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Polaris Compliance Consultants
FDA's New Website Is Here!
FDA

This past weekend, FDA launched its newly refurbished website. The redesign was intended to make the new site more interactive, display better on mobile devices, and make finding things easier for both the public and pros like us. It also lays the foundation for future APIs (that’s Application Program Interface, not Active Pharmaceutical Ingredient), so 3rd party apps can integrate with the site and make use of the data it stores. A word to the wise: an FDA spokesperson says, "Most URLs will change. Automatic redirects will be established, but users should update their bookmarks.” Don’t count on the redirects to last forever – you may want to update your precious trove of bookmarked FDA pages sooner rather than later.

Data Fun Facts
Visual Capitalist
  • Daily, 500 million tweets are posted
  • Daily, 3.5 billion Google searches are conducted
  • Daily, 300 billion emails are sent
  • Daily, 4 petabytes are posted to Facebook (that’s 1000 times bigger than a terabyte, so 1000 times more than what the latest laptop hard drives can store)
There are more goodies on this great info-graphic from Visual Capitalist.

Plain English Translation for ISO 9001
Praxiom

Praxiom’s Plain English outline and its companion summary can help you navigate the QMS standards behemoth that is ISO 9001. (I wonder if we can order a set of Plain English translations for the GDPR?) The folks at Praxiom have shown exquisite taste in the past by adding a link on their website to Polaris’ own (and admittedly snarky) views on using Plain English in industry.

Alphanumeric Soup: Q&A 4 GDPR & CTR
European Commission

And speaking of the GDPR, the European Commission has published a Q&A detailing the interplay between it and the Clinical Trials Regulation. A sampling of points discussed on social media: (1) Interaction between the CTR and GDPR depends on whether data is being processed purely for research or for the purpose of health protection. These two main categories of processing activities fall under different legal bases. The guidance lays out the implications for sponsors under each set of circumstances. (2) If subjects withdraw their consent to participate in the trial, the investigator should talk to them to determine whether their withdrawal of consent relates solely to participation in trial activities or whether they also withdraw consent to the processing of their data.

Acceleration by Regulation
PwC
 
Says author Alec Gaffney on Twitter: “Four seemingly subtle changes FDA has recently made to its digital health approach have the potential to massively change how pharma companies develop, seek approval for, and market their products.”  #3 is really interesting – an app that acts as a companion to a drug will be treated as promotional labeling, and not subject to traditional pre-market approval. Another interesting tidbit – 69% of physicians polled said they’d be very or somewhat willing to prescribe a mobile app to a patient

Cutting Trial Timelines
Life Science Leader

In this piece from last year, Lilly shares their efforts to reduce study recruitment time. They developed the LillyTrialGuide portal, consisting of IRB-approved micro-sites which describe each study in lay terms, and can pre-screen visitors based on their answers to I/E-inspired questions. Lilly has also nurtured relationships with patient advocacy groups who can raise awareness of current clinical studies and inspire the trust of potential participants. Storing screening data in the cloud allows Lilly to respond faster to overly restrictive I/E criteria, as well as track and contact individuals who, excluded from a study in the past, may now meet inclusion criteria.

BIMO Stats for FY 2017
FDA

How have the FDA Bioresearch Monitoring (BIMO) inspection results changed in a year?
The good: a significant drop in the number of GLP inspections (and a modest drop in the number of IRB inspections) that resulted in OAIs.
The same: the 7 most common deficiencies for Clinical Investigator, IRB, GLP, Sponsor, and CRO inspections are virtually unchanged.

Part 11 vs Annex 11
Mohamed Anvar Deen, CSV Validation Lead with SUN Pharmaceuticals Limited, MasterControl

This info-graphic strolls through 21 CFR Part 11 from beginning to end and maps its sections to the corresponding topics in Annex 11. The author told us that his graphic identifies topics that Part 11 covers that Annex 11 does not. Mr. Deen is working on a new graphic that will map the two regs from the other direction, identifying topics that Annex 11 covers that Part 11 does not. We’ll keep a look out for it to include in the next Polaris newsletter. (How’s that for suspense?)

For those who prefer a written comparison, one of our auditors reached into her archives to share this analysis from Master Control.

Sites Prepare for the Site-less World
SCRS

Responding to an increase in virtual trials (aka remote trials, direct-to-participant trials, and a new one...cyber trials), SCRS announced last week that it is launching a digital initiative to help sites understand the value of, and how to become, “virtual capable.” SCRS is kicking off their new initiative with a webinar May 28 (free to members, $79 for non-members).

FDA Answers Your RBM Questions
FDA

As we slide into RBM 2.0, FDA has published a new guidance to address implementation questions from industry. This free pre-recorded webinar from CDER SBIA (Small Business and Industry Assistance) provides an overview of the guidance. (Be patient, the redesigned website still has a kink or two.)

Polaris Compliance Consultants Corner

For many few years, the first item in the Polaris newsletter has always been our most recent blog post, followed by news articles from around industry. Perhaps you noticed that this newsletter does not begin with a Polaris post. Before incapacitating panic sets in, you should know that we’re just changing things up a bit by sending the blog promotion separately from the news articles. You can expect to receive a link to our latest blog post in mid June. In the beginning of August, we’ll issue the next industry newsletter. In the mailing after that, the next Polaris blog post will land in your inbox, and so on. By splitting the blog from the news, we think we can deliver the same quantity and quality of content to you as in the past, but served up in more easily consumable portions. Bon appetit.
 


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Older Posts

When Sites, eSystems, and Inspections Meet

FDA Puts Santa on the Naughty List

The One-Hour Study Site Audit

What Surprises GCP Auditors?

Hackin' the GDPR

eSource Terminology Untangled

Delegation of Authority Logs: Tips for Monitors

Study Sites: Show 'Em Your QC

Love at First Site: Early Signs of Strong PI Oversight


Anticipating Tensions Between Clinical Care and Study Protocol

Coping with Scoping your CSV/Part 11 Audit

Notes 2 Fix Your Notes 2 File

When GCP and GMP Meet

Site Selection: Don't Forget About the Study Drug

When is a Customer NOT a Customer?

Avoiding Protocol Deviations

Outsourcing Options for Small Sponsors

FDA Site Inspections: 5 Tips for Success


A Musical Parody: She's More Than a Warehouse to Me


Movie Quotes for QA Professionals

SOP Revision, SWAT Style

Study Sites: Too Many Vendors, Too Little Time


A Musical Parody: the Sound of Compliance

Q&A SOPs for Research Sites

Big Changes for ICH GCP and EU Regs

The CAPA Detective


A Musical Parody: the Modern Risk-based Monitor

Remote SDV/SDR: Alternatives to Redact/Fax

How to Tip Off a GCP Auditor in 25 Words or Less

Regulatory Tools Go UFO: Useful, Free & Online

What Does Risk-based Monitoring Mean for QA Auditing?

Anatomy of a GMP Vendor Qualification Program

Is the SDV in RBM Misunderstood?

Results of First Ever REMOTE Clinical Trial

Questions All Auditors Should Ask: the Use and Misuse of Audit Checklists

On the Quality of Vendor/Supplier Audit Responses


The Plain Writing Act of 2010: Lessons for Industry

Risk-based Monitoring vs. Traditional Monitoring: the ADAMON Project

What if you Needed SOPs to Run your Household?

Key Points of FDA's Draft Guidance on Quality Agreements for Contract Manufacturers

Ignorance Isn't the Problem; Preconception Is

Who's Looking Out for the Investigator

What SOPs Do I Need As A Dietary Supplement Distributor?

Yes, SOPs are Hard to Write...It's Not Just You

Turning GMPs Into Marketing Advantage

 


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