WCG IRB’s Post

Since the EMA's notification of the revised transparency rules in October 2023, Sponsors and CROs have been revisiting their document redaction strategies to adapt to the removal of deferral mechanisms for CTIS submissions under the EU CTR. While we await the technical implementation of the revised transparency rules in CTIS in the second quarter of 2024, here are some of my thoughts about how the new rules may afford some relief and better structure to the CTIS stakeholders' experience.

CTIS will be the single-entry point for submitting, assessing, authorizing, supervising, and reporting a #clinicaltrial in all Member States of the EU. During this transition period, Anaya Rehman and Certara's experts can help you prepare for the important changes associated with this regulation. Learn more about CTIS on the blog: https://lnkd.in/eWWCCRJR Contact our team to learn how we can help with your next submission: https://lnkd.in/e9KJkyxf #CTIS #RegulatoryAffairs

Hello GLP Community Members! Today, let us probe the intriguing OECD Guidance Document on "Multi-site non-clinical studies." Multi-site studies are witnessing a surge in the conduct of non-clinical studies as this collaborative approach allows to leverage diverse expertise, specialized facilities, resources, diverse test populations and geographically relevant environmental conditions. However, it's important to acknowledge the numerous challenges that accompany the execution of such studies. Together we can pool the experiences, insights and obstacles that have been encountered and the valuable lessons learned along the way to enhance our understanding and improve our practices during the conduct of multi-site non-clinical studies. This topic is not only beneficial for those who are new to GLP but also serves as a valuable refresher for seasoned members of our community. I encourage everyone involved in the conduct of multi-site studies to consult the OECD website for comprehensive guidance. The full document can be accessed via the following link: [https://lnkd.in/dnqYcG_R ]. #oecd #GLP #regulatorycompliance #training #preclinicalresearch #regulatorycompliance #compliancemonitoring #nonclinical #nonclinicalresearch #multisite #SQA #RQA

IBC - comprehensive and salutary 2023 amendments to CIRP Regulations 2016 at a glance given in the press release of IBBI is shared for information and ready reference. #ibc #cirpregulations2016 #amendments #legaldeli

❗️TMF TUESDAY TIP❗️ When reviewing your IRB approved documents, please check to see if the documents approved match the submission package documents (most current version). I’ve seen mistakes happen where the wrong version of a document was submitted and the IRB approved it. What are some examples of how you are being proactive to maintain a healthy TMF? Bonus Tip: Ask your study coordinator to send you the submission package to review prior to them sending to their respective IRB for approval. This can save you time and money! #tmf #etmf #tmfgroup #clinicalresearch #irb #granularlevel #documentmanagement #clinicaltrialassistant

The #MDCG issued guidance on the content of the #clinicalinvestigationplan for #medicaldevice #clinicaltrials. A quick review reveals no big surprises: The template for the synopsis (MDCG 2024-3 Appendix A) though, does ask for the #clinicaldevelopmentstage (typically only in the CIP itself) and the EUDAMED number, but not for the #studyassessments throughout the study (giving an idea regarding the burden for the subjects). The guidance regarding the content of the CIP (MDCG 2024-3) does not reveal big surprises either when used to following guidance by #ISO14155 and local EU Regulatory Bodies, although there is a lot of emphasis regarding some topics like the benefits and risks, listings of foreseeable AE’s and anticipated ADE’s, and statements that need to be included on #regulatorycompliance and #publicationpolicy to name a few.

Do you need help navigating the transition under the EU CTR or learning more about the revised CTIS transparency rules, which take effect on 18 June 2024? Read more in our newest factsheet: #CTR #CTIS #ClinicalTrialsRegulation #Regulatory #ClinChoice #ClinChoiceCanHelp

5x key #EU #JCA changes, in the revised text of the Implementing Acts voted on by member states on 30th April 2024: 1️⃣ 🤒 Patient expert selection could be via national HTA agencies if insufficient groups available at the EU-level; multi-country groups preferred 2️⃣ 🗓 Assessment scope will be issued just 10 days after D120 LoQ 3️⃣ 🙋♀️ HTD can now request a meeting to discuss scope, to take place within 20 days of scope publication 4️⃣ 📬 Dossier submission now 100 days after scoping (a whole extra 10 days!!) 5️⃣ 🔏 A review/appeal process for agreeing commercially confidential redaction in the final JCA is now allowed for - but no timeline is specified. Contact our Europe #HTA experts to discuss what these changes mean for you: Catherine Chamoux, Sameera Tak, Gavin Outteridge Ref: See Articles 6, 10, 11 , 12 and 20 of the 30th April text.

The #EUHTA JCA implementing acts have received a positive opinion from the HTA Committee and will be adopted by the European Commission in the coming weeks. Others have already commented here on Linkedin that the number of changes compared to the draft version are very modest. While timelines are slightly improved, and the HTD can now request an assessment scope explanation meeting, there is still very limited willingness to involve the HTD, or leverage the extensive information that the HTD will have about their product and the evidence base. I took note that the Annex still stipulates that the cut-off for information retrieval, such as structured literature reviews to support indirect treatment comparison analyses, should be a maximum of 3 months before dossier submission. By pegging the cut-off to the dossier submission date (not time of assessment scope communication), EMA clock stops can trigger last-minute comprehensive updates of information retrieval - at a time where the the HTD should really be spending their time on updating and executing the high-quality statistical analyses needed for the JCA. I wonder if HTA Committee is aware just how much time and effort these things take. And whether the framework that's materializing is really fit for ensuring the "high quality of the dossier and the smooth conduct of the joint clinical assessment" that the implementing acts talk about. #HTAESIG #EFSPI #EUHTA

SFDA Update:: SFDA guidance on the Equivalence of Topical Products.. If you are handling Saudi Market Regulatory, this guidance would be of immense use. 2nd June,2024 Sharing for your reference n benefit. Date of Implementation: 1st Jan 2025 Date of Idsue : 2nd June,2024