Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 01 May 2008
The first article in this series discussed the phase 1 clinical trial reviewed and cleared by the UK Medicines and Healthcare products Regulatory Agency (MHRA) that nevertheless resulted in six research subjects suffering life-threatening injuries.
It is crucial that the lessons learned from this tragedy result in practical operational changes within the pharmaceutical industry, especially in the small company setting where pressures to move compounds through the development pathway quickly are tremendous. This article examines the lessons that must be learned from this experience. Part 3 will examine the role of risks, the research subject and the part that can be played by regulatory professionals in ensuring that research subjects are adequately informed and consented before participating in clinical trials.
Regulatory Focus newsletters
All the biggest regulatory news and happenings.