Accumulus Synergy’s Post

CIRS has undertaken a number of studies on the utility of public and non-public assessment reports from reference agencies, seeking to answer several questions: - Are public assessment reports (PARs) useful for reliance purposes? - What information can be found in reference agency PARs? - Why do agencies utilise non-public documents? - Is the terminology “unredacted” appropriate, or is better terminology needed? - What are the challenges and solutions for the using public and non-PARs?   The studies have been published as CIRS R&D Briefings 92 and 94 and will be presented during a webinar on 28th August at 3pm (UK).   Register for the webinar here >> https://lnkd.in/eZPYu_4F #RegulatoryScience #RegulatoryAffairs #regulatoryreliance #pharmaceuticals

Join us on 28 August for a CIRS - Centre for Innovation in Regulatory Science webinar on the utility of Public Assessment Reports (PARs). Discover insights from the latest IFPMA-commissioned report, explore the challenges of accessing PARs and its use for reliance purposes, and join a dynamic Q&A session. Register now: https://lnkd.in/eZPYu_4F #RegulatoryAffairs #RegulatoryReliance #Reliance

How are public and non-public review documents being used for regulatory reliance?   The latest CIRS R&D Briefing focuses on a study that gathered the perceptions of companies and regulatory agencies on the use and importance of non-public documents (e.g. full assessment reports), and public documents (e.g. public assessment reports) during a reliance review. The study found that public documents were not usually the only source of information for reliance, and that non-public documents were key for evaluating sameness and understanding reference agency decision making. Various challenges were identified in relation to the use of review documentation for reliance, and potential solutions were suggested, such as to develop best practices for the content and evaluation of reference agency reports.   Download the R&D Briefing >> https://lnkd.in/erqAPNVy #RegulatoryScience #pharmaceuticals #RegulatoryAffairs #RegulatoryReliance #RiskBasedDecisions

📢 New Blog Post Alert: Are You Ready for EAEU? Countdown to the Deadline – December 31, 2025. Explore the current status and be prepared to navigate the #EAEU regulatory landscape with expert insights and recommendations by Nargiz Asgarova, RegBridge’s Chief Executive Officer. Key Highlights: 🔹 Overview of EAEU regulatory framework and latest updates. 🔹 Current challenges in harmonizing regulatory practices and the risk of drug shortages. 🔹 Detailed action plan to ensure compliance. 🌐 Read the full blog post here: https://lnkd.in/eVbYQhcr #RegBridge #RegulatoryAffairs #HealthcareCompliance #Pharmaceuticals #MedicinalProducts #RegulatoryUpdates #IndustryInsights #DrugSafety #HealthcareRegulations

Simplify your electronic submissions with DSI’s end-to-end publishing services. Our integrated approach not only ensures compliance with current and future requirements but also saves you time and costs by eliminating the need for multiple contractors and redundant activities. Discover how our regulatory experts can streamline your submissions: Learn More https://bit.ly/48ndNIZ #RegulatoryAffairs #ElectronicSubmissions #PharmaCompliance #Pharmaceuticals #Biotech #PharmaExperts #DrugDevelopment #LifeSciences #RegulatoryStrategy #PharmaIndustry

Navigating USFDA regulations can be complex, but it doesn’t have to be. At RABT Global, we specialize in end-to-end Regulatory Publishing and Submission Services to ensure your submissions are accurate, compliant, and on time. Partner with us and focus on innovation while we handle the complexities of regulatory compliance. Let's connect to discuss how we can support your submissions! https://lnkd.in/g3fz5eHG #RegulatoryAffairs #USFDACompliance #eCTD #LifeSciences #SubmissionServices #PharmaRegulations #DrugApproval #RegulatoryPublishing #Biotech #Pharmaceuticals #MedicalDevices #HealthcareInnovation #RABTGlobal

🚀 Dive into EMA’ latest guide on LPPV requirements. Uncover crucial updates, their impact across countries, and tips to stay compliant. A must-read for staying ahead in drug safety! #Pharmacovigilance #DrugSafety #EMA #Compliance #Healthcare

Quality is “doing it right when no one is looking”…and building a culture of quality starts with the right tools. This is where the eQMS comes in. Our white paper guides you through the selection process, so you can make the best choice for your organization's unique needs. Download it here 👇 https://lnkd.in/e8BQtwcF #eQMS #regulatorycompliance #GMP #GxP #pharmaceuticals #biotech #medicaldevices

Arriello's Rafaela Araújo provides a comprehensive breakdown of the key changes in the EMA's document “Information on the Member States requirement for the nomination of a pharmacovigilance contact person at national level". If you'd like to discuss how this update affects your plans for Local Pharmacovigilance in the EU drop me a message here or at solutions@arriello.com. #LPPV #Pharmacovigilance #DrugSafety

Are You Ready for #EAEU? Countdown to the Deadline – December 31, 2025. If you’d like to know more about EAEU regulatory framework, latest regulatory updates, current challenges and whether Pharmaceutal industry be able to align with EAEU regulations by December 2025, as well as get Step-by-Step Guide and detailed Check-list for Upgrade procedure - check out my New Blog Post below 👇: 🌐 https://lnkd.in/eyfes6tK RegBridge | #Regulatory beyond borders #RegulatoryAffairs #RegulatoryUpdates #IndustryInsights #PharmaRegulation #RegulatoryCompliance