RAPS Quebec Local Networking Group

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 Y., 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

📢 📢 📢 RAPS Quebec Local Networking Group is excited to announce an upcoming in-person networking opportunity for women leaders in Drug Safety, Medical Information, Quality, and Regulatory Affairs initiated by ZENITH PV happening at the end of November in Montreal. 📌 What: The main goal is to build your network with fellow colleagues while discussing hot topics in the pharmaceutical industry in a relaxing setting. ❔ How to participate: Please send a private message to RAPS Quebec LNG for additional details. 📍 📅 ⏰Event Details: End of November with exact information to be confirmed via poll - please reach out to RAPS Quebec LNG through private message to express your interest in attending. ✅ Cost: FREE! There is no cost to attend this event and it is up to you what refreshments to purchase individually. We look forward to seeing you there! #RAPS #DrugSafety #MedicalInformation #Quality #RegulatoryAffairs #WomenLeaders #Networking

📣 What is new in the field of medical devices biocompatibility assessment? In this discussion, Marina Daineko shares a brief overview of the most recent regulatory developments on this subject in the EU and US. Marina Daineko is a seasoned Biocompatibility Consultant based in Poland, specializing in ISO 10993-1. With extensive experience in the medical device industry, she adeptly develops biocompatibility assessment aligned with ISO 14971:2019, EU Medical Device Regulation as well as FDA Guidance. Her expertise extends to ensuring compliance with regulatory requirements across various global markets. Marina works as a consultant at Intrinsic Medical Group, LLC. that offers a diverse spectrum of Biological Safety services to fit the needs of a wide range of medical device manufacturers. Their strategies are proven to meet the requirements of modern day foreign body and domestic regulations. This video covers the following topics: ✅ ⌛ (5:55 minutes remaining): Updates to ISO 10993 standard series in EU ✅ ⌛ (4:08 minutes remaining): FDA ASCA Program, FDA Guidance on Chemical Analysis and Recommendations ✅ ⌛ (2:35 minutes remaining): Advice to regulatory professionals in light of the upcoming changes Regulatory Affairs Professionals Society (RAPS) #medicaldevices #regulatoryaffairs #biocompatibility

🌐 RAPS Quebec Local Networking Group est ravi de présenter notre événement en personne à Montréal sur les soumissions à la FDA pour les instruments médicaux 🌐   Ne manquez pas l'opportunité de participer à notre prochain événement en personne avec le conférencier Eric Franca directeur adjoint du FDA CDRH, Division of Standards Conformity Assessment.   Par une webdiffusion en direct, Eric discutera des normes reconnues par la FDA pour les instruments médicaux, notamment eSTAR et ASCA (Accreditation Scheme for Conformity Assessment). Il expliquera comment citer ces normes pour maximiser leur efficacité en tant qu'outils permettant de soutenir et de rationaliser les soumissions des instruments médicaux.   Après la présentation informative d’Eric, une séance de réseautage en personne aura lieu au cours de laquelle des canapés, des boissons gazeuses, ainsi que du café et du thé seront disponibles pour favoriser des discussions fructueuses.    Détails de l'événement clé: 🚀 Title: FDA Road Show-Upping Your Conformity Assessment Game: Putting Standards to Work to Streamline Device Review 📅 Date: mercredi, October 23rd, 2024 ⏰ Heure: 17:30 - 21:00 HAE 📍 Lieu: Le Crystal Reception Hall, 5285 Henri Bourassa Blvd O. ✅ Inscription – Membres: $55 CAD / Non-Membres: $68 CAD 🚗 Stationnement: Gratuit!   Inscrivez-vous maintenant pour garantir votre place et obtenir des informations précieuses de notre conférencier expérimenté et développer votre réseau.   Cliquez ici pour vous inscrire: https://lnkd.in/dRZK7v2R   Ne manquez pas cette opportunité d'apprentissage exceptionnelle car les places sont limitées. Au plaisir de vous voir à l'événement!   Veuillez noter que la présentation sera en anglais, tandis que la séance de réseautage sera bilingue (français et anglais).   #RAPSQuebecLNG #RAPS #InstrumentsMédicaux #FDA #AffairesRéglementaires