9th Annual Biomarkers Congress
Clinical Trials for Special Populations
Danubius Hotel
Regents Park,18 Lodge Road, St.John's Wood
London, UK
http://www.informa-ls.com/populations
Clinical Trials for Special Populations
http://www.informa-ls.com/populations
Danubius Hotel
Regents Park
London
UK

Schedule of Presentations:

Wednesday, January 28, 2009
08:15:00 Registration and morning coffee
08:50:00 Opening remarks from the Chairperson
09:00:00 Writing a successful protocol for clinical trials in special populations Tobias Suiter
09:00:00 Designing Effective Protocols for Clinical Trials for Special Populations
09:35:00 Using study start up groups to perform an effective feasibility study
10:10:00 Morning coffee and networking break
10:50:00 Utilising biomarkers to identify the population with benefit David Wilson
11:25:00 Biomarkers in oncology clinical trials Chee Gee See
12:00:00 Ensuring Safety in Clinical Trials for Special Populations
12:00:00 Special provisions to ensure safety in paediatric clinical programmes Philippe Auby
12:35:00 Lunch
14:00:00 Special safety considerations for trials in the elderly population Assem S el Baghdady
14:35:00 Special considerations for trials for renally and hepatically impaired patients Jurgen Borlak
15:10:00 Afternoon tea and networking break
15:45:00 Successfully translating a trial from the general population to a special population: Obesity Cyrus Ghobadi
16:20:00 Disease system dynamics: estimating disease progression and disease modification in type 2 diabetes patients using a mechanism-based modelling approach Willem de Winter
16:55:00 Panel discussion on ensuring safety in clinical trials for special populations
17:15:00 Closing remarks from the Chairperson
17:20:00 End of day one
Thursday, January 29, 2009
08:55:00 Opening remarks from the Chairperson
09:00:00 Tried and Tested Practices for Operations and Recruitment
09:00:00 Recruitment strategies for paediatric studies Matthew Peak
09:35:00 Working with paediatric populations: A case study Hartwig Gajek
10:10:00 Morning coffee and networking break
10:45:00 Study population selection in the elderly population: Considerations on patient inclusion, exclusion, compliance and ethics
11:20:00 Successful alternatives: A case study contrasting two different, but successful, strategies generating sufficient data from an elderly population to permit licensure of novel antiviral treatments for influenza Penelope Ward
11:55:00 Spotlight session
12:25:00 Panel discussion on addressing the operational hurdles involved with carrying out clinical trials in special populations
12:40:00 Networking lunch
14:00:00 Legal Regulatory and Ethical Issues Affecting Clinical Trials for Special Populations
14:00:00 Successfully navigating the ethics committee Adrian Liepins
14:35:00 Implementing the paediatric regulation in a pharmaceutical company David G McIntosh
15:10:00 Afternoon tea and networking break
15:40:00 Feedback from the regulators on the paediatric regulation and the first PIP submissions Jacqueline Carleer
16:15:00 Informed consent in clinical trials with minors and incapacitated adults
16:50:00 Closing remarks from the Chairman
16:55:00 End of conference
4th Annual Pharma R&D Asia Congress
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