|
|
FDA Makes Changes to User Fee Program in Order to Comply with Congress' "Safety First" Initiative: What's the Impact?
In 1992, the first prescription drug user fee program (PDUFA) was created. At the time, this was viewed by most as a risky endeavor since similar user fee programs for government services failed after a couple of years. The risk that the board took in supporting the user fee program has paid off. For the past 15 years, the FDA has provided reliable, predictable reviews for the pharmaceutical and biotechnology industry. However, the drug review system may be starting to unravel.
Janet Woodcock has been asked by FDA Commissioner Andrew von Eschenbach to reassume her position as head of CDER and eliminate the problems facing the FDA's user fee program. She established PDUFA and effectively managed the user fee program until 2003 when she accepted new assignments under the FDA's Critical Path Initiative. Her track-record and reputation makes her an excellent candidate for the job.
The user fee program is in flux, and the FDA is under pressure to implement new drug safety initiatives. Patient safety is paramount to the FDA, and Congress is pressing hard by putting more emphasis on patient safety. The FDA's responsibility to its sponsors under PDUFA has permitted occasional missed deadlines in the review process. But for the first time, the FDA is issuing a center-wide directive allowing review times to slide.
The FDA's struggle to meet congress' safety initiative under PDUFA will impact and change the review process dramatically.
Read full story
|
|
Indiana's Governor Selects Ping Poulsen to Attend Women's Leadership Summit
Ping Poulsen, President and CEO of Safis Solutions, was selected by Indiana's Governor Mitch Daniels to attend the 2008 Business and Professional Women's Leadership Summit on April 29-30, at the Hyatt Regency on Capitol Hill, in Washington D.C.
The Summit unites government leaders and outstanding women to develop solutions to secure America's future in a global economy. Speakers will address key issues such as strengthening our economic security and protecting Americans from higher taxes, lowering the cost of health care while increasing quality, improving educational accountability and student achievement, and enhancing opportunities for entrepreneurs. Members of Congress, Administration officials, and other experts from both industry and academia will be Summit speakers.
For more information, See Website. |
|
Safis Welcomes Compliance Analyst Steve Wilson
At Safis, we are continuously adding value to our staff and pleased to announce the hiring of Steve Wilson!
Steve Wilson joins Safis as a Compliance Analyst. Wilso brings 10 years of regulated industry experience in the pharmaceutical industry to Safis. Prior to joining Safis, he held roles as a software validation and hardware qualification engineer, quality analyst, test lead, copy editor, technical writer, and document management librarian. Wilson's areas of expertise include validation, software testing, IQ/OQ/PQ, SOP creation, technical writing, website development, and user guide development. Wilson attended the University of Cincinnati and received an Oracle Database Administration certification from IUPUI. |
|
2008 Second Quarter Events
April
April 24, John Steichen, RAC, Senior Compliance Advisor at Safis Solutions shared his expert insight on regulatory and quality systems in the Biomedical Division at this month's Midwest ASQ Discussion Group. See Website.
April 29, The Institute of Validation Technology (IVT) held a conference entitled, "Computer System Validation in FDA-Related Industries." The event gave attendees the opportunity to learn industry best practices from leading computer validation experts. See Website.
May
May 14-16, IBC Life Sciences will hold their 16th annual Bioassay Conference. Attendees will learn about developing, qualifying, validating and maintaining the all-important biological assay. This meeting is specially designed for scientists, analysts, assay statisticians, and managers who work with biological assays during development of routine product releases. Also, regulatory and quality assurance professionals who deal with submitting or overseeing complex assays will also gain much needed insight to successfully deal with biological assays. See Website.
May 16, Indiana University's Kelley School of Business, Center for the Business of Life Sciences will hold a conference entitled, "Life Sciences is a Capital Idea." See Website. June
June 17-20, The Bio International Covention will be held in San Diego, CA. The convention will include 20,00 business leaders, scientists, executives, investors, and industry leaders who want to learn what's next in biotechnology. See Website.
June 18, The IQAA will conduct a meeting entitled "SIX SIGMA - Introduction and Application Techniques." The event will discuss different methods used in Six Sigma. Small workshops will be available during the session to help you learn how to apply these techniques to your everyday work environment. See Website.
June 22-26, The Drug Information Association will hold its 44th Annual DIA Meeting. Event topics include: adaptive clinical designs/adaptive methods, approval pathways for products to treat rare diseases, biotechnology, clinical and regulatory considerations for personalized medicines, combination device and therapeutic products, critical path initiative, multinational clinical trials including developing countries, patient recruitment and retention, and pediatrics. See Website.
|
|
|
Safis Solutions, LLC is a regulatory compliance consulting company serving pharmaceutical, medical device and biotech companies worldwide to ensure health authority requirements are met. Areas of expertise include regulatory approval, clinical strategies, quality systems, validation, IT services, auditing, and post-market surveillance programs. Let Safis Solutions help you excel in today's complex regulatory compliance environment.
|
|
|
|
|
Case Study
Our client: A large device and diagnostic company chose Safis to deliver ongoing quality and validation services.
See full. |
Tamara Beall joined Safis Solutions in 2005 as a Senior Compliance Analyst. Her extensive experience in system validation, software testing, technical writing, and document production makes her a valuable part of our staff. She also has specialized experience in FDA-compliant computer system validation (CSV). Prior to joining Safis, Tamara had experience working as a quality consultant, test analyst, marketing and technical operations coordinator, and consulting analyst. Tamara's broad work experience is complemented by her regulatory expertise in 21 CFR Parts 11 and 820. |
|
Did You Know?
President and CEO, Ping Poulsen is a competitive athlete in addition to being a successful entrepreneur. Her competitiveness is exemplified in her successful
entrepreneurial career as well as in the sport of table tennis, where she won the Indiana State
Championship on April 19, 2008. See Article. | |
