Polaris Compliance Consultants
Serious Concerns Over EU Medical Device Regs
World Trade Organization

This summer, the U.S. issued a statement to the WTO, urging the EU to delay implementation of the MDR and IVDR, citing concerns that both are behind schedule. As a result, numerous devices in the EU could be taken off the market. Industry is worried about their continued access to the EU's $125 billion medical device market ($20 billion of which is supplied by U.S. products).

Not Your Average GMP Naughty List
Pharmaceutical Online

This two-part series – Part 1 and Part 2 -- counts down the top 10 FDA GMP inspectional observations from FY2018. This is not your typical listicle – FDA panelists at the Xavier University PharmaLink conference offer their insights about each observation category.

Common Protocol Template for GLP
Clinical Leader

BioCelerate, the subsidiary of TransCelerate focused on making industry-wide improvements to nonclinical research, recently released a second draft of its common protocol template for repeat-dose toxicology studies. Like the clinical protocol template that parent company TransCelerate introduced 4 years ago, this template is designed to help CROs and sponsors reduce errors, realize efficiencies, and lower study costs. BioCelerate’s common protocol team is currently collecting and evaluating public feedback, and planning additional discussions with stakeholder groups to further improve the template.

Is Virtual a Reality?
ACRP, SCRS, Outsourcing-Pharma

FDA certainly thinks so. During CBI’s Direct-to-Patient Clinical Trials conference in August, CDER Officer Dr. Isaac Rodriguez-Chavez affirmed agency support for decentralized trials. He also offered this advice to conference attendees: “Don’t make it too hard on yourself. The [regulatory] standards are the same” for decentralized trials as they are for more traditional trial models.

Service providers think so, too. Marken has announced a home care and nursing service specifically devoted to supporting virtual clinical trials. Like new direct-to-patient IP supply chain services and remote IC collection services, home nursing care represents another example of specific new sub-industries springing up to support decentralized and site-less trials.

How about industry orgs? Yep, them too. This summer, both ACRP and SCRS announced they are offering free training for their members to learn how to conduct hybrid and virtual trials. (Earlier this year, SCRS conducted a survey which asked about study sites’ most pressing needs for the near and mid-term. Sites responded that they needed to start looking into hybrid and virtual trials to bring down costs and compete with sites that already offer these kinds of trials.) Training for members of both industry groups will be conducted by VirTrials.

Patient Front & Center
TransCelerate BioPharma, Inc., FDA
TransCelerate BioPharma unveils its Patient Protocol Engagement Toolkit (P-PET), a comprehensive set of materials that sponsors can use to engage patients during protocol development. The goal of P-PET is to improve the experience of the participants, reduce the burden studies take on them, and hopefully*, realize a reduction in dropout rates as a result. The top horizontal menu (the one with the orange square) will take you through all phases of the protocol life cycle.

Unassociated, but not unrelated, FDA issued a draft guidance on Patient-Focused Drug Development (PFDD) which describes methods for identifying which disease and treatment burdens matter most to patients to better guide endpoint and product development.

*Grammar purists among you have no doubt noted the lazy use of the word "hopefully." We tend to keep things informal here, but if misplaced adverbs annoy you, please feel free to substitute the phrase, "it is to be hoped" instead. A few of us on the Polaris editorial board applaud your commitment to proper usage.

Polaris Compliance Consultants Corner

Polaris gives its peeps a paid Day of Service each year so employees can spend time volunteering to improve our communities. On October 2nd, some our RTP-area folks spent the day at Note in the Pocket, an organization that makes sure impoverished and homeless children in Wake County have the clothing they need to go to school. We went through donations, folded and sorted items by size, function, and season. Kids in need are provided with 2 weeks’ worth of outfits, shoes, outerwear, and underwear so they can just go about the business of being school children. You can check out Note in the Pocket and their wonderful mission here.

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Older Posts

Clinical Trial Tips: Practical and Actionable

Getting the Most From Your GMP Supplier Audit

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


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