Day 1
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09:00 | Opening – Welcome Ceremony | ||||||
Session I. Regulatory Science
Chairs:
Béla Merkely, Budapest, Hungary Péter Ferdinandy, Budapest, Hungary |
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10:00 | Keynote Address I: KN-1How Regulatory Science Can Enable WHO’s Triple Billion Objectives? Zsuzsanna Jakab Deputy Director-General, World Health Organization (WHO), Geneva, Switzerland |
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10:40 | Keynote Address II: KN-2Regulatory Perspectives – Where We Came from, Where Are We Today, Where Are We Headed? Carl Peck Founder and Chairman at NDA Partners LLC., San Luis, CA, USA |
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11:20 | Coffee Break, Exhibition and Poster Session | ||||||
Session II.Regulatory Science, Nanomedicine and Complex Drugs
Chairs:
Beat Flühmann, Glattbrugg, Switzerland Joseph W. Polli, Chapel Hill, RTP, NC, USA |
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11:50 | PL-1Regulatory Science in Drug Development Vinod P. Shah Pharmaceutical Consultant, North Potomac, MD, USA Member of NBCD-Working Group, North Potomac, MD, USA |
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12:15 | PL-2Where to Go with Nano? Daan J.A. Crommelin Department of Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands |
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12:40 | PL-3Complex Drugs: What Are They and Why Do They Need Special Attention? Jon S.B. de Vlieger Coordinator of NBCD-Working Group, Utrecht, The Netherlands Foundation Lygature, Utrecht, The Netherlands |
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13:05 | Panel Discussion I. A Forward-Looking Practical Consequence of Regulatory Science in General and the Complex Drugs Moderators:
Daan J.A. Crommelin, Utrecht, The Netherlands Vinod P. Shah, North Potomac, MD, USA |
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Panelists: Erem Bilensoy, Ankara, Turkey Krisztián Fodor, Budapest, Hungary Vijay U. Kshirsagar, Mumbai, India Carl Peck, San Luis, CA, USA Jon S.B. de Vlieger, Utrecht, The Netherlands |
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13:25 | Lunch and Exhibition | ||||||
Session III. Regulatory Aspects of Nanomedicine Products
Chairs:
Lajos Balogh, North Andover, MD, USA Subramanian R. Vaidya, Mumbai, India |
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14:40 | PL-4How Should Synthetic Follow-Ons of Biological Products Be Regulated? What Are the Implications for Automatic Substitution? Jens Heisterberg Novo Nordisk, Søborg, Denmark |
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15:05 | PL-5Same Product Different Regulatory Approach Around the World: Glatiramer Acetate Paolo Rocco, Paola Minghetti Department of Pharmaceutical Sciences, University of Milan, Milan, Italy |
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15:30 | PL-6NBCD: Regulatory Science in Motion. Where We Are and Where We Are Going? Marisa Papaluca Amati Regulatory Science Expert, London, UK |
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15:55 | Coffee Break, Exhibition and Poster Session | ||||||
Session IV. Complexity of Nanomedicine, Nanopharmaceuticals, Pharmacovigilance
Chairs:
José A. Guimarães Morais, Lisbon, Portugal Romána Zelkó, Budapest, Hungary |
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16:25 | PL-7Nanomedicines: Previous Accomplishments and Ongoing Efforts Scott McNeil Department of Pharmaceutical Sciences, University of Basel, Switzerland |
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16:50 | PL-8How to Deal with Complexity of Nanomedicine in Practice Stefan Mühlebach Department of Pharmaceutical Sciences, Division of Clinical Pharmacy & Epidemiology, Hospital Pharmacy, University of Basel, Switzerland |
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17:15 | PL-9Pharmacovigilance of Complex Drugs; Traceability of Biologics and Implications for Other Complex Products Kevin Klein, Peter Stolk Foundation Lygature, Utrecht, The Netherlands Utrecht University, Utrecht, The Netherlands Exon Consultancy, Amsterdam, The Netherlands |
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17:40 | Panel Discussion II. How Can We Prepare for a Wave of New Complex Drug Products to Come? Scientific, Regulatory and Practical Considerations.
Moderators:
Beat Flühmann, Glattbrugg, Switzerland Jon S.B. de Vlieger, Utrecht, The Netherlands |
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Panelists: Marisa Papaluca Amati, London, UK Jens Heisterberg, Søborg, Denmark Scott McNeil, Basel, Switzerland Stefan Mühlebach, Basel, Switzerland Paolo Rocco, Milan, Italy |
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18:10 | End of Day 1. | ||||||
Day 2
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Session V. Drug Research and Development Strategies
Chairs:
Imre Klebovich, Budapest, Hungary Vinod P. Shah, North Potomac, MD, USA |
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09:00 | Keynote Address III: KN-3Industry Perspectives in Modern Drug Research and Development Strategies Péter Gergely Executive Director, Novartis Institutes of BioMedical Research, Basel, Switzerland |
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09:40 | Keynote Address IV: KN-4A Multitargeted Approach to Treating Inflammatory Conditions Mark Latymer Senior Medical Director, Inflammation & Immunology Global Medical Affairs, Biopharmaceuticals Group, Pfizer Inc., Sandwich, Kent, UK |
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10:20 | PL-10Drug Development Strategy in the United States: An Industrial View of DMPK Joseph W. Polli Past President of American Association of Pharmaceutical Scientists (AAPS), Arlington, VA, USA Director, Medical Information and Scientific Communications, ViiV Healthcare, Research Triangle Park (RTP), NC, USA |
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10:45 | Coffee Break, Exhibition and Poster Session | ||||||
Session VI. Prodrug, Regulatory Science, Drug-Device Combination Products
Chairs:
Panos Macheras, Athens, Greece Georg A. Petroianu, Abu Dhabi, United Arab Emirates |
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11:15 | PL-11Prodrug Nano-Squalene Bioconjugate Drug Products Leslie Z. Benet1,2, Patrick Couvreur2
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11:40 | PL-12Regulatory Science Challenges – Encourage Innovation through an Adaptive Regulatory System Krisztián Fodor Regulatory Science and Patient Safety Department, Gedeon Richter Plc., Budapest, Hungary |
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12:05 | PL-13Regulatory Pathway for Drug-Device Combination Products in US David R. Savello Co-founder and Partner, NDA Partners LLC, Rochelle, VA, USA |
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12:30 | Panel Discussion III. New Perspectives the Drug Research and Development Strategies. Evaluation of Drug-Device Combination Products Moderators:
Péter Gergely, Basel, Switzerland Clive G. Wilson, Glasgow, Scotland, Belfast, Northern Ireland, UK |
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Panelists: Leslie Z. Benet, San Francisco, CA, USA István Greiner, Budapest, Hungary Mark Latymer, Sandwich, Kent, UK Joseph W. Polli, Triangle Park (RTP), NC, USA David R. Savello, Rochelle, VA, USA |
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13:00 | Lunch and Exhibition | ||||||
Session VII. FIP Strategy, Advances in Drug Delivery System
Chairs:
Balázs Hankó, Budapest, Hungary Vijay U. Kshirsagar, Mumbai, India |
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14:15 | PL-14The Place of Science in the “One FIP Strategy” Dominique Jordan President of International Pharmaceutical Federation (FIP), The Hague, The Netherlands |
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14:40 | PL-15Supramolecular Structure and Stability of Nanofibrous Drug Delivery Systems Romána Zelkó University Pharmacy Department of Pharmacy Administration, Semmelweis University, Budapest, Hungary |
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15:05 | PL-16Advanced Drug Delivery Systems: From Nano- and Microparticles to Smart Pills István Antal Department of Pharmaceutics, Semmelweis University, Budapest, Hungary |
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15:30 | PL-17Advances in Transdermal Drug Delivery System Dange Veerapaneni Sparsha Pharma International Private Ltd, Hyderabad, India |
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15:55 | Coffee Break, Exhibition and Poster Session | ||||||
Session VIII. Global Harmonization of Regulations
Chairs:
Éva Szökő, Budapest, Hungary Judit Tarnai, Budapest, Hungary |
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16:25 | PL-18Future of the Hungarian Drug Market – Role of the Hungarian Regulatory Authority Mátyás Szentiványi Director General, National Institute of Pharmacy and Nutrition, Budapest, Hungary |
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16:50 | PL-19Global Biosimilar Drug Development: Any Chance for Consolidation after 15 Years of Positive Regulatory Experience? Zsolt Holló Egis Pharmaceuticals Plc, Budapest, Hungary |
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17:15 | PL-20Innovative Submissions vs Global Regulatory Guidelines (ICH, WHO) Tamás L. Paál National Institute of Pharmacy and Nutrition, Budapest, Hungary Institute of Pharmaceutical Technology and Regulatory Affairs, Faculty of Pharmacy, University of Szeged, Szeged, Hungary |
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17:40 | Panel Discussion IV. Advances in Drug Delivery System Global Harmonization of Regulations – Dream or Reality? Moderators:
Henning H. Blume, Oberursel, Germany Mátyás Szentiványi, Budapest, Hungary |
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Panelists: Beat Flühmann, Glattbrugg, Switzerland José A. Guimarães Morais, Lisbon, Portugal Zsolt Holló, Budapest, Hungary Dominique Jordan, The Hague, The Netherlands Tamás L. Paál, Budapest, Szeged, Hungary Dange Veerapaneni, Hyderabad, India |
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18:10 | End of Day 2. | ||||||
Day 3
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Session IX.Patient-Centric Drug Research
Chairs:
Henning H. Blume, Oberursel, Germany Milena Jadrijević-Mladar Takač, Zagreb, Croatia |
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09:00 | Keynote address V: KN-5Merging Science and Patient in Future Drug Development to Enhance Safety and Effectiveness Sven Stegemann Graz University of Technology, Graz, Austria ACG Ltd., Müllheim, Germany |
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09:40 | PL-21Nanomedicines – Ensuring Patient Safety through Regulatory Clarity Mike P. Isles Executive Director, European Alliance for Access to Safe Medicines (EAASM), Essex, UK |
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10:05 | PL-225-Lipoxygenase: Its Noncanonical Function Unravels its Inhibitors as Powerful Antileukemic Drugs Dieter Steinhilber1,2, Eugen Proschak2
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10:30 | Coffee Break, Exhibition and Poster Session | ||||||
Session X.Vaccine Development in Global Pandemic Time
Chairs:
Leslie Z. Benet, San Francisco, CA, USA Olavi Pelkonen, Oulu, Finland |
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11:00 | PL-23Lipopeptide Nanoparticulate Vaccine Candidates for the Induction of Protective Immune Responses István Tóth1,2,3, Mariusz Skwarczynski1
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11:25 | PL-24An Academic Approach to Vaccine Development in a Global Pandemic: A Personal Account Allegra Peletta1, Chutitorn Ketloy2, Eakachai Pompetchara2, Gerrit Borchard1
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Session XI.Biopharmaceutics, Dissolution/Drug Release
Chairs:
A. Atilla Hincal, Ankara, Turkey Lakshmanan Ramaswamy, Mumbai, India |
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11:50 | PL-25Novel Oral Finite Time Pharmacokinetics Panos Macheras Department of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece PharmaInformatics Unit, ATHENA Research Center, Athens, Greece Department of Pharmaceutical Sciences, State University of New York, Buffalo, USA |
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12:15 | PL-26The Gut in a Beaker: More Challenges for In Vitro Testing Clive G. Wilson1,2, Gavin W. Halbert1,3, Ibrahim Khadra1, Claire Dunn1
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12:40 | PL-27The Relations between Q3 Measurements, In Vitro Release and TCS Flavian Ştefan Rădulescu1, Dalia Simona Miron1, Vinod P. Shah2
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13:05 | PL-28Bioequivalence for Highly Variable Drugs and Biosimilars: Agreements, Disagreements and Harmonization László Endrényi† 1, László Tóthfalusi2
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13:30 | Lunch and Exhibition | ||||||
Session XII.Progress in (Bio)Analytical Technologies
Chairs:
Danilo Corradini, Rome, Italy Attila Felinger, Pécs, Hungary |
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14:40 | PL-29Advanced (Multi-Dimensional) Separations for Practical Applications Alina Astefanei1,2, Andrea F.G. Gargano1,2, Gino Groeneveld1,2, Bob W.J. Pirok1,2,
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15:05 | PL-30Advances in LC/MS for the Characterization and Bioanalysis of Biotherapeutics Jonathan L. Josephs1, Aaron Bailey2, Stephane Houel3
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15:30 | PL-31Confident Analytical Characterization from Drug Discovery to Development Krisztina Radi1, Kristina Srzentić2, Amy Claydon1
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15:55 | Coffee Break, Exhibition and Poster Session | ||||||
Session XIII. Biopharmaceutics
Chairs:
Shashikant D. Joag, Mumbai, India István Tóth, Brisbane, QLD, Australia |
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16:25 | PL-32ADMET in Drug Development: What is the Role of Animals between In Silico – In Vitro and In Vivo Humans? Olavi Pelkonen Research Unit of Biomedicine/Pharmacology and Toxicology, Faculty of Medicine, University of Oulu, Oulu, Finland |
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16:50 | PL-33Ionone: The Molecule That Shaped the History of Western Civilization Georg A. Petroianu College of Medicine and Health Sciences, Khalifa University, Abu Dhabi, United Arab Emirates |
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17:15 | Panel Discussion V. New Challenges in the Field of the Patient-Centric Drug Research, Biopharmaceutics, Dissolution and (Bio)Analysis
Moderators:
A. Atilla Hincal, Ankara, Turkey José A. Guimarães Morais, Lisbon, Portugal |
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Panelists: Gerrit Borchard, Geneva, Switzerland Mike P. Isles, Essex, UK Jonathan L. Josephs, Waltham, MA, USA Panos Macheras, Athens, Greece Peter J. Schoenmakers, Amsterdam, The Netherlands Dieter Steinhilber, Stockholm, Sweden Frankfurt, Germany Olavi Pelkonen, Oulu, Finland Sven Stegemann, Graz, Austria, Müllheim, Germany István Tóth, Brisbane, QLD, Australia Clive G. Wilson, Glasgow, Scotland, Belfast, Northern Ireland, UK |
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17:45 | Poster Award Ceremony
Chair of the Poster Award Committee:
Stefan Mühlebach, Basel, Switzerland Members of the Poster Award Committee:
Georg A. Petroianu, Abu Dhabi, United Arab Emirates Flavian Ştefan Rădulescu, Bucharest, Romania Peter J. Schoenmakers, Amsterdam, The Netherlands |
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18:00 | A New Book Launch | ||||||
Doctor Honoris Causa Professors of the Faculty of Pharmacy, Semmelweis University (Semmelweis Publisher, Budapest, 2020) Imre Klebovich (Editor) Department of Pharmaceutics, Semmelweis University, Budapest, Hungary |
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18:25 | Closing Ceremony | ||||||
End of Conference |


