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Organizers

Deadlines

March 20, 2014

Early registration

April 10, 2014

Hotel reservation

April 10, 2014

Cancellation without penalty

Platinum sponsors

Akkreditált Továbbképzési Kreditpont szerzési lehetőség:

A Semmelweis Egyetem Továbbképzési Központja gyógyszerészek és orvosok részére a GYOFTEX és OFTEX Portálokon akkreditálta a BEW 2014 Workshop-ot az alábbi kódokkal:
SE-GYTK/2014.I./00027,
illetve SE-TK/2014.I./00432.

Megszerezhető: „Minősített szabadon választható" típusú továbbképzési pontszám 25.

Továbbképzési pont igazolás kérése a Regisztrációs Asztalnál!

Final scientific program

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The Workshop starts on Monday at 9:00 am., May 19, 2014
9:00	Opening Welcome Imre Klebovich Co-Chair of the Workshop Co-Chair of the Committee on Pharmaceutical Sciences Chair of Working Committee on Separation Sciences of the Hungarian Academy of Sciences (MTA) Budapest, Hungary Ágoston Szél Rector of Semmelweis University Budapest, Hungary Sabine Kopp World Health Organization (WHO) Geneva, Switzerland Hilda Kőszegi-Szalai GYEMSZI - National Institute of Pharmacy, Deputy Director General Budapest, Hungary Roger L. Williams Former CEO and Chair, Council of Experts, United States Pharmacopeial Convention (USP) Rockville, MD, USA Leslie Z. Benet Founder President of the American Association of Pharmaceutical Scientist (AAPS) San Francisco, CA, USA Clive G. Wilson Past-President of the European Federation for Pharmaceutical Scientists (EUFEPS) Glasgow, Scotland, UK Vinod P. Shah Co-Chair of the Workshop International Pharmaceutical Federation/SIG, Chair of Regulatory Sciences (FIP) Former President of the American Association of Pharmaceutical Scientist (AAPS) North Potomac, MD, USA
Session 1: Regulatory Perspectives Chairs: Stefan Mühlebach (Glattbrugg, Basel, Switzerland), K. Wayne Riggs (Vancouver, BC, Canada)
9:30	Hurdles and Challenges in Harmonising Drug Regulations Tamás L. Paál University of Szeged, Szeged, Hungary GYEMSZI-National Institute of Pharmacy, Budapest, Hungary
10:00	Basic Concepts: They Keep Changing Leslie Z. Benet University of California, San Francisco, CA, USA
10:30	Coffee Break, Exhibition
Session 2: Regulator Perspectives: Quality and Bioequivalence Chairs: Tamás Paál (Szeged, Budapest, Hungary), Romána Zelkó (Budapest, Hungary)
11:00	FDA Perspective on Product Quality and Bioequivalence Vinod P. Shah International Pharmaceutical Federation / SIG Chair of Regulatory Sciences, North Potomac, MD, USA
11:30	WHO Perspectives on Quality Assurance and Medicinal Safety Sabine Kopp World Health Organization, WHO, Geneva, Switzerland
12:00	Newer Considerations and Regulatory Guidance on BE - EMA Perspective Evangelos Kotzagiorgis European Medicines Agency, EMA, London, UK
12:30	Panel Discussion I. - Q & A Moderators: Gordon L. Amidon (Ann Arbor, MI, USA), Roger L. Williams (Rockville, MD, USA)
13:00	Lunch, Exhibition
Session 3: Advances in Pharmacokinetics Chairs: Surendra K. Bansal (New York, NY, USA), Meir Bialer (Jerusalem, Israel)
14:00	Impact of Bioequivalence Studies on the Progresses of Pharmaceutical Sciences in Generic Industry Within Last 35 Years Impact of Bioequivalence Studies on Scientific Development of Generic Pharma Industry A. Atilla Hincal IDE Pharmaceutical Consultation Ltd. Co., Ankara, Turkey
14:30	Advances in Pharmacokinetics Related EMA Regulations José A. G. Morais University of Lisbon, Lisbon, Portugal
15:00	Oral Drug Absorption: Science and Regulation Panos Macheras National and Kapodistrian University of Athens, Athens, Greece
15:30	Coffee Break, Exhibition
Session 4: Drug and Food Interactions Chairs: László Endrényi (Toronto, ON, Canada), Peep Veski (Tartu, Estonia)
16:00	Drug Interactions - Alcohol, Smoking and Caffeine Imre Klebovich Semmelweis University, Budapest, Hungary
16:30	*Application of an In Vitro* Lipolysis Model to Predict Positive Food Effect James E. Polli** University of Maryland, Baltimore, MD, USA
17:00	Panel Discussion II. - Q & A Moderators: Sabine Kopp (Geneva, Switzerland), Vinod P. Shah (North Potomac, MD, USA)
Social Programs
19:00	Concert of the Semmelweis Chamber Orchestra in the Matthias Church, Conductor László Tardy 1014 Budapest, Szentháromság Square 2. Entry by badge and invitation card only.
20:30	Banquet Dinner in the Hungarian National Gallery Royal Palace of Buda, Building C., 1014 Budapest, Szent György Square 2. Entry by badge and invitation card only. Welcome Addresses by: Ferenc Joó President of Section of Chemical Sciences of the Hungarian Academy of Sciences (MTA) Éva Szökő President of the Hungarian Society for Pharmaceutical Sciences (HSPS) László Vécsei President of the Section of Medical Sciences of the Hungarian Academy of Sciences (MTA) Vinod P. Shah and Imre Klebovich Co-Chairs of the Workshop The Performers of the Evening: Botafogo Dance Ensemble Jenő Esze's Dance and Salon Music Band Event Sponsor:

Day 2 - Tuesday, May 20, 2014
Session 5: BCS, Dissolution and Biowaiver Chairs: Olavi Pelkonen (Oulu, Finland), István Tóth (Saint Lucia, Qld, Australia)
9:00	Role of Dissolution in Regulating Pharmaceutical Products Vinod P. Shah International Pharmaceutical Federation / SIG Chair of Regulatory Sciences, North Potomac, MD, USA
9:30	BCS and Beyond: Limitations and Harmonization (The New Science of BE) Gordon L. Amidon University of Michigan, Ann Arbor, MI, USA
10:00	Exploiting BDDCS and the Role of Transporters Leslie Z. Benet University of California, San Francisco, CA, USA
10:30	Coffee Break, Exhibition
Session 6: Advances in Dissolution Chairs: Evangelos Kotzagiorgis (London, UK), Constantin Mircioiu (Bucharest, Romania)
11:00	Advances in IVIVC James E. Polli University of Maryland, Baltimore, MD, USA
11:30	Bioperformance Dissolution Standards: In Vivo Predictive Dissolution (IPD) Gordon L. Amidon University of Michigan, Ann Arbor, MI, USA
12:00	Panel Discussion III. - Q & A Moderators: Daaj J. A. Crommelin (Utrecht, The Netherlands), Clive G. Wilson (Glasgow, Scotland, UK)
12:30	Lunch, Exhibition
Session 7: Regulatory Trends in Bioanalysis Chairs: Hilda Kőszegi-Szalai (Budapest, Hungary), José A.G. Morais (Lisbon, Portugal)
13:30	Bioanalytical Method Validation and Samples Analysis - Lessons Learned from Regulatory Inspections Surendra K. Bansal F. Hoffmann-La Roche Inc., New York, NY, USA
14:00	Where Are We with Respect to Global Harmonization in Bioanalytical Methods Validation? Daniel Tang ICON Development Solutions, APAC, Shanghai, China
14:30	Analytical Aspects of Biologics Applied in Pharmaceutical Development Felix Heise, Hanns-Christian Mahler F. Hoffmann-La Roche Ltd., Basel, Switzerland
15:00	Challenges in Using Capillary Electrophoresis in Analyzing Therapeutic Proteins Jim Thorn AB SCIEX Separations Ltd., Warrington, UK
15:30	Coffee Break, Exhibition
Session 8: Biosimilars and Complex Drug Products Chairs: István Greiner (Budapest, Hungary), Milena Jadriević-Mladar Takač (Zagreb, Croatia)
16:00	Biosimilars: Status Regulatory Pathways and Remaining Questions Daan J. A. Crommelin Utrecht University, Utrecht, The Netherlands
16:30	Interchangeability: A Challenge for Non-Biological Complex Drugs Stefan Mühlebach Vifor Pharma Ltd., Glattbrugg, Switzerland University of Basel, Basel, Switzerland
17:00	Assessment of the Similarity and Interchangeability of Biological Drug Products (NBCDs) László Endrényi, László Tóthfalusi* University of Toronto, Toronto, ON, Canada *Semmelweis University, Budapest, Hungary
17:30	Panel Discussion IV. - Q & A Moderators: Nicholas M. Fleischer (Washington, DC, USA), Sven Stegemann (Bornem, Belgium)
Social Programs
19:30	Concert of the Dohnányi Orchestra Budafok in the Liszt Ferenc Academy of Music, Conductor Gábor Hollerung 1061 Budapest, Liszt Ferenc Square 8. After the Concert: Coctail Reception in the Liszt Ferenc Academy of Music, 1st floor Entry by badge and invitation card only. The Sponsor of the Concert:
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Day 3 - Wednesday, May 21, 2014
Session 9: Looking into the Future Chairs: István Antal (Budapest, Hungary), Atilla Hincal (Ankara, Turkey)
9:00	Reducing Regulatory Burden for Well Established Drugs Roger L. Williams US Pharmacopeia, Rockville, MD, USA
9:30	New Challenges but Rewarding Opportunities in Translating Pharmaceutical Development Projects into Successful Therapeutics Imre G. Bajusz Novartis Pharmaceuticals Ltd., Basel, Switzerland
10:00	Challenges of the Biosimilars – A Perspective István Greiner Gedeon Richter Plc., Budapest, Hungary
10:30	Coffee Break, Exhibition
Session 10: Looking into the Future: New Trends? Chairs: Imre G. Bajusz (Basel, Switzerland), Irene Krämer (Mainz, Germany)
11:00	The Me-Too Paradigm - a Threat for Pharmaceutical Progress? Roadmap Towards a New Quality Target Product Profile (QTPP) for Enhanced Therapeutic Entities Sven Stegemann Capsugel, Bornem, Belgium
11:30	505(b)(2) New Drug Application Pathway vs. Abbreviated New Drug Application Pathway for Drug Approval in the US Nicholas M. Fleischer The Weinberg Group Inc., Washington, DC, USA
12:00	Modified Release Products: It's Time for International Harmonisation Henning H. Blume SocraTec R&D Ltd., Oberursel, Germany
12:30	Panel Discussion V. - Q & A Moderators: Leslie Z. Benet (San Francisco, CA, USA), Panos Macheras (Athens, Greece)
13:00	Lunch, Exhibition
Session 11: Looking into the Future: Biopharmaceutical Aspects Chairs: Mitsuru Hashida (Kyoto, Japan), Arto Urtti (Helsinki, Kuopio, Finland)
14:00	Dosage Form Attributes and Biopharmaceutical Performance Clive G. Wilson University of Strathclyde, Glasgow, Scotland, UK
14:30	Applications of Cyclodextrins in Drug Formulations Lajos Szente CycloLab Ltd., Budapest, Hungary
15:00	Novel Approaches in Drug Delivery Systems István Antal Semmelweis University, Budapest, Hungary
15:30	Coffee Break, Exhibition
Session 12: Looking into the Future: New Delivery Systems Chairs: Daniel Tang (Shanghai, China), Lajos Szente (Budapest, Hungary)
16:00	Pharmacovigilance Aspects of Biosimilar Products Irene Krämer University of Johannes Gutenberg, Mainz, Germany
16:30	Advances in Targeted and Gene Delivery Mitsuru Hashida Kyoto University, Kyoto, Japan
17:00	Ocular Drug Delivery: Formulation and Bioequivalence Issues Arto Urtti Centre for Drug Research, University of Helsinki, Helsinki, Finland School of Pharmacy, University of Eastern Finland, Kuopio, Finland
17:30	Panel Discussion VI. - Q & A Moderators: James E. Polli (Baltimore, MD, USA), Henning H. Blume (Oberursel, Germany)
18:00	Closing remarks *Vinod P. Shah* and *Imre Klebovich* Co-Chairs of the Workshop
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The Workshop ends on Wednesday at 18:30.