Sebia USA’s Post

Still time to register for this Educational Webinar on A1c in relation with the updated Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus #sebia #HbA1c #capillarys #webinar

Great opportunity to catch up with the updated Guidelines and Recommendations for Laboratory Analysis in the #Diagnosis and Management of #Diabetes Mellitus.

🔥 #Free 🔥registration is available for virtual attendance at the #FDA’s 2024 Regulatory Education for Industry (REdI) Conference on May 29 and 30 with multiple tracks for CDER, CDRH and CBER. #regulatory #training #education #lucentclinical

This regulatory education conference opportunity is a great way to hear directly from the regulators. It's being offered in-person and virtually, and if you're unable to attend live, you can watch afterward as your schedule permits. I'm planning on virtually attending some sessions live and will catch up on others of interest later this week. #fda #regulatorycompliance

That's a wrap - What a resounding market reaction to the Virta Health GLP Resource! "It was really well done. I downloaded it and am going to use it as a template for ongoing strategy “stuff” ... "I just wanted to say props on the document, it's nicely put together and very well-targeted." ... "I would love to get a link to your GLP-1 insights deck! I hear it's very well done!" ... "I especially like the questions to ensure alignment and the evaluation prompts." Excited to see where all these new and revised GLP strategies land in 2024 and 2025. #glp1s #glpstrategy #obesity #benefitsstrategy

All #IVD devices in the #UK must have the correct conformity mark (#UKCA, CE, or UKNI). For CTIMPs in Great Britain, if clinical performance data is lacking, analytical performance evidence must be submitted to the #MHRA in a form of summary reports of each study or protocol. Or, as a Tabular Summary if the analytical performance study has not been carried out. This is our new entry in our library of documents👉 https://lnkd.in/eNShjuf2

📣 🎇 Today, we proudly launch a new Resource Center dedicated to clinical research guidelines, guidance, and regulations! Check it out > https://bit.ly/4eW5AgM ACRP is committed to being your trusted source for the most accurate and up-to-date information related to clinical research guidelines and regulations. The Resource Center features a list of Authorities and Organizations with the most relevant resources for our clinical research community, including those references in our continuing education and certification programs. Visit this page often as ACRP and its ICH E6(R3) Working Group members prepare webinars, blogs, articles, and handouts to clarify the changes to the ICH E6(R)3 Guidelines. Share this post with your professional networks, please! FDA U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP), United States Department of Health and Human Services CDER Small Business and Industry Assistance (SBIA) ISO - International Organization for Standardization World Medical Association #ICH #ICHguidelines #ICHE6R3 #GoodClinicalPractice #GCP #FDA #FDAGuidance #ISO #HHS #OHRP #DeclarationOfHelsinki #ClinicalReseachGuidelines #ClinicalResearchRegulations #ClinicalResearchGuidance #ClinicalResearch #ClinicalTrials #ACRP

Join Advarra on September 5th for an exclusive educational webinar on developing a robust #sIRB action plan to streamline your research processes. Learn valuable insights from IRB experts - Joshua Fedewa and Adam J McClintock and enhance your compliance strategies. #ResearchCompliance #Webinar #Advarra #sIRB

As 2023 closes and 2024 starts, why not try some reflection: How was your year? What went well? What didn't? What did you most enjoy? Do you have regrets? What did you succeed at? What have you learnt? What will you do differently? What do you need to stop? What do you want to start? Remember you can reflect and reset at any time of year, and if you need help with alcohol or substances, please visit our website www.ascert.biz for useful information, advice and support #ASCERT25 #ReducingHarm #SupportingPositiveChange

Sponsors now have some details of the expectations for posting CSRs on CTIS. Some CSRs are coming due for early adopters. It's great to have this clarity coming from the EMA. The #CTD2024 DIA event discussion with regulators provided some key updates on EU CTR. Here are a few key highlights: ✅ The scope for CSRs under CTIS is clear now, it is the same as Policy 0070. This includes CSR sections 1 through 15 and appendixes 16.1.1, 16.1.2, and 16.1.9. Module 2 is not in scope for CTIS publication. ❇️ CSRs are going to be due for upload on CTIS before Policy 0070 based on regulatory timelines.  There was a lot of discussion around how this will be challenging for sponsors. ✅ CSRs are not expected to be reviewed on CTIS. ❇️ There are more CSRs in scope for publication on CTIS then EMA Policy 0070. Remember Policy 0070 only covers central procedures whereas CTIS includes any submission to any EUA countries individually. ✅ There was a brief discussion around posting technical results on CTIS. It was suggested that for now, the EUDRACT form could be used to upload results to CTIS. ❇️ A final note worth a heads up is that if you transition a study as part of a substantial modification to a new sponsor, updating the org ID number triggers the system to publish documents. Brief note on Policy 0070: ✳️ EMA expects to provide an update on plans for part 2 restart for packages that have been on hold sometime in 2025. ✳️ Phase 2 implementation details are not currently under any discussion within the EMA. #CTD #CTT #ClinicalTrialTransparency #EUCTR #CTIS #CSRs #Policy0070