Preliminary Programme

Day 1
Tuesday, 17 March 2020

09:00 Opening – Welcome Ceremony
Session I.
Regulatory Sciences
10:00 Keynote Address I:
Regulatory Perspectives – Where We Came from, Where Are We Today and Where Are We Headed?
Carl Peck
Founder and Chairman at NDA Partners LLC., San Luis, CA, USA
10:40 Regulatory Science in Drug Development
Vinod P. Shah
Pharmaceutical Consultant, North Potomac, MD, USA
Member of NBCD-Working Group, North Potomac, MD, USA
11:05 Coffee Break, Exhibition and Poster Session
Session II.
Nanomedicine and Complex Drugs
11:35 Where to Go with Nano?
Daan J.A. Crommelin
Department of Pharmaceutical Sciences, Utrecht University,
Utrecht, The Netherlands
12:00 Complex 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
12:25 1st Questions and Answers (Q and A)
12:55 Lunch and Exhibition
  Session III.
Regulatory Aspects of Nanomedicine Products
14:10 Are Synthetic Follow-Ons of Biotech Products Generics? Implications for Interchangeability?
David Truloff
Novo Nordisk, Copenhagen, Denmark
14:35 Same Product Different Regulatory Approaches Around the World; Glatiramer Acetate
15:00 NBCD: Regulatory Science in Motion. Where We Are and Where We Are Going
Marisa Papaluca Amati
Regulatory Science Expert, London, UK
15:25 Coffee Break, Exhibition and Poster Session
Session IV.
Complexity of Nanomedicine, Nanopharmaceuticals, Pharmacovigilance
15:55 How to Deal with Complexity of Nanomedicine in Practice
Stefan Mühlebach
Department of Pharmaceutical Sciences, Unit of Clinical Pharmacy and Epidemiology, University of Basel, Switzerland
16:20 Pharmacovigilance of Complex Drugs; Traceability of Biologics and Implications for Other Complex Products
Kevin Klein
Foundation Lygature, Utrecht, The Netherlands
16:45 Panel Discussion I.
How Can We Prepare for a Wave of New Complex Drug Products to Come? Scientific, Regulatory and Practical Considerations
17:15 End of Day 1.

Day 2
Wednesday, 18 March 2020

Session V.
Drug Research and Development Strategies 
09:00 Keynote Address II:
Industry Perspectives  
09:40 Drug Development Strategy in United States
Joseph W. Polli
President of American Association of Pharmaceutical Scientists (AAPS), Arlington, VA, USA
ViiV Healthcare, Research Triangle Park (RTP), NC, USA
10:05 Regulatory Science Challenges – Encourage Innovation Through an Adaptive Regulatory System
Krisztián Fodor
Gedeon Richter Plc., Budapest, Hungary
10:30 Coffee Break, Exhibition and Poster Session
Session VI.
Drug-Device Combination Products
11:00 Regulatory Pathway for Drug-Device Combination Products in US
David R. Savello
NDA Partners LLC, Palo Alto, CA, USA
11:25 The Practical Consequences of the New Medical Device Combination Products
11:50 Industry – Case Studies
2nd Questions and Answers (Q and A)
Lunch and Exhibition
Session VII.
Advances in Drug Delivery System 
14:00 Peptides and Vaccines Delivery Systems
István Tóth
School of Chemistry & Molecular Biosciences, University of Queensland, Brisbane, QLD, Australia
14:25 Supramolecular Structure and Stability of Nanofibrous Drug Delivery Systems
Romána Zelkó
University Pharmacy Department of Pharmacy Administration, Semmelweis University, Budapest, Hungary
14:50 Advanced Drug Delivery Systems: From Nano-and Microparticles to Smart Pills
István Antal
Department of Pharmaceutics, Semmelweis University, Budapest, Hungary
15:15 Advances in Transdermal Drug Delivery System
Dange Veerapaneni
Sparsha Pharma International Private Ltd, Hyderabad, India
15:40 Coffee Break, Exhibition and Poster Session
Session VIII.
Global Harmonization of Regulations
16:10 Future of the Hungarian Drug Market – Role of the Hungarian Regulatory Authority
Mátyás Szentiványi
National Institute of Pharmacy and Nutrition, Budapest, Hungary
16:35 Global Biosimilar Drug Development: Any Chance for Consolidation after 15 Years of Positive Regulatory Experience?
Zsolt Holló
Egis Pharmaceuticals Plc, Budapest, Hungary
17:00 Innovative Submissions vs Global Regulatory Guidelines (ICH, WHO)
Tamás L. Paál
National Institute of Pharmacy and Nutrition, Budapest, Hungary
Faculty of Pharmacy, University of Szeged, Szeged, Hungary
17:25 Panel Discussion II.
Global Harmonization of Regulations – Dream or Reality
17:55 End of Day 2.

Day 3
Thursday, 19 March 2020

Session IX.
Patient-centric Drug Research
09:00 Keynote address III:
Merging Science and Patient in Future Drug Development to Enhance Safety and Effectiveness
Sven Stegemann
Graz University of Technology, Graz, Austria
09:40 Nanomedicines: Patient and Pharmacy Perspectives
Mike Isles
European Alliance for Access to Safe Medicines (EAASM), Essex, UK
10:05 The Picture of the World Vaccination
10:30 5-Lipoxygenase: Its Noncanonical Function Unravels its Inhibitors as Powerful Antileukemic Drugs
Dieter Steinhilber
President of European Federation for Pharmaceutical Sciences (EUFEPS), Stockholm, Sweden
Institute for Pharmaceutical Chemistry, University of Frankfurt, Frankfurt, Germany
10:55 Coffee Break, Exhibition and Poster Session
Session X.
Biopharmaceutics, Dissolution/Drug Release
11:25 ADMET in Drug Development: What Is the Role of Animals Between In SilicoIn Vitro and In Vivo Humans?
Olavi Pelkonen
Department of Pharmacology and Toxicology, University of Oulu,
Oulu, Finland
11:50 Back to the Basics: Reconsidering the Assumptions of Drug Dissolution, Release and Pharmacokinetics
Panos Macheras
Department of Pharmacy, National and Kapodistrian University of
Athens, Athens, Greece
12:15 The Gut in a Beaker: More Challenges for In Vitro Testing
Clive G. Wilson
Strathclyde University, Glasgow, Scotland, UK
ReVana Therapeutics Ltd., Belfast, Northern Ireland
12:40 The Relations Between Q3 Measurements, In Vitro Release and TCS
Flavian Ştefan Rădulescu
Center for Drug Sciences, Faculty of Pharmacy, University of Medicine and Pharmacy Carol Davila, Bucharest, Romania
13:05 Bioequivalence for Highly Variable Drugs: Agreements, Disagreements and Harmonization
László Endrényi 1, László Tóthfalusi 2
1 Department of Pharmacology and Toxicology, University of Toronto, Toronto, ON, Canada
2 Department of Pharmacodynamics, Semmelweis University, Budapest, Hungary
13:30 Lunch and Exhibition
Session XI.
Progress in (Bio)Analytical Technologies
14:45 Advanced (Multi-Dimensional) Separations for Practical Applications
Peter Schoenmakers
van ‘t Hoff Institute for Molecular Science (HIMS),
University of Amsterdam, Amsterdam, The Netherlands
15:10 Analytical Fingerprint-like Similarity: The Foundation for Approval of Biosimilars
15:35 Analytical Toolbox for Proteins: Moving to Full Characterisation
16:00 Advanced LC/MS Technologies for the Characterisation and Monitoring of Complex Biotherapeutics
16:25 Coffee Break, Exhibition and Poster Session
16:55 Poster Award Ceremony
17:10 A New Book Launch
Doctor Honoris Causa Professors of Faculty of Pharmacy,
Semmelweis University
(Semmelweis Publishing House, Budapest, 2020)
Imre Klebovich (Editor)
Department of Pharmaceutics, Semmelweis University, Budapest, Hungary
17:35 Closing Ceremony
End of Conference