Frits Stulp’s Post

Last month I picked the brains of Remco and Frits about the new IDMP information shared by the European Medicines Agency on the PMS info day 🧠. It’s an exciting time in the Regulatory world, moving more and more towards a data-centric world in Europe. The actions expected from the pharmaceutical industry get more concrete, especially in the area of managing medicinal product shortages. Listen to the recording to find out more about our view on these latest requirements. #IDMP #RegulatoryAffairs

EVENT | PMS Info-Day 📅 April 16, 2024 📍 EMA premises 🎯 Target Audience: Representatives from human trade organizations and national competent authorities 🔝 Exciting upcoming event at the European Medicines Agency in #Amsterdam! Asphalion experts Beatriz Ugalde and Laura Casals have been invited to take part in the Product Management Service Info-Day! ▶ The #PMS Info-Day aims to bring together representatives from various human trade organizations and national #competentauthorities, offering valuable insights on PMS and its implications on other #EMA #digitalservices, presenting a unique opportunity to delve into important topics and engage in meaningful discussions. 👁 Check out the key information here! https://lnkd.in/dPfWKHYr 📧 Need help for your Regulatory Operations? Contact us at: [email protected] #PMSInfoDay #IndustryInsights #Networking #RA #RegulatoryAffairs #RegulatoryOperations #DataManagement #MeetTheExpert #WeAreAsphalion #WeCare #KnowledgeFromExperience https://bit.ly/3VD40Kt

Don't miss these important EMA events! PMS Info Day & SPOR Status Update Following engaging sessions through our IRISS IDMP TG meetings in January and March where we discussed EMA developments with Veronica Lipucci Di Paola, Marcos Fernandez Gomez, and Nora Weitbrecht, two exciting events in line with these previous updates are planned. European Medicines Agency (EMA) has lined up two informative events in April, tailored for both Industry and Network audiences. Tune in to these live sessions streamed on the EMA YouTube Channel: 1️⃣ Product Management Service (PMS) Info-day (April 16, 2024 | 9:15 – 17:30 PM CEST) Dive deep into PMS and its impact on EMA's digital landscape. Explore synergies with other solutions, latest developments, and best practices. Event details: https://lnkd.in/dPfWKHYr 2️⃣ SPOR Status Update Webinar (April 10, 2024 | 10:00 – 12:30 CEST) Latest information regarding SPOR Data Management services with highlights and key insights. Event details: https://lnkd.in/eCRKk_GF Save the dates and stay tuned for more details on agenda and presentations through EMA channels 💊🚀 #EMA #IRISS #ProductManagement #SPOR #DataManagement # PMS #IDMP #EMAEvents #IndustryUpdates

Putting few key slides on my blog on Singapore Healthier SG implementation

🤝 Strategic partnerships drive innovation and organizational transformation. To further strengthen our capabilities in alliance development and management, Veza Alliance Management has joined the Association of Strategic Alliance Professionals (ASAP), the premier global community advancing excellence in strategic partnerships and collaborations. This membership aligns with our commitment to fostering impactful partnerships across sectors. Having built successful collaborations in biotech, healthcare, economic development, and academia, we recognize that strategic alliance management is both an art and a science. ASAP's resources and global network will enhance our ability to: ➡ Drive innovation through structured collaboration ➡ Apply best practices in alliance management ➡ Connect with fellow practitioners across industries ➡ Access cutting-edge tools and methodologies ➡ Participate in professional development and certification As organizations increasingly rely on partnerships to achieve their strategic objectives, the principles of effective alliance management become critical. We look forward to both learning from and contributing to ASAP's community of practice. #StrategicPartnerships #Innovation #Collaboration #AllianceManagement

Great reading with inputs, tips and mistakes to avoid for PMS trend analysis

SAVE THE DATE 11:30AM EST November 13  Join the DIA Direct Community Webinar on Driving Adoption and Value Across the RIM Ecosystem, including an expert discussion of how to maximize the ROI from your Regulatory Information Management (RIM) system and tips on change management and engaging stakeholders. Register here:  Driving Adoption and Value Across the Regulatory Information Management (RIM) Ecosystem https://lnkd.in/enrAf2x3

Thank you to everyone who attended the CDM and DRR Technical Workshop in Singapore! Your active participation—through thoughtful questions, insights, and shared experiences—made the session truly engaging. My top three questions from today were: 1. How is CDM different from FpML in representing structured products? 2. Can CDM and DRR be extended? 3. Can CDM and DRR be used for UPI requests and validation? 1. CDM is "better positioned" than FpML to support structured products by having a more generic/flexible product representation. 2. Both CDM and DRR can be extended but ideally extensions should be brought back to the open projects. 3. CDM and DRR can help on UPI request generation and UPI validation. Feel free to reach out f you’re interested in discussing more details of these answers ;) In the afternoon, there was a Reporting Seminar with strong representation from various firms. It was invaluable to hear diverse perspectives on regulatory reporting across Asia, in my case, particularly from buy-side firms. They shared the challenges of implementing new APAC regulations amidst limited resources and complex data workflows, including UPI. It will be interesting to see how the buy-side, and also the sell-side, can adopt more strategic approaches to future regulatory changes and how CDM and DRR can play a role in that. A special thanks to ISDA and S&P Global Global for organizing these insightful events. Olivier MIART Xiangjing Ng Matthew Meyer Higgins Struan Lloyd Scott O'Malia Chris Childs Priya Kundamal Benoit Gourisse Richard Baker Amit Manchanda Xiaobo LIU Sze Ying LOOI Julia Leong

Thanks to Markus Pöttker for moderating an informative roundtable discussion during the TT Lifesciences 6th Annual PMS and Vigilance conference this afternoon on typical methods for gathering feedback from customers in order to fulfil MDR/IVDR Annex III requirements. The popular options included: 1. Salesforce-driven customer surveys 2. Patient circles 3. Innovation and knowledge focus groups with KOLs 4. E-commerce platform reviews and ratings Whilst common challenges such as data privacy and protection, quality and adequacy were raised. Experience was shared on converting an entire organisation to adopt the IMDRF common language and coding system to categorise feedback, complaints and vigilance data. The discussion circled back to the critical role of a device-specific, well-defined and appropriate PMS plan. Key take aways: * Not all methods of data collection are appropriate for all devices. * PMS plan should be specific to the device! * PMS plan must include defined methods to collect and analyse data which includes indicators and thresholds * Be persistent in aiming for IMDRF adoption across your entire organisation (PMS, Risk Management, Clinical)

Are you a MEL practitioner implementing MSD programmes? Join us tomorrow as we delve into practical examples how to measure measure systemic change. I will be sharing experience as a guest speaker in this webinar: https://lnkd.in/eKGrjRAT USAID’s five-part skill-building webinar series tailored for MEL Managers, Specialists, and others working on MEL systems in MSD projects. When: Wednesday, December 4, 8-10AM ET Where: Zoom https://lnkd.in/ev_7XBgm Theme: "Is it systemic?" "How do I know?" "What am I looking for?" Learn how to identify whether observed changes are truly systemic—taking root within the system, gaining independent momentum, and creating lasting impact beyond the project's direct support. https://lnkd.in/eKGrjRAT