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-1Regulatory Perspectives – Where We Came from, Where Are We Today, Where Are We Headed? Carl Peck Founder and Chairman at NDA Partners LLC., Formerly Director, Center for Drug Evaluation and Research/FDA, San Luis Obispo, CA, USA |
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| 10:35 | Keynote Address II: KN-2How Regulatory Science Can Enable WHO’s Triple Billion Objectives? Mariângela Simão Assistant Director-General, World Health Organization (WHO), Geneva, Switzerland |
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| 11:10 | Coffee Break, Exhibition and Poster Session | ||||
| Session II.Regulatory Science, Strategy in DMPK
Chairs:
Beat Flühmann, Glattbrugg, Switzerland Carl Peck, San Luis Obispo, CA, USA |
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| 11:40 | 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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| 12:05 | PL-2Drug 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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| 12:30 | PL-3Regulatory 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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| 12:55 | Panel Discussion I. A Forward-Looking Practical Consequence of Regulatory Science in General
Moderators:
Joseph W. Polli, Research Triangle Park (RTP), NC, USA Vinod P. Shah, North Potomac, MD, USA |
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| Panelists: Stefan Mühlebach, Basel, Switzerland Carl Peck, San Luis Obispo, CA, USA Mariângela Simão, Geneva, Switzerland |
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| 13:20 | Lunch and Exhibition | ||||
| Session III. Regulatory Aspects of Nanomedicine, Biological and Complex Drug and Products Chairs:
Lajos Balogh, North Andover, MD, USA Subramanian R. Vaidya, Mumbai, India |
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| 14:35 | 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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| 15:00 | PL-5Complex 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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| 15:25 | PL-6Same 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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| 15:50 | Coffee Break, Exhibition and Poster Session | ||||
| Session IV. Complexity of Nanomedicine, Nanopharmaceuticals
Chairs:
José A. Guimarães Morais, Lisbon, Portugal Romána Zelkó, Budapest, Hungary |
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| 16:20 | PL-7Nanomedicines: Previous Accomplishments and Ongoing Efforts Scott McNeil Department of Pharmaceutical Sciences, University of Basel, Switzerland |
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| 16:45 | 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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| 17:10 | Panel Discussion II. Scientific, Regulatory and Practical Considerations of Complex Drug Products, Nanopharmaceuticals and Biological Products
Moderators:
Beat Flühmann, Glattbrugg, Switzerland Jon S.B. de Vlieger, Utrecht, The Netherlands |
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| Panelists: Jens Heisterberg, Søborg, Denmark Scott McNeil, Basel, Switzerland Stefan Mühlebach, Basel, Switzerland Paolo Rocco, Milan, Italy |
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| 17:40 | End of Day 1. | ||||
Day 2
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| Session V. Drug Research, Vaccine and Bioconjugate 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 Tamás Shisha1, Péter Gergely2 1 Director, Translational Medicine Autoimmunity, Novartis Institutes of BioMedical Research, Basel, Switzerland 2 Executive director, Novartis Institutes of BioMedical Research, Basel, Switzerland |
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| 09:35 | Keynote Address IV: KN-4Vaccine Development in Global Pandemic Time Tibor Fabó Medical Director, Pfizer Biopharmaceuticals, Budapest, Hungary |
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| 10:10 | PL-9Prodrug Nano-Squalene Bioconjugate Drug Products Leslie Z. Benet1,2, Patrick Couvreur2 1Department of Bioengineering & Therapeutic Sciences, Schools of Pharmacy & Medicine, University of California San Francisco, San Francisco, CA, USA 2Université Paris-Saclay and Institut Universitaire de France, Paris, France |
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| 10:35 | Coffee Break, Exhibition and Poster Session | ||||
| Session VI. Novel Vaccine Development Strategies
Chairs:
Leslie Z. Benet, San Francisco, CA, USA Olavi Pelkonen, Oulu, Finland |
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| 11:05 | PL-10mRNA-lipid Nanoparticle COVID-19 Vaccines: Structure and Stability Daan J.A. Crommelin Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands |
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| 11:30 | PL-11An Academic Approach to Vaccine Development in a Global Pandemic: A Personal Account Allegra Peletta1, Chutitorn Ketloy2, Eakachai Pompetchara2, Gerrit Borchard1 1School of Pharmaceutical Sciences of Western Switzerland (ISPSO), University of Geneva, Geneva, Switzerland 2Chula Vaccine Research Center (Chula VRC), Faculty of Medicine and Department of Laboratory Medicine, Chulalongkorn University, Bangkok, Thailand |
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| 11:55 | PL-12Lipopeptide Nanoparticulate Vaccine Candidates for the Induction of Protective Immune Responses István Tóth1,2,3, Mariusz Skwarczynski1 1School of Chemistry and Molecular Biosciences, The University of Queensland, Brisbane, QLD, Australia 2School of Pharmacy, The University of Queensland, Brisbane, QLD, Australia 3Institute for Molecular Bioscience, The University of Queensland, Brisbane, QLD, Australia |
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| 12:20 | Panel Discussion III. New Perspectives of the Drug Research and Novel Vaccine Development Strategies Moderators:
Leslie Z. Benet, San Francisco, CA, USA István Greiner, Budapest, Hungary |
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| Panelists: Gerrit Borchard, Geneva, Switzerland Daan J.A. Crommelin, Utrecht, The Netherlands Tibor Fabó, Budapest, Hungary Joseph W. Polli, Triangle Park (RTP), NC, USA Tamás Shisha, Basel, Switzerland | |||||
| 12:45 | Lunch and Exhibition | ||||
| Session VII. Nanotechnological and Transdermal Drug Delivery Systems
Chairs:
A. Atilla Hincal, Ankara, Turkey Panos Macheras, Athens, Greece |
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| 14:00 | PL-13Supramolecular Structure and Stability of Nanofibrous Drug Delivery Systems Romána Zelkó University Pharmacy Department of Pharmacy Administration, Semmelweis University, Budapest, Hungary |
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| 14:25 | PL-14Advanced Drug Delivery Systems: From Nano- and Microparticles to Smart Pills István Antal Department of Pharmaceutics, Semmelweis University, Budapest, Hungary |
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| 14:50 | PL-15Advances in Transdermal Drug Delivery System Dange Veerapaneni Sparsha Pharma International Private Ltd, Hyderabad, India |
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| 15:15 | Coffee Break, Exhibition and Poster Session | ||||
| Session VIII. Global Harmonization of Regulations, Dissolution, Drug-Device Combination and Biosimilar Products
Chairs:
Éva Szökő, Budapest, Hungary Judit Tarnai, Budapest, Hungary |
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| 15:45 | PL-16Future 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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| 16:10 | PL-17The Relations between Q3 Measurements, In Vitro Release and TCS Flavian Ştefan Rădulescu1, Dalia Simona Miron1, Vinod P. Shah2 1Center for Drug Sciences, Faculty of Pharmacy, University of Medicine and Pharmacy Carol Davila, Bucharest, Romania 2Pharmaceutical Consultant, North Potomac, MA, USA |
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| 16:35 | PL-18Regulatory 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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| 17:00 | 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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| 17:25 | 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: István Antal, Budapest, Hungary Beat Flühmann, Glattbrugg, Switzerland Zsolt Holló, Budapest, Hungary Carl Peck, San Luis Obispo, CA, USA David R. Savello, Rochelle, VA, USA Dange Veerapaneni, Hyderabad, India Romána Zelkó, Budapest, Hungary |
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| 17:50 | End of Day 2. | ||||
Day 3
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| Session IX.Patient-Centric Drug Research, FIP Strategy
Chairs:
Henning H. Blume, Oberursel, Germany Balázs Hankó, Budapest, Hungary |
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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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| 09:35 | PL-20The Place of Science in the “One FIP Strategy” Dominique Jordan President of International Pharmaceutical Federation (FIP), The Hague, The Netherlands |
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| 10:00 | PL-215-Lipoxygenase: Its Noncanonical Function Unravels its Inhibitors as Potential Antileukemic Drugs Dieter Steinhilber1,2, Eugen Proschak2
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| 10:25 | Coffee Break, Exhibition and Poster Session | ||||
| Session X.Challenges of Drug Development from In Silico to In Vivo Biopharmaceutics
Chairs:
Milena Jadrijević-Mladar Takač, Zagreb, Croatia Vijay U. Kshirsagar, Mumbai, India |
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| 10:55 | PL-22ADMET 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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| 11:20 | PL-23The Gut in a Beaker: More Challenges for In Vitro Testing Clive G. Wilson1,2, Gavin W. Halbert1,3, Ibrahim Khadra1, Claire Dunn1 1Strathclyde Institute of Pharmacy and Biomedical Sciences, Strathclyde University, Glasgow 2ReVana Therapeutics Ltd., McClay Research Centre, Belfast, Northern Ireland, UK 3Cancer Research Formulation Laboratories, University of Strathclyde, Glasgow, Scotland, UK |
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| 11:45 | PL-24Drugs are Absorbed in Finite Time: A New Era in Biopharmaceutics and Pharmacokinetics Panos Macheras PharmaInformatics Unit, ATHENA Research Center, Athens, Greece Department of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece Department of Pharmaceutical Sciences, State University of New York, Buffalo, USA |
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| 12:10 | Panel Discussion V. New Challenges in the Field of the Patient-Centric Drug Research, Biopharmaceutics, In Vitro, In Vivo Drug Development
Moderators:
A. Atilla Hincal, Ankara, Turkey José A. Guimarães Morais, Lisbon, Portugal |
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| Panelists: Dominique Jordan, The Hague, The Netherlands Panos Macheras, Athens, Greece, Buffalo, NY, USA Olavi Pelkonen, Oulu, Finland Sven Stegemann, Graz, Austria, Müllheim, Germany Dieter Steinhilber, Frankfurt, Germany Clive G. Wilson, Glasgow, Scotland, UK, Belfast, Northern Ireland, UK |
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| 12:35 | Lunch and Exhibition | ||||
| Session XI.Progress in (Bio)Analytical Technologies
Chairs:
Danilo Corradini, Rome, Italy Attila Felinger, Pécs, Hungary |
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| 13:50 | PL-25Advanced (Multi-Dimensional) Separations for Practical Applications Alina Astefanei1,2, Andrea F.G. Gargano1,2, Gino Groeneveld1,2, Bob W.J. Pirok1,2, Peter J. Schoenmakers1,2 1van ‘t Hoff Institute for Molecular Science (HIMS), University of Amsterdam, Amsterdam, The Netherlands 2Centre of Analytical Sciences Amsterdam, Amsterdam, The Netherlands |
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| 14:15 | PL-26Advances in LC/MS for the Characterization and Bioanalysis of Biotherapeutics Jonathan L. Josephs Senior Director, Genentech, A Member of the Roche Group, San Mateo, CA, USA |
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| 14:40 | PL-27Confident Analytical Characterization from Drug Discovery to Development Krisztina Radi1, Kristina Srzentić2, Amy Claydon1
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| 15:05 | Coffee Break, Exhibition and Poster Session | ||||
| Session XII.Biopharmaceutics
Chairs:
Shashikant D. Joag, Mumbai, India István Tóth, Brisbane, QLD, Australia |
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| 15:35 | PL-28Nanomedicines – 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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| 16:00 | PL-29Ionone: 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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| 16:25 | Panel Discussion VI. Novel Bioanalytical Applications, Nanomedicines and Safety Issues
Moderators:
Scott McNeil, Basel, Switzerland Olavi Pelkonen, Oulu, Finland |
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| Panelists: Mike P. Isles, Essex, UK Krisztina Radi, Hemel Hempstead, United Kingdom, UK Peter J. Schoenmakers, Amsterdam, The Netherlands Georg A. Petroianu, Abu Dhabi, United Arab Emirates Clive G. Wilson, Glasgow, Scotland, Belfast, Northern Ireland, UK |
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| 16:50 | Poster Award Ceremony
Chair of the Poster Award Committee:
Stefan Mühlebach, Basel, Switzerland Members of the Poster Award Committee:
Gerrit Borchard, Geneva, Switzerland Georg A. Petroianu, Abu Dhabi, United Arab Emirates Peter J. Schoenmakers, Amsterdam, The Netherlands |
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| 17:05 | 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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| 17:45 | Closing Ceremony | ||||
| End of Conference |
