Mat Parowicz’s Post

𝐓𝐫𝐚𝐧𝐬𝐢𝐭𝐢𝐨𝐧𝐢𝐧𝐠 𝐲𝐨𝐮𝐫 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐭𝐫𝐢𝐚𝐥𝐬 𝐟𝐫𝐨𝐦 𝐭𝐡𝐞 𝐄𝐔 𝐃𝐢𝐫𝐞𝐜𝐭𝐢𝐯𝐞 𝐭𝐨 𝐭𝐡𝐞 𝐧𝐞𝐰 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧?  The shift from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR) is a significant change for sponsors across the EU/EEA. Our latest blog breaks down everything you need to know to navigate this transition smoothly and stay compliant. 📰 Read the full blog: https://lnkd.in/gDNqjkkq 𝐈𝐧 𝐭𝐡𝐢𝐬 𝐛𝐥𝐨𝐠, 𝐲𝐨𝐮 𝐰𝐢𝐥𝐥 𝐞𝐱𝐩𝐥𝐨𝐫𝐞:  ✅ Key differences between CTD and CTR  ✅ Step-by-step transition timeline  ✅ Best practices for compliance  ✅ Tips for using the Clinical Trial Information System (CTIS) Ensure your trials are fully compliant before the 2025 deadline. Celegence is here to support you with expert guidance and innovative solutions. Need assistance? 🤝 Learn more about how we can help: https://lnkd.in/g9bGxh6U #ClinicalTrials #EURegulation #CTR #CTIS #PharmaIndustry #RegulatoryCompliance #Celegence 

Excited to share that I recently had the privilege of attending the sensational Good Clinical Practice (GCP) & Pharmacovigilance (PV) symposium hosted by the U.S. FDA, MHRA-UK, and Health Canada. 🚨 Top Picks from the Symposium: Updates to ICH E6(R3) Clinical Trials with Decentralized Elements and GCP Inspections The Future of GCP Inspections Clinical Study Conduct 💡 Key Takeaways: The symposium wasn't just informative; it was a glimpse into the future of healthcare innovation. The speakers painted a compelling picture of a future where trials are more accessible, transparent, and patient-focused than ever before. #gcp #fda #fdacompliance #clinicaltrials #fdaregulations #mhra #canada #clinicalresearch #inspection #clinicalstudies #clinicalsolutions #ich #ICHE6R3 #usfda #europe #health

New version 3 March 2024 of EU CTR Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation published on EudraLex Volume 10   Includes new Annex I with overview of Member States' requirements for dossier part II in the first administrative transition step   https://lnkd.in/dPSwunZX   #euctr #euctd #clinicaltrialseu #ctis #clinicaltrialsregulation #clinicaltrialsdirective #eudralexvolume10 #euclinicaltrialstransition #eutransitiontrials

📃𝐃𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐬 𝐒𝐡𝐚𝐩𝐢𝐧𝐠 𝐭𝐡𝐞 𝐅𝐮𝐭𝐮𝐫𝐞 𝐨𝐟 𝐌𝐞𝐝𝐢𝐜𝐢𝐧𝐞.💊 The third layer in Clinical trial study is the documents that are involved in making the Process successful and credible. Here is the list of all the Documents associated with the Clinical trial study (FEEL FREE TO ADD IF SOMETHING IS MISSING): 𝐏𝐫𝐞-𝐒𝐭𝐮𝐝𝐲 𝐃𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐬: Clinical Trial Protocol Informed Consent Form (ICF) Investigator's Brochure (IB) Regulatory Submission Documents 𝐒𝐭𝐚𝐫𝐭-𝐔𝐩 𝐃𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐬: Site Initiation Visit Report Ethics Committee Approval Letter 𝐒𝐭𝐮𝐝𝐲 𝐂𝐨𝐧𝐝𝐮𝐜𝐭 𝐃𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐬: Case Report Form (CRF) Source Documents Monitoring Visit Reports Adverse Event (AE) and Serious Adverse Event (SAE) Reports Clinical Study Report (CSR) 𝐂𝐥𝐨𝐬𝐞𝐨𝐮𝐭 𝐃𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐬: Data Locking Report Site Closeout Visit Report Final Investigational Product Accountability Report Archiving Plan and Completion Certificate 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐒𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧𝐬: New Drug Applications (NDA) Periodic Safety Reports 𝐏𝐨𝐬𝐭-𝐓𝐫𝐢𝐚𝐥 𝐃𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐬: Publications Clinical Trial Registry Updates #clinicaltrials #clinicalresearch #documents

How can a Rapid Response Team save your CTIS submission? Tight deadlines for responding to requests for information (RFIs) is an unmistakable feature of the EU Clinical Trials Information System (CTIS). All clinical trials in the EU must be submitted in CTIS, and one deadline missed can be the end of your whole application. A dedicated Rapid Response Team serves as your guardian angel during the CTA process. Martina Johannesson shares a summary of learnings from preparing RFI responses in CTIS. Do you need support with clinical regulatory affairs? Let’s connect! contact@arexadvisor.com #regulatoryaffairs #clinicalreg #EUCTR #CTIS #drugdevelopment #arexadvisor #clinicaltrials

Last Year of Transition for CTD projects to CTR Currently there are thousands and thousands of projects not yet in the transitioning process to CTR (via CTIS). Just to give one example: Per estimate of the EMA for The Netherlands close to 1400 studies will need transfer for authorized studies by NCAs and approved by ECs per the Clinical Trial Directive (CTD) to the Clinical Trial Regulation (CTR via CTIS). End of January 2024 only 15% of the studies were transferred for NL. It looks similar bad in other countries. By end of Feb 2024 in total ca. 915 trials were transitioned, where ca. 73% were validated by the NCAs/ECs. I estimated there are still a couple of thousands of trials to be transitioned. Important is to understand that the clinical trial in transition will not be evaluated again, since it is an approved trial under CTD. One must submit all what was approved, plus very few „new“ documents, statements (e. g. GDPR compliance statement). Very important is to describe the regulatory cornerstones in all member states. For this purpose, a template of the Cover Letter is existing which should be used. Additional documents approved only in some member states should be included as well. This must be clearly explained in the cover letter. Additional needs for documents of CTR do not apply, but might apply at a later point, e. g. when a substantial modification takes place. Nevertheless, can it not be excluded that more extensive requests from ECs/NCAs can come during the transition process, although not likely. In that case the whole process can take up to 106 days. The current planning of the EMA is that trials transferred before 16 October 2024 the process will take between 22 days (without validation requests) and 37 days (with validation requests). In average up to Feb 2024 it took 43 days. So, it is very recommendable to do transfers now.  Before transfer the protocol must either be harmonized (so same protocol in all countries in case of EU international trials) or be consolidated. Also, before transfer it could be your protocol needs to undergo an amendment in all EU countries, which also is a time-consuming process and in some very few countries this can take numerous months. Be aware of the revised CTIS transparency rules. By end of June 2024 the EMA will publish these rules, at least that is the plan.

Attend the informative workshop by the FDA titled "A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium". Emphasizing the importance of Good Data Governance Practices for ensuring the integrity of clinical trial data, Pharmacovigilance, and informed decision-making, discussions also covered Risk Evaluation and Mitigation Strategy (REMS), recent guidelines on Remote Regulatory Assessments (RRAS), alongside insights into Post-Pandemic Trials and the adaptation of protocols. Deliberations on GCP Harmonization, updates to ICH E6(R3), and the future of GCP inspections provided valuable insights into regulatory compliance and the need for industry alignment. Overall, it was an invaluable opportunity to hear from esteemed professionals and thought leaders, and to learn about advancements and updates in clinical research and Pharmacovigilance. #gcp #fda #cder #clinicalresearch #clinicaltrials #regulatoryaffairs #gcp #regulatorycompliance

Excited to share that I've completed my certification course in Good Clinical Practice! 🎓 In this course I've gained 1.complete introductory knowledge about GCP principles 2. IRB/IEC Review and Approval and Protocol Adherence 3. Drug Development Process 4. Essential Documents in Clinical Trials: Protocol, CRF, Inform Consent, Investigator's Brochure, Study Progress Report.....and much more Ready to apply this knowledge to ensure the highest standards in clinical research. #Certification #ProfessionalDevelopment #Healthcare #ClinicalResearch #GCP

Inspection reports or letters are always valuable, as: 💡 They can help you to understand what inspectors are looking at during an inspection. 💡 They can help you to understand the (current) inspectors' view on particular topics. 💡 They can work as a mirror and can give you new insights for your own organisation. (Note: Does your organisation have processes in place to allow for continuous improvement? Regular lessons learned sessions, a "suggestions for improvement"-mailbox, process improvement-projects, quality circles,...?) Have a look at the Infringement Notices published by the Medicines and Healthcare products Regulatory Agency after they performed a number of GCP inspections ((and don't forget to look at what the MHRA says on their page about the inspectee responses). Thanks for sharing this information, Shaun H.! #qualityculture #qualitymindsets #continuousimprovement #lessonslearned

👇 Following the posts below: 𝗗𝗼 𝘆𝗼𝘂 𝗿𝗲𝗴𝘂𝗹𝗮𝗿𝗹𝘆 𝗿𝗲𝘃𝗶𝗲𝘄 𝗳𝗿𝗲𝗲𝗹𝘆 𝗮𝗰𝗰𝗲𝘀𝘀𝗶𝗯𝗹𝗲 𝗶𝗻𝘀𝗽𝗲𝗰𝘁𝗼𝗿 𝗿𝗲𝗽𝗼𝗿𝘁𝘀 𝗼𝗿 𝘄𝗮𝗿𝗻𝗶𝗻𝗴 𝗹𝗲𝘁𝘁𝗲𝗿𝘀 𝗼𝗿 𝗼𝘁𝗵𝗲𝗿 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝘃𝗲 𝗶𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝘀𝗵𝗮𝗿𝗲𝗱 𝗯𝘆 𝗼𝗿𝗴𝗮𝗻𝗶𝘀𝗮𝘁𝗶𝗼𝗻𝘀, 𝘄𝗵𝗶𝗰𝗵 𝗮𝗿𝗲 𝗿𝗲𝗹𝗲𝘃𝗮𝗻𝘁 𝘁𝗼 𝘆𝗼𝘂𝗿 𝘄𝗼𝗿𝗸𝗳𝗶𝗲𝗹𝗱?    They can bring you so much new information and valuable insight also for your own organisation - 𝙁𝙊𝙍 𝙁𝙍𝙀𝙀!   When you are eager to continously improve the quality in your organisation:    💡 Don't forget to leverage external sources to collect new insights and ideas.    💡 Make a list of interesting websites and review them on a regular basis.    💡 Even when you think, "we don't do work in or for the UK so these infringement letters are not relevant", I would recommend you still read the ones shared below, when you work in clinical research. They include findings which touch upon the basis of good clinical practice.    #qualityculture #continousimprovement #mhra