Project Leader :

Prof. Gian Franco Gensini
(Florence Faculty of Medicine, Italy)
Prof. Riccardo Gionata Gheri
(Florence University Careggi Hospital, Italy)
Dr. Vladimir Popov
(Department of Cardiology Moscow Medical Academy named after Sechenov, Head of Clinical Pharmacology, Central Hospital ? 6 of Russian Railways, Moscow, Russia)

Description:

An average of 4,000 people are needed to test a new drug before it can be sold in Italy. According to several studies, hundreds of drugs are developed each year, creating intense competition for test subjects. The US & EU are actively involved in Clinical Trials; therefore, the hopes for a widening market are now limited. Each day's delay getting a major drug on the market costs $1.3 million in unrealized sales, according to industry estimates.
In this case, Eastern European countries are now more attractive for Western Pharmaceuticals Companies.
Several factors influence the decision to conduct phase II & III Clinical Trials in the CEE and CIS regions. One advantage is that we can find drug naïve populations, which are ideal for Clinical trials. In great multi-national studies, it is usual that CEE countries are 2-4 months ahead of their patient recruitment schedule, and many Italian companies are initiating rescue projects in the CEE in the case that their patient recruitment of their ongoing US-based or Western European trials fail to meet the requirements/goals. The great recruitment performance of the CEE countries is maintained by many factors: wide availability of naive (untreated) patients, lack of, or insufficient availability of, preventive medicine, and shortage of available therapy. Although all CEE countries have adopted European (EU) guidelines, the reality forces physicians to use what is available rather than what is recommended by recent science. Patient willingness to participate in clinical trials is necessary. There is an abundance of high quality investigational sites in the CEE because the number of teaching hospitals, university clinics, and postgraduate medical schools is high. More practitioners in the CEE are employed by teaching hospitals and university clinics than in Western Europe. GCP guidelines are fully implemented (GCP training of the investigators is required by the regulatory authority.) As the result of high scientific standards, FDA inspections reported fewer findings of violations in CEE trial sites than in its Western European counterparts. Salaries in the region's healthcare sector are incredibly low in comparison with Italian salaries. Therefore, the investigator fee represents a significant income for CEE physicians. Investigators are motivated by more than just the financial reward to take part in a clinical trial and perform well. Co-operating with Italian companies in scientific research is a sign of merit - it is well known that only the best candidates are selected. Because of the great development experienced in the past decade, many physicians and pharmacists are willing to work in the pharmaceutical industry, using their expertise in clinical research. The highly regarded academic and industrial training programs of the CEE region produce a valuable human resource pool for research professionals.
The main purpose of the conference is to join and link into one event
1) European Pharma Industry - who is doing clinical trials and research with new compounds
2) Regulatory from Italy, Russia, Ukraine and some other CEE countries
3) Researchers and investigators from Italy, Russia, Ukraine and CEE countries who participate in these trials
4) Medical doctors from Italy and CEE who are using these Italian medications in real clinical practice in clinics

The conference will provide a forum for people responsible for managing European clinical trials at the institutional level to discuss and work through the various challenges they face in their work in a supportive environment with peers and colleagues. Particular emphasis will be placed on the practicalities of ensuring patient safety by adhering to Good Clinical Practice (GCP) whilst complying both with "local", national, and European legislation.

Scientific Secretariat:
Prof. Gian Franco Gensini
(Florence Faculty of Medicine, Italy)
Prof. Riccardo Gionata Gheri
(Florence University Careggi Hospital, Italy)
Dr. Vladimir Popov
(Department of Cardiology Moscow Medical Academy named after Sechenov, Head of Clinical Pharmacology, Central Hospital ? 6 of Russian Railways, Moscow, Russia)

Programme:

(Preliminary programme - updates and modifications are still possible. All the meetings will be held at Vivahotel Alexander )

Thursday, February 12th 2009
Vivahotel Alexander Meeting Hall
h. 16.00: Registration
h. 18.00: Welcome and introduction by the promoting organizations
Romualdo Del Bianco Foundation
Florence Faculty of Medicine
h. 19.00: Welcome cocktail

Friday, February 13th 2009
Vivahotel Alexander - Meeting Hall
h. 9.00 - 10.50: PLENARY SESSION I
h. 9.00 - 10.10: Breakfast workshop: Country Updates on Clinical Trial Regulations and Compliance (Russia, Italy, Ukraine)

h. 9.15 - 9.30: Russia
Clinical trials in Russia in 2007
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 trials?

h. 9.35 - 9.50: Italy
Clinical trials in Italy in 2007
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 trials?
Italian Healthcare System

h. 9.55 - 10.10: Ukraine
Clinical trials in Ukraine in 2007
Overview of Ukrainian drug law
Current regulatory requirements for clinical trials

h. 10.15 - 10.45:STATE-OF-THE-ART LECTURE:
Update on European Clinical Trials Directive and ICH GCP European Union's Clinical Trials Directive

h. 10.50 - 11.20: coffee break

Vivahotel Alexander - Primavera Hall
h.11.30 - 13.00:SESSION II: Statistics and Data Management
Electronic Trial and Document Management
Statistical Planning - Hypothesis Formulation & Sample Size
Statistical and Data Management Issues in Respiratory and Cardiovascular Drug Development
Developing a Protocol for a Randomised Controlled Trial
Statistical Planning - Hypothesis Formulation & Sample Size

Questions time

Vivahotel Alexander - Venere Hall
h.11.30 - 13.00:SESSION III: Clinical Safety & Pharmacovigilance
Pharmacovigilance - beyond 2007
Clinical Safety in Clinical Trials: The New EU Directive and Guidance
Pharmacovigilance and adverse event reporting
The management of adverse drug reactions: from diagnosis to signals.
WHO Programme for International Drug Monitoring

Questions Time

13.15 - 14.15: Lunch break

Vivahotel Alexander - Meeting Hall
h. 12.30 - 15.30: POSTER PRESENTATION
Will be selected among the abstracts submitted by participants. There will be a poster session during lunch-time of each day . During that time posters should be attended by the Authors.

Vivahotel Alexander Primavera Hall
h. 14.30 - 16.00: SESSION IV : Drug Discovery and New Technologies

Vivahotel Alexander - Venere Hall
h. 14.30 - 16.00: SESSION V - Workshop: How to Initiate and Manage Clinical Trials in UE (: Regulatory, Operational and Clinical Challenges CRO and sponsor experience.
CEE is emerging as an increasingly interesting and attractive place to conduct clinical trials. However, the industry still has more questions than answers about the regulatory, customs, and operational environment in this region. This workshop will provide an introduction and practical advice about the initiation and management of clinical trials in CEE and how to take advantage of the benefits this region offers and how to overcome the challenges and obstacles. Issues to be covered:
Attractiveness and difficulties of running Clinical Trials in CEE
FDA and EMEA acceptance of data from CEE
Quality of data from CEE
Patient recruitment - feasibility and recruitment
Monitoring and auditing trials in CEE
Logistics and customs issues.
GCP compliance

Questions and Discussion

h.17.00: possibility of visiting the Uffizi Gallery offered by the Romualdo Del Bianco Foundation (under confirmation)


Saturday, February 14th 2009
Vivahotel Alexander Meeting Hall
h. 9.00 - 10.00: PLENARY SESSION VI - STATE-OF-THE-ART LECTURE: How to interpret clinical Guidelines. Their Implications, and New Clinical Evidence.

h. 10.00 - 10.30: coffee break

Vivahotel Alexander Primavera Hall
h. 10.30 - 13.00: SESSION VII: Latest Advances in clinical trials - Cardiology & Hypertension

Vivahotel Alexander Venere Hall
h. 10.30 - 13.00: SESSION VIII: Latest Advances in clinical trials - Endocrinology, Obesity and Bone Metabolism

13.30 - 14.20: Lunch break

Vivahotel Alexander Meeting Hall
h. 12.30 - 15.30: POSTER PRESENTATION
Will be selected among the abstracts submitted by participants. There will be a poster session during lunch-time of each day. During that time posters should be attended by the Authors.

Vivahotel Alexander Primavera Hall
h. 14.30 - 17.00: SESSION IX: Latest Advances in clinical trials - Pulmonology & asthma treatment

Vivahotel Alexander Venere Hall
h. 14.30 - 17.00: SESSION X: Latest Advances in clinical trials - Clinical Oncology

h.18.00: possibility of visiting the Accademia Gallery (David of Michelangelo) offered by the Romualdo Del Bianco Foundation (under confirmation)

Sunday, February 15th 2009
Departure or post conference tour (upon request)

___________________________________________________________

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 10 December 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
Reduced registration fee until 10 December: 200,00 Euro
Full registration fee from 11 December 2008: 215,00 Euro

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
- 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 10 November 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

IMPORTANT DEADLINES:
10 November 2008 Abstract submission - Confirmation of the acceptance of the abstract within 20 November
10 November 2008 Special prices for the hotel reservation
10 December 2008 Registration with the payment of reduced registration fee
10 December 2008 Abstract uploading

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.

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