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DIA Workshop on Optimising Variations Regulatory Framework

Towards EU Accession


Speakers

  • Manuela  Stojanovic-Pejovski

    Manuela Stojanovic-Pejovski

    • Executive Director
    • Farmabrend Nova, North Macedonia

  • Ana  Petrovic

    Ana Petrovic

    • Managing Director
    • Association of Research-Based Medicine Producers in Bosnia & Herzegovina (UIPL), Bosnia and Herzegovina

  • Angelika  Joos, MPharm

    Angelika Joos, MPharm

    • Executive Director, Global Regulatory Policy
    • Merck Sharp & Dohme (Europe) Inc., Belgium

    Angelika Joos, MPharm, 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 various Committees of the European Federation of Pharmaceutical Manufacturers and Associations. She is also involved in international policy activities as the MSD delegate in the IFPMA Regulatory Science Committee, and the BIO and the PhRMA international Committees.

  • Ivana  Ferber, MPharm, MS

    Ivana Ferber, MPharm, MS

    • Regulatory Affairs Lead Croatia/Bosnia and Herzegovina
    • Merck Sharp & Dohme, Croatia (Hrvatska)

    Regulatory Affairs Lead for Croatia and for Bosnia and Herzegovina at Merck Sharp & Dohme. More than 20 years of experience in pharmaceutical industry. Before joining industry spent 8 years in academic settings at Department of Pharmacology, Medical Faculty as junior researcher-assistant and completed post-graduated study at Faculty of Natural Science, Zagreb. Pharmacist by vocation (Faculty of Pharmacy, Zagreb University). It takes passion, courage and wining mindset to bring innovative medicines to patients. Undeniably, it is even more important in these unprecedented times. I am privileged and excited to be part of this process and to be able to follow the product throughout life cycle.

  • Maja  Lovrek, MPharm

    Maja Lovrek, MPharm

    • Head of Medicines Authorisation Division
    • Agency for Medicinal Products and Medical Devices, Croatia (Hrvatska)

    Maja Lovrek Romcevic graduated from Faculty of Pharmacy & Biochemistry, UNIZG. 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 rejoined HALMED as the Head of Medicines Authorisation Division, involved in the preparation for the EU accession, strenghtening of HALMED’s regulatory and assessment capacities & integration in the EU procedures. Responsible for the organisation and oversight of marketing autorisations procedures, including validation of applications, regulatory support and assessment of quality, safety and efficacy for national, MRP/DCP and CP procedures.

  • Sara  Torgal, MPharm

    Sara Torgal, MPharm

    • Scientific Programmes Manager
    • DIA, Switzerland

  • Susanne  Ausborn, PhD

    Susanne Ausborn, PhD

    • Global Head International Regulatory Policy
    • F. Hoffmann-La Roche Ltd., Switzerland

    M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry. Susanne is with Roche since 2001, being currently Global Head International Regulatory Policy. Susanne has extensive experience with global filings, is a strong advocate for global regulatory convergence and is engaged in numerous workshops/ meetings with regulators from various emerging markets around the globe. Currently, she is the Vice Chair of EFPIA IREG, Chair of the EFPIA Russia network and member of EFPIA Middle East network.

  • Lina  Cacic

    Lina Cacic

    • Senior Advisor - Specialist I for Validation of Applications
    • Agency for Medicinal Products and Medical Devices (HALMED), Croatia (Hrvatska)

    Dipl. Ing. Biology, University of Zagreb. Employed in HALMED since 2007, responsibilities included: assessment of Quality documentation for MA / Renewals / Variations for Biologicals; assessment of Quality documentation for Variations for Human medicines; participation in drafting secondary legislation, guidelines, instructions & internal SOPs in the ?eld of medicines to ensure approximation with the EU legislation & other international acts / guidelines. Since 2015, primary responsibility is the assessment of validity of applications for variations for human medicines and giving regulatory support and advices for variation application, including administrative, quality and safety variations, in national and MRP/DCP procedures.

  • Riccardo  Luigetti

    Riccardo Luigetti

    • International Affairs Officer
    • European Medicines Agency, Netherlands

  • Sabina  Uzeirbegovic

    Sabina Uzeirbegovic

    • Croatian CMDh Member
    • Agency For Medicinal Products and Medical Devices, Croatia (Hrvatska)

  • Susanne  Winterscheid, PMP

    Susanne Winterscheid, PMP

    • Head of Licensing Division 3
    • BfArM, Germany

    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.

  • Veronica  Popa

    Veronica Popa

    • MCT8-AHDS Foundation, Romania

  • Ranela  Ceci, PhD

    Ranela Ceci, PhD

    • specialist
    • National Agency For Medicinal Products and Medical Devices, Albania

    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

  • Sulltane  Havolli, MBA, MPharm

    Sulltane Havolli, MBA, MPharm

    • Senior review officer
    • KOSOVO MEDICINES AGENCY, Kosovo

    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, MS

    Melly Lin, MS

    • Regional Policy Lead
    • F. Hoffmann-La Roche Ltd, Switzerland

    Melly Lin serves as Regional Policy Lead for Balkan Region in Roche, responsible for technical regulatory policy engagement with pharmaceutical associations and regulatory agencies. She is also serves as Senior China Regulatory Advisor by providing advices to technical teams in defining regulatory strategies for development and marketed projects in China. She was previously Roche China CMC Policy Lead for over 8 years. She was member of DIA China Advisory Committee and active in leading scientific exchange on CMC-related topics.

  • Ivana  Zadro, MS

    Ivana Zadro, MS

    • Senior Advisor - Specialist II for Validation of Applications
    • Agency For Medicinal Products and Medical Devices (HALMED), Croatia (Hrvatska)

    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.

  • Elona  Chilku

    Elona Chilku

    • Agency for Medicines and Medical Devices of Macedonia (MALMED), North Macedonia

    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, PhD

    Frank Montgomery, PhD

    • Global Head Regulatory CMC, GRAPSQA
    • AstraZeneca, United Kingdom

    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

    Lejla Rizvanbegovic-Taletovic

    • Regulatory Affairs Head
    • Sanofi d.o.o., Bosnia and Herzegovina

    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.

  • Biljana  Tubic

    Biljana Tubic

    • Head of Department of Medicinal Products
    • Agency for Medicinal Products and Medical Devices (ALMBiH), Bosnia and Herzegovina

  • Samvel  Azatyan, MD, PhD

    Samvel Azatyan, MD, PhD

    • Team Lead, Regulatory Convergence and Networks (RCN/REG)
    • World Health Organization (WHO), Switzerland

    Dr. Samvel Azatyan is a pediatrician with a Ph.D. degree in clinical pharmacology and medical products regulation. Dr Azatyan has more than 20 years of international experience in regulation of medical products, including supporting regulatory collaboration, convergence and harmonization. He is working in the World Health Organization since 1999 and is currently leading the Regulatory Networks and Harmonization Group in the Regulatory Systems Strengthening Team at the Organization's Headquarters in Geneva, Switzerland.

  • Amra  Hadziabdic Deljkovic, MPharm

    Amra Hadziabdic Deljkovic, MPharm

    • Regulatory Affairs Manager
    • Novartis, Bosnia and Herzegovina

    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.

  • Milena  Lješkovic

    Milena Lješkovic

    • Head of Department for Marketing Authorisation
    • Agency for Medicines and Medical Devices of Montenegro, Montenegro

    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

  • Bojan  Trkulja

    Bojan Trkulja

    • Managing Director
    • The Association of the Manufacturers of Innovative Drugs – INOVIA, Serbia

    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.

  • Ana  Holt

    Ana Holt

    • Senior Health Specialist
    • The World Bank, United States

  • Mirjana  Ipsha-Koceva, MD

    Mirjana Ipsha-Koceva, MD

    • Regulatory Coordinator
    • Merck Sharp & Dohme (MSD), North Macedonia

    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.

  • Loubna  Djemame

    Loubna Djemame

    • Consultant, Health, Nutrition and Population
    • World Bank, United States

  • Sylvie  Meillerais, MSc

    Sylvie Meillerais, MSc

    • Director Global CMC Policy
    • MSD (Europe) Inc., Belgium

    Sylvie has been engaged in regulatory policy activities for close to 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. She is an active member of the EFPIA Manufacturing and Quality Experts Group and of the Middle East network, where she leads the Life Cycle Management efforts. She is further engaged in IFPMA CMC & Quality policy activities. Sylvie holds a Maîtrise in Biochemistry from the University of Bordeaux II.

  • Winona Rei  Bolislis, MA

    Winona Rei Bolislis, MA

    • Regulatory Science and Policy Associate
    • Sanofi, France

    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  Byrne

    Gordon Byrne

    • Technical Regulatory Lead - Innovation
    • Hoffmann-La Roche Ltd, Switzerland

    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.

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