Synevo Clinical Trials Symposium 2017

Synevo Clinical Trials Symposium 2017


Dear colleagues and friends,

I am very pleased to announce you that we have reached this year at the 9th edition of our symposium organized in Bucharest, Romania.

We invite you all to join us for our event dedicated to professionals working in clinical research field, pharma sponsors, biotech companies and CRO’s representatives, investigators (clinicians and general practitioners, laboratory specialists (lab physicians, chemists, biologists, biochemists, etc.).

You will have the chance to listen presentations of very well known speakers, KOL in their field, into a relaxing environment where you can also build and cultivate relationships and do the networking with your peers. .

The event is credited with CME credits. To register, please see the form bellow.

Please be aware that there is a limited number of participants. We are looking forward to see you on 17th of November 20117, Intercontinental Hotel, Bucuresti, Romania.

Cristina Florescu Moraid, Md, Msc, EuSpLM
Regional Director Romania, Moldova, Bulgaria and Serbia Synevo Central Lab

4

Sectiuni

18

Lectori

527

Participanti

10

Tari participante

9

ani de traditie

AGENDA

  • 08:00-09:00Participants Registration and welcome coffee

    Ronda Hall, INTERCONTINENTAL Hotel Bucharest
  • 09:00-09:15Welcome and Opening Remarks

    Cristina Florescu Moraid, MD, MSc, EUSpLM - Synevo Central Lab Regional Country Director Romania, Republic of Moldova, Bulgaria & Serbia
  • 09:15-11:15INVESTIGATOR SECTION

    Chairman for Investigator Section:
    Prof. Constantin Mircioiu - MD, PhD-Vicepresident of National Ethics Committee Romania

    09:15-09:40
    Assoc. Prof. Vlad Vintila Dr. - PhD, Emergency and University Hospital, Bucharest, Romania
    Title: "Which is the best research evidence to use?"

    09:40-10:05
    Prof. Victoria Arama, MD, PhD - Scientific Researcher II- INBI Matei Bals Bucharest, Romania
    Prof. Dr. Ștefan Sorin Aramă - Head of Psychopathology and Immunology, Department of Dental Medicine, University of Medicine and Pharmacy ”Carol Davila” București, Bucuresti, Romania
    Title: "Matei Bals National Institute for Infectious Diseases" experience in clinical trials, in acute and chronic infections - pitfalls and opportunities.

    10:05-10:30
    Assoc. Prof. Anca Ruxandra - MD, PhD, Senior Specialist in General Surgery, Department of Surgery lll, Craiova County Emergency Clinical Hospital Romania
    Title: “The role of clinical trials in treatment of intra-abdominal infections in adults; experience of the 3rd department of general surgery”

    10:30-10:55
    ROZALINA LEPADATU - Immunologic Disorders Patients Association, Bucharest, Romania
    Title: “Patient involvement in clinical trial in Romania”
  • 10:55-11:30MORNING COFFEE AND NETWORKING BREAK

  • 11:30-13:10LABORATORY SECTION

    Chairman for Laboratory Section:
    BENEDIKT VON BRAUNMÜEHL - COO Medicover Diagnostics Services, Germany

    11:30-11:55
    Tim Stiles - Director, Qualogy Ltd, Northampton, United Kingdom
    Title: "Good Clinical Practice (GCP): how does a laboratory that supports a clinical trial ensure compliance with these Regulations"

    11:55-12:20
    Thomas Streichert MD, PhD - Director of Clinical Chemistry Department, University Hospital Koln, Germany
    Title: “Indirect methods for reference ranges”

    12:20-12:45
    Prof. Dr. Eva Ajzner - MS, PhD, University of Debrecen Medical Health Science Center, Hungary
    Title: ''How laboratories assist clinicians in utilization of laboratory tests? An international survey in 850 European laboratories.''

    12:45-13:10
    Prof. Dr. Trefor Higgins PhD PhD - University of Edmonton Alberta, Canada
    Title: ” How to react when laboratory results do not match the clinical pattern”
  • 13:10-14:00BUSINESS LUNCH BREAK

    Intercontinental Hotel - details will be provided at registration desk.
  • 14:00-15:40CRO & SPONSOR SECTION

    Chairman for CRO & Sponsor Section:
    Julian Platon MD, PhD - Platon Strategies and Operations R'nD & MA Consulting - Switzerland

    14:00-14:25
    Dr. Galli Claudio PhD - Medical Scientific Liaison, Abbott Diagnostics, Italy
    Title: "Advances in diagnosing HCV and HCC"

    14:25-14:50
    Kristi Kruusmaa - Head of Research & Development, Universal Diagnostics, Spain
    Title: “Clinical Application of Metabolomics in Early Colorectal Cancer Detection”

    14:50-15:15
    Catalina Sarbu MD - General Manager, Parexel International, Romania
    Title: Essentials on the EU Regulation 536/2014 and the EU centralized approach for authorizing clinical trials across EU

    15:15-15:40
    Julian Platon, MD, PhD Platon Strategies and Operations R'nD & MA Consulting - Elvetia
    Title: „Combining Clinical Operations & Medical Affairs: A Sponsors View“
  • 15:40-16:00AFTERNOON COFFEE AND NETWORKING BREAK

  • 16:00-17:20REGULATORY & VARIA SECTION

    Chairman for Regulatory & Varia Section:
    Assoc. Prof. Diana Loreta Paun- PhD, Presidential Administration of Romania, Presidential Adviser

    16:00-16:20
    Clara Nicoleta Necula -Kendart Systems, Neva Training, Bucuresti, Romania
    Title: ''Electronic Case Report Form - Importance To Clinical Trials overall precess and Human Health''

    16:20-16:40
    Prof. Constantin Mircioiu - MD, PhD-Vicepresident of National Ethics Committee Romania
    Title: "Questions & Answers concerning Assessment Part II of Clinical Trial by Ethics Committees in EU 536/2014 context"

    16:40-17:00
    Mariusz Kardas - Director Gdansk Fundation for Management (GFKM), Poland
    Title: “How to run successfully a clinical trial project?”

    17:00-17:20
    Karine Gradziel - Sales and Marketing Manager CRYO INTERNATIONAL / an AirLiquide Company, Poland
    Title: “Optimization of temperature controlled solutions for clinical trials transport”

    17:20-17:30
    Psih. Adrian Gemanaru - Director of 'Black Sea' Autism Association, Romania
    Title: “Charity Project - Developing of Therapeutic Beach for Children with Autism and Disabilities in Constanta, Romania?”
  • 17:30-17:45TOMBOLA

  • 17:45-18:30Musical Soiree

    Daniela Vladescu - Soprano
    After graduating from the George Enescu Music School in Bucharest (1963-1975), she studied canto at the Ciprian Porumbescu Conservatory in Bucharest. (in the class coordinated by prof. Arta Florescu şi Eugenia Moldoveanu)
    Between 1979-1985, she is one of the lead singer of the musical theater in Braşov and then between 1985-1993, then lead singer with the Romanian Opera House in Bucharest.
    1993-present: lead singer at the Ion Dacian Operetta National Theater of Bucharest.
    Since the year of 2006 till now, she is the Managing Director of Opera and Ballet National Theater Oleg Danovski in Constanta, Romania
  • 18:30Closing the session and grant diplomas


LECTORI

Cristina Florescu-Moraid, MD, MSc, EUSpLM - EVENT ORGANIZER

Cristina Florescu-Moraid, MD, MSc, EUSpLM - EVENT ORGANIZER

Synevo Central Lab Country Director Romania, Republic of Moldova, Bulgaria & Serbia


Cristina Florescu-Moraid is responsible for Synevo Central Lab’s operations in Romania since 2005. Cristina Florescu-Moraid was responsible for management of more than 80 studies and was involved in another 100 projects prior to her manager career. Cristina Florescu-Moraid got her Medical Doctor Diploma in 1997 from Carol Davila University of Medicine and Pharmacy in Bucharest, Romania and was accredited as Laboratory Medicine Specialist in 2005 and as Senior Laboratory Medicine Specialist in 2011, by the Romanian College of Physicians.

Dr. Florescu Moraid got her Master of Science Diploma in 2006 from Health Insurance National House and accomplished Postgraduated School of Clinical Trials Management at Gdansk Foundation for Management Development Gdansk in 2012. She graduated the Postgraduated Leadership Development Programme at University of Sussex, UK in 2014.

She is invited speaker for laboratory medicine and clinical research scientifc events and organize several courses and trainings for specialists working in clinical trials field.

Dr. Florescu-Moraid has more than 10 years of experience in laboratory and clinical trials industry now.

BENEDIKT VON BRAUNMÜHL - COO Medicover Diagnostics Services, Germany

BENEDIKT VON BRAUNMÜHL

COO Medicover Diagnostics Services, Germany


Education
Bachelor in Business Administration, Lorange Institute of Business in Zürich.
Previously
Member of the Executive Committee and Head of Global Commercial Operations in QIAGEN, Head Latin America at Novartis Vaccines & Diagnostics, Director Global Marketing at Chiron, and several positions at ASTA Medica.
Other current assignments
Several assignments within the Group. Chairman of the Supervisory Committee of PathoQuest

Anca-lleana Ruxanda - Senior Specialist in General Surgery

Anca- lleana Ruxanda

Senior Specialist in General Surgery, Department of Surgery lll, Craiova County Emergency Clinical Hospital


Catalina Sarbu - General Manager Business Administration – PAREXEL Romania

Catalina SARBU

General Manager Business Administration, Associate Director Clinical Operations – PAREXEL Romania


University of Medicine and Pharmacy, Bucharest, Romania - Medical Doctor Degree

Saint Antoine University, Paris, France - Hematology and Blood Transfusion courses

General Practitioner – Center of Hematology, Ploiesti, Romania

Medical coordinator at A&A Medical, Bucharest, Romania

Manager Clinical Operations and Country Manager – PAREXEL International Romania since 1999

Clara Nicoleta Necula - Neva Training, Bucuresti, Romania

Clara Nicoleta Necula

Neva Training, Bucuresti, Romania


Din anul 2010, Dr. Necula este fondatorul companiei Neva Training, companie de consultanță în domeniul medical-farmaceutic, poziție din care a format și dezvoltat numeroase echipe de angajați din acest domeniu, din toate departamentele (Sales și Telesales, Service, Marketing, HR). Programele Neva Training includ consultanță în marketing, recrutare, evaluare competențe și evaluare în teren, training, coaching și coaching the coach. Toate proiectele Neva Training sunt programe perfect customizate, adaptate specificului fiecărei companii în parte, în care standardele înalte, dăruirea și implicarea maximă au reprezentat valori incontestabile. Companiile-partenere care au ales expertiza Neva Training vin din toate subdomeniile industriei farmaceutice: companii producătoare de medicamente originale și generice, companii producătoare, importatoare și distribuitoare de suplimente nutritive, companii de echipamente medicale, centre medicale și lanțuri farmaceutice, atât în farma umană și cât și în farma veterinară.

De-a lungul timpului, Dr. Necula a contribuit la creșterea performanței și împlinirea angajaților din domeniul medical-farmaceutic, iar abordarea Neva Training a vizat atât competențele de comunicare&vânzare, leadership&management, cât și dezvoltare personală.

Diana Paun - MD, Consilier de Stat - Departamentul Sănătate Publică, Romania

Diana Paun - MD,

Consilier de Stat - Departamentul Sănătate Publică, Romania


Dr. Diana Loreta Paun (n. 1968) este absolventa a Facultatii de Medicina si doctor în Medicina a Universita?ii de Medicina si Farmacie “Carol Davila” din Bucuresti. Este medic primar endocrinolog si conferentiar universitar la Disciplina Endocrinologie a Universitatii de Medicina si Farmacie “Carol Davila”. A lucrat în cadrul Institutului National de Endocrinologie “C.I.Parhon” ca medic, cercetator, cadru didactic, iar în perioada 2006-2015 ca manager. Detine un atestat de studii complementare în Managementul Serviciilor de Sanatate si a absolvit programul de master „Management al Sanatatii Publice si al Serviciilor de Sanatate”. De asemenea, a urmat mai multe programe de perfectionare în management, de auditor în domeniul calitatii, de formator si expert în achizitii publice. Dr. Diana Loreta Paun este membru în asociatii profesionale nationale (Asociatia de Endocrinologie Clinica din România, Societatea Româna de Endocrinologie) si internationale (Societatea Germana de Endocrinologie, Societatea Europeana de Endocrinologie (ESE), membru al Chapterului din Romania al AACE (American Association of Clinical Endocrinologists) si presedinte al acestuia în intervalul 2011-2012. A publicat studii si lucrari stiintifice în reviste de specialitate recunoscute national si international, precum si lucrari în domeniul managementului sanitar. A participat ca director sau membru al echipei în proiecte de cercetare stiintifica nationale si internationale precum si în proiecte educationale si de formare continua. Dr. Diana Loreta Paun a fost numita Consilier de Stat la data de 1 iunie 2015.

Éva Ajzner, M.D. Ph.D. - Jósa University Hospital, Nyíregyháza, Hungary

Éva Ajzner, M.D. Ph.D.

Head of the Department of Laboratory Medicine and Clinical Microbiology, Jósa University Hospital, Nyíregyháza, Hungary

+36 (42) 599-790


Éva Ajzner, M.D. Ph.D., is Private Professor, accredited PhD tutor of the University of Debrecen Medical Health Science Center. She is head of the Department of Laboratory Medicine and Clinical Microbiology, Jósa University Hospital. Dr. Ajzner received her PhD in the field of experimental hemostasis from the University of Debrecen in 2003. She currently serves as president of the Hungarian Society of Laboratory Medicine and member of the Laboratory Medicine Council of the National Advisory board of Healthcare in Hungary. She is chair of the joint Working Group on Post-analytical Phase of the European Federation of Clinical Chemistry and Laboratory Medicine and European Organisation for External Quality Assurance Providers in Laboratory Medicine. Her research interests are applied haemostasis, post-analytical, interpretative responsibilities of laboratories and near patient testing.
Galli Claudio - Dr, PhD - Abbott, Italy

Galli Claudio

Dr, PhD - Abbott, Italy


Medical degree, cum laude, University of Rome “La Sapienza”. Specialized in Gastrointestinal Diseases cum laude, University of Rome “La Sapienza”. PhD in Infectious Diseases, University of Rome “La Sapienza”. Member of the following scientific societies: Italian Association for the Study of the Liver; European Society of Clinical Microbiology and Infectious Diseases (ESCMID); European Society of Medical Virology (SIVIM); Italian Ligand Assay society (ELAS); Italian Society for Blood Transfusion (SIMTI). Associate Director Medical Scientific Liaison Europe, Abbott Diagnostics (ADD), Roma, Italy. Teacher at >80 national or regional CME (continuous medical education) courses covering clinical and laboratory aspects in infectious disease, cardiovascular diseases and oncology. Professor at contract (Università degli Studi di Roma “La Sapienza”) from November 1998 to October 2000. Seminars on “Automated and semautomated systems for laboratory analysis” at the 1st Speciality school in Clinical Pathology, University of Roma “La Sapienza”. Seminars on "Automation and computerization in clinical mircobiology” at the Specialty school in Microbiology and Virology, University of Roma “La Sapienza” from 1994 to 1999. Seminars on “Automated and semautomated systems for laboratory analysis” at the 1st Speciality school in Clinical Pathology, University of Roma “La Sapienza” in 1997 and from 2001 to 2007. Seminars (evaluation of laboratory assays, screening assays for MST and HIV; quantitative determination of HIV- RNA: principles and methodology; quantitative determination of HIV-1 RNA: clinical applications) at the Italian NIH (Istituto Superiore di Sanità; December 2002-February 2003). Seminars on epidemiology and diagnosis of hepatitis B virus (HBV) and hepatitis C virus (HCV) infections at the Laboratory of Epidemiology and Biostatistics of the Istituto Superiore di Sanità (May-June 1996). Author or co-author of 159 scientific papers on national journals and 65 scientific papers on international peer-reviewed journals. More than 300 oral communications and posters at congresses, meetings and workshops, both in Italy and abroad; >150 lectures and presentations at congresses, meetings, workshops.
Julian Platon - MD, PhD - R&D and Medical Affairs Consultant, Switzerland

Dr. Med. Julian V. Platon

R&D and Medical Affairs Consultant, Switzerland


After his A Level in Bucharest he relocated to Germany in 1983 where he obtained the German Matura and studied Medicine in Cologne, London and Beer-Sheva. In parallel to his Conferral of Doctorate in Surgery he worked as a physician in the Department of Internal Medicine in Cologne, Germany.

Since 1994 Dr. Platon had different national and international, operational and executive medical positions in the Pharmaceutical, Medical Devices and Clinical Research Organization industry in Germany, USA and Switzerland. A special focus was addressed to Medical Affairs, Clinical Development & Operations and Pharmacovigilance (incl. QPPV). Stations of his professional life were Schwarz Pharma, Hoffmann-La Roche, Abbott, PharmaPart, Solvay and Alexion.

Dr. Platon is married, has three children and lives in Basel, Switzerland where he works as strategic and operational consultant in R & D and in Medical Affairs.

julian.platon@gmail.com

Kristi Kruusmaa - Head of Research & Development, Universal Diagnostics, Germany

Kristi Kruusmaa

Head of Research & Development, Universal Diagnostics, Germany


Kristi Kruusmaa has joined UniversalDX since foundation in 2012 and holds the position of Head of Research. UniversalDX is an innovative biomedicine company focused on early detection of cancer using leading edge technologies. Kristi is in charge of all research activities ranging from setting up clinical studies to designing research experiments for product development as well as monitoring the data analysis and interpretation and final test set-up alongside to giving presentations, talking with clinicians, collaborator and investors.

She has been working on the field of molecular biology since 2003 and has several years of experience in clinical and experimental study set up. She received her master of biochemistry and biotechnology at Tallinn University of Technology 2011 and is currently finishing PhD at University in Ljubljana with special emphasis on diagnostic test development.

Ștefan Sorin Aramă - Șeful Disciplinei de Fiziopatologie și Imunologie, Facultatea de Medicină Dentară, UMF ”Carol Davila” București, Romania

Prof. Dr. Ștefan Sorin Aramă

Șeful Disciplinei de Fiziopatologie și Imunologie, Facultatea de Medicină Dentară, UMF ”Carol Davila” București, Romania


Dr. Ștefan Sorin Aramă este medic primar Medicină Internă, având titlul de Profesor universitar la UMF Carol Davila București. De asemenea, acordă consultații și efectuează endoscopii digestive la Centrul Medical Neolife din București.

Domeniile sale științifice de interes sunt reprezentate de: Infecția cu Helicobacter pylori; bolile hepatice cronice; fiziologia și patologia microbiotei intestinale; infecția HIV/SIDA.

În ceea ce priveste activitatea de cercetare științifică, Prof. Dr. Ștefan Sorin Aramă a fost coordonator știintific, responsabil de partener sau membru in echipa de cercetare în 8 granturi științifice câștigate prin competiții naționale sau internaționale, precum și investigator în peste 10 trialuri clinice internaționale.

Din punct de vedere al activității științifice, Prof. Dr. Ștefan Sorin Aramă este unic autor a 4 monografii sau cărți de specialitate, a 15 capitole în alte monografii, autor principal sau coautor la 52 de articole publicate în reviste indexate în baze de date internaționale, 80 de studii publicate în rezumat în volumele unor manifestări ştiinţifice din ţară şi din străinătate.

Domnia sa este conducător de doctorat în cadrul Școlii doctorale a UMF ”Carol Davila” București din 2009, îndrumând până în prezent elaborarea tezelor a 14 doctoranzi. A făcut parte din comitetele științifice la 15 congrese și conferințe naționale.

Tim Stiles - Director at Qualogy Ltd, Northampton, United Kingdom

Tim Stiles

Director at Qualogy Ltd, Northampton, United Kingdom


Qualogy is an internationally renowned consultancy firm that provides assistance to organisations implementing GCP and GLP regulations and GCLP guidelines. In addition, Qualogy Archives provide dedicated contract archiving services for the archive of GLP, GCP and GMP materials. This includes Investigator site file and Trial Master Files.

Tim has worked within the GxP regulated arena for over thirty five years. Prior to founding Qualogy in 1995, Tim worked as the Director of Quality Assurance within a large Contract Research Organisation (CRO) in the UK.

Tim was a member of the International Expert Group within The Organisation for Economic Co-operation and Development (OECD), which worked on the 1997 revision of their principles of Good Laboratory Practice.

A co author of RQAs guidance “Good Clinical Laboratory Practice (GCLP)” he has developed an international GCLP Accreditation Scheme for laboratories analysing samples from clinical trials.

Tim is a current member of the RQA Board of Directors with responsibility for Global Engagement. He is also a past Chairman of RQA when it was The British Association of Research Quality Assurance. Tim has been pro-active with Governments and Industry to develop and enhance the Quality Assurance Profession.

Trefor Higgins - Prof. Dr., Canada
Victoria Arama - INBI Matei Bals Bucharest, Romania

Dr. Victoria Arama

Sef de Sectie la Institutul National de Boli Infectioase Prof Dr Matei Bals Bucuresti,


Dr Victoria Arama este medic primar - Sef de Sectie la Institutul National de Boli Infectioase Prof Dr Matei Bals Bucuresti, avand titlul de Profesor universitar la UMF Carol Davila Bucuresti, Facultatea de Medicina, Disciplina de Boli Infectioase - Matei Bals.

Domeniile sale stiintifice de interes sunt reprezentate de: Infectiile virale (virusuri herpetice, virusuri hepatitice, infectia HIV/SIDA, virusuri gripale, papilomavirusuri); Terapia antivirala; Vaccinologia ; Rezistenta bacteriana la antibiotice; Infectiile in sarcina; Infectiile la imunodeprimati; Infectiile fungice si terapia antifungica.

In ceea ce priveste activitatea de cercetare stiintifica, Prof Dr Victoria Arama a fost coordonator stiintific sau membru in echipa de cercetare a numeroase granturi stiintifice castigate prin competitii nationale si internationale, precum si investigator principal in peste 40 de trialuri clinice internationale.

Din punct de vedere al activitatii stiintifice, Prof Dr Victoria Arama este autor a 4 monografii stiintifice si a peste 40 de capitole in alte monografii. Este membra a numeroase societati stiintifice nationale si internationale (ISID, ECCMID, EASL, GEEP, IHMF) si a publicat ca autor / coautor peste 500 lucrari stiintifice in reviste medicale din tara si strainatate.

Prof Dr Victoria Arama este membra in Comitetul Stiintific al revistei medicale franceze Medecine et Maladies Infectieuses si membra in Comitetul Editorial la alte 7 reviste medicale romanesti recunoscute.

Vlad Damian Vintila MD

Vlad Damian Vintila

Associate Professor of Internal Medicine and Cardiology at the 3rd Internal Medicine and Cardiology Department “Carol Davila” University, Emergency and University Hospital Bucharest


In 2000 he graduated the Medical School at “Carol Davila” University of Medicine and Pharmacy in Bucharest as chief of his promotion. He followed the medical training as resident in Internal Medicine and then Cardiology at Emergency and University Hospital in Bucharest, becoming Consultant in Internal Medicine in 2007, and Consultant in Cardiology in 2010. He gained a fellowship on echocardiography of the European Society of Cardiology in 2006 in The United Kingdom. In 2011 he became a certified interventional cardiologist. In parallel with the medical activity he entered the academic community, currently being Associate Professor of Internal Medicine and Cardiology at the 3rd Internal Medicine and Cardiology Department “Carol Davila” University, Emergency and University Hospital Bucharest. The medical and academic activity is completed with research work, Doctor Vintila graduating the PhD fellowship in 2013 and in 2014 being part of a postgraduate European Project, POSDRU/159/1.5/S/141531. During the last 10 years he has been involved in clinical research projects in various fields of cardiology, acute coronary syndromes, heart failure, dyslipidemia, atrial fibrillation, diabetes mellitus and hypertension. He is married and has 2 children.
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PARTNERS

00 Kendart
02 abbott
01 bizmedica
03 agilrom
04 World Courier

REGISTRATION FORM - SYMPOSIUM REGISTRATION FEE

REGISTRATION IS OPEN

If you wish to participate, please read the information and fill up the requested details.

After receiving your registration form, we will answer your request.


FEES

1 AUGUST – 15 SEPTEMBER 2017, registration is free of charge

16 SEPTEMBER - 15 NOVEMBER 2017, EURO 50 per participant

17 NOVEMBER 2017, on desk fee EURO 100 per participant

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Cancellations:
Cancellations made one month prior to the start of the conference will be refunded less 50% administration charge. Refunds will be made after the conference. Cancellations made within one month of the conference start date will receive no refund. Substitutes are accepted up to 3 days before the conference. Any cancellation will be accepted latest one month before the event and should be informed in written form.
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LOCATION

Hotel Intercontinental