Title:
4th Annual Clinical Forum 2010
Date(s) And Time(s):
Oct 11 2010 7:00AM - Oct 13 2010 12:00PM
Location:
Lisboa Congress Center
Praça das Industrias
1300-307 Lisboa
PORTUGAL
Interest Area(s):
Clinical Research,Clinical Safety/Pharmacovigilance,Clinical Data Management/ eClinical,Quality Assurance/Quality Control,Statistics,IT/Validation,Medical Communications
Overview:
Dear Friends and Colleagues,
I have great pleasure in inviting you to participate in the DIA 4th Annual Clinical Forum 'Navigating the Future' from 11-13 October 2010, in Lisbon, Portugal.
From the 14th to 17th century Portugal led the Old World in navigating to seek new and exciting expansion opportunities. Emerging from a global recession is an opportune time to contemplate how strategically and operationally we can successfully navigate clinical development through 2010 and beyond.
The 1755 Lisbon earthquake, a catastrophic human disaster throughout Portugal and Northern Africa was one of the key drivers of the philosophy of enlightenment, thinking beyond Man and God. We saw another example in the recent volcanic eruption in Iceland which has and is having an impact on how we do business today in an eClinical world. We invite you to join us to seek enlightenment in the best strategies, processes and technologies to navigate clinical development through the first half of the 21st century.
We received an exciting mix of abstracts to support clinical research professionals from a variety of disciplines including:
• Clinical Data Management/eClinical
• Clinical Operations
• Clinical Research
• Peri- and Post-Approval Studies
• Drug Safety and Risk Management
• Quality Assurance
• Clinical Endpoints
• e-Technology and Validation
• Medical Information and Communications
There will also be several structured tutorials and workshops including one specifically for the future of regulatory clinical trial environment.
The Programme Committee decided to continue with the Clinical Forum tradition of the successful plenary debate. This year’s provocative topic will be of great interest to our audience: ‘This House Believes that Increasing Bureaucracy Is Killing the Future of Clinical Trials’. Eloquent presenters will defend and oppose this claim while the audience has an opportunity to actively participate.
With many networking opportunities we anticipate this event to be the conference for clinical operations professional within Europe in 2010.
We look forward to seeing you in Lisbon in October.
Julianne Hull
Programme Chair
Pfizer, UK
Target Audience:
Professionals at all levels in the following disciplines:
• Clinical Data Management
• eClinical
• Clinical Research
• Clinical Operations
• Post Marketing development
• Medical Information & Communications
• Clinical Safety & Pharmacovigilance
• Personal Development
• Validation
• Quality Assurance
Event Code:
10103
Contact Information:
DIA EUROPE
ELISABETHENANLAGE 25, POSTFACH
4002 BASEL, SWITZERLAND
PHONE: +41 61 225 51 51
FAX: +41 61 225 51 52
E-MAIL: DIAEUROPE@DIAEUROPE.ORG
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Disclosure Policy:
It is Drug Information Association policy that all faculty participating in continuing education activities must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Faculty disclosures will be included in the course materials.
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 | Networking Dinner Buffet |
| Date & Time:
Tuesday, Oct 12 2010 6:30PM - 9:00PM
Description:
The Clinical Forum will offer delegates the opportunity to build business relationships and expand their professional contacts at social and networking events while enjoying excellent local food and wine.
Gain new perspectives, exchange ideas and generate new clients from one-on-one discussions with speakers, exhibitors and fellow delegates from various industry sectors and over 20 countries. Explore the latest technologies on the exhibit floor and connect with colleagues from the industry, government and academia.
From refreshment and coffee breaks to interactive working lunches, evening receptions and an optional networking dinner at a unique venue, the Clinical Forum’s planned schedule of social and networking events offers something for
everyone.
Networking Buffet Dinner
Tuesday, 12 October 2010
18:30 - 21:00
The Networking Buffet Dinner will take place in the Lisboa Congress Centre, which is situated in close vicinity to the beautiful Tagus River. Enjoy the pleasant view of the riverside while partaking of the culinary specialties of Portuguese cuisine.
This is an optional event and is not included in the registration fee. Tickets are available for € 36.00 including VAT.
Typically over 90% of conference participants attend the Networking Dinner. Places are limited and on a first come first served basis. Please secure your place as early as possible.
To register please click here
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| Tutorial:CDISC STANDARDS: DETAILING THE DATA FLOW |
| Date & Time:
Monday, Oct 11 2010 9:00AM - 12:30PM
Instructor(s):
Pierre-Yves Lastic, DrSc
Senior Director, Data Privacy & Healthcare Interoperability Standards
sanofi-aventis, France
Stephen E. Wilson, DrPH
Director, Division of Biometrics III, CDER
FDA, United States
Description:
This tutorial will describe the CDISC standards (SDTM, ODM, ADaM,LAB, define XML and protocol), demonstrating how the models can be leveraged to achieve the true eClinical trial. The tutorial will detail, at a practical level, the flow of information using the standards from protocol setup through data capture, analysis and onwards to submission.
Learning Objectives:
At the conclusion of this tutorial, participants should be able to:
• Discuss the basics of the SDTM, ODM, define .xml, LAB and ADaM standards.
• Explain the CDISC standards and their value to eClinical trials.
• Describe the data flow, using the CDISC standards, from clinician to submission.
• Explain how to leverage the standards to improve regulatory compliance.
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| Tutorial 2:EDC AND ePRO PRACTICES |
| Date & Time:
Monday, Oct 11 2010 9:00AM - 12:30PM
Instructor(s):
Jonathan R. Andrus, MS
Vice President, Data and Study Operations
BioClinica, Inc., United States
Bryan McDowell,
Clinical Trial Head, Dermatology, Gastroenterology,Urology Therapeutic Area
Novartis Pharma AG, Switzerland
Description:
Electronic Data Capture (EDC) and Electronic Patient Reported Outcomes (ePRO) tools are routinely used in hundreds of clinical trials each day. More sponsors are choosing EDC and ePRO as either an alternative, or a complement, to paper-based clinical trials.
This will be an interactive tutorial that will look at the many aspects of EDC and ePRO that are particularly important from a data management & clinical trial management viewpoint. From an interactive standpoint, tutorial participants will be provided with case studies that they will be asked to explore together in groups. The intention of these case studies is to help the participant better understand the subject and apply best practice techniques using a real world case study.
EDC and ePRO will be explored in terms of data management & clinical trial activities pertinent during the Study Start, Conduct, and Study Closeout phases of a clinical trial. In particular:
• Deployment considerations
• Data integration of EDC and non-EDC sources
• SOP considerations
• Planning for the unplanned
• How to prepare your organisation to execute a trial in EDC and ePRO
• Training considerations
• Managing change in EDC and ePRO studies
• Partnering with clinical research to get the most efficiency during data clean-up and lock from using EDC and ePRO
• Data archival considerations
Learning Objectives:
At the end of this tutorial participants should be able to:
• Understand best practices related to the implementation, management and close out of EDC and ePRO studies
• Understand how to apply some of these best practices through interactive group exercises
• Be better prepared to effectively manage technology-based clinical trials
Target Audience:
All individuals involved in the organisation and management of clinical trials.
This includes:
• Clinical project managers
• Clinical data managers
• Clinical quality assurance professionals
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4th Annual Clinical Forum
Lisbon 2010
Fee: 3m x 3m booth space......... EUR 4'235 (includes 21% Portuguese VAT)
Booth Rental Fee includes (per 3m x3m booth space):
• One (1) complimentary full-meeting registration;
• Two (2) complimentary exhibit booth personnel registrations;
• Pre-fitted shell scheme booth structure;
• Fascia board with 25 character company name;
• One (1) electrical connection;
• Three (3) Spotlights;
• One (1) table;
• Two (2) chairs;
• One (1) wastebasket
Additional expenses associated with the exhibit, including special booths, drayage, additional lighting, phone, internet connection, carpeting, additional electrical connections, etc., will be the responsibility of the exhibitor, unless otherwise noted. Any additional staff required above those allocated per 3m x 3m space must register as a full attendee incurring full registration fees.
Exhibit Show Dates:
11-13 October 2010
Installation: 10-11 October 2010
Lisboa Congress Centre
Lisbon, PORTUGAL
DIA Contact Information:
Natacha Scholl
Exhibits Manager, Europe
+41 61 225 51 59
Natacha.Scholl@diaeurope.org
Useful Links:
• Application & Contract for Exhibit Space
• Floor Plan
• Exhibitor Services Kit
Exhibiting Companies:
| Amedon GmbH & PharmaForms GmbH |
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| Aris Global |
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| Averion International Corp |
| MA ,
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| C3i, Inc. |
| NJ ,
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| clinIT AG |
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| CRF Health |
| PA ,
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| DATATRAK International |
| TX ,
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| ERT |
| NJ ,
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| Guy's St. Thomas NHS Foundation Trust |
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| IntraLinks, Inc. |
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| invivodata |
| PA ,
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| Medidata Solutions Worldwide |
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| NNIT |
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| OmniComm Europe GmbH |
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| Online Business Applications |
| IL ,
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| PAREXEL International |
| MA ,
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| Perceptive Informatics, Inc |
| MA ,
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| Pharma Consulting Group AB |
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| Phastar Pharmaceutical Services |
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| PHT |
| MA ,
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| RPS, Inc. |
| PA ,
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| TechTeam Global NV/SA |
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| Vitalograph |
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| Woodley Equipment Company |
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| XClinical GmbH |
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DIA has blocked a number of rooms at special rates and conditions in the hotels .
For detailed information including varied booking deadlines please click here to access the Clinical Forum website > Hotel/Travel Information > Hotel information
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Meeting
| Member Standard (+ 21 % VAT) | €1365.00 | | NonMember Standard (+ 21 % VAT) | €1480.00 | | Member Academia (+ 21 % VAT) | €1024.00 | | NonMember Academia (+ 21 % VAT) | €1139.00 | | Member Government (+ 21 % VAT) | €683.00 | | NonMember Government (+ 21 % VAT) | €798.00 | | One Day Rate Member Government (+ 21 % VAT) | €410.00 | | One Day Rate Member Industry (+ 21 % VAT) | €819.00 | | One Day Rate Member Academia (+ 21 % VAT) | €614.00 | | One Day Rate NonMember Academia (+ 21 % VAT) | €729.00 | | One Day Rate NonMember Government (+ 21 % VAT) | €525.00 | | One Day Rate NonMember Industry (+ 21 % VAT) | €934.00 |
Additional Offerings:
| Networking Dinner Buffet - Standard Rate | €30.00 | | Tutorial:CDISC STANDARDS: DETAILING THE DATA FLOW - Standard Rate | €250.00 | | Tutorial 2:EDC AND ePRO PRACTICES - Standard Rate | €250.00 |
Group Discounts:
Group Discounts Available – Send 3 participants and the 4th is free!
Conditions apply. Online registration not available for this offer. Call DIA in Europe on +41 61 225 51 51 or email for further information.
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