Preliminary scientific programme

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November 12, 2018:  Day 1

9:00 Opening – Welcome Ceremony

Session I.: EQUIVALENCE

 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

Session II.: CHALLENGES I

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
Tamás Szolyák
National Institute of Pharmacy and Nutrition, Budapest, Hungary
12:00 1st Q & A
12:30 Lunch, Exhibition

Session III.: NANOMEDICINES I

13:45 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
Frederick National Laboratory, Frederick, MD, USA
14:45 Nanomedicines in Clinical Practice, Critical Aspects to Consider
Beat Flühmann
Vifor Pharma Group, Glattbrugg, Switzerland
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
University of Geneva, School of Pharmaceutical Sciences, Geneva, Switzerland
16:15 Panel Discussion I.: Critical Quality Attributes for Complex Drugs
Moderator:

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

Panelists:

  • Henning H. Blume, Oberursel, Germany
  • Ernő Duda, Szeged, Hungary
  • Stefan Mühlebach, Glattbrugg, Basel, Switzerland
  • Scott E. McNeil, Frederick, MD, USA
  • Tamás Szolyák, Budapest, Hungary
17:45 End of Day 1

November 13, 2018:  Day 2

Session V.: BIOSIMILARS I

9:00 Biosimilars, Ever Evolving Landscape
Erik Bogsch
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

Session VI.: BIOSIMILARS II

11:00 Biosimilar Pathway: EMA Approach – Pharmacist Perspectives
Irene Krämer
University of Johannes Gutenberg, Pharmacy Department at the Medical Center, Mainz, Germany 
11:30 Clinical Evaluation and Interchangeability of Biotech Products and Biosimilars
Arnold G. Vulto
Erasmus University, Medical Center Rotterdam, Rotterdam, The Netherlands
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
12:30 2nd Q & A
12:45 Lunch, Exhibition

Session VII.: CHALLENGES II

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

Session VIII.: COMPLEXITIES OF BIOSIMILARS

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
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
University of Szeged, Szeged, Hungary
National Institute of Pharmacy and Nutrition, Budapest, Hungary
17:30 Panel Discussion II.: Moving Towards Harmonization
Moderator:

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

Panelists:

  • Beatriz da Silva Lima, Lisbon, Portugal     
  • Tamás L. Paál, Budapest, Hungary
  • Tamás Szolyák, Budapest, Hungary
18:00 End of Day 2

November 14, 2018:  Day 3

Session X.: NANOMEDICINES II

9:00 Complexities Involved with Liposome Formulations
Daan J.A. Crommelin
Utrecht University, Department of Pharmaceutics, Department of Pharmaceutical Sciences, 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, 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
Moderator
:

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

Panelists:

  • Sesha Neervannan, Irvine, CA, USA
  • Scott E. McNeil, Frederick, MD, USA
12:30 Lunch, Exhibition

Session XI.:  BIOEQUIVALENCE, Dissolution

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
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
14:45 Bioequivalence Studies and Evaluations for DPI Drug Products: Regulatory Authorities Challenges
A. Atilla Hincal
Hacettepe University, Department of Pharmaceutical Technology, Ankara, Turkey
15:15 Coffee break, Exhibition and Poster Session

Session XII.: PROGRESS IN ANALYTICAL TECHNOLOGIES

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
16:15 Characterization of Complex Drug Molecules
Speaker to be identified
 16:45 Characterization of Proteins
Speaker to be identified
 17:00  Poster Awards Ceremony, Closing Remarks