In global drug development, supportive trials -- such as those in special patient populations -- are required to complement the regulatory submission package. Studies in hepatically or renally impaired patient populations are therefore often performed in parallel to Phase III trials in order to have them completed when the NDA is filed. However, in aging populations with reduced organ function, these studies can provide valuable information on interpretation of clinical data generated in Phases II and III.

In this audio conference, the speaker discusses the strategic and organizational aspects of these trials, while providing a deeper understanding of their value in special patient populations.

This audio conference covers:

• The organizational aspects of special population trials
• Assessing the value of trials in special populations
• Strategic considerations on when to perform these trials
• Differences between American and EU guidelines, and their consequences

About the speaker:

Dr. Christian Reh has more than 20 years of early drug development experience in the pharmaceutical and CRO industries. Since 2000 he has overseen all scientific and operational aspects of PRA's Early Development Unit in Central and Eastern Europe, which focuses on Phase I/early Phase II trials in a variety of different patient populations.

Dr. Reh has held several positions as project manager, investigator, scientific director, chief scientific officer and chief medical officer at major clinical pharmacology units in Europe. During this time, he gained international management experience working in the UK for several years. Dr. Reh has performed approximately 500 early phase trials, brought nearly 45 drugs first into man, and approximately 20 drugs first into patient.

Who should attend?

• Heads of Clinical Development
• Clinical Trial Managers
• Regulatory Affairs Directors/Managers
• Outsourcing Managers

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.