIA. Nick’s current focus is on the revision of the general pharmaceutcal legislation, regulatory aspects of the Innovative Health Initiative (IHI), and the interface between the drug, device and diagnostics legislative frameworks in the EU. Prior to working at EFPIA, Nick spent 25 years at Pfizer within their Global Regulatory Sciences team. His last role in Pfizer was as Head of Europe and International Regulatory Policy. In this role he was also Co-Chair of EFPIA's Regulatory Strategy Committee. During 2019 Nick was President of TOPRA and Chairman of TOPRA's Board of Directors. Nick has a graduate degree in Genetics/Microbiology and a master’s degree in Information Science

Amanda is working at AstraZeneca as a Regulatory Advocacy Strategy and Improvement Director within the Global Regulatory Policy team, She is responsible for managing regulatory policy advocacy and activities within the AZ priority policy pillar of “Expedited, Collaborative and Reliance pathways”. She has over 25 years of experience in Regulatory Affairs across multiple Therapy Areas and regions, Amanda is a member of the industry network for South East Europe.

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

Marko Eric is a pharmacist. He joined the Medicines and Medical Devices Agency of Serbia (ALIMS) in 2009 at the National Pharmacovigilance Center, where he currently works as the coordinator of the development of the national pharmacovigilance system. In addition to standard PV assessments, he deals with cooperation with state institutions and pharmacovigilance promotion. He is a member of the commission for human medicines and numerous task forces and working groups for regulatory affairs. Participates in the drafting of national legislation and guidelines for human medicines. Currently at ALIMS, he is the main leader of the digitalisation project of regulatory affairs for medicines.

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.

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.

Master of Science in Pharmacy, communicator, and certified diplomat. Manager for International Cooperation, European Integrations, and Communications at ALIMS for 15+ years. Recognized worldwide as Serbia’s leading public health official and international expert, project leader, and communicator with thousands of media reports to his name and many lectures across the globe. Leader on several major EU, WHO, and Council of Europe projects and official in many groups and bodies. 2021/22 US State Department Hubert H. Humphrey Fellow at Emory University in Atlanta, Georgia, US and CDC. Valedictorian of the Diplomatic Academy of Ministry of Foreign Affairs of Serbia 2010/11. Accomplished writer and scriptwriter too.

Izabela Majic is a pharmaceutical professional with the degree from Stockholms University and 20 years of work experience in international pharmaceutical organisations including several global positions related to Pharmaceutical Quality and Regulatory. She worked also for 5 years at the Croatian Medicines and Medical devices (HALMED) as EU GMP and Pharmacovigilance inspector and Head of Inspectorate. In her current role she is performing audits and consulting in the area of Pharmacovigilance, GMP and GCP. She is actively involved in several working groups supporting Industry and Regulators world wide as external advisor and educator.

Professor Siniša Tomic is Head of the Agency for Medicinal Products and Medical Devices of Republic of Croatia. He has been leading the Agency since 2015, and has been at this position previously from October 2003 to November 2011. He has a University Degree in Medical Biochemistry from Faculty of Pharmacy and Biochemistry, University of Zagreb and PhD from Faculty of Biology and Pharmacy, Friedrich Schiller University of Jena, Germany. Prof. Tomic is the Co-Chair of the BEMA Steering Group, member of the European Medicines Agency Management Board and member of the Heads of Medicines Agencies. He also teaches at Pharmacy Programs at the Universities of Split and Rijeka.

At WHO, Marie works as the Team lead for the Facilitated Product Introduction Team supporting the Member States by implementing various approaches and mechanisms, including collaborative procedures, reliance approaches, and joint activities at the national, regional, and international level to facilitate and accelerate the introduction of priority medical products in countries. Before joining the WHO in May 2019, Marie worked for 9 years at the European Medicines Agency in London as a Regulatory Affairs Officer. Before that, she worked in the pharmaceutical industry, contract research organization and consultancies in the United Kingdom, Spain and France.

Dr Magda Bujar is Senior Manager, Regulatory Programme and Strategic Partnerships and has over 10 years’ experience working in Regulatory Policy and Science. She has co-authored a number of publications and has presented and chaired at major scientific meetings including those of the Drug Information Association (DIA) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Prior to joining CIRS, Magda carried out research spanning scientific, engineering and policy issues regarding the development of medicines. She received her Master of Science in Biochemical Engineering from University College London (UCL) and a Doctor of Philosophy from the University of Hertfordshire.

Victoria Palmi, Senior International Affairs officer, has over 20 years of experience at the European Medicines Agency (EMA). She supports international collaboration programs and reliance as part of her role in the International Affairs office. Previously, Victoria worked as Product Lead in different therapeutic areas within the Evaluation of Medicines department. During this time, she led initiatives that accelerated assessment and early access to priority medications.

Ajten Ademi Avduramani, committed to regulatory oversight in the pharmaceutical sector, aiming to enhance public health outcomes. Graduated with a Master of Pharmacy from State University of St. Cyril and Methodius in 2011in Skopje. Commenced regulatory work at the Agency for Medicines and Medical Devices (MALMED) in 2018, assuming the role of Senior Associate in the Department for Human Medicines. Currently pursuing specialized studies in Pharmaceutical Regulation, furthering expertise in regulatory affairs. Actively engages in the Commission for Medicinal Products for Human Use and the Commission for Clinical Research in North Macedonia, contributing to the advancement of healthcare standards through regulatory initiatives.

Senior professional with 25 years of pharmaceutical experience, last 11 years employed at the Agency for medical products and devices of Bosnia and Herzegovina. Currently serving as Head of Division for Pharmacovigilance and Materiovigilance. Working on reforming the Bosnian Pharmacovigilance system, ensuring the implementation of effective national PV strategies and harmonisation with EU Legislative.Expirensed GXP inspector with main focus in GVP inspection. Passionate PV professional. Most activities as Inspector are focused on detecting signals that potentially indicate the presence of counterfeit/falsified medicines in legal supply chains.Membership EDQM Working Group for traceability drug in hospital settings/CD-P-PH/PC since 2021.

Andrew Deavin has spent over 25 years in Regulatory Affairs, after having gained a M.Sc. and Ph.D. in Immunology and working in vaccine research. He has managed regulatory projects in development, registration and life-cycle primarily in vaccines but also in haematology/oncology. Andrew has worked both in European Regulatory Affairs and in International for vaccine products in strategy and issue resolution. He is currently in Regulatory Policy working externally to reduce complexity in the regulatory environment and enhance access of innovative vaccine products. Andrew is GSK’s Global Policy Lead supporting Vaccines as well as Regulatory Policy Lead for GSK products in Greater China and Intercontinental region.

Biljana is a pharmacist from the State University, Faculty of Pharmacy, Skopje. She joined MALMED in 2008, with 16 years of experience in pharmaceutical legislation, covering inspection, licensing, medicines consumption, marketing authorization, pricing, and clinical trials. Currently, she is a Counsellor in the Department for Licensing, issuing licenses for import/export of medicines and serving as MALMED’s QP manager. She has participated in international projects to harmonize national legislation and is a member of the working group for EU accession within the Ministry of Health. Since 2018, she has been a member of the Ethics Committee for clinical trials and is now part of drafting group of the Law of Medicines and Medical Devices.

Srdjan Lucic is a pharmacist. He joined Roche in 2005 covering different positions and areas of responsibility. He has been a certified GxP auditor since 2016, and has special expertise in the field of GDP/GMP controls. As an active and long-term member of the Association of Innovative Drug Manufacturers in Bosnia and Herzegovina (regulatory group, management board), participates in the development of national drug policies through partnership and collaboration with Regulatory authorities. He recently completed post-graduate studies in the field of pharmaceutical informatics and pharmacoeconomics. He is excited to be actively engaged in the development of new pharmaceutical regulation

Barbara Kovacic Bytyqi has been working in Agency for Medicinal Products and Medical Devices of Croatia (HALMED) since January 2018 as a pharmacovigilance assessor for national and EU procedures, mainly involved in assessments of periodic safety update reports (PSUR) and risk management plans (RMP). In November 2023, she was appointed Head of Pharmacovigilance and Rational Pharmacotherapy Department at HALMED. Currently, she is an Alternate in Pharmacovigilance Risk Assessment Committee (PRAC).

Alessandra holds a Master’s degree in Pharmaceutical Chemistry and Technology from University of Rome La Sapienza and is a licensed pharmacist. She has been in the Pharma Industry for about 20 years covering roles of increasing responsibility in Regulatory Affairs, Quality and CMC. She is currently part of the Pfizer Regulatory-CMC Inflammation and Immunology organization and is responsible for clinical and commercial portfolio submission strategy. Alessandra is a member of the EFPIA ERAO variations subteam and MQEG lifecycle management team.

Francesca Mangia joined the Regulatory Affairs department at F. Hoffmann-La Roche after completing her Doctoral Degree in Structural Biology and Biophysics at the University of Basel. She works in the CMC Regulatory International Operation & Policy group at F. Hoffmann-La Roche where she drives filings strategy in International Markets integrating Reliance approaches and advocating for convergence and harmonization.

Dilaver serves as the Principal Regulatory Submissions Lead at Roche, bringing over twelve years of expertise in handling global submissions across various dossier formats such as paper, electronic, and eCTD. His professional background includes actively contributing to the successful implementation of eCTD projects within the organization by offering training, developing processes, executing and validating systems, as well as establishing direct collaborations with Health Authorities to streamline submission processes effectively in different regions.

Erna Kasumovic is an assistant director at the Directorate for European Integration of Bosnia and Herzegovina. She has an extensive knowledge and experience in harmonizing legislation in Bosnia and Herzegovina with the EU. Her expertise is in particularly in the techniques and methods of aligning legislation with EU acquis in various fields of EU law, as well as in analysing and monitoring the implementation of these legislation. She has played an important role in the development of numerous strategies and action plans related to the European integration process, with a particular focus on analysing both EU and national legislations. She is the co-author of the Guidelines for harmonizing BiH regulations with the EU acquis.

Tanja Nedjic is a pharmacist and specialist in Pharmaceutical Tehnology. Joined the Medicines and Medical Devices Agency of Serbia (ALIMS) in 2005 at the Licencing Departmant where she worked as a part of Validation Group, SmPC/PIL/Labeling Harmonisation Group, as organiser of Committees for Medicnes for Human Use, secretary on Committee sessions and as a deputie menagere of Licencing Depatment. Activly took part in Ttwinning Project with France Agency 2005-2009. From 2015. she is assessor of bioeqiuvalence studies at Clinical Efficacy and Safety Evaluation Department. Participates in the drafting of national legislation and guidelines for human medicines. Currently, she is member of the team for digitalisation project.

Svetlana Vujovic is a pharmacist who graduated from the Faculty of Pharmacy, University of Montenegro. She is pharmacovigilance associate in the Pharmacovigilance department at the Centre for market affairs and safe use of medicines at the Institute for Medicines and Medical Devices of Montenegro. She has been working in the pharmacovigilance department for three years. Her main areas of interest include spontaneous reporting and risk communication.

Mrs. Elena Cvetanovska, a Master of Pharmacy graduate from Ss Cyril and Methodius University in Skopje, is a Senior Associate at the Department of Human Medicines at MALMED, North Macedonia. Since joining MALMED in 2018, she has been specializing in Quality Control at the Faculty of Pharmacy. With a decade of experience as a Quality Analyst in the pharmaceutical industry, she focused on raw materials, intermediaries, and finished drug products. She played a significant role in MALMED's twinning project with Lithuania's State Medicines Control Agency. During the COVID-19 pandemic, she was part of the working group evaluating vaccine documentation and serves on MALMED's Marketing Authorization Board.

Iva Klarica Domjanovic is currently working as principal coordinator for interchangeability of medicines at the Agency for Medicinal Products and Medical Devices of Croatia, but also as an assessor of pharmacokinetic studies for innovative drugs. She defended her doctoral dissertation in the field of pharmacogenomics and finished Master studies at the University of Manchester in the field model-based drug development. She participates in graduate and postgraduate teaching at the Faculty of Pharmacy and Biochemistry of the University of Zagreb and Faculty of Medicine in Osijek. Iva is member of several working groups in EMA involved in the area of clinical pharmacology and modelling and simulations.

Over 20 years of experience in administrative, expert and developmental tasks in the fields of medicinal products for human use. Tasks related to the release of the national annex to the European Pharmacopoeia. Member of the Committee of Experts on OMCL Falsified Medicines Working Group. Technical Auditor in the Mutual Joint Audits and Visits (MJAs/MJVs) programme of the OMCL Network. Member in delegation of Bosnia and Herzegovina in the European Pharmacopoeia Commission.

Marijana Danevska, Doctor of medicinal science, Master in public health, graduated at State University, Faculty of Medicines, has been part of agency of medicines and medical devices since 2015. Since than she is working as Senior Associate in the Department for pharmacovigilance. In mean time she has finished specialization of pharmaceutical legislation and also specialization of pharmacovigilance at State faculty of pharmacy. She has been actively involved in all projects for pharmacovigilance as well as in digitalization of pharmacovigilance system in North Macedonia.

Dženana Delic graduated from the Faculty of Pharmacy in 2012 and started her career in pharmacy, carefully listening to the needs and requirements of patients. Since 2019, she has replaced her pharmacist position with that of an analyst who oversees the effects and correctness of medications, serving as a senior associate for pharmacopoeia at the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina. She completed her specialization in the field of drug testing and quality control in 2023, thereby affirming her expertise and dedication to the pharmaceutical profession.

Andela Draškovic is a regulatory associate in the Marketing Authorization department at the Centre for Medicines at the Institute for Medicines and Medical Devices of Montenegro. She has been a member of the managing board of the Institute for the past two years. Andela holds a degree from the Faculty of Pharmacy, University of Montenegro. She has also studied, as an exchange student, at the University of Ljubljana, Faculty of Pharmacy. She is currently pursuing specialization studies in Industrial pharmacy, at the Faculty of Pharmacy, University of Belgrade, and is a PhD student at the Faculty of Medicine in Podgorica.