by Matt Foor | Apr 24, 2012
The next RAPS Indiana Chapter meeting has been scheduled for May 14th, 2012 from 4:00-6:00PM at IUETC Ice Miller Room. Please save the date for this discussion. Jody Roth will be speaking about “Key Regulatory Trends in 2011 Biological Approvals.” To...
by Matt Foor | Apr 24, 2012
In its biosimilars advice document, the EMA answers 43 questions about the process for approving biosimilars. Part of this process includes biosimilar GMPs (good manufacturing practice) as well as inspection requirements in Europe. For facilities located outside of...
by Matt Foor | Apr 23, 2012
Pearl Pathways is excited to announce the recent hiring of J. Ellen Looney as an IRB administrator. Ellen brings fourteen years of clinical trial experience to Pearl Patwhays and her hiring has Pearl Pathways CEO, Diana Caldwell, very pleased, “Our staff and...
by Matt Foor | Apr 19, 2012
According to a Government Accountability Office (GAO) report, FDA was inconsistent in its review of pre-market approval applications. These findings were based on the years starting in 2003 and ending in 2010. The report also said FDA was “especially” inconsistent...
by Matt Foor | Apr 10, 2012
Save the date for the Eighth Annual Research Symposium presented by St. Vincent Health. The event will be held on Wednesday June 13, 2012 from 7:00am-4:00pm at the Lilly Conference at the Marten House. Topics to be discussed include Regulatory Updates, Family...
