IPERION - a Deloitte business

🌟 Key updates in Good Clinical Practice (GCP) guidelines The GCP guidelines (ICH E6 R3) are being revised to enhance clinical trial efficiency, data integrity, and patient safety. Over the last weeks, we have shared with you the key takeaways in our GCP post series: 📅 Introduction of GCP revision & timeline: https://lnkd.in/eDqDB8am 🔄 Changes in GCP guidelines: https://lnkd.in/eTdJfCsK 🗂️ New GCP Structure: https://lnkd.in/ey2kfsqE ✅ Why you should be compliant with GCP: https://lnkd.in/e6iphp-6 🚀 Ready for the new GCP guidelines: https://lnkd.in/ePBrhBYb 👉 Now we are curious about how you are gearing up for this change in your organization. Are you in the midst of preparations, seeking guidance, or still contemplating? Let us know! #Iperion #aDeloittebusiness #ClinicalTrials #GCP #GoodClinicalPractice #Compliance

🤓 How are you progressing on ESMP readiness? EMA presented recently more details on the plans for the European Shortages Monitoring Platform (ESMP). What are the main take-aways?   1. The enrichment requirements and timelines remain unchanged. Especially for products on the Union List of Critical Medicines, actions in XEVMPD and PMS are required: • XEVMPD: Create additional records to reach one record per pack size • PMS: Enrich PMS data with structured pack size (e.g. “2 vials” or “20 tablets”) • PMS: Enrich PMS with manufacturing information (manufacturing sites as listed in the dossier, including the type of activities they perform) 2. In preparation for ESMP, it is important to get processes in place for the three types of shortage monitoring: • Union list of critical medicines • MSSG-led preparedness • Crisis reporting   👉 Contact us if you would like to discuss any of the preparation steps for ESMP! • Gathering ESMP data from your documents (M3 and SmPC) • Defining a PMS submission approach (via product UI or API) • Updating your shortage management processes #Iperion #aDeloittebusiness #ESMP #shortages #xEVMPD #PMS

🌟 Ready for the new GCP guidelines? Let us guide you! As the Good Clinical Practice (GCP) guidelines evolve, staying compliant is key to success. Our extensive experience in life sciences and healthcare, combined with deep regulatory knowledge, uniquely equips us to support your readiness for GCP Revision 3. 🚀 Here is how we can help: • Gap Analysis: We assess your current processes, documentation, and systems against the new GCP standards. • Identify Improvements: Pinpoint potential gaps to ensure full compliance. • Custom Roadmap: Provide tailored recommendations and a strategic plan to align with the revised guidelines. Beyond readiness assessments, we can assist with GCP strategy optimization, including post-merger integration of GCP processes.  👉 Interested? Please reach out to us to learn how we can support your organization’s needs. Sebastian Payne & John Popp #Iperion #aDeloittebusiness #ClinicalTrials #GCP #GoodClinicalPractice #Compliance

In case you missed the webinar "PMS and IDMP: Latest Guidance and What You Need to Do to Prepare" organized by Generis, here are some highlights and key insights 👇 Remco Munnik provided an in-depth overview of the current IDMP landscape and the latest updates from the PMS Info Day. Jack Kelleher demonstrated Generis' innovative data management platform designed to guide organizations towards IDMP readiness. 🙏 A big thank you to Karolina Rogowska and the Generis team for organizing this informative webinar! #Iperion #aDeloittebusiness #IDMP #PMS #DataManagement

🔍 Why is GCP compliance crucial for pharmaceutical companies? Adherence to Good Clinical Practice (GCP) is not just a regulatory requirement; it is a cornerstone of successful clinical trials. Here is why GCP compliance is critical: 🩺 Participant Safety: Ensuring the well-being of trial participants is paramount. Non-compliance risks their safety and ethical breaches. 🌍 Market Access: Without GCP compliance, obtaining marketing authorization becomes a significant hurdle, potentially blocking entry to crucial markets. 📊 Data Integrity: Reliable trial data is the bedrock of approval processes and public trust. 🏆 Reputation: Compliance enhances your company’s reputation, fostering investor confidence and consumer trust. ⚖️ Legal Consequences: Non-compliance can lead to legal issues and financial penalties, depending on regional regulations. Aligning with GCP standards is not merely about compliance; it is about ensuring excellence and trust in your clinical trials. We can guide you through the complexities of GCP compliance, helping your trials meet global standards efficiently.  Feel free to reach out to us! Sebastian Payne & John Popp #Iperion #aDeloittebusiness #ClinicalTrials #GCP #GoodClinicalPractice #Compliance

🚀 Another short GCP update The revision of the Good Clinical Practice (GCP) guidelines introduces a new structure. This new structure is designed to provide clearer guidance and improved readability, facilitating compliance and better understanding. It consists of the following components: 1. General GCP principles 2. Annex 1: Interventional clinical trials 3. Annex 2: Non-traditional interventional trials 📅 Timeline for Adoption: • GCP Guideline (revision 3) and Annex 1: Expected Q4 2024 • Annex 2: Projected for Q2 2025 👉 Stay ahead by staying informed and feel free to reach out to us with any questions! Sebastian Payne John Popp #Iperion #aDeloittebusiness #ClinicalTrials #GCP #Pharmaceuticals #RegulatoryUpdates

🤓 Have you watched the recording yet? Two months ago, we have hosted a live broadcast where we provided a comprehensive overview of the PMS information day by European Medicines Agency, as well as our expert perspective on the impact of the latest EMA SPOR timelines on industry. 👉 Do you have questions or want more information? Drop a comment below or directly reach out to us. We are here to help! Jeanneke Spruit Frits Stulp Remco Munnik #Iperion #aDeloittebusiness #EMA #PMS #RegulatoryCompliance https://lnkd.in/eFGw2VMB

🌐 Here we are again, with another update on the Good Clinical Practice (GCP) guidelines The upcoming revision of the GCP guidelines introduces substantial changes that cut across all aspects of trial conduct, from planning and initiation to performance, oversight and reporting. Here is a closer look at the key changes: 1. Enhanced Data Integrity: Implement stricter data protocols to ensure accuracy and reliability. 2. Patient Safety First: Integrate comprehensive risk assessments for heightened patient protection. 3. Streamlined Processes: Adopt flexible, tech-friendly procedures to accelerate trial timelines. 4. Global Harmonization: Align your international trial protocols for seamless global studies. 5. Increased Transparency: Boost public trust with clearer disclosure of trial results and processes 🚀 These changes are poised to not only enhance the efficiency and effectiveness of clinical trials but also ensure that they meet the highest standards of ethics and patient care. The revisions will require companies to revisit their current clinical trial processes to meet these new standards. 👉 Stay tuned for more updates, and do not hesitate to reach out to learn how these changes could impact your operations and how we can assist in navigating these updates. Sebastian Payne John Popp #Iperion #aDeloittebusiness #ClinicalTrials #GoodClinicalPractice #GCP #Innovation #PatientSafety #DataIntegrity

🌟 Exciting News in Clinical Research The Good Clinical Practice Guideline (ICH E6 GCP) is currently under revision to cater to the advancements and changes in the clinical trial landscape. This significant update aims to enhance clinical trial efficiency, improve data integrity, and strengthen patient safety. 🔍 Why the Revision? The landscape of clinical research is rapidly evolving with technological advancements and increased global participation. The revision addresses these changes by integrating modernized processes and promoting greater harmonization across international borders. ⏳ Timeline for Revision: The review process is currently underway, with expert panels discussing key enhancements. Implementation is expected to roll out in phases. Hereby the latest timelines according to the ICH workplan for ICH E6 (R3) of February 2024: https://lnkd.in/eh5VjQkF 👉 Stay tuned as we continue to provide updates and insights into how you can prepare for these changes. Feel free to reach out to us directly to discuss how these upcoming changes can benefit your organization. Sebastian Payne John Popp #Iperion #aDeloittebusiness #ClinicalResearch #GoodClinicalPractice #GCP

🕒 The countdown is on! As we edge closer to the end of the Clinical Trial Regulation (CTR) transition period on January 30, 2025, it is crucial for everyone in industry to ensure their clinical trials are transitioned on time. The European Medicines Agency has recently highlighted the importance of timely transitioning to avoid disruptions in clinical trial activities and to leverage the benefits of the new regulatory framework. 🇳🇱 For those conducting trials in the Netherlands, you have an excellent opportunity to streamline your transition process. The Dutch Competent Authority, Central Committee on Research Involving Human Subjects (CCMO), has set an expedited transition process in place valid until October 16, 2024. For submissions after this date, the CCMO cannot guarantee a timely approval. 👉 Key takeaways? Ensure that you have a transition plan in place and start transitioning now! Need any help? Please feel free to reach out to us. Sebastian Payne John Popp #Iperion #aDeloittebusiness #ClinicalResearch #ClinicalTrialRegulation #CTR