Pearl Pathways continues to see an increase in its national exposure. PharmaVOICE has featured Pearl Pathways twice in the last year. In the January PharmaVOICE article titled “Commercialization to Repertoire”, Pearl Pathways president and CEO, Diana Caldwell, explained Pearl’s expansion of the breadth of services it can offer to its cusomtomers. In April, Chief Operating Officer, Gretchen Bowker, gave her views on the current state of IRBs in the PharmaVOICE article titled “Remaking the RULES”. To read Diana’s comments about Pearl’s expansion, click here. To see the article featuring Gretchen’s views about IRBs, click here.
Please join us for the IHIF Annual Meeting on Monday, May 7 and Tuesday, May 8. IHIF will release its 2011 Annual Report and present the Statewide Strategic Plan for Indiana’s Health Science Sector. Pearl will have 3 or 4 teammates on hand so be sure to look for us there! To register, click here.
A map has been released to display the locations of all FDA cGMP (Current Good Manufacturing Practice) warning letters issued in fiscal 2011. It is evident that the FDA is continuing its crackdown on overseas manufacturing plants as warning letters increased by 40% from last year. Mexico and India accounted for one-third of the total number of warning letters issued. It is also worthy to note that for the first time since 2009, no facility in South America received a warning letter. To read more, click here.
*image courtesy of Nick Taylor from in-pharmatechnologist.com
The European Medicines Agency (EMA) has released draft guidelines regarding continuous process verification (CPV) to bring its policies in line with ICH Q8, Q9, and Q10. The goal is to gain information a manufacturer can use to make adjustments during production to maintain drug quality, “If appropriate, the product may benefit from a defined period of enhanced sampling and monitoring to help increase process understanding as part of continuous improvement,” the EMA wrote. While the EMA has acknowledged the benefits CPV can provide, it also says a hybrid approach using traditional process validation is also an option. To read more, click here. To view the EMA’s draft guideline, click here.
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 register, click here.
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 the European Economic Area (EEA), the EMA typically does GMP compliance inspections if more than three years have passed since their last regulatory visit. For these situations, the EMA wants these facilities to send an early warning inspection request to avoid delays. Also, the EMA has created a fast-tracks process which means that the inspection will take place within three months of receiving the early warning inspection request. To read more click here. To view the biosimilars advice document, click here. For help with your GMP quality system or auditing services, contact Pearl at firstname.lastname@example.org.
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 clients are lucky to have Ellen join the Pearl team. Her drive and expertise will greatly contribute to supporting our internal company growth as well as client’s needs.” To view the full press release, click here. To see the coverage of Ellen’s hiring by insideindianabusiness.com, click here.
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 with applications marked “expedited”. In addition to inconsistency, the report also found that 510(k) submission times had increased 61%, from an average of 100 days to 161 days between 2005 and 2010, although the FDA still met performance goals for those applications. To read more, click here.
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 Medicine, Women’s Health, Family Medicine, and Internal Medicine. To learn more, please call 317-338-2194.