Polaris Compliance Consultants
Don't Worry -- It's Not About A.I.
Applied Clinical Trials

Ok, maybe these clinical trial innovations don’t get the headlines and hype that some of the others do -- yeah, block chain, we’re looking at you -- but these practices have the potential to significantly improve clinical research.

Support for Continuous Manufacturing

Continuous Manufacturing offers a number of advantages over the traditional process of manufacturing drugs in batches. It’s faster, more reliable, and better positioned to support a Precision Medicine world. And the regulators are all in. CDER is not just supporting the process, but promoting it by sponsoring research in both academia and industry. They’re also establishing a number of programs to help companies transition to a continuing manufacturing environment.  

And what’s ICH doing? They’re working on a new guideline ICH Q13, “Continuous Manufacturing of Drug Substances and Drug Products.” Here’s what they’ve done, where they are, where they’re going, and when.

Avoiding the Same Old Tech Trap

How often have we seen this play out? There’s a new technology that has potential to improve clinical research. It gets lots of press. Some brave first adopters run a pilot and hail their success at industry conferences. They get a lot of Twitter followers.

But how do we move from pilot studies to large scale implementation? Where are the risks? Are the regulatory implications clear? Are the sites gonna kill us? Will the vendors be ready?

This is just about where we are with a number of patient-facing digital technologies in clinical trials. Many agree that they’ll eventually transform the way we do research, but despite their promise, they all face these implementation challenges. With their new Patient Technology Toolkit, TransCelerate is hoping to help companies circumvent this all-too-familiar technology adoption trajectory.

Annex 11 vs Part 11: (Another) Visual Comparison
Mohamed Anvar Deen, CSV Validation Lead with SUN Pharmaceuticals Limited

In our last newsletter, we included an info-graphic that walked through 21 CFR Part 11 and identified their corresponding sections in Annex 11. This made the two regulations easy to compare and highlighted which Part 11 elements are not covered in Annex 11. This new graphic looks at these regs from the other direction. From this vantage point, you can see that there are a lot more elements that Annex 11 covers that Part 11 does not, than the other way around.

ICH E8 Revisions (with Virtual Change Bars)
ICH / Clinical Pathways
As promised, revisions to ICH E8, “General Considerations for Clinical Trials,” is now out for public comment. This is the first revision of ICH E8 since it was adopted in 1997; changes to trial design and conduct in the last two decades have made much of the original guideline out of date.

Remember when ICH did us the solid of highlighting the proposed revisions to E6 with change bars? Good times. The E8 revision doesn’t have change bars because so much of the guidance has changed! But don’t worry, we got your back. Here’s a summary of the notable revisions to E8, courtesy of our friends at Clinical Pathways.

Cannabis-derived CBD: Still TBD
Food and Drug Law Institute

According to Wikipedia, CBD stands for Cannabidiol. But be careful, Wikipedia warns, that’s “not to be confused with Cannabinol or Cannabinodiol.” Uh, ok. No wonder there’s confusion in the regulatory world, and this FDLI article lays it out.

(Note, both hemp and marijuana are strains of cannabis. Hemp, legalized under the 2018 Farm Bill, is very low in THC, the compound in marijuana that produces a high. When this article uses the phrase “cannabis-derived compounds,” it’s referring to marijuana-derived, as opposed to hemp-derived. See? Clear as day.)

“The cannabis industry is the next frontier, growing rapidly and becoming one of the highest grossing industries in the country. The problem is, through no fault of its own, it is also the “wild west” of industries in many ways operating without guidance or regulation from the federal agencies that have jurisdiction of its products.”

The Deal Is Done

After more than two years, all 28 EU members are now included in the agreement between FDA and EMA that mutually recognizes the results of each other’s GMP inspections. This completed agreement will reduce the inspection burden on US and EU member countries, and free up their resources to inspect manufacturing facilities in other countries.

NCBI / BrackenData

Q: When can a TMF be considered sufficiently accurate and complete? What attributes does the TMF need to have so that a clinical trial can be adequately reconstructed from documented data and procedures?

A: “Developing a risk-based approach for quality assessments of TMFs

And speaking of managing TMF risk, how would you like to manage the essential documents associated with the “most international clinical study” being conducted today? How many countries do you think that might include? (Answer’s here.)

Your Periodic RBM Update

Adoption of Risk-based Monitoring may have started slowly, but if this graphic from ACRO is reflective of industry as a whole, things have evidently picked up significantly.

Polaris Compliance Consultants Corner

Polaris President Celine Clive will be attending and presenting at the Annual Meeting of SQA’s MidWest Regional Chapter. If you’ve ever thought about hanging out your own shingle, you might enjoy Celine’s talk on the tips, techniques, and considerations for successful QA and compliance contractors. Folks who hire compliance consultants may pick up some useful knowledge, too.

Celine will also be attending AHPA’s Inaugural Hemp-CBD Dietary Supplement Congress in Denver Aug 15-16. If you’re planning to attend, she’d love to meet up with you.

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