IPERION - a Deloitte business

🚀 Are you excited about the New Year and New Capabilities? Explore the acceleration of preparing for EMA ESMP Reporting with Deloitte's Generative AI Tool! 🚀   With our cutting-edge Generative AI capabilities, we can streamline manufacturer data collection preparation for the upcoming EMA ESMP mandatory shortage reporting. As highlighted in our previous post, the EMA’s recent webinar on PMS submissions announced the ESMP launch early next year.   Key deadlines include: 📅 February 2025: Mandatory reporting for products on the ULCM, including xEMVPD Pack Size Submissions. 📅 December 2025: PMS Submissions need to include Manufacturer, Operation Type, and structured Pack Size data. 🔍 Optional Reporting will also be available for non-ULCM products.   Why This Matters: The EMA plays an important role in monitoring and mitigating critical medicine shortages, ensuring a coordinated and effective response. By utilizing detailed manufacturing insights, we help maintain adequate supply and prevent crises.   Our Case Study: Recently, we completed a project for a top 5 Pharma company, extracting and remediating their full set of manufacturer data. This included extraction from M.3.2.S.2.1 and M.2.P.3.1 documents and mapping to OMS Loc IDs and RMS functions.   ⏱️ With our GenAI-tool, we significantly reduced the time required for extraction and mapping compared to manual methods. No matter the portfolio size, we can extract, remediate, and transform data into the desired format within weeks.   #GenerativeAI #Pharma #EMA #ESMP #IDMP #DataTransformation #AI #MedicineShortage #Efficiency #SupplyChainManagement

Dear LinkedIn followers, we wish you a joyful holiday season! 📚 For those seeking the perfect read during the festive period, the EMA has got you covered with some exciting new material. 📢 Exciting Update! Today, EMA published a new version of its ISO IDMP Implementation Guide – Chapters 2, 3, Annex A to Chapter 5, and Chapter 9. Main updates on version 2.2 of Chapter 2 - Data elements for the electronic submission of information on medicinal products for human use: 🆕 Introduction of new elements to match the implementation of SPOR services: Introduction of Packaged PMS ID (as section 5.1) Manufacturer references at medicinal product and manufactured item levels as new data elements 🔍 Introduction of the PMS label in applicable RMS lists for better clarity: Introduction of a “PMS” (RMS ID 200000027036) label in the “IT Application Applicability” RMS section of the applicable term of the lists 🔢 Updated numbering of Chapter 2 sections: Manufacturer (previously as 1.20) was separated as a new section (section 2) 📑 Updated reference to RMS lists: References to newly created RMS lists and updates to existing ones to support PMS data entry ⚙️ Updated technical information: Updates on conformance, data type, value, ISO/FHIR elements name/paths, and FHIR Complementary Information Version 3 of Chapter 3 - Process for the electronic submission of medicinal product information introduces the process of enrichment of missing PMS data and data elements subject to be enriched. Chapter 5 Annex A - Product data elements accessible by stakeholder group was updated with the latest data element list referred to Chapter 2. Version 2 of Chapter 9 - Process for submitting existing data on medicinal products authorised for human use – SIAMED II & XEVMPD to PMS deltas includes the update on the deltas for products authorised in Luxemburg. In December 2024, the grouping criteria for the products authorised in Luxemburg changed to be the same as the products authorised in Belgium. #EMA #ISOIDMP #RegulatoryAffairs #DataSubmission #SPORServices #PMSData https://lnkd.in/dVP6WR4S

EMA has published their electronic Product Information (ePI) pilot report!   The one-year pilot resulted in the successful creation and publication of ePI in real regulatory procedures at EMA and the NCAs of Spain, Denmark, the Netherlands, and Sweden. Whereas EMA has identified recommendations and improvements to further develop their ePI initiative in 2025, the pilot concludes that stakeholders – including pharmaceutical industry – should incorporate ePI into their planning and preparation activities.   Through attached poll, we would like to know your opinion on ePI readiness and plans. If you are not sure how to position ePI within your company, feel free to drop us a message.   Interested in reading the full ePI pilot report? You can find it here: https://lnkd.in/dRU5VMFm #electronicproductinformation #ePI #EMA #ePIpilot #pilot #digitaltransformation

Yesterday in EMA´s quarterly system demo, the recent developments on electronic Product Information (ePI) were presented. Besides the anticipated ePI pilot report (expected to be published next week), EMA improved the ePI versioning, developed PMS linking, and the testing of FHIR import functionality has started.   With ePI being an established topic on EMA’s list of upcoming digital transformations, it is important to already start asking yourself the below questions.   Uncertain how ePI impacts your company? Feel free to reach out to us for a chat!    #electronicproductinformation #ePI #EMA #systemdemo #digitaltransformation  

It is amazing to receive such great feedback on the “Decoding electronic Product Information” course for LS Academy we provided last week! We really enjoyed sharing the latest developments on ePI implementation and engaging in discussions with you.   Missed the session? Find below our three take-aways: 1. Multiple regulators are advancing e-labelling initiatives. With EMA’s investment in digital transformation and the ePI pilot now concluded, next steps are planned for 2025.  2. Taking control of your PMS data, understanding FHIR, and integrating the use of the PLM Portal in the organization are essential fundamentals for a successful ePI adoption. Our observation with other digital transformation projects? The effort and timelines required to successfully integrate the required changes are often underestimated by industry. 3. With this inevitable ePI change, it’s fascinating to see how new technologies such as Artificial Intelligence bring new opportunities to accelerate the generation of labelling documents.     Do you have questions about ePI and would like to discuss ePI in more depth with us? Remco Munnik and Nadia Goutziers are happy to help. #ePI #DigitalTransformation #eLabelling #PMSDataManagement #FHIR #PLMPortal #AIinPharma #LabelingInnovation #RegulatoryAffairs  

🌟Update from EMA’s webinar on submissions to PMS related to the ESMP launch early next year 🌟 - Mandatory Reporting: Prepare for mandatory reporting for products listed on the ULCM starting from February 2025. - xEMVPD Pack Size Submissions: Due by February 2025. - PMS Submissions: Include Manufacturer, Operation Type, and structured Pack Size data by December 2025. Optional Reporting: From February 2025, optional PMS submissions for non-ULCM products. - Data Carrier Identifiers: From January 2025, industry can optionally submit Data Carrier Identifiers (GTIN, NTIN, PPN) to link ePI with PMS data. This will facilitate patient access to electronic Product Information (ePI). - For CAPs: Submit via ServiceNow. - For non-CAPs: Submit via PMS UI/API. To further assist the industry, EMA will continue disseminating information, including the publication of Chapter 3 of the European IDMP Implementation Guide by year-end. This chapter will detail the process and PMS data elements required for submission. 📢 Let’s connect to discuss how your organization can effectively prepare for the expanding requirements of structured PMS data submissions. 📢 #EMA #PharmaUpdates #PMS #ESMP #IDMP #RegulatoryCompliance #PharmaIndustry #DataSubmissions #ePI #HealthcareInnovation #Pharmaceuticals #DigitalHealth

The shift to move from traditional paper product information to electronic Product Information (ePI) is one of the exiting transformations the pharmaceutical industry and patients are looking forward to. But… what does it entail?   Join our presenters Remco Munnik, Tim Jessel, Will Powell, and Nadia Goutziers in their journey to decode ePI and answer questions such as: - What is the regulator’s vision on ePI? - How does ePI impact the pharmaceutical industry? - What can (and should) you do to prepare for this transition? - What GenAI possibilities are unlocked?   Want to learn more on Wednesday 20 November? Registration is still open https://lnkd.in/d-Rc9viU   #ePI #productinformation #pharmaceuticalindustry #patients #AI #GenAI #EMA #PMS

The shift to move from traditional paper product information to electronic Product Information (ePI) is one of the exiting transformations the pharmaceutical industry and patients are looking forward to. But… what does it entail?   Join our presenters Remco Munnik, Tim Jessel, Will Powell, and Nadia Goutziers in their journey to decode ePI and answer questions such as: - What is the regulator’s vision on ePI? - How does ePI impact the pharmaceutical industry? - What can (and should) you do to prepare for this transition? - What GenAI possibilities are unlocked?   Want to learn more on Wednesday 20 November? Registration is still open https://lnkd.in/d-Rc9viU   #ePI #productinformation #pharmaceuticalindustry #patients #AI #GenAI #EMA #PMS

🌟 Electronic Submissions and Data Management in Regulatory Affairs 🌟 Our team (Jeanneke Spruit and Remco Munnik) are ready for tomorrow´s training session on "Electronic Submissions and Data Management in Regulatory Affairs" with LS Academy. Guided by the expertise of Jeanneke and Remco, the session will deep dive into the complexities of regulatory submissions and the pivotal role of data management. During this training, Jeanneke and Remco will bring their knowledge, practical insights and experience, to make complex topics accessible and engaging. From understanding the life cycle management of eCTD submissions, the outlook of 4.0, to mastering data initiatives and abbreviations: eAF, ePI, xEVMPD, ISO IDMP, CESP, ESMP and more.... This training is for anyone involved in regulatory affairs looking to enhance their skills in electronic submissions and data management. #LSAcademy #RegulatoryAffairs #DataManagement #ProfessionalDevelopment #LearningJourney

🌟 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