November 12, 2018: Day 1
| 9:00 | Opening – Welcome Ceremony | |
Session I.: EQUIVALENCE |
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| 9:30 | What is Equivalence as it Applies to Drug Products Vinod P. Shah Pharmaceutical Consultant, North Potomac, MD, USA Member of NBCD Working Group, North Potomac, MD, USA |
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| 10:00 | Landscape of Complex Drugs Jon S.B. de Vlieger Lygature, Member of NBCD Working Group, Utrecht, The Netherlands |
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| 10:30 | Coffee Break, Exhibition and Poster Session | |
Session II.: CHALLENGES I |
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| 11:00 | Scientific Challenges in Biosimilar and Non-Biological Complex Drugs Similars Stefan Mühlebach Vifor Pharma Group, Glattbrugg, Switzerland University of Basel, Department of Pharmaceutical Sciences, Basel, Switzerland Chair of NBCD Working Group, Utrecht, The Netherlands |
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| 11:30 | Challenges in Bringing Scientific Innovations Into the Market Tamás Szolyák National Institute of Pharmacy and Nutrition, Budapest, Hungary |
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| 12:00 | 1st Q & A | |
| 12:30 | Lunch, Exhibition | |
Session III.: NANOMEDICINES I |
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| 13:45 | Bioequivalence Decision Based on Biodistribution Beatriz da Silva Lima University of Lisbon, Department of Pharmacological Sciences, Lisbon, Portugal |
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| 14:15 | Nanomedicine Characterization: The Spectrum of Complexity Scott E. McNeil Frederick National Laboratory, Frederick, MD, USA |
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| 14:45 | Nanomedicines in Clinical Practice, Critical Aspects to Consider Beat Flühmann Vifor Pharma Group, Glattbrugg, Switzerland |
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| 15:15 | Coffee Break, Exhibition and Poster Session | |
Session IV.: Complexity of nanoparticles |
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| 15:45 | Complexity of Iron Carbohydrate Preparations and Their Evaluation Gerrit Borchard University of Geneva, School of Pharmaceutical Sciences, Geneva, Switzerland |
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| 16:15 | Panel Discussion I.: Critical Quality Attributes for Complex Drugs Moderator:
Panelists:
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| 17:45 | End of Day 1 | |
November 13, 2018: Day 2
Session V.: BIOSIMILARS I |
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| 9:00 | Biosimilars, Ever Evolving Landscape Erik Bogsch Gedeon Richter Plc., Budapest, Hungary |
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| 9:30 | Biosimilar Pathway: US Approach Vinod P. Shah Pharmaceutical Consultant, North Potomac, MD, USA Member of NBCD Working Group, North Potomac, MD, USA |
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| 10:00 | Opportunities and Challenges in Developing Biosimilar Products Zsolt Holló EGIS Pharmaceutical Ltd., Budapest, Hungary |
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| 10:30 | Coffee Break, Exhibition and Poster Session | |
Session VI.: BIOSIMILARS II |
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| 11:00 | Biosimilar Pathway: EMA Approach – Pharmacist Perspectives Irene Krämer University of Johannes Gutenberg, Pharmacy Department at the Medical Center, Mainz, Germany |
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| 11:30 | Clinical Evaluation and Interchangeability of Biotech Products and Biosimilars Arnold G. Vulto Erasmus University, Medical Center Rotterdam, Rotterdam, The Netherlands |
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| 12:00 | Controversies on the Switching and Substitution of Biological and Non-Biological Complex Products László Endrényi1, László Tóthfalusi2 1University of Toronto, Department of Pharmacology and Toxicology, Toronto, ON, Canada 2Semmelweis University, Department of Pharmacodynamics, Budapest, Hungary |
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| 12:30 | 2nd Q & A | |
| 12:45 | Lunch, Exhibition | |
Session VII.: CHALLENGES II |
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| 14:00 | Drug-Loaded Micro-and Nano Fibrous System as Enabling Formulations Romána Zelkó Semmelweis University, University Pharmacy Department of Pharmacy Administration, Budapest, Hungary |
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| 14:30 | Strategies in Developing a Transdermal Dosage Form Dange Veerapaneni Sparsha Pharma International Pvt. Ltd., Hyderabad, India |
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| 15:00 | In Vitro Release and Q3 Measurements for Topical drugs Flavian S. Radulescu University of Medicine and Pharmacy ”Carol Davila”, Department of Biopharmaceutics, Bucharest, Romania |
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| 15:30 | Coffee Break, Exhibition and Poster Session | |
Session VIII.: COMPLEXITIES OF BIOSIMILARS |
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| 16:00 | Advances in the Analysis of Originator and Biosimilar Protein Therapeutics Pat J. Sandra Ghent University, Department of Organic Chemistry, Gent, Belgium Research Institute for Chromatography, Kortrijk, Belgium |
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| 16:30 | Glycosylation Aspects of Biosimilarity András Guttman The Sciex Research Laboratory, Brea, CA, USA |
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Session IX.: Regulatory Harmonization |
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| 17:00 | Is there a Possibility of Regulatory Harmonization? Tamás L. Paál University of Szeged, Szeged, Hungary National Institute of Pharmacy and Nutrition, Budapest, Hungary |
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| 17:30 | Panel Discussion II.: Moving Towards Harmonization Moderator:
Panelists:
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| 18:00 | End of Day 2 | |
November 14, 2018: Day 3
Session X.: NANOMEDICINES II |
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| 9:00 | Complexities Involved with Liposome Formulations Daan J.A. Crommelin Utrecht University, Department of Pharmaceutics, Department of Pharmaceutical Sciences, Utrecht, The Netherlands |
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| 9:30 | Bioequivalence of Liposomal Parenterals: Nice-to-Know vs. Need-to-Know Henning H. Blume SocraTec C&S Ltd., Oberursel, Germany |
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| 10:00 | Application of Nanotechnology to Targeted and Innovative Therapies Erem Bilensoy Hacettepe University, Department of Pharmaceutical Technology, Ankara, Turkey |
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| 10:30 | Coffee Break, Exhibition and Poster Session | |
| 11:00 | Panel Discussion III.: United States Government Accountability Office (GAO) Report and Draft Guidance on Drug Products, Including Biological Products that Contain Nanomaterials, December 2017 Moderator:
Panelists:
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| 12:30 | Lunch, Exhibition | |
Session XI.: BIOEQUIVALENCE, Dissolution |
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| 13:45 | The Gut in the Beaker: What Matters in Simulated Media Clive G. Wilson University of Strathclyde, Strathclyde Institute of Pharmacy & Biomedical Sciences, Glasgow, Scotland, UK |
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| 14:15 | A Reaction-Limited In Vivo Dissolution Model for the Study of Drug Absorption: Implications for the Biopharmaceutic Classification of Drugs Panos Macheras National and Kapodistrian University of Athens, Department of Pharmacy, Athens, Greece |
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| 14:45 | Bioequivalence Studies and Evaluations for DPI Drug Products: Regulatory Authorities Challenges A. Atilla Hincal Hacettepe University, Department of Pharmaceutical Technology, Ankara, Turkey |
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| 15:15 | Coffee break, Exhibition and Poster Session | |
Session XII.: PROGRESS IN ANALYTICAL TECHNOLOGIES |
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| 15:45 | Advances in Bioanalytical Mass Spectrometry in Support of Drug Therapies László Prókai University of North Texas, Health Science Center, Fort Worth, TX, USA |
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| 16:15 | Characterization of Complex Drug Molecules Speaker to be identified |
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| 16:45 | Characterization of Proteins Speaker to be identified |
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| 17:00 | Poster Awards Ceremony, Closing Remarks | |