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.

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.

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.

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.

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.

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.

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.

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.

Jadranka Mirkovic is a Pharmacist by education. After short employment at the Farmacy Faculty and working as responsible pharmacist in two Pharmacies, she followed a career in pharmaceutical industry for almost 10 years, where she had a wide range of responsibilities on different markets. Since 2013, she has been working in ALIMS (Medicines and Medical Devices Agency of Serbia). At the Agency, at her current position, she is in charge of marketing authorisation of human medicines processes, PV, Import licences and clinical trials of human medicines.

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.

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

Ania Mitan serves as the Senior Vice President & Managing Director, EMEA and India. She is former Executive Director of the commercial organization at Celgene, where she built the oncology business in the EMEA region with healthcare partners to shape quality delivery systems and new commercialization models in personalized medicine, specifically with novel cell and gene therapies. She began her career at Eli Lilly and Company, serving as Head of Commercial Development for EU mid-size countries, Head of Primary Care Business Unit for the UK and Ireland, and Head of Marketing for the Critical Care Unit. Ania earned her MBA from Simmons College and MSc in Pharmacy from Silesian Medical Academy (Poland).

Lamis is currently International value & access partner for Europe in Hematology, and prior to that was leading the Market Access & Public Affairs team at Novartis Oncology for Central, Eastern, Southern Europe, Russia & CIS. She has 20+ years’ experience in the Pharmaceutical industry in Middle East, North Africa and Europe regions, among which 9 years in Market access. Lamis is also a #EUnite ambassador and workstream lead for community and capability building, and served as workstream lead in several cross-functional regional projects on Reimagining market access internally and externally and Unbossed leadership for access leaders. Lamis is a passionate believer in the power of people, mindset, and collaboration in driving change.

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"

After working for Lilly and Merck, Francesca Cerreta joined the EMA in 1996. There, she has set up the parallel scientific advice programme with FDA, worked in CNS and Scientific Advice, and coordinated the PRIME scheme, the digital therapeutic matrix, and the geriatric medicines strategy activities.

Martin Harvey is Head of International Affairs at the European Medicines Agency (EMA), EU. He first joined the EMA legal team after serving as a European affairs consultant in Brussels. He headed the Office of the Executive Director, served as Head of Communication, and then moved to the Agency's International Affairs team. He took an 18-month career break with Unitaid, the WHO-hosted partnership dedicated to innovation in global health from 2019-2020. Martin has served on the DIA Advisory Council for EMEA; and as program advisor for DIA's EuroMeeting and Global Annual Meeting. He holds law degrees from the University of Dundee (UK) and the Vrije Universiteit Brussels (Belgium). He is a Fellow of DIA since 2018.

Michal Pilkiewicz, IQVIA expert in the field of healthcare systems and relations with government agencies, distributors, pharmacies, hospitals and industry organizations in Europe. Responsible for monitoring the impact of major legal and technological changes on the market like new reimbursement schemes, Digital Health, e-commerce, Falsified Medicines Directive or General Data Protection Regulation (GDPR). His professional experience includes the FMCG, pharmaceutical and e-commerce market. He has been working in the pharmaceutical industry since 2001. Currently in the position of General Manager Ukraine, Adriatic & Baltic IQVIA, previously Director Supplier Services EE, Country Manager Poland and Sales Director CEE.

Kristiina Puusaari is an eSubmission coordinator at the European Medicines Agency (EMA) working on Programme and Project Management for electronic submission systems and projects, such as eCTD, EMA eSubmission Gateway, electronic Application Form (eAF), Common Repository, PSUR Repository and the Single Submission Portal. Kristiina is the business domain expert for the EMA eSubmission systems as well as the Chair of the eSubmission Change Management Board. Kristiina also represents EMA in the ICH M8 IGW/EGW.

She graduated from the Faculty of Pharmacy, University of Belgrade and specialized in Pharmacoeconomics and pharmaceutical legislation. She started working at the Institute for Medicines and Medical Devices in 2009. For the last ten years, she was the head of the Department for monitoring consumption and determining the maximum prices of medicines, as well as the Center for Medical Devices, and for the last year she has been the head of the Center for Marketing and Safe Use of Medicines. Since 2011, she has been appointed by the Ministry of Health as the National Focal Point for antibiotic consumption in order to implement the Agreement between the Ministry of Health and WHO for Europe in the relevant area (antibiotic consumption).

Tim is responsible for managing a team of Global Delivery Managers who support regulatory submissions around the world. He is experienced in regulatory systems strategy and implementation and helping to define a roadmap for systems and data management, and is also the chair of the EFPIA eCTD Sub-Group where new & upcoming regulatory guidelines relating to eCTD and other telematics initiatives are discussed.

Momir Radulovic leads the Slovenian Medicines and Medical Devices Agency since December 2018. He is a member of EMA Management Board, a member of EC Pharmaceutical Committee, HMA Management Group, Chair of EURIPID Board of Participants and member of EU Network Training Centre Steering Group. His previous work experience includes Hospital and Community Pharmacy and Pharma industry, focused on oncology medicines, HIV and vaccines. By living and working in countries with diverse Health systems and cultural environments he has learned to adapt swiftly to changes and to seize the opportunities that those can offer. He has track record of strong results, enjoy prioritizing, simplifying complex ideas and acting on them with high levels of energy.

Jelena Anicic, pharmacist, has been working in Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina (www.almbih.gov.ba) since 2011 as Advisor for providing quality in regulatory services in Quality Assurance Department. She performs services regarding the creation of documentation for providing system of quality ISO 9001 in Agency and monitoring and implementation EU and ICH regulations and instructions. She also works assessment of MA renewal and assessment of MA varriation. She is involved in development and implementation of READY! system and e-Portal in Agency. She is member of EDQM Standard Terms Working Group.

Danica Kontek is the principal coordinator for non-prescription medicinal products at the Croatian Agency for Medicinal Products and Medical Devices. She graduated from the Faculty of Pharmacy and Biochemistry in Zagreb. After her internship in a community pharmacy, she joined HALMED working in the field of regulatory affairs. She is responsible for the coordination of national marketing authorisation procedures, renewals of marketing authorisation and variations as well as for the coordination of OTC medicinal products and scientific advice.

Deputy Managing Director of the Institute for medicines and medical devices of Montenegro, Mira got a master's degree from the Faculty of Law, University of Belgrade in the field of International Law, International Relations and European integration. She has more than 15 years of regulatory experience in various areas of public health and negotiations on accession to the EU. Since 2013 she has been working on regulation in the field of medicines and medical devices. She is the representative of Montenegro in EU negotiating groups for medicines and medical devices and in EMACOLEX-the association of lawyers of member states of the EMA, as well as in other international organizations and working bodies important for the pharmaceutical market.

Sini is working as Regulatory, Drug Development and Manufacturing Director at EFPIA since 2014 and leads the team since 2018. She is responsible for various regulatory policy and advocacy activities in relation to regulatory science and regulatory strategy. She has previously worked over 5 years at AZ R&D Global Regulatory Affairs in Sweden and 3 years as Executive Director of Finnish Pharmacists' Society. She is currently doing a part-time PhD for professionals programme at the University of Utrecht and WHO collaboration centre for pharmaceutical policy and regulation. She is a Board member of Industrial Pharmacy Section in International Federation for Pharmacists and Pharmaceutical Sciences since 2010.

Dr. Grozdanova is a University Professor with respected academic pharmacy career, and scientific and expert professional engagements in several working committees in Ministry of Health, Macedonian Agency for drugs and as National Coordinator for Immunization. She has specialization in quality drug control and PhD in immunochemistry. Her education was at the universities in Switzerland and Sweeden, and expert trainings at the WHO and UNICEF centres in Austria, Georgia, and Denmark. She is author of national health rulebooks, action and technical plans, scientific papers for biologicals/vaccines, and project coordinator for several national and regional projects. She has received Fulbright scholarship for Postdoctoral studies in Boston, USA.

University Professor with over 20 years of academic career and professional engagements in several working committees in Ministry of Health, PhD in Obstetrics and gynaecology, Serbia She he had educational study visits at Graz, Vienna and Hamburg University, and WHO/UNICEF expert trainings in Great Britany, and in cooperation with UNFPA from 2017 in different projects for improvement of perinatal health .She participated as author of national health rulebooks, action plans, and technical reports for and is project coordinator for several national and regional projects.

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.

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.

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.