Scientific and Regulatory Advances in Biological and Non Biological Complex Drugs: A to Z in Bioequivalence

Transcription

1 SRACD 2018 rd 3 International Symposium on Scientific and Regulatory Advances in Biological and Non Biological Complex Drugs: A to Z in Bioequivalence ****Superior Hotel Danubius Health Spa Resort Margitsziget Margaret Island, Budapest, Hungary November 12 14, 2018 SECOND CIRCULAR

2 2 Preface rd The 3 International Symposium on Scientific and Regulatory Advances in Biological rd and Non Biological Complex Drugs: A to Z in Bioequivalence (3 SRACD) is organised in Budapest, Hungary, November 12 14, 2018 as a follow-up of a successful series of Bioequivalence Workshops (BEW series) and two SRACD in 2014 and 2016 which were the first in a series of Symposia in Europe in the field of Complex Drugs. As the science and technologies are advancing, the pharmaceutical world is entering into more advanced drug delivery systems and dosage forms and more general into drugs with higher complexity. The aim of this symposium is to bring the scientific advances and regulatory challenges for generic equivalence/biosimilarity of complex drugs. The symposium will address regulatory aspects of biological and non-biological complex drugs (NBCDs) and the paradigm shift compared to the requirements for fully characterized small molecular drugs and the established formulations. The symposium will also discuss advances in bioanalytical methodologies to characterize these complex drugs and their critical quality attributes including nanostructures affecting biodistribution. Topics will be addressed regarding the bioequivalence evaluation of complex drugs. The symposium will also provide an update on harmonization attempts for bioequivalence of small molecular drugs with an insight into drug dissolution/drug release and bioanalytical advances, including the use of Mass Spectrometry (MS), as a most progressively developing (bio-)analytical technics today. As a new format, Panel discussions will be held to discuss hot topics with moderators, invited experts and session speakers. The symposium will also offer ample opportunities for the participants to interact with not only international speakers on different topics, but with the representatives of CROs and exhibitors of different laboratory equipment services. Prominent representatives of pharmaceutical authorities are invited to contribute to the scientific programme. In order to enhance the participation of young research scientists in the international symposium, posters are welcome and will be presented in an attractive format. Selected posters will be awarded. Together with exciting advanced science insight also in the challenges for good use of such medicinal products, the meeting venue will provide all participants an enriching stay in the beautiful area of the Margaret Island and the special atmosphere of the UNESCO protected Music Fountain and Water Tower in Budapest. We are delighted to welcome you to one of the most prestigious International Pharmaceutical Research and Regulatory Science event in Budapest. Prof. Imre Klebovich Prof. Vinod P. Shah Co-Chairs of the Symposium Prof. Stefan Mühlebach Organised by the Semmelweis University, Department of Pharmaceutics, Budapest, Hungary in co-operation with the Committee on Pharmaceutical Sciences, Working Committee on Separation Sciences of the Hungarian Academy of Sciences (MTA) Non-Biological Complex Drugs Working Group (NBCD) Hungarian Society for Pharmaceutical Sciences (HSPS) under the auspices of the International Pharmaceutical Federation (FIP) European Federation for Pharmaceutical Sciences (EUFEPS) Organisers Prof. Imre Klebovich, Budapest, Hungary klebovich.imre@pharma.semmelweis-univ.hu Prof. Vinod P. Shah, North Potomac, MD, USA dr.vpshah@comcast.net Prof. Stefan Mühlebach, Glattbrugg, Basel, Switzerland stefan.muehlebach@viforpharma.com Erem Bilensoy, Ankara, Turkey Henning H. Blume, Oberursel, Germany Erik Bogsch, Budapest, Hungary Gerrit Borchard, Geneva, Switzerland Daan J. A. Crommelin, Utrecht, The Netherlands Jennifer B. Dressman, Frankfurt am Main, Germany László Endrényi, Toronto, ON, Canada Beat Flühmann, Glattbrugg, Switzerland A. Atilla Hincal, Ankara, Turkey Imre Klebovich, Budapest, Hungary Panos Macheras, Athens, Greece Imre Klebovich (Chair), Budapest István Antal, Budapest György Bagdy, Budapest Zsolt Holló, Budapest Tamás Janáky, Szeged Diamond Congress Ltd. Mr. Attila Varga H-1255 Budapest, P.O. Box 48, Hungary Scott E. McNeil, Frederic, MD, USA Stefan Mühlebach, Glattbrugg, Basel, Switzerland Sesha Neervannan, Irvine, CA, USA Tamás L. Paál, Szeged, Budapest, Hungary Olavi Pelkonen, Oulu, Finland Lakshmanan Ramaswamy, Mumbai, India Pat J. Sandra, Gent, Belgium Vinod P. Shah, North Potomac, MD, USA Jon S. B. de Vlieger, Utrecht, The Netherlands Clive G. Wilson, Glasgow, Scotland, UK Romána Zelkó, Budapest, Hungary Hedvig Juhász, Budapest Tamás Szolyák, Budapest Éva Szökő, Budapest György Thaler, Budapest László Tóthfalusi, Budapest Co-Chairs International Scientific Advisory Board Local Organising Committee Symposium Secretariat diamond@diamond-congress.hu Phone: Fax:

3 Main Topics of the SRACD 2018 Symposium Main Topics of the SRACD 2018 Symposium Complex Drugs including Nanomedicines Advances in (Bio-)Analytical Testing Landscape of complex drugs Scientific challenges in biological and non-biological complex drug Industry Perspectives New perspectives in bioanalytical techniques and LC-MS/MS Analytical challenges for complex drug products Advances in bioanalytical techniques Challenges in characterizing nanoparticle drugs analytical toolbox for proteins Critical quality attributes in analytics Innovations into practice Challenges in the pharmaceutical industry Development of nanomedicines: an industry view Regulatory Perspectives FDA: Nanomedicines from discovery to approval EMA: Equivalence approach; non-clinical aspects Regulatory pathways for biosimilars: EMA and FDA approach Advances in Dissolution / Drug Release Dissolution in biorelevant dissolution media Drug release from novel dosage forms Complexity involved in drug release from nanomedicine: a complex scenario Dissolution / Drug release of nanomedicines Bioequivalence Update on harmonization Biologicals and Biosimilars Biosimilar landscape Evaluation of monoclonal antibodies biosimilars Clinical practice: Substitution, interchangeability (Non-Biological) Complex Drugs and Similars What are NBCDs and what makes them special? Complexity of iron carbohydrate drugs and their evaluation Liposomes Ophthalmic drug products Challenges in determining BE Copaxone follow versions Nanotechnology Liposome formulations Nanofibers in drug delivery Nanopharmaceuticals Nanobiotechnology Nanotechnology in targeted drug delivery Nanomedicines in clinical practice: Critical aspects to consider Biodegradable Polymers Development, technological, analytical, regulatory and clinical aspects 4 5

4 FINAL SCIENTIFIC PROGRAMME Monday, November 12, 2018: Day 1 Morning Monday, November 12, 2018: Day 1 Afternoon Session III: Nanomedicines I 9:00 9:30 10:00 10:30 Opening Welcome Ceremony Session I: Equivalence 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 Landscape of Complex Drugs Jon S. B. de Vlieger Lygature, Member of NBCD Working Group, Utrecht, The Netherlands 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 Session IV: Complexity of Nanoparticles 11:00 Session II: Challenges I 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 15:45 16:15 Complexity of Iron Carbohydrate Preparations and Their Evaluation Gerrit Borchard School of Pharmaceutical Sciences Geneva-Lausanne, University of Geneva, University of Lausanne, Switzerland Critical Quality Attributes for Complex Drugs Panel Discussion I 11:30 12:00 Challenges in Bringing Scientific Innovations into the Market Krisztián Fodor National Institute of Pharmacy and Nutrition, Budapest, Hungary st 1 Q and A Moderators: Daan J. A. Crommelin, Utrecht, The Netherlands Beat Flühmann, Glattbrugg, Switzerland Panelists: Henning H. Blume, Oberursel, Germany Stefan Mühlebach, Glattbrugg, Basel, Switzerland Scott E. McNeil, Frederick, MD, USA Krisztián Fodor, Budapest, Hungary 12:30 Lunch and Exhibition 17:15 End of Day 1 18:00 Welcome Reception 6 7

5 Tuesday, November 13, 2018: Day 2 Morning 10:30 Session V: Biosimilars I 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 Session VI: Biosimilars II 11:00 Biosimilar Pathway: EMA Approach Pharmacist Perspectives Irene Krämer University Medical Center, Johannes Gutenberg-University, Mainz, Germany 15:30 Session VII: Challenges II 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 16:00 16:30 Tuesday, November 13, 2018: Day 2 Afternoon Session VIII: Complexities of Biosimilars, Bioanalytics 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 Glycosylation Aspects of Biosimilarity András Guttman The Sciex Research Laboratory, Brea, CA, USA 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, Chenglu, China 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 12:00 Controversies on the Switching and Substitution of Biological and Non-Biological Complex Drug Products 1 2 László Endrényi, László Tóthfalusi 1 University of Toronto, Department of Pharmacology and Toxicology, Toronto, ON, Canada 2 Semmelweis University, Department of Pharmacodynamics, 12:30 Budapest, Hungary nd 2 Q and A 17:30 18:00 Moving Towards Harmonization Moderators: Henning H. Blume, Oberursel, Germany Vinod P. Shah, North Potomac, MD, USA Panelists: Beatriz da Silva Lima, Lisbon, Portugal Tamás L. Paál, Budapest, Hungary Krisztián Fodor, Budapest, Hungary End of Day 2 Panel Discussion II 12:45 Lunch and Exhibition 19:30 Concert and Banquet Dinner 8 9

6 Wednesday, November 14, 2018: Day 3 Morning 10:30 Session X: Nanomedicines II 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 11:00 Panel Discussion III Wednesday, November 14, 2018: Day 3 Afternoon Session XI: Dissolution, Bioequivalence 13:15 Application of In Vitro Dissolution Studies to Evaluate Drug Interaction Imre Klebovich, Dávid Virág, István Antal, Vinod P. Shah 1 Department of Pharmaceutics, Semmelweis University, Budapest, Hungary 2 Pharmaceutical 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 1,2 Panos Macheras 1 Laboratory of Biopharmaceutics-Pharmacokinetics, Department of Pharmacy, School of Health Sciences, National and Kapodistrian University of Athens, Athens, Greece 2 Pharmainformatics Unit Athena Research and Innovation Center, 14:45 Athens, Greece 14:15 Bioequivalence Studies and Evaluations for DPI Drug Products: Regulatory Authorities Challenges 1,3 1,2 1 A. Atilla Hincal, Cemre Özseven, Pellin Yargan-Atak 1 IDE Pharmaceutical Consultancy on Registration and Biopharmaceutics CRO Services Ltd., Kavaklidere, Ankara, Turkey 2 Ankara University Pharmacy Faculty, Ankara, Turkey 3 Hacettepe University, Department of Pharmaceutical Technology, Hacettepe, Ankara, Turkey Session XII: Progress in Analytical Technologies United States Government Accountability Office (GAO) Report and Draft Guidance on Drug Products, Including Biological Products that Contain Nanomaterials, December 2017 Moderators: 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 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 rd 3 Q and A 12:00 Lunch and Exhibition 17:15 Poster Awards Ceremony 17:30 Closing Remarks 10 Béla Merkely, Imre Klebovich, Vinod P. Shah, Stefan Mühlebach 11

7 Registration Registration Registration is required for all conference participants preferably until October 10, It is recommended to make the registration online. In order to avoid double charges, please register only ONCE. The deadline to pay the early bird fee is October 10, Any registration and payment received after that date will be accepted as regular registration. Confirmation will be sent to all participants by the organisers upon receipt of registration and payment. Online registration: Cancellation policy of registration All cancellations and changes must be sent to Diamond Congress Ltd. in written form. All refunds will be processed after the Symposium. Please send your exact bank account details in the written cancellation, unless you paid by credit card. Registration fees Registration Types Early Bird Fee paid until October 10, 2018 Regular Fee paid after October 10, 2018 Refund of the registration fee will be made as follows: Registration fee for participants Registration fee for Ph.D. Students (*) 495 EUR 570 EUR 370 EUR 430 EUR 100% refund (minus an administrative fee of 50 EUR) in case of cancellation received before September 30, % refund in case of cancellation received before October 15, No refund in case of cancellation received after October 15, Accompanying person's fee 270 EUR 270 EUR Registration fee for members of Hungarian scientific societies(**) 95,000 HUF 110,000 HUF Payment Registration fee for Ph.D. student members of Hungarian scientific societies(**) 75,000 HUF 85,000 HUF All payments should be made in Euro or for the Hungarian participants in HUF. All charges due to bank transfers have to be paid by the sender. In any case please bring the proof of payment with you to the registration desk. Registration fees include VAT * Proof of student status should be justified at the time of registration ** Members of METT, MGYT, MFT, MKE, MBKE and Public body members of the Hungarian Academy of Sciences. Bank transfer has to be made to Diamond Congress Ltd. SRACD2018 Delegate and Ph.D. student registration fees include: Access to all scientific sessions Admission to the exhibition Printed material of the Symposium Conference bag Welcome Reception (November 12) Concert and Banquet Dinner (November 13) Coffee breaks Lunches (November ) Raiffeisen Bank Zrt. Address: H-1015 Budapest, Széna tér 1/a. International Bank Account Number: for EUR: HU for HUF: HU SWIFT code: UBRT HUHB Credit Card Accompanying persons' fees include: Welcome reception (November 12) Lunches (November ) Concert and Banquet Dinner (November 13) Sightseeing tour (November 13) VISA, EuroCard/MasterCard, American Express Card number with expiry date, card holder's name, billing address of the cardholder, CVV code (the last three digits on the back of the credit card where the signature is only VISA and EC/MC) are needed during the online registration

8 Address of the Symposium Venue Danubius Health Spa Resort Margitsziget **** Superior Address: H-1007 Budapest, Margitsziget (Margaret Island), Hungary Accommodation Hotels listed below are the official conference hotels recommended by the organisers. You can book a room at the special conference rates by using the hotel reservation links at the official website: VAT, city tax and the breakfast are included in the prices. Danubius Health Spa Resort Margitsziget ****Superior Address: H-1007 Budapest, Margitsziget (Margaret Island) Location from the Symposium venue:on site Exhibition and Sponsorship Room prices: Superior room for 1 person: Superior room for 2 persons: 105 EUR/room/night 115 EUR/room/night The Symposium organisers invite and expect many exhibitors, sponsors and advertisers from all branches of related sciences, profit-oriented or non-profit institutions for the conference. If you are interested in sponsoring / exhibiting at the meeting, we can offer you floor space for your own stand. Diamond Congress Ltd., our partner for the Symposium and exhibition organisation offers numerous alternatives for you to promote your business and can work closely with you to create a package tailored to your company's needs. The exhibition will be visited by your core target group from all over the world. You will have the opportunity to promote your products and services and discuss their merits in detail with interested visitors and specialists. Description 267 rooms (227 twin, 12 double-double, 4 single, 16 Junior suites, 8 suites); Rooms for disabled people, connecting rooms. Executive floor with Executive breakfast lounge. Air-conditioning, balcony, bathrobe, hairdryer, minibar, safe, TV, free WiFi, telephone, coffee- and teamaking facilities. Business centre, room service, laundry, souvenir shop, concierge service, transfer, carrental service, car park and garage. SPA, WELLNESS, FITNESS: Indoor and outdoor pools, adventure pool with jacuzzi, thermal bath, therapeutic exercise thermal bath, sauna, steam room, aroma cabin and fitness room. The use of spa and fitness area included the hotel room rate. Further services (extra): salt cave, cardio centre, laser eye clinic, dental clinic, solarium, infra-sauna, Emporium Hair and Beauty, cosmetic surgery. For further information please visit: http: /

9 Call for Poster Abstracts In addition to the invited lectures of the symposium poster presentations are also welcome to encourage the participation of young scientists and researchers from both academic and industrial background. The main streams of the symposium are organised around the seven main topics as follows: The SRACD logo and its inspirational original Welcome Reception Monday, November 12, :00 21:30 Complex Drugs Including Nanomedicines Industry Perspectives Regulatory Perspectives Biologicals and Biosimilars (Non-Biological) Complex Drugs and Similars Advances in (Bio-)Analytical Testing Advances in Dissolution / Drug Release Bioequivalence Aspects of Nanotechnology Biodegradable Polymers Participants interested in presenting a poster are kindly requested to submit their onepage abstract online via the Symposium website latest by October 10, Authors receive notification on acceptance continuously. The organisers of the SRACD 2018 offer awards to the best three poster authors. These awards will be given to the winners at the end of the Symposium right before the closing ceremony. Formal requirements All abstracts must be written in English The abstract text should be within 2500 characters (together with space) and typeface: Arial Type, 12 pt, single space The abstract title must be brief (max. 2 lines allowed in Title Case format) and clearly indicate the nature of the investigation Authors' number is maximized to 10 names Workplaces: max. 10 different workplaces The abstract must represent original work and should be as informative as possible. Conclusions must be supported by data. Please include 5 keywords at the end of the abstract text. It is the author's responsibility to submit a correct abstract. Any error in spelling, grammar or scientific fact will be reproduced as typed by the author Submitted abstracts can be seen, modified or deleted within the whole period of the abstract submission online Once the abstract has been submitted, modified or deleted, the corresponding author will automatically receive an acknowledgement of receipt, modification or cancellation (by ) Correspondence regarding the abstracts such as confirmation of submission, notification of acceptance or rejection and instructions for presentation will only be sent to the corresponding author. It is his/her responsibility to forward the information to all coauthors The presenting author is required to register for the Symposium and pay the registration fee as a condition of presenting the poster. Poster information Posters will be mounted throughout the whole symposium. The recommended poster size is a standing A/0 (84 cm x 118 cm) as the size of the poster board is 90 cm at width and 120 cm at height. Music will be performed by the "MADARAK" music band. The band "MADARAK" ("Birds") was formed 24 years ago. They received the Emerton Award in 2001, as well as the Golden Arrow Award in They play a specific type of music that could be translated something like a "party music", which means that they play in various styles, always depending Széchenyi on and Chain according Bridge to the actual audience. They had more than 3000 performances. They performed together with bands of Jerry Lee Lewis, Chuck Berry and Little Richard already in

10 Concert before the Banquet Dinner Monday, November 13, :30 Gergely Bogányi Gergely Bogányi was born in Vác in 1974, and began playing piano in his hometown at the age of 4. He studied at the Franz Liszt Academy of Music and the Sibelius Academy in Helsinki, before completing his education at Indiana University in Bloomington under László Baranyay, Zsuzsa Esztó, Matti Raekallio and György Sebők. He has placed in numerous music competitions, and was the winner of the 1996 International Franz Liszt Piano Competition in Budapest. In , t h e B o g á n y i - K e l e m e n Tr i o (Barnabás Kelemen violin, Tibor Bogányi cello, Gergely Bogányi piano) came first in the international trio competition in Kuhmo, Finland. Today, Gergely Bogányi is one of the most popular artists in concert halls around the world. His repertoire includes over 30 piano concertos and a significant portion of the piano literature, including all of Chopin's solo piano compositions. In 2002, in a series of recitals in Finland and Hungary, he performed Liszt's 12 Transcendental Études and all of Chopin's solo piano pieces, winning the Gramofon Award for the year's best concert series. In 2000, he was awarded the Liszt Prize, and the President of Finland awarded him the Grand Cross of the White Rose of Finland in In 2003, the Pest County Committee unanimously rewarded him for 'Services to the Culture of Pest County'; and Ferenc Mádl, then President of the Hungarian Republic, presented him with the Kossuth Prize in In 1996, he was named a Citizen of Honour of his home town of Vác, and also of Zebegény in In 2008, he was recognised with the Junior Prima Award, and in 2011 with the Prima Award. Symposium Banquet Dinner Monday, November 13, :30 23:00 The dinner will be held in the Restaurant Gundel. The name GUNDEL could rightly stand for the history of modern Hungarian gastronomy and hospitality. Károly Gundel refined the Hungarian cuisine and created delicious dishes of his own taste. His pioneering work placed Hungary on the world map of gastronomy. During the evening our guests will be served an outstanding menu with fine dishes and excellent wines. Participation in the programme is included in the registration fee. Organised shuttle will be available from Margaret Island to Gundel Restaurant at 19:00 and back to the hotel at 23:

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