Florentine East-West Medical Congress: Latest Advances in Clinical Trials - From Clinical Trial to Clinical Practice
From: Thursday, February 12, 2009  To: Sunday, February 15, 2009

  And by:

Under the Auspices of:
AIOM
AME
SIC
ANMCO
SIE
SIMI
Azienda USL11 Empoli





  S
ponsored by:
CROM S.r.l. - Verona


Organisation by:
Fondazione Internazionale Menarini Florence Faculty of Medicine
Fondazione Romuldo Del Bianco


General Oranization:
Promo Florence Events

Project Leader:




Thursday, February 12th 2009 Galleria Luca Giordano – Palazzo Medici Riccardi, Via Cavour 2 Opening Ceremony 17.00 Welcome addresses of the Authorities 17.30 Welcome and Introduction Gian Franco Gensini (Dean, Faculty of Medicine and Surgery, Florence University) Riccardo Gionata Gheri (Chief, Endocrine Unit, AUSL11, Tuscany Region, National Health Service) Vladimir Popov (Moscow Medical Academy named after I.M. Sechenov) Alessandro Casini (President, Fondazione Internazionale Menarini) Paolo Del Bianco (President, Fondazione Romualdo Del Bianco) Oriana Zerbini (Medical Director, CROM) 19.00 Welcome cocktail Friday, February 13th 2009 Vivahotel Alexander – Meeting Hall 08.30 Registration – Each speaker is requested to leave a copy of his/her presentation at the registration desk Plenary Session I 09.00 Breakfast workshop: “Country Updates on Clinical Trial Regulations and Compliance (Russia, Italy, Ukraine)” Co-Presidents: Deputy of Tuscany Region (Florence, I) V. Popov (Moscow, Russia) 09.15 O. Verstakova (Moscow, Russia) · Clinical trials in Russia in 2008 · Overview of Russian federal drug law · Current regulatory requirements for clinical trials · Principle criteria for choosing hospitals to conduct clinical trials · Certification of hospitals · Russian Healthcare System reform – How will this impact on trials? 09.35 G. Rasi (Rome, I) · Clinical trials in Italy in 2008 · Overview of Italian federal drug law · Current regulatory requirements for clinical trials · Principle criteria for choosing hospitals to conduct clinical trials · Certification of hospitals · Italian Healthcare System reform – How will this impact on trials? · Italian Healthcare System 09.55 I.V. Nizhenkovskaya (Kiev, Ukraine) · Clinical trials in Ukraine in 2008 · Overview of Ukrainian drug law · Current regulatory requirements for clinical trials 10.15 D. Agnusdei (Florence, I) Main Lecture on: “Future of medical education for healthcare professionals: partnership between industry & academia” 10.50 Coffee break Vivahotel Alexander - Primavera Hall 11.30 P. Morelli (Verona, I) Statistical planning – hypothesis formulation and sample size 11.50 A. Conti (Florence, I) Electronic trial and the ‘Caveats’ for a correct hypothesis formulation 12.10 L. Comarella (Verona, I) Statistical and Data Management issues in respiratory and cardiovascular drug development 12.30 General discussion 13.00 Lunch Vivahotel Alexander - Venere Hall Parallel Session III - Clinical Safety & Pharmacovigilance President: A. Mugelli (Florence, I) 11.30 E. Serrotti (Florence, I) Pharmacovigilance in clinical practice 11.50 A. Mugelli (Florence, I) The Tuscan pharmacovigilance system 12.10 A.P. Viktorov (Kiev, Ukraine) Pharmacovigilance in Ukraine: formations and challenges 12.30 V. Popov (Moscow, Russia) Drug safety: Drug-related QT interval prolongation 12.50 General discussion 13.00 Lunch Vivahotel Alexander - Primavera Hall Parallel Session IV - Drug Discovery and New Technologies President: T. Mazzei (Florence, I) 14.30 A. Khokhlov (Yaroslavl, Russia) Association between adherence and effectiveness, safety to drug therapy of arterial hypertension 14.50 G. Lisova (Kharkiv, Ukraine) The methodological peculiarities of the usage of peritoneal dialysis in patients with diabetic kidney affections 15.10 F. de Braud (Milan, I) Early clinical trials for new drugs development in comparison with traditional cytotoxics 15.30 A.E. Dorofeyev (Donetsk, Ukraine ) Clinical trials experience of biologic agents in inflammatory bowel disease patients 15.50 I. Sarvilina (Rostov on Don, Russia) Technological platform for molecular diagnostics of drug reactions 16.10 General discussion Vivahotel Alexander - Venere Hall Parallel Session V 14.30 Workshop: “How to Initiate and Manage Clinical Trials in CEE (Regulatory, Operational and Clinical Challenges): CRO and sponsor experience” President: O. Zerbini (Verona, I) 14.45 V. Popov (Moscow, Russia) Attractiveness and difficulties of running Clinical Trials in Russia 15.00 L. Krzysztofa (Warsaw, Poland) Experience from Clinical Research in Poland 15.15 M. Mosconi (Verona, I) Patient recruitment: also the Sponsor / CRO can play an important role 15.30 V.N. Nelyubin (Moscow, Russia) System of external quality assessment of clinical laboratory 15.45 S. Colazzo (Verona, I) Quality of data from Central Eastern Europe: the Auditor’s Experience 16.00 L. Cantini (Livorno, I) Quality of data from CEE - independent Medical expert experience 16.15 A.V. Kabanov (Yaroslavl , Russia) Controversial points of Clinical Trials 16.30 General discussion Saturday, February 14th 2009 Vivahotel Alexander Meeting Hall Plenary Session VI - State of the Art Lectures 09.00 A. Zanchetti (Milan, I) How to interpret clinical Guidelines. Their implications, and new clinical evidence 09.20 P. Zagnoni (Ferrara, I) Critical evaluation of guidelines in the treatment of the epilepsies 09.40 V. Zaporozhan (Odessa, Ukraine) Сlinical trials in the context of Nooethics 10.00 Coffee break Vivahotel Alexander - Primavera Hall Parallel Session VII: “Latest Advances in Clinical Trials – Cardiology & Hypertension” President: G.F. Gensini (Florence, I) 10.30 C. Borghi (Bologna, I) How to manage hypertension in high risk patients: the evidence from clinical trials 11.15 N. Bulanova (Moscow, Russia) Stroke prevention in patients with atrial fibrillation 11.55 R. Abbate (Florence, I) New antiplatelet and anticoagulant drugs 12.40 N. Gorovenko (Kiev, Ukraine) Pharmacogenetics in the clinical trials 13.00 General discussion At the conclusion: Yong-Seok Lee (Seoul, South Korea) Antiplatelet Trial in Acute Ischemic Stroke: Feasibility of Non-inferiority Test (*) (*) Presented as a poster 13.15 Lunch Vivahotel Alexander - Venere Hall Parallel Session VIII: “Latest Advances in clinical trials – Endocrinology, Obesity and Bone Metabolism” President: R.G. Gheri (Empoli - Florence, I) 10.30 R.G. Gheri (Empoli – Florence, I) Endocrine clinical trials in internet 10.50 C.M. Rotella (Florence, I) Comparison among different pre-treatment predictors of weight loss in the medical treatment of obesity 11.20 M.L. Brandi (Florence, I) Osteoporosis: when clinical trials can last 10 years 11.40 A. V. Dreval (Moscow, Russia) Seven subtypes of diabetes mellitus revealed in IVGTT 12.00 J.G. Pokramovich (Moscow, Russia) Oktreotid-depot therapy of acromegaly with long action somatostatin analogue 12.20 N. Pertseva (Dniepropetrovsk, Ukraine) Problems in clinical trials in diabetic patients 12.40 General discussion 13.15 Lunch Vivahotel Alexander - Primavera Hall Session IX: “Latest Advances in Clinical Trials – Pulmonology & Asthma Treatment” President: M. Pistolesi (Florence, I) 14.30 P. Paggiaro (Pisa, I) Latest advances in clinical trials – pulmonology & asthma treatment 14.50 Y.I. Feshchenko (Kiev, Ukraine) Predicaments, which we collided in our practice during conducting of clinical trials 15.10 Z.R. Aisanov (Moscow, Russia) Major problems of clinical trials in respiratory medicine 15.30 T.V. Kobets (Simferopol, Crimea, Ukraine) Efficacy Polysim - 4 in children with recurrent bronchitis 15.50 T.A. Pertseva (Dniepropetrovsk, Ukraine) Patients with COPD: randomized clinical trials and patient’s adherence to the national and international treatment guidelines 16.10 L.A. Iashyna (Kiev, Ukraine) Ways of improvement of compliance during clinical trials with the use of modern technologies in patients with respiratory diseases 16.30 General discussion Vivahotel Alexander - Venere Hall Session X: “Latest Advances in Clinical Trials – Clinical Oncology” President: F. de Braud (Milan, I)) 14.30 F. Di Costanzo (Florence, I) Adjuvant treatment in early gastric cancer: yes or not? 15.00 E. Mini (Florence, I) Latest advances in the treatment of colorectal cancer: results from clinical trials and pharmacogenomic research 15.30 G. Fiorentini (Empoli - Florence, I) Integrated and locoregional approaches in oncology 16.00 N. Berdnikova (Moscow, Russia) Study of safety and efficiency of indol-3-carbinol (I-3-C) at benign breast diseases 16.30 General discussion __________________________________________________________ Premise of the conference: The meeting halls and show-rooms are at Vivahotel Alexander, Viale Guidoni, 101, in Florence. How to reach Vivahotel Alexander: - by car: Highway A1 or A11 “North Florence” Gate, about 1 km far from Florence airport, centre of Florence direction - by plane (Florence "A. Vespucci" Airport ): 800 mt from the Airport - by train (arrival to Santa Maria Novella Central Railway Station): then, city bus no. 22 (cost 1,20 Euro) from Piazza dell’Unità Italiana bus stop (in front of the Central Railway Station, opposite Santa Maria Novella Church), get off in Viale Guidoni, “Val di Sieve” bus stop Language of the conference: The official language will be English Participation at the conference: A. PARTICIPATION AS A SPEAKER Call for Abstracts Florentine East-West Medical Congress " Latest Advances in clinical trials - from clinical trial to clinical practice " welcomes the submission of abstracts for original contribution to the field. All abstracts submitted will go through a preview process carried out by an international review panel. Only abstracts that have been reviewed and accepted by the Scientific Secretariat will be presented. Guidelines • All abstracts must be written in English. • The participants interested in participating as a speakers are requested to fill out the Registration Form and send the abstract to the Scientific Secretariat (represented by Prof. Riccardo Gionata Gheri and Prof. Vladimir Popov ) and to the Organizing Secratariat. Only if the abstract is approved, the password to the participant-speaker for the abstract uploading will be sent. The confirmation of the acceptance of the abstract will be sent to the applier within 20 November 2008. The deadline for the payment of the participation fee and the abstract uploading is 25 January 2008. •It is the author’s responsibility to submit a correct abstract. Any errors in spelling, grammar or scientific fact will be reproduced as submitted by the author. The text should not exceed 4,000 characters, including blanks. One table or figure can be inserted allowing 500 characters per table / figure. The full address with telephone, fax numbers, and e-mail address of the corresponding author must be provided. The corresponding author will receive all the subsequent communication concerning the submitted abstract, preferably by e-mail. Notification of acceptance or rejection Notification of acceptance or rejection will be sent to the corresponding author. Please note that only the corresponding author will receive this email concerning the abstract and is responsible for informing all co-authors of the status of the abstract. Authors whose abstracts have been accepted will receive instructions for the presentation of their abstract. For registration and payment of the registration and accommodation fee it is possible to click here Rule of Two Each presenting author may present a maximum of two abstracts at the Conference. There is no limit to the number of abstracts that can be submitted by one author. Abstract categories The abstract categories are the general heading under which abstracts will be submitted and reviewed. Clinical Epidemiology - New Therapeutic Development in Cardiology - New Therapeutic Development in Oncology - New Therapeutic Development in Pulmonology - New Therapeutic Development in Endocrinology - Trial Conduct and Results in Cardiology - Trial Conduct and Results in Oncology - Trial Conduct and Results in Pulmonology - Trial Conduct and Results in Endocrinology - New Drug Targets in Cardiology - New Drug Targets in Oncology - New Drug Targets in Pulmonology - New Drug Targets in Endocrinology - Bioekvivalence Studies - Academic Health Centers/Investigator Sites - Clinical Trial Management / Clinical Supplies - Ethical Issues of Clinical Trials - Quality Assurance and Monitoring - Clinical Data Management - Patient Recruitment, Enrollment, and Retention - Clinical Research and Development - Clinical Safety and Pharmacovigilance - Good Clinical Practices - Regulatory Affairs - Statistics - Meta-Analysis - Medical Writing - Evidence-Based Medicines - Information Technology B. PARTICIPATION AS AN AUDITOR For registration and payment of the registration and accommodation fee please click here Registration at the conference Registration fee: 200,00 Euro. Registration will remain open until 25th January 2009. Fee includes: - welcoming cocktail on February 12th - lunch, 2 coffee breaks and dinner on February 13th - lunch, 2 coffee breaks and dinner on February 14th - full conference (badge of recognition, folder, program) - cultural visits to the main Florentine Museums (upon confirmation) Conference registration and payment: · By credit card - click here
(We accept the payments by credit card when the name of the Credit card holder is the same as the name of registered participant) · By bank transfer 1. Registration - click here 2. Payment by the bank transfer: IBAN code: IT 91 I 06160 02821 000915509C00, SWIFT code: CRFI IT 3F XXX Cassa di Risparmio di Firenze, Agenzia 21, Via Mugello 27 50 127 Firenze made out to: Fly Events srl “Fiorentine East West Medical Congress, Reg. Nr. …..” (please indicate the registration nr.) Via del Giglio n. 10 – 50123 FIRENZE – ITALIA Kindly send us the certificate of the money bank transfer by e-mail (info@promoflorenceevents.com) or by fax to the nr. +39 055 28 32 60 specifying the registration number, your name and the name of the event. PLEASE NOTE: all paid fees shall be net of all bank costs and commissions Accommodation 3 Night Hotel Packages, arrival on the 12th of February 2008 and departure on the 15th of February 2008 (on the bed with breakfast basis, price per person for 3 nights) The prices are valid until 30 December 2008
, after this date the prices can be changed and the hotel reservation will be possible on request by writing to info@promoflorenceevents.com. 4 stars hotel, in the conference site: - single room: 215 Euro - double single use room: 235 Euro - double room: 135 Euro (price per person) - triple room: 127 Euro (price per person) 3 stars hotel, conference area: - single room: 200 Euro - double single use room: 220 Euro - double room: 130 Euro (price per person) - triple room: 117 Euro (price per person) Hotel reservation and payment: · By credit card - click here (We accept the payments by credit card when the name of the Credit card holder is the same as the name of registered participant) · By bank transfer 1. Registration - click here 2. Payment by the bank transfer: IBAN code: IT 91 I 06160 02821 000915509C00, SWIFT code: CRFI IT 3F XXX Cassa di Risparmio di Firenze, Agenzia 21, Via Mugello 27 50 127 Firenze made out to: Fly Events srl “Fiorentine East West Medical Congress, Reg. Nr. …..” (please indicate the registration nr.) Via del Giglio n. 10 – 50123 FIRENZE – ITALIA Kindly send us the certificate of the money bank transfer by e-mail (info@promoflorenceevents.com) or by fax to the nr. +39 055 28 32 60 specifying the registration number, your name and the name of the event. PLEASE NOTE: all paid fees shall be net of all bank costs and commissions Cancellation policies: The cancellations of the registration fees and hotel packages carried out before November 10 2008 will be reimbursed with a 70 Euro deduction for secretarial costs. After this date no reimbursements will be possible, unless the cancellation is for a visa problem. In this case 50% of the paid amount will be reimbursed. Any reimbursement will be given at the end of the congress and will be realised by the bank transfer for which IBAN and SWIFT code are necessary. In certain cases reimbursements by any other mean will be given; however, all the expenses of the transfer will be paid by the applicant. Letter of invitation If you require an official letter of invitation in order to attend the conference, please write to the organising secretariat at info@promoflorenceevents.com. The letter will assist delegates who need to obtain their governments or departments permission to attend the conference or obtain required visa from Italian consulate abroad. Delegates from countries within the European Union / Schengen Area will only need a valid passport or ID to travel to Italy. All other delegates should contact the nearest Italian embassy or consulate for visa details Certificate of attendance All participants will be issued a certificate of attendance at the close of the conference. ECM Credits 8 ECM credits are available for the participants Insurance The organisers bear no responsibility for untoward events in connection with, before, during and after the conference. Participants are strongly advised to take out their own personal and travel insurance coverage. Sponsoring Florentine East-West Medical Congress Latest Advances in clinical trials - from clinical trial to clinical practice is welcoming all sponsors working in the field. If some pharmaceutical Industries are interested in giving a contribution or participating in the conference please contact:info@fondazione-delbianco.org Organising Secretariat Promo Florence Events Promotion and Organization of Events Art-Culture-Science Palazzo Coppini Via Del Giglio 10 50123 Firenze, Italy Tel. +39 055 285588 Fax. +39 055 283260 Email info@promoflorenceevents.com www.promoflorenceevents.com

 
Papers presented


Prof. Dorofeyev Andrey
Donetsk National Medical University - Donetsk (Ukraine)


Mr. FILIPPO DE BRAUD
ISTITUTO EUROPEO DI ONCOLOGIA - MILANO (ITALY)


Prof. Alexander Dreval
MONIKI - Moscow (Russia)


Prof. Yuriy Feshchenko
National Institute of Phthisiology and Pulmonology named after F.G. Yanovsky - Kiev, (Ukraine)


Prof. Natalia Gorovenko Gorovenko
National Medical Academy of Postgraduate Education - Kiev (Ukraine)


Prof. Liudmyla Iashyna
State organization "National Institute of Phthisiology and Pulmonology named after F.G. Yanovsky AMS of Ukraine" - Kiev (Ukraine)


Dr. Nizhenkovska Iryna
SPhC - Kyiv (Ukraine)


Dr. Andrey Kabanov
Yaroslavl State Medical Academy - Yaroslavl (Russia)


Prof. Tetyana Kobets
Crimean State Medical University - Simferopol (Ukraine)


Prof. Ganna Lisova
Regional Clinical Centre of Urology and Nephrology - Kharkiv (Ukraine)


Mrs. Berdnikova Nadyia
Clinical Pharmacology Department of the Scientific Centre of Biomedical Technologies, 23# Hospital Medsantrud - Moscow (Russia)


Dr. BULANOVA NATALIYA
EDUCATIONAL RESEARCH MEDICAL CENTRE MANAGEMENT DEPARTMENT ON THE PRESIDENT OF THE RUSSIAN FEDERATION - MOSCOW (RUSSIA)


Dr. Vladimir Nelyubin
Central Hospital № 6 of Russian Railways - Moscow (Russia)


Prof. Tetyana Pertseva
DSMA - Dnipropetrovsk (Ukraine)


Dr. Nataliia Pertseva
Dnepropetrovsk State medical academy - Dnepropetrovsk (Ukraine)


Dr. Julia Pokramovich
Julia Pokramovich - Moscow (Russian Federation)


Dr. Vladimir Popov
Central Hospital ¹ 6 - Moscow (Russia)


Prof. Irine Sarvilina
Medical Centre "Novomedicina" - Rostov-on-Don (Russia)


Dr. Olga Verstakova
Institute of Pre-clinical and Clinical Expertise of Drugs Scientific Center on Expertise of Medical Application Products - Moscow (Russia)


Prof. Oleksii Viktorov
National Scientifical Center “Institute of Cardiology by name of acad. N.D. Stragesko” AMSc Ukraine - Kyiv (Ukraine )


Prof. Valeriy Zaporozhan
Odessa State Medical University - Odessa (Ukraine)


Prof. Ayasnov Zaurbek
Pulmonology Research Institute - Moscow (Russia)