Durham Research Collaborative, LLC’s Post

It’s officially been one year since the #NSA reached a particularly “bumpy period” of its implementation. The instability began in August 2023 when Texas courts invalidated key components of the IDR process, including administrative fees and the methodology for calculating the #QPA. These rulings forced the closure and reopening of the IDR portal multiple times as the #CMS and #HHS worked to update systems and issue guidance. Despite efforts to stabilize the process, including issuing guidance and proposing new regulations, significant regulatory updates have been delayed, as Texas Medical Association works to conduct more lawsuits to strengthen the federal #IDR process for providers. For further insight, visit https://lnkd.in/eTpN5nAN.

💡 Did you know, that in addition to submitting #ideas to the FDA for guidance *they should develop*, you can also submit #DRAFT #guidance for them to consider. 👉 Look in the comments for a guidance document draft by #patients. Look under "How to Provide Input into Topics for Guidance Development" on the website to find out how. https://lnkd.in/eWnK2GzA #regulatory #fda #guidance #development #stakeholders #howto

The new ABPI Code of Practice 2024 came into force earlier this week. While most of the changes introduced are not dramatic (though as ever these rules do not get more lenient), there are some points worth noting: ⚖ The revised constitution and procedural rules for the PMCPA have the potential to make the handling of complaints much more akin to civil litigation. The PMCPA's dispute resolution bodies now have formal powers to issue case management directions in accordance with an "overriding objective" and perceived procedural errors will be appealable, opening the way to interlocutory applications by well-resourced parties. There is also an "abridged procedure" for certain categories of routine complaint. 💉 Prescription-only medicines advertisements will contain a lot less small print, now that prescribing information in offline media can be provided on a webpage accessible through a QR code. 🚫 There have been no updates to clarify the areas which clients often find most challenging, such as joint working and collaborative working with the NHS, package deals, and how best to manage responsibility for the activities of third parties such as outside contractors and non-UK group companies. Even with the best will in the world, it is still very easy to stumble into non-compliance. Read more about what's new in my article on Lexis below: https://lnkd.in/ecHCjFUK #medicines #healthcare #advertising #compliance #abpi #pmcpa Bristows LLP

#UK just published a new model Master #Confidentiality #Disclosure #Agreement (mMCDA). It must be used by commercial sponsors to contract with NHS and HSC organisations which might participate in their research studies https://lnkd.in/d4vuNPcC #NHS #MHRA #clinicalresearch #medicalresearch #compliance #regulatoryaffairs #dataprivacy #gfpr

EU Clinical Trial Regulation: A Fresh Take on Simplifying and Harmonizing Rules 🏥 Remember when we talked about the EU Clinical Trial Regulation 536/2014? Well, it's officially replaced the old Directive, and here's a quick refresher: 🔗 Coordinated Assessment: One decision from a reporting member state for multinational applications. 🖥️ CTIS: A shiny new portal for streamlined data submission and processing. 📅 Important Dates: Mandatory CTIS use from January 31, 2023, and compliance for existing trials by January 31, 2025. 📜 Transparency: More public insight, with protections for personal data and confidentiality. 💬 Informed Consent: Clear rules for consent procedures, with simplified options for low-risk trials. ⏰ Deadlines: Strict timelines and mandatory reporting within seven days for serious breaches. Adapting your strategies to these changes is crucial 👉 https://lnkd.in/er-iUViG #EURegulations #Law #Lawyer #clinicaltrials

Zwiers is proud to have contributed to the March issue of Regulatory Focus Quarterly with a paper on public disclosure of EU clinical trial application data and documents. Check out this publication (Vol 4, 1: P14-30) providing practical guidance on how to navigate the CTR rules in the context of global transparency. Interested in Zwiers’ services? Go to ww.az-regulatory.com #regulatory #clinicaltrialregulation #transparency #global #publicdisclosure #clinicaltrials

CMCPS® Requirement 2 – Examination Applicants must undertake and pass the CMCPS® exam administered by ICHCC. The exam assesses their knowledge and competence in medical care planning, including assessment skills, legal and ethical standards, care coordination, documentation, crisis management, and interdisciplinary collaboration. The current version of the exam consists of fifty (50) questions. #ICHCC #ICHCCCMCPS #CMCPS #Certification #Healthcare #MedicalCostProjection #ProfessionalDevelopment

Medical billers and coders are in high demand. This course offers valuable training in legal, ethical, and regulatory concepts central to this field, including HIPAA compliance, official coding guidelines, and third-party payer requirements. https://smpl.is/9515n

Zwiers is proud to have contributed to the March issue of Regulatory Focus Quarterly with a paper on public disclosure of EU clinical trial application data and documents. Check out this publication (Vol 4, 1: P14-30) providing practical guidance on how to navigate the CTR rules in the context of global transparency. Interested in Zwiers’ services? Go to ww.az-regulatory.com #regulatory #clinicaltrialregulation #transparency #global #publicdisclosure #clinicaltrials

CMS Final Rule Update: Legal opinions on the CMS Final Rule have been released by several law firms. The opinions so far have echoed what we knew to be true about the CMS Final Rule. This opinion from Arnall, Golden, and Gregory was especially interesting. The link is in the comments. #CMS #FinalRule #Medicare #FMO #AEP2025