Project Leader:
Dr. 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

To contacting the Project Leader, please write to: vpopov@esmar.com.ua or
clinpharmcb6@mail.ru

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 and hundreds of drugs are developed each year, touching off intense competition for test subjects. The US & EU are actively involved in Clinical Trials so the perspectives of the market widening are limited now. Each day's delay getting a major drug to market costs $1.3 million in unrealized sales, by 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 CEE and CIS region. One advantage is that we can find drug naïve population which is ideal for Clinical trials.
In great multi-national studies it is usual that CEE countries are 2-4 months ahead of patient recruitment schedule and many Italian companies are initiating rescue projects in CEE if the patient recruitment of their ongoing US-based or Western European trial fails 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, 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 There is an abundance of high quality investigational sites in CEE because the number of teaching hospitals, university clinics and postgraduate medical schools is high. More practitioners 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 Western European counterparts.
Salaries in the region's healthcare sector are incredibly low in comparison with Italy 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 in to 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.

Florence Scientific Committee
Chairman: Prof. Gian Franco Gensini
Dr. Riccardo Gionata Gheri

Programme Committee (alphabetic order):
Dr. Natalia Bulanova Moscow, Russia
Prof. Filippo De Braud, Milan, Italy
Prof. Gian Franco Gensini, Florence, Italy
Dr. Riccardo Gionata Gheri Florence, Italy
Dr. Paolo Morelli, Verona, Italy
Dr. Vladimir Popov , Moscow, Russia
Dr. Zerbini Oriana, Verona, Italy

Programme:
Day 01 - Thursday, April 3rd 2008
Registration
Welcome and introduction
Romualdo Del Bianco Foundation

Day 02 - Friday, April 4th 2008

BREAKFAST WORKSHOP
Country Updates on Clinical Trial Regulations and Compliance. Current regulatory requirements for clinical trials. Healthcare System reform and clinical trials (Italy, Ukraine, Russia, Poland)
Speakers: a representatives of the Italian, Russian, Ukrainian MOH

STATE-OF-THE-ART LECTURE

Update on European Clinical Trials
Directive and ICH GCP European Union’s Clinical Trials Directive

PLENARY SESSION I
Statistics and Data Management

PLENARY SESSION II
Clinical Safety & Pharmacovigilance

Lunch

POSTER PRESENTATION
Will be selected among the abstracts submitted by participants. There will be a poster session during lunch-time of each day from 12.30 to 15.30 hrs. During that time posters should be attended by the Authors.

PLENARY SESSION III
Drug Discovery and New Technologies

Workshop: How to Initiate and Manage Clinical Trials in CEE ( Russia, Ukraine, Poland): Regulatory, Operational and Clinical Challenges CRO and sponsor experience.

Questions and Discussion

Day 03 – Saturday, April 5th 2008

BREAKFAST WORKSHOP
New international clinical Guidelines in 2007

STATE-OF-THE-ART LECTURE
How to interpret clinical Guidelines. Their Implications, and New Clinical Evidence.

PLENARY SESSION I
Latest Advances in clinical trials – Cardiology

PLENARY SESSION II
Latest Advances in clinical trials – Endocrinology

Lunch

POSTER PRESENTATION
Will be selected among the abstracts submitted by participants. There will be a poster session during lunch-time of each day from 12.30 to 15.30 hrs. During that time posters should be attended by the Authors.

PLENARY SESSION III
Latest Advances in clinical trials – Pulmonology

PLENARY SESSION IV
Latest Advances in clinical trials – Oncology

Satellite Symposia

Questions and Discussion

day 04 – Sunday, April 6th 2008
Departure

The official language will be English

Registration at the conference:
Participants are requested to fill up the Registration Form
Once the form completed and sent, then they will receive on line a password for uploading their abstract on the web page.
Finally, the participants are requested to proceed with the payment of the fee and accommodation; here below are the economic condition.

Payment of the Participation Fee and Accommodation:
click here
DEADLINE FOR PAYMENT OF THE PARTICIPATION FEE AND ACCOMMODATION: MARCH 10, 2008
For every question about the economic aspects, payment and accommodation, mail here
(organization by Promo Florence Events Srl)

Registration Fees:
195 Euro, which covers:
- welcome dinner on April 3rd
- lunch, 2 coffee breaks and dinner on April 4th
- lunch, 2 coffee breaks and dinner on April 5th
- cultural visits to the main Florentine Museums (upon confirmation)

Accommodation(*):
4 stars hotel, conference area:
- single room: 250 Euro
- double single use room: 310 Euro
- double room: 165 Euro
- triple room: 155 Euro
3 stars hotel, conference area:
- single room: 205 Euro
- double single use room: 250 Euro
- double room: 140 Euro
- triple room: 125 Euro
(*) prices are par person, for 3 nights


Important deadlines:
10 March 2008 Registration
10 March 2008 Hotel accommodation
10 March 2008 Abstract submission

Premise of the conference
The meeting halls and show-rooms are on Vivahotel Alexander in Florence.
How to reach:
- 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

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 peer-review process carried out by an international review panel.
Only abstracts that have been reviewed and accepted by the Conference Committee will be presented
Deadline for submission: 10 March 2008

Guidelines
• All abstracts must be written in English.
• The deadline for abstract submission is March 10, 2008. Abstracts will not be accepted after this date.
• All abstracts must be submitted online through the conference website, after completing the registration and received the password by the project leader. Abstracts sent by fax, post will not be considered. 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 by the end of March 2008. 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.


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

Contacts
Organising secretariat (programme, registration, invitation letters, visa application, abstract submission)
Dr. Simone Giometti
ROMUALDO DEL BIANCO FOUNDATION
Headquarters: Palazzo Coppini - Via del Giglio n. 10 - 50123 FLORENCE - ITALY
Phone: + 39 055 216066
Fax: + 39 055 283260
E-Mail: :info@fondazione-delbianco.org

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@fondazione-delbianco.org

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.


Final Program
The Final Program will be available on-site.


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 you are interested in becoming a sponsor please contact:info@fondazione-delbianco.org


The conference will be realised upon the achievement of the participation of 50 persons at March 10, 2008

for other information click here