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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 Krisztián Fodor 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 | Nanomedicines: 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 Nanotechnology Characterization Laboratory, Leidos Biomedical Research Inc., 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 Member of NBCD Working Group, Utrecht, The Netherlands |
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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 School of Pharmaceutical Sciences Geneva-Lausanne, University of Geneva, University of Lausanne, Switzerland |
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| 16:15 | Panel Discussion I.: Critical Quality Attributes for Complex Drugs Moderators:
Panelists:
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| 17:15 | End of Day 1 | |
| 18:00 | Welcome Reception | |
November 13, 2018: Day 2
Session V.: BIOSIMILARS I |
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| 9:00 | Biosimilars, Ever Evolving Landscape Erik Bogsch Biotechnology Business Unit – R&D and Manufacturing, 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, University Medical Center, Mainz, Germany |
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| 11:30 | The Interchangeability of Biotech Products: Issues to Consider Now and Further Into our ’OMICS’ Future Robert D. Sindelar Faculty of Pharmaceutical Sciences, University of British Columbia, Centre for Health Care Research Institute and UBC, Vancouver, BC, Canada Global Drug Commercialization Centre, China |
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| 12:00 | Controversies on the Switching and Substitution of Biological and Non-Biological Complex Drug 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 University Pharmacy Department of Pharmacy Administration, Semmelweis University, Budapest, Hungary |
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| 14:30 | Strategies in Developing a Transdermal Dosage Form Sravani Vadladi, Takeshi Ito, Dange Veerapaneni Sparsha Pharma International Pvt. Ltd., Hyderabad, Telangana, India |
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| 15:00 | In Vitro Release and Q3 Measurements for Topical drugs Flavian Stefan Rădulescu, Dalia Simona Miron Center for Drug Sciences, Faculty of Pharmacy, University of Medicine and Pharmacy Carol Davila, Bucharest, Romania |
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| 15:30 | Coffee Break, Exhibition and Poster Session | |
Session VIII.: COMPLEXITIES OF BIOSIMILARS, Bioanalytics |
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| 16:00 | Advances in the Analysis of Originator and Biosimilar Protein Therapeutics Pat J. Sandra, Johan Vandenbussche, Isabel Vandenheede, Mieke Steenbeke, Emmie Dumont, Gerd Vanhoenacker, Koen Sandra 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 National Institute of Pharmacy and Nutrition, Budapest, Hungary Faculty of Pharmacy, University of Szeged, Szeged, Hungary |
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| 17:30 | Panel Discussion II.: Moving Towards Harmonization Moderators:
Panelists:
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| 18:00 | End of Day 2 | |
| 19:00 | Concert and Banquet Dinner |
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November 14, 2018: Day 3
Session X.: NANOMEDICINES II |
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| 9:00 | Complexities Involved in Liposome Formulations Daan J.A. Crommelin Department of Pharmaceutical Sciences, Utrecht University, 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, Faculty of Farmacy, 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 Moderators:
Panelists:
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| 12:00 | Lunch, Exhibition | |
Session XI.: Dissolution, BIOEQUIVALENCE |
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| 13:15 | Application of In Vitro Dissolution Studies to Evaluate Drug Interaction Imre Klebovich1, Dávid Virág1, István Antal1, Vinod P. Shah2 1Department of Pharmaceutics, Semmelweis University, Budapest, Hungary 2Pharmaceutical Consultant, North Potomac, MD, USA |
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| 13:45 | A Reaction-Limited In Vivo Dissolution Model for the Study of Drug Absorption: Implications for the Biopharmaceutic Classification of Drugs Panos Macheras1,2 1Laboratory of Biopharmaceutics-Pharmacokinetics, Department of Pharmacy, School of Health Sciences, National and Kapodistrian University of Athens, Athens, Greece 2Pharmainformatics Unit ”Athena” Research and Innovation Center, Athens, Greece |
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| 14:15 | Bioequivalence Studies and Evaluations for DPI Drug Products: Regulatory Authorities Challenges A. Atilla Hincal1,3, Cemre Özseven1,2, Pellin Yargan-Atak1 1IDE Pharmaceutical Consultancy on Registration and Biopharmaceutics CRO Services Ltd., Kavaklidere, Ankara, Turkey 2Ankara University Pharmacy Faculty, Ankara, Turkey 3Hacettepe University, Department of Pharmaceutical Technology, Hacettepe, Ankara, Turkey |
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| 14:45 | Coffee break, Exhibition and Poster Session | |
Session XII.: PROGRESS IN ANALYTICAL TECHNOLOGIES |
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| 15:15 | Advances in Bioanalytical Mass Spectrometry in Support of Drug Therapies László Prókai Department of Pharmacology and Neuroscience, Institute of Healthy Aging, University of North Texas, Health Science Center, Fort Worth, TX, USA |
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| 15:45 | Micro-Flow Imaging as Analytical Tool in Pharmaceutical Development of Microparticulate Complex Drugs Miranda M.C. van Beers Dr. Reddy’s Research & Development B.V., Leiden, The Netherlands |
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| 16:15 | Advanced LC/MS Technologies for the Characterization and Monitoring of Complex Biotherapeutics Jonathan L. Josephs, Aaron O. Bailey, Stephane Houel, Terry Zhang, Haichuan Liu, Michael Blank Thermo Fisher Scientific, San Jose, CA, USA |
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| 16:45 | 3rd Q & A | |
| 17:15 | Poster Awards Ceremony | |
| 17:30 | Closing Remarks Béla Merkely, Imre Klebovich, Vinod P. Shah, Stefan Mühlebach |
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