The 25th Annual Meeting of the Society for Quality Assurance finished on the 23rd of April, so much for live blogging, with an interesting array of speakers from the U.S. Food & Drug Administration, Health Canada, & the Environmental Protection Agency along with QA professionals from academia, industry, and independent souls such as myself. Here are some of the highlights:
The British MHRA (the counterpart of FDA in the UK) is conducting more inspections in the United States. They are interested in how a sponsor manages clinical trial vendor and what the contracts look like.
FDA is working on re-writing the Compliance Program Policy Manuals for both Sponsor/CRO/Monitor inspections and Institutional Review Boards (IRBs). This is particularly important for IRBs since the CPGM has been outdated since 1997, 12 years ago. The CPGM is the document that FDA field investigators use to conduct an inspection and is Must Reading for everyone concerned with FDA inspections. There is a link to the IRB CPGM on the references section to the right.
FDA also presented at a panel on Part 11 (electronic records, electronic signatures). I found that I left the session more confused than when I went in. I will put two guidance documents on the reference section to the right. One is the “Scope and Application” document which the FDA representative said was more important than most guidance documents because it is “interpreting regulations” not just offering FDA’s current thinking, which is how guidance documents are usually described. The other document is “Computerized Systems Used in Clinical investigations” which offers helpful definitions and guidance on SOPs. I am still not sure what the FDA position on hospital or medical center electronic medical records (EMRs) is. If anyone out there has info they wish to share on EMRs, I certainly would appreciate it.
I enjoyed sessions by QA professionals. One interesting suggestion was to create a “story board” for lengthy clinical trials, so the changes can survive SOP changes, protocol amendments and staff turnover. Another interesting suggestion was to give a slide presentation to the Vendor during a qualification audit and not just listen to the vendor’s dog and pony show. Letting the vendor know what your needs are can facilitate a smooth audit and direct it in the appropriate direction.
The one thing I felt was lacking was an overall analysis of what is happening with drug and medical device safety at FDA these days. There are a lot of things going on and it would have been nice to hear a discussion of what is in store. I’m certainly curious.
Finally, I am attaching an article about the Declaration of Helsinki and FDA. I had referenced it in one of my first posts and forgot to put it in. My own viewpoints have changed a little since it came out last year but Gerd Fortwengel, the principal author, did a great job of describing the changes to FDA regulations.