VCI partners for cGMP e-learning
SyberWorks is collaborating with the Validation and Compliance Institute (VCI) to provide FDA compliance training, including a programme covering cGMP production.
Archives for January 14, 2010
Lonza to close Riverside API plant
Lonza will shut down its API plant in Riverside, Pennsylvania, US by the end of the year as part of a plan to cut costs and shift small-molecule production to Asia.
Cambridge Consultants “invaluable” in deal says Consort Medical
Cambridge Consultants (CC) says experience developing auto-injector technologies was critical to its contract appraisal work during Consort Medical’s £16.8m (€11.5m) takeover of The Medical House (TMH).
Rise of multi-site trials prompts FDA guidance on IRBs
The FDA has issued draft guidance detailing the information that should be submitted to an IRB as part of the continuing review of a clinical trial, with particular emphasis placed on the rise of multi-site studies.
Adaptive methods can improve personalised medicine trials; CEO
Conducting trials in smaller patient populations when developing personalised medicines poses challenges, such as how to recruit patients fast enough, but these can be overcome using adaptive methods, according to a CEO.