Final scientific programme

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November 12, 2018: Day 1

9:00 Opening – Welcome Ceremony


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
10:00 Landscape of Complex Drugs
Jon S.B. de Vlieger
Lygature, Member of NBCD Working Group, Utrecht, The Netherlands
10:30 Coffee Break, Exhibition and Poster Session


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
11:30 Challenges in Bringing Scientific Innovations into the Market
Krisztián Fodor
National Institute of Pharmacy and Nutrition, Budapest, Hungary
12:00 1st Q & A
12:30 Lunch, Exhibition


13:45 Nanomedicines: Bioequivalence Decision Based on Biodistribution
Beatriz da Silva Lima
University of Lisbon, Department of Pharmacological Sciences, Lisbon, Portugal
14:15 Nanomedicine Characterization: The Spectrum of Complexity
Scott E. McNeil
Nanotechnology Characterization Laboratory, Leidos Biomedical Research Inc., Frederick National Laboratory, Frederick, MD, USA
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
15:15 Coffee Break, Exhibition and Poster Session

Session IV.: Complexity of nanoparticles

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
16:15 Panel Discussion I.: Critical Quality Attributes for Complex Drugs

  • Daan J. A. Crommelin, Utrecht, The Netherlands
  • Beat Flühmann, Glattbrugg, Switzerland


  • Henning H. Blume,Oberursel, Germany
  • Stefan Mühlebach,Glattbrugg, Basel, Switzerland
  • Scott E. McNeil, Frederick, MD, USA
  • Krisztián Fodor, Budapest, Hungary
17:15 End of Day 1
18:00 Welcome Reception

November 13, 2018: Day 2


9:00 Biosimilars, Ever Evolving Landscape
Erik Bogsch
Biotechnology Business Unit – R&D and Manufacturing, Gedeon Richter Plc., Budapest, Hungary
9:30 Biosimilar Pathway: US Approach
Vinod P. Shah
Pharmaceutical Consultant, North Potomac, MD, USA
Member of NBCD Working Group, North Potomac, MD, USA
10:00 Opportunities and Challenges in Developing Biosimilar Products
Zsolt Holló
EGIS Pharmaceutical Ltd., Budapest, Hungary
10:30 Coffee Break, Exhibition and Poster Session


11:00 Biosimilar Pathway: EMA Approach – Pharmacist Perspectives
Irene Krämer
University of Johannes Gutenberg, University Medical Center, Mainz, Germany 
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
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
12:30 2nd Q & A
12:45 Lunch, Exhibition


14:00 Drug-Loaded Micro-and Nano Fibrous System as Enabling Formulations
Romána Zelkó
University Pharmacy Department of Pharmacy Administration, Semmelweis University, Budapest, Hungary
14:30 Strategies in Developing a Transdermal Dosage Form
Sravani Vadladi, Takeshi Ito, Dange Veerapaneni
Sparsha Pharma International Pvt. Ltd., Hyderabad, Telangana, India
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
15:30 Coffee Break, Exhibition and Poster Session


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
16:30 Glycosylation Aspects of Biosimilarity
András Guttman
The Sciex Research Laboratory, Brea, CA, USA

Session IX.: Regulatory Harmonization

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
17:30 Panel Discussion II.: Moving Towards Harmonization

  • Henning H. Blume, Oberursel, Germany
  • Vinod P. Shah, North Potomac, MD, USA


  • Beatriz da Silva Lima, Lisbon, Portugal
  • Tamás L. Paál, Budapest, Hungary
  • Krisztián Fodor, Budapest, Hungary
18:00 End of Day 2
19:00 Concert and Banquet Dinner

November 14, 2018: Day 3


9:00 Complexities Involved in Liposome Formulations
Daan J.A. Crommelin
Department of Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands
9:30 Bioequivalence of Liposomal Parenterals: Nice-to-Know vs. Need-to-Know
Henning H. Blume
SocraTec C&S Ltd., Oberursel, Germany
10:00 Application of Nanotechnology to Targeted and Innovative Therapies
Erem Bilensoy
Hacettepe University, Faculty of Farmacy, Department of Pharmaceutical Technology, Ankara, Turkey
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

  • Stefan Mühlebach, Glattbrugg, Basel, Switzerland
  • Jon S.B. de Vlieger, Utrecht, The Netherlands


  • Sesha Neervannan, Irvine, CA, USA
  • Scott E. McNeil, Frederick, MD, USA
12:00 Lunch, Exhibition

Session XI.:  Dissolution, BIOEQUIVALENCE

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
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
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
14:45 Coffee break, Exhibition and Poster Session


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
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
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
16:45 3rd Q & A
17:15 Poster Awards Ceremony
17:30 Closing Remarks
Béla Merkely, Imre Klebovich, Vinod P. Shah, Stefan Mühlebach