RAPS Quebec Local Networking Group

📢📢📢 RAPS Quebec Local Networking Group is excited to announce our first virtual event of 2025! Please join us for our Webinar: "Clinical Evaluation Under MDR Explained by a Notified Body" featuring Riccardo Persia, MD, Clinical Toxicologist who is currently a Clinical Manager and Internal Clinician at Ente Certificazione Macchine. 🚀 Title: Clinical Evaluation Under MDR Explained by a Notified Body 📅 Date: Monday, February 24th, 2025 ⏰ Time: 11:00 am to 12:00pm (Eastern Time US & Canada) 💻 Location: Virtual ✅ Registration: Member $0 / Non-Member $25 Dr. Riccardo Persia will outline details of clinical evaluation under MDR (Medical Device Regulation) requirements focusing on MDR Art. 61(10), namely the demonstration of conformity to GSPRs without clinical data and the provisions of MDCG 2024-10 (Medical Device Coordination Group) concerning the clinical evaluation of orphan medical devices. Space is limited so be sure to register here: https://lnkd.in/eWG3jpCj Looking forward to seeing you there! #RAPS #RegulatoryAffairs #MedicalDevices #MedicalDeviceReporting #OrphanMedicalDevices

🎙️ Regulatory Insights Brewed Fresh on RegXpresso! ☕ Excited to share our latest episode of RegXpresso, where we explore the evolving requirements of the FDA’s upcoming Quality Management System Regulation (QMSR) for medical devices. Meet our expert panelists: - Yuan Li, PhD holds a doctorate degree in Mechanical Engineering. His research at the University of Memphis and the University of Tennessee Health Science Center produced 13 peer-reviewed publications on spinal pathologies and novel implants. After entering the medical device industry, he specialized in Regulatory Affairs, managing product approvals/clearances (510K, CE certification) across the US, EU, and APAC regions. He moved into notified bodies in 2015, initially as an Orthopedic product reviewer and lead auditor, later advancing to management roles. He currently oversees North American operations at DQS, supporting market expansion and regulatory compliance. - George Bell has a bachelor’s degree in engineering along with 5 certificates in quality. George’s career has been spent working in the medical device and pharmaceutical industries. He has experience in engineering and quality departments working on new design, manufacturing, post market surveillance as well as authoring FDA 510k and technical files.  George has extensive FDA remediation experience, working on 483’s, warning letters and consent decrees. As a member of notified bodies, he has performed ISO13485, MDD, MDR and MDSAP audits. George currently leads a team of 17 medical device auditors at DQS. As manufacturers prepare for QMSR compliance, this episode sheds light on: ✅ Strategies that medical device manufacturers can adopt now for a smooth transition to QMSR in 2026 ✅ Impacts on post-market surveillance and complaint-handling processes under the new QMSR framework ✅ Risk management considerations, especially with the QMSR’s closer alignment to ISO 13485 ✅ Challenges for legacy devices transitioning from QSR to QMSR ✅ Documentation requirements, including design controls and production processes, crucial for meeting QMSR expectations Join the conversation and stay ahead in regulatory excellence by tuning into the full episode below. Get actionable insights from our experts to navigate these regulatory changes and prepare for success in an evolving medical device landscape. #FDA #QMSR #RegulatoryAffairs #MedicalDevices #QualityManagement #RAPSQuebecLNG

As 2024 comes to a close, RAPS Quebec Local Networking Group is reflecting on the successes of our first year as a Local Networking Group!   We are happy to share with you some of our key events and initiatives from 2024: ✔️ RegXpresso Since launching in September, we have hosted 8 interviews with regulatory affairs experts covering topics from AI in Regulatory Affairs to Medical Device Biocompatibility Assessments. Thank you to Claire Dyson, Kia Kahhali, Tibor Zechmeister, Marina Daineko, SUMATHA KONDABOLU, Tiea Theurer, Manar Hammood, and Danny Kroo – we are excited to continue RegXpresso in 2025! ✔️ Regulatory Conferences 📍 Regulatory Affairs Professionals Society (RAPS) Convergence - Our team members SUMATHA KONDABOLU, Emma CY YUEN, MSc MTOPRA CAPM, and NADINE ADIA attended the RAPS Convergence in Long Beach, California. They had a great time connecting with the RAPS Ontario Chapter and RAPS Western Canada Chapter! 📍 With ISoP Events - SUMATHA KONDABOLU attended the 23rd Annual Meeting of ISoP which brought together global leaders in RA and PV. 📍 DIA Annual Meeting - SUMATHA KONDABOLU attended this event on Regulatory, Clinical, Safety, and Pharmacovigilance in Gatineau! ✔️ Networking Events 📍 In collaboration with ZENITH PV we participated in the inaugural Women Leader’s Circle covering topics in Drug Safety, Medical Information, Quality and Regulatory Affairs. 📍 In collaboration with Women In Bio - Greater Montreal we hosted an in-person event on Careers Advancement in Regulatory Affairs with Saleh Bessissow, Sylvie Ducharme, Valérie Joseph, and Khaled Yahiaoui, M.Sc, RAC. ✔️ Webinar 📍 We hosted a webinar on Quality with SUMATHA KONDABOLU, Vanessa Lucien, Kossi D. Molley, Chemist, LSSBB, PMP, and Ashley S.   Looking back at this first year as a RAPS LNG we are grateful to all of those who supported and attended our events!   We are excited to see you again in 2025 with even more exciting opportunities!   #RAPS #Networking #RegulatoryAffairs #2025

As 2024 comes to a close, RAPS Quebec Local Networking Group is reflecting on the successes of our first year as a Local Networking Group!   We are happy to share with you some of our key events and initiatives from 2024: ✔️ RegXpresso Since launching in September, we have hosted 8 interviews with regulatory affairs experts covering topics from AI in Regulatory Affairs to Medical Device Biocompatibility Assessments. Thank you to Claire Dyson, Kia Kahhali, Tibor Zechmeister, Marina Daineko, SUMATHA KONDABOLU, Tiea Theurer, Manar Hammood, and Danny Kroo – we are excited to continue RegXpresso in 2025! ✔️ Regulatory Conferences 📍 Regulatory Affairs Professionals Society (RAPS) Convergence - Our team members SUMATHA KONDABOLU, Emma CY YUEN, MSc MTOPRA CAPM, and NADINE ADIA attended the RAPS Convergence in Long Beach, California. They had a great time connecting with the RAPS Ontario Chapter and RAPS Western Canada Chapter! 📍 With ISoP Events - SUMATHA KONDABOLU attended the 23rd Annual Meeting of ISoP which brought together global leaders in RA and PV. 📍 DIA Annual Meeting - SUMATHA KONDABOLU attended this event on Regulatory, Clinical, Safety, and Pharmacovigilance in Gatineau! ✔️ Networking Events 📍 In collaboration with ZENITH PV we participated in the inaugural Women Leader’s Circle covering topics in Drug Safety, Medical Information, Quality and Regulatory Affairs. 📍 In collaboration with Women In Bio - Greater Montreal we hosted an in-person event on Careers Advancement in Regulatory Affairs with Saleh Bessissow, Sylvie Ducharme, Valérie Joseph, and Khaled Yahiaoui, M.Sc, RAC. ✔️ Webinar 📍 We hosted a webinar on Quality with SUMATHA KONDABOLU, Vanessa Lucien, Kossi D. Molley, Chemist, LSSBB, PMP, and Ashley S.   Looking back at this first year as a RAPS LNG we are grateful to all of those who supported and attended our events!   We are excited to see you again in 2025 with even more exciting opportunities!   #RAPS #Networking #RegulatoryAffairs #2025

🎙️ Regulatory Insights Brewed Fresh on RegXpresso! ☕ Excited to share the latest episode of RegXpresso, where we explore the evolving requirements of the Medical Device Single Audit Program (MDSAP) with Claire, a subject matter expert in medical device compliance and quality management. Claire Dyson is the Managing Director at the DQS DQS Medizinprodukte UK LTD, Advanced Innovation Technology Centre. Claire has a doctorate in rational drug design and over 10 years of experience in medical devices that interact with or deliver medicines or biological responses. Most of her career has been spent in industry, mainly in Switzerland. She moved into certification bodies in 2018 and has been involved in several transformative change projects, including new accreditations and designations. As manufacturers gear up for their next MDSAP audits, this episode provides clarity on: ✅ Updates to MDSAP audit model guidance and their impact on scheduling. ✅ New expectations for post-market surveillance audits from regulatory authorities. ✅ Adjustments needed in Quality Management Systems (QMS) to meet the latest guidance. ✅ Best practices to align internal audit processes across multiple jurisdictions. Join the conversation and stay ahead in regulatory excellence. 💼📈 🚀 Catch the full episode below This video covers the following topics: ⏳ 7:08 (minutes remaining) - MDSAP https://lnkd.in/eMuk8Y-c ⏳ 6:25 (minutes remaining) - MDSAP Audit Approach https://lnkd.in/dW_76Bkn ⏳ 4:42 (minutes remaining) - Health Canada - MDSAP https://lnkd.in/dvn89Wqk Claire’s insights offer actionable guidance to help organizations navigate these changes and prepare for success in a global regulatory environment. 🌍💡 #MDSAP #MedicalDevices #RegulatoryAffairs #Compliance #QualityManagement #RegXpresso #Innovation

🌟 Reflecting on an Inspiring Evening at the Women Leader's Circle! 🌟 Last evening, we RAPS Quebec Local Networking Group had the privilege of collaborating and attending the inaugural Women Leader's Circle, a networking and social event designed for women in Drug Safety, Medical Information, Quality, and Regulatory Affairs. It was truly empowering to be surrounded by a diverse group of talented and inspiring women who shared their experiences, challenges, and aspirations. The event provided a relaxed and supportive environment where meaningful connections were made, stories were exchanged, and insights were gained. A huge thanks to ZENITH PV for creating this wonderful platform to bring like-minded professionals together. Events like these remind us of the strength and potential we have when we come together to support and uplift one another. 💡 Here’s to more conversations, collaborations, and opportunities for growth as we continue to navigate and shape the future of our industry! #WomenInLeadership #RegulatoryProfessionals #NetworkingEvent  #ZenithPV #RAPSQuebecLNG

📢 What is the future of #AI in #pharma and #medtech industries? How will the introduction of AI technology be regulated in these industries and how can regulatory/quality professionals prepare to the shift? In this video, we have an insightful discussion with the expert in the field, Kia Kahhali. Kia Kahhali is the President/ CEO of APS Compliance Consultants Inc. After 20 years in the field, Kia founded APS in 2018 to offer world-class equipment and computerized system validation services while pioneering cutting-edge lab automation software solutions. APS are specialists in ensuring data integrity and compliance for pharmaceutical, biotech, and other GMP-regulated industries. Focusing on Good Manufacturing Practice (GMP) environments, APS helps companies navigate complex regulatory landscapes by providing software, consulting services, and data governance solutions that streamline processes and enhance data quality. This video covers the following topics: ⏳ 11:28 - Brief overview of the existing regulatory documents on the use of AI in pharma / medtech ⏳ 8:39 - Impact of the AI regulatory framework on GxP systems ⏳ 5:30 - Practical advice to pharma/medtech companies on the AI implementation in business Regulatory Affairs Professionals Society (RAPS) #AI #pharma #regulatoryaffairs #medtech

📢 📢 📢 RAPS Quebec Local Networking Group is happy to share that our Vice Co-Chair SUMATHA KONDABOLU will be attending the upcoming DIA (Drug Information Association) Canada Annual Meeting taking place November 14-15 in Gatineau QC. 🌐 Be sure to connect with Sumatha who is representing our RAPS Quebec LNG, she will be happy to meet with you to discuss the exciting topics spanning Regulatory, Clinical, Safety, and Pharmacovigilance! For more details on the event itself please see the following link: https://lnkd.in/ecDn74Hq #RAPS #RegulatoryAffairs #Pharmacovigilance #ClinicalResearch #ClinicalTrials #RealWorldEvidence

📢 📢 📢 RAPS Quebec Local Networking Group is excited to share that our Vice Co-Chair SUMATHA KONDABOLU will be leading a discussion on “How to Be Constantly Audit-Ready” at the upcoming Education & Networking Event hosted by the RAPS Ontario Chapter. 📍 The event will take place in Ottawa on Wednesday November 13th from 16:00-19:00 at 403 Bank Street (Staples Studio Ottawa Coworking Space). 🌐 If you are attending this event, be sure to connect with Sumatha who is representing our RAPS Quebec LNG! She will be happy to network with you and share her insight on audit readiness! 📋 #RAPS #RegulatoryAffairs #Networking #Audits

🔎 Having difficulty following up on all MDCG guidance documents that have been recently issued by the European Commission? In this episode, Tibor Zechmeister gives a straight to the point overview of the key categories of the recent MDCG documents and explains their significance to the manufacturers. Tibor Zechmeister has worked in medical device regulatory affairs for more than 12 years. He has established and co-founded businesses addressing neurodegenerative illnesses, serving in capacities as head of regulatory, PRRC, and thus witnessing the challenges of medical device manufacturers within the European regulatory framework. Tibor currently oversees Regulatory and Quality at Flinn.ai, where he ensures compliance and quality for state-of-the-art automation and AI tools for regulatory compliance. Additionally to this, he works as an External Auditor at Notified Body 1304. This video covers the following topics: ⌛ 8:45s - Why it is important to comply with the current versions of MDCG ⌛ 7:35s - An overview of MDCG 2024-11 on Qualification of IVDDs ⌛ 6:07s - An update of MDCG 2020-16 on Classification of IVDDs ⌛ 5:00s - "Nice to read / know" category of MDCG documents ⌛ 3:20s - Advice to regulatory / quality professionals on ensuring compliance to MDCG documents ( ✔️ Bonus: how to avoid getting into a trouble with a NB auditor 😊 ) Regulatory Affairs Professionals Society (RAPS) #regulatoryaffairs #medicaldevices #mdr #compliance