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X-WR-CALDESC:Events for OCRA-DG - Regulatory Affairs
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BEGIN:VEVENT
DTSTART;VALUE=DATE:20240917
DTEND;VALUE=DATE:20240920
DTSTAMP:20260415T090750
CREATED:20230807T184635Z
LAST-MODIFIED:20240505T052851Z
UID:27456-1726531200-1726790399@ocra-dg.org
SUMMARY:RAPS Convergence
DESCRIPTION:Early Registration until 31 May 2024 at 11:59 pm EST. Early Registration rate is $2\,785 for non-RAPS Members and $2\,205 for RAPS Members. \nOCRA Members receive 10% off RAPS Convergence registration rate!  Contact Membership@ocra-dg.org to obtain the special promo code!
URL:https://ocra-dg.org/event/raps-convergence/
CATEGORIES:Events,In Person,Joint Meetings,OCRA Meetings
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20241014T120000
DTEND;TZID=America/Los_Angeles:20241014T131500
DTSTAMP:20260415T090750
CREATED:20240830T060800Z
LAST-MODIFIED:20241001T194942Z
UID:30266-1728907200-1728911700@ocra-dg.org
SUMMARY:Inherently Safer Design
DESCRIPTION:Inherently Safer Design\nDate: Monday\, October 14\, 2024\nTime: 12pm – 1:15m PT\nAudience:\n– Medical device and IVD regulatory affairs professionals\n– Risk Management professionals\n– Systems Engineers\n– Engineering management and design engineers\n– Clinical Affairs professionals\nPlatform: Zoom \nControl of risk is fundamental to producing a safe and effective medical device. ISO 14971\, application of risk management to medical devices\, specifies a Risk Control Prioritization that lists first\, in order of effectiveness\, Designing for Inherent Safety. Designing for Inherently Safer Systems can be achieved by eliminating a particular hazard and by eliminating the probability of occurrence of harm. The current situation is that ISO 14971 and its companion document ISO 24971 provide few examples and limited guidance on applying a consistent methodology for implementing inherently safer design. This webinar seeks to resolve this by providing a OCRA-DG Page 2 of 4 Rev. 05/31/2024 methodology for helping teams implement creative solutions for achieving inherently safer designs. Numerous examples using guidewords that are unique to the design of inherently safer systems are provided. Inherently safer design is applicable at all phases of design and operation\, from concept to end use. However\, the greatest benefit is achieved the sooner it is applied in the design cycle. Inherently safer design will be shown to be simple and elegant using the information and methodology provided with this webinar. \nLearning Objectives: \n\nAttendees will leave with an in depth understanding of designing for inherently safer systems.\nAttendees will leave with specific tools\, including a methodology\, for leading design teams with the implementation of inherently safer design solutions.\nAttendees will bring back a renewed understanding of the importance of applying these inherently safer design techniques sooner in the design cycle.\n\nRegister now to secure your spot and empower your team for success! \n  \n\n\nAbout the Speaker\n \nJerry Valenti\, P.E. (electrical)\n-PRN Medical Solutions\, Engineering Consultant (Design Assurance) \n-30+ Years Medtech experience\, Verification\, Design Assurance\, Regulatory Review and Submission\n \nBy formal training\, Jerry is an electrical engineer and has his Professional Engineering license in California. His most recent successes include leading the submission for MDR certification for the first product launch of a Class II medical device for a local startup company. Experience includes expertise with Design Controls for FDA 21CFR820 and ISO 13485 with specific emphasis on Product Verification\, and Software Quality Assurance for product software for patient monitoring devices\, and patient connected therapeutic delivery devices. He is a Certified Tester (Foundation Level) from the International Software Testing Qualifications Board. Risk Management expertise includes hazard analysis and FMECA development\, verification of effectiveness of mitigation controls\, and Risk Management File creation and maintenance. Jerry is a member of Orange County Regulatory Affairs – Discussion Group\, and American Society for Quality. \n  \n\n  \nFree for Members and Nonmembers \nRegister Now! \n  \n\n  \nThank you to our Sponsors!\n  \n \n  \n \n  \n  \n  \n \n  \n          \n  \n  \n  \n       \n  \n                                   
URL:https://ocra-dg.org/event/inherently-safer-design/
LOCATION:Webinar
CATEGORIES:Events
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20241030T120000
DTEND;TZID=America/Los_Angeles:20241030T130000
DTSTAMP:20260415T090750
CREATED:20240830T061039Z
LAST-MODIFIED:20241001T200851Z
UID:30267-1730289600-1730293200@ocra-dg.org
SUMMARY:Clinical Trial Management in Academic Medical Centers
DESCRIPTION:Clinical Trial Management in Academic Medical Centers\nDate: Wednesday\, October 30\nTime: 12:00pm-1:00pm PT\nAudience: Audiences interested in clinical trial management.\nPlatform: Zoom \nClinical trials are crucial for the development of safe and effective medical products and enhancing the quality of patient care worldwide. Effective clinical trial management ensures compliance with regulatory requirements\, prioritizes participant safety through safety protocols and monitoring for adverse effects\, ensures research validity\, as well as the collection and management of high-quality\, accurate data. Above all\, promoting the ethical conduct throughout the clinical trial process. This presentation introduces clinical trial management principles for academic medical center investigator sites. \nLearning Objectives: \n\nIntroduction to clinical trial management principles.\nPractical approaches to implementing and conducting clinical trials at academic medical centers.\n\nRegister now to secure your spot and get empowered for success! \n  \n\n\nAbout the Speaker\n \nTony Succar\, PhD\n– MScMed(OphthSc)\n– Assistant Professor\n– USC Department of Regulatory and Quality Sciences\, USC Mann School of Pharmacy\n– 18 years clinical trials experience  \n\nTony Succar is an Assistant Professor in the Department of Regulatory and Quality Science\, USC Mann School of Pharmacy\, University of Southern California. He previously worked as a Clinical Research Project Manager at Massachusetts Eye and Ear\, Harvard Medical School\, managing multi-center industry sponsored and investigator initiated clinical trials for drugs\, biologics\, medical devices and combination products. He completed his Postdoctoral Fellowship at the University of Southern California Keck School of Medicine\, and earned his Master of Science in Medicine (Ophthalmic Science) and PhD from the University of Sydney. \n  \n  \n\n  \nFree for Members and Nonmembers \nRegister Now! \n  \n\n  \nThank you to our Sponsors!\n \n  \n \n  \n  \n  \n \n  \n          \n  \n  \n  \n       \n  \n                                   
URL:https://ocra-dg.org/event/clinical-trial-management-in-academic-medical-centers/
LOCATION:Webinar
CATEGORIES:Events
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20241114T183000
DTEND;TZID=America/Los_Angeles:20241114T183000
DTSTAMP:20260415T090750
CREATED:20241029T220855Z
LAST-MODIFIED:20241105T054833Z
UID:30547-1731609000-1731609000@ocra-dg.org
SUMMARY:2024 Ocra-DG Holiday Party
DESCRIPTION:End-of-year Holiday Party/Member & Sponsor Appreciation Dinner\nDate: Thursday\, November 14\, 2024\nTime: 6:30pm – 9:30m PT\nEvent: A thank you to our members and sponsors. \n  \n\n  \nFree for Members\, Sponsors and Guests \nRegister Now! \n  \n\n  \n 
URL:https://ocra-dg.org/event/2024-holiday-party/
LOCATION:Brio Italian Grille Spectrum
CATEGORIES:Events,In Person,Networking,OCRA Meetings
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250131T180000
DTEND;TZID=America/Los_Angeles:20250131T200000
DTSTAMP:20260415T090750
CREATED:20241105T054128Z
LAST-MODIFIED:20250127T204732Z
UID:30555-1738346400-1738353600@ocra-dg.org
SUMMARY:OCRA-DG Open House
DESCRIPTION:Explore upcoming conferences\, webinars\, and networking opportunities while connecting with fellow regulatory professionals over hors d’oeuvres.\n  \n  \n  \n  \n  \n  \nEvent: Introducing the new 2025 Board to OCRA members \nDate: Friday\, January 31\, 2025\nTime: 6pm-8pm\nLocation: Solstice Irvine Seasonal Kitchen & Bar\, 18555 Jamboree Rd\, Irvine\, CA 92612 \nDon’t miss the Raffle at the Open House for:\n3 free tickets to the Spring Seminar\n3 free tickets to the Annual Conference \nThis event is free for Members and Non-Members. \n   \nRegister Now \n  \n\n  \n 
URL:https://ocra-dg.org/event/ocra-dg-open-house/
LOCATION:Solstice Irvine Seasonal Kitchen & Bar\, 18555 Jamboree Rd\, Irvine\, CA\, 92612\, United States
CATEGORIES:Events,In Person,Networking,OCRA Meetings
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250213T080000
DTEND;TZID=America/Los_Angeles:20250213T130000
DTSTAMP:20260415T090750
CREATED:20250107T100848Z
LAST-MODIFIED:20250207T011507Z
UID:30624-1739433600-1739451600@ocra-dg.org
SUMMARY:Spring Seminar
DESCRIPTION:  \nThis Event is Sold Out!\nWe have reached the capacity for the 2025 Spring Seminar.\nPlease check our Events Calendar for other great networking opportunities. \n  \n\n  \nAre you ready to expand your knowledge\, connect with industry professionals\, and gain fresh insights to kickstart your spring with purpose? Our upcoming Spring Seminar is the perfect opportunity to do just that! \nWhether you want to learn\, network\, or discover cutting-edge trends\, this event has something for everyone! Don’t miss the chance to be part of OCRA. \nDate: Thursday\, February 13th\, 2025\nTime: 8am – 1pm PT\nLocation: AbbVie Irvine Campus\n2525 Dupont Dr\, Irvine\, CA 92612 \nLet’s learn\, grow\, and make meaningful connections this spring. We can’t wait to see you there! \n  \n\n  \nFDB Speakers \nYear in Review\nJune-Mei Han\nCalifornia FDB \n  \n\n  \nMed Device Industry Speaker \nAI Impact on MDR Conformity Assessment\nBalazs Bozsik\nTechnical Director – Medical Audit/SGS North America \n  \n\n  \nPharma Device Industry Speaker \nPre-IND Communication\nDr. Bruce W. Kovacs\, MD\nAfectaPharm \n  \n\n  \nAbbvie Panel Med Device \nWhich Way FDA\, what should we expect in 2025?\nAlan Stevens \nCombo Product: Director\, Regulatory Affairs\, Combo Product\, AbbVie \nCarlos Torres\nAdvertising and Promotion: Senior Manager\, RA US Advertising and Promotion\, AbbVie \nFelipe Martins\nStrategy: Associate Director\, RA Global Regulatory Strategy\, AbbVie \n  \n\n  \nPharmaceutical Panel Speakers \nPharmaceutical Labeling\nNatalie Tolli\nVP\, RA Intercontinental/ Regulation and Policy Intelligence\, AbbVie \nMirabelle Pao\nDirector\, RA CMC\, AbbVie \nEmily Wawro\nDirector\, RA Global Regulatory Strategy\, AbbVie \n  \n\n\nConference Schedule\nTHURSDAY\, FEBRUARY 13\, 2025\n \n\n\n8:00–9:00: Registration\, Networking & Breakfast \n9:00–9:45: Opening Plenary \n9:45–10:15: Pharma Industry Speaker \n10:15–10:45: Device Notified Body Speaker \n10:45–11:00: Break & Refreshments \n11:00–11:30: Pharma Panel \n11:30–12:00: Device Panel \n12:00–12:30: Closing Remarks & Raffle \n\n\n\n  \n\n  \nWant to Learn More? \nClick on the flyer to learn all the details about the Seminar\, including schedule\, speakers and registration info! \n 
URL:https://ocra-dg.org/event/spring-conference/
LOCATION:AbbVie Irvine Campus\, 2525 Dupont Dr\, Irvine\, 92612\, United States
CATEGORIES:Events,In Person,Networking,OCRA Meetings
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250313T120000
DTEND;TZID=America/Los_Angeles:20250313T130000
DTSTAMP:20260415T090750
CREATED:20250223T203815Z
LAST-MODIFIED:20250304T191615Z
UID:30961-1741867200-1741870800@ocra-dg.org
SUMMARY:Webinar Series - Decentralized Clinical Trials
DESCRIPTION:Date: Thursday | March 13\, 2025 \nTime: 12 noon to 1pm PT \nLocation: Zoom \nRegistration: \nRegistration: Free for OCRA-DG members and nonmembers \nSpeaker: Wendi Lau\, DRSc\, Senior Director of Clinical Development Operations at AbbVie Inc. \nRegister Now \n  \n\n  \nWe are thrilled to announce Wendi Lau\, Senior Director of Clinical Development Operations at AbbVie Inc.\, as one of our esteemed speakers! \nWith 30+ years of experience in clinical research\, Wendi has contributed significantly to clinical trial operations\, data management\, and medical writing. Her impressive academic background includes: \n\nB.S in Chemistry (University of Illinois)\nM.S. in Biology (Northeastern Illinois University)\nDoctorate in Regulatory Science (USC)\, where her thesis examined decentralized clinical trials\n\nIn addition to her work at AbbVie\, Wendi is a lecturer at USC\, helping to shape the next generation of clinical research professionals.\nJoin us at the seminar to hear Wendi’s invaluable insights into the future of clinical trials and the evolving landscape of decentralized studies! \nLearning Objectives: \n\nNew FDA regulations and changes\nImpact of AI on MDR\nPathways for Pre-IND and much more!
URL:https://ocra-dg.org/event/decentralized-clinical-trials/
CATEGORIES:Events,Networking,OCRA Meetings,Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250314T183000
DTEND;TZID=America/Los_Angeles:20250314T203000
DTSTAMP:20260415T090750
CREATED:20241105T054600Z
LAST-MODIFIED:20250224T021701Z
UID:30556-1741977000-1741984200@ocra-dg.org
SUMMARY:March 14 Happy Hour
DESCRIPTION:OCRA-DG March 14 Happy Hour\nDate: Friday | March 14\, 2025 \nTime: 6:30pm-8:30pm PT \nLocation: Postino Irvine at 2981 Michelson Dr suite E\, Irvine\, CA 92612 \nRegistration: Free for OCRA-DG members; $10 for nonmembers \nEvent: Inviting members and nonmembers of the SoCal Regulatory Affairs community to socialize and network. \nShared plates will be provided for attendees. \n  \nRegister Now \n  \n 
URL:https://ocra-dg.org/event/march-14-happy-hour/
LOCATION:Postino Irvine\, 2981 Michelson Dr\, Suite E\, Irvine\, 92612\, United States
CATEGORIES:Events,In Person,Networking,OCRA Meetings
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250320T120000
DTEND;TZID=America/Los_Angeles:20250320T130000
DTSTAMP:20260415T090750
CREATED:20250224T022107Z
LAST-MODIFIED:20250304T191723Z
UID:30971-1742472000-1742475600@ocra-dg.org
SUMMARY:Webinar Series - Pediatric Drug Labels
DESCRIPTION:Date: Thursday | March 20\, 2025 \nTime: 12 noon to 1pm PT \nLocation: Zoom \nRegistration: \nRegistration: Free for OCRA-DG members and nonmembers \nSpeaker: Dr. Christopher Landon\, President of Landon Pediatric Foundation \nRegister Now \n  \n\n  \nDr. Chris Landon\, MD\, is a renowned pediatric pulmonologist and innovative researcher with over 40 years of experience in advancing respiratory care. He earned a B.S. in Psychobiology from UC Riverside and an M.D. from USC Keck School of Medicine. Following his residency at Stanford University Hospital and a fellowship in Allergy\, Immunology\, and Respiratory Medicine at Children’s Hospital at Stanford\, he further refined his expertise with a Global Health certificate from Harvard University. His publications span telemedicine\, remote patient monitoring\, COPD and asthma management\, pediatric sleep apnea\, and the integration of artificial intelligence and blockchain in healthcare.
URL:https://ocra-dg.org/event/pediatric-drug-series/
CATEGORIES:Events,Networking,OCRA Meetings,Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250402T183000
DTEND;TZID=America/Los_Angeles:20250402T200000
DTSTAMP:20260415T090750
CREATED:20250315T221307Z
LAST-MODIFIED:20250317T054649Z
UID:31105-1743618600-1743624000@ocra-dg.org
SUMMARY:April 2 - OCRA Career Panel
DESCRIPTION:Join us for the “Navigating Your Path: OCRA Career Panel in Regulatory Affairs“\, an engaging online workshop designed to illuminate the diverse career paths within the regulatory affairs field. Whether you’re a university student\, a healthcare professional looking to transition into regulatory affairs\, or a regulatory affairs professional seeking career growth and new opportunities\, this event is tailored for you! \nOur esteemed panelists\, with backgrounds spanning drugs\, medical devices\, and biologics\, will share their unique career journeys and provide invaluable guidance on job hunting\, interviewing\, and transitioning into regulatory affairs. Gain insights into career development strategies and learn how to achieve long-term success in this dynamic field. \nDon’t miss this opportunity to connect with industry experts\, ask your burning questions\, and take the next step in your regulatory affairs career. Secure your spot today and start navigating your path to success! \n  \nPanel\n \nJulie Manchester\, RAC\, VP\, Regulatory Affairs & Quality at Autonomix Medical \nMs. Manchester is a Biotech/Med Device executive with over 15 years of quality and regulatory experience within the medical device\, cosmetics\, pharmaceutical\, and product testing industries. \nhttps://www.linkedin.com/in/juliemanchester \n  \nJulie will share with us: \n\nCareer Journey: Transitioning from a chemist and quality manager in laboratories to leadership role in medical device quality and regulatory affairs.\nKey Challenges: Overcoming obstacles when moving from laboratory work to quality and regulatory affairs\, and the transferable skills that helped.\nExpectations for Juniors: Essential qualities\, skills\, and attributes sought when hiring and mentoring junior regulatory professionals.\nCareer Growth Strategies: Practical advice for advancing in regulatory affairs\, including promotions and career transitions to find the best fit.\n\n\n  \n \nShepard Bentley\, RAC\, Principal Consultant at Bentley Biomedical Consulting LLC \nShep Bentley is a regulatory affairs consultant with 20+ years’ experience providing regulatory clearances and approvals for devices\, drugs and combination products. Offices and affiliations across United States\, Canada\, Europe\, Brazil and Asia. \nhttps://www.linkedin.com/in/shep-bentley-29939a2 \n  \nShepard will share with us: \n\nTechnology Transition Experience: Insights on translating early-stage university innovations to real-world products and the role of regulatory affairs in this process.\nRegulatory Experience: Key differences and similarities across pharma\, biotech\, and medical devices regulatory affair\, and considerations for choosing companies and fields early in your career.\nEmerging Opportunities & Trends: Insights into new and evolving career opportunities in regulatory affairs driven by technological innovation.\n\n  \n\n  \n \nPaula Lengerke Diaz\, MD\, Regulatory Manager at 4D Molecular Therapeutics  \nPaula Lengerke Diaz is a Regulatory Manager at 4D Therapeutics\, a clinical-stage biopharma company developing genetic medicines for rare diseases. Trained as a medical doctor in Colombia\, she previously served as a Hematology & Oncology Research Fellow at Mayo Clinic and was an associate member at an angel investment firm. Her diverse background bridges medicine\, research\, and regulatory strategy in the biopharma industry. \nhttps://www.linkedin.com/in/paulalengerke \nPaula will share with us: \n\nCareer Journey: Transition from medical doctor\, academic researcher to regulatory affairs\, leveraging academic and clinical experience.\nCurrent Job Sharing: Sharing experience as a regulatory manager in the genetic therapy field\, overseeing clinical trials and crafting regulatory strategies.\nJob hunting Advice: Job hunting tips\, breaking into regulatory affairs\, networking strategies\, and advice for students and professionals in clinical field exploring alternative careers.\n\n  \n\n  \n \nNora Xi\, MS\, Regulatory Affair Associate Specialist at Applied Medical  \nNora Xi is a Regulatory Affairs Associate Specialist at Applied Medical with 2.5 years of experience in the medical device industry. She holds an M.S. in Regulatory Science from the University of Southern California and a B.S. in Biomedical Engineering from City University of Hong Kong. \nhttps://www.linkedin.com/in/nora-xi-7aa469197 \nNora will share with us: \n\nLanding first regulatory affair job as an International Student – how to overcome language and job sponsorship challenges.\nJob Hunting & Interview Success – Resume\, interviews\, and LinkedIn tips for securing internship and full-time jobs in regulatory affair field.\nThe Power of Networking – How to network and get involved in professional organizations for long-term career growth.\n\n\n  \nDate: Wednesday | April 2\, 2025 \nTime: 6:30pm – 8pm PT \nLocation: Zoom \nRegistration: Free for OCRA-DG members and nonmembers \nTopic: OCRA Career Panel \nRegister Now \n 
URL:https://ocra-dg.org/event/april-2-ocra-career-panel/
CATEGORIES:Events,Networking,OCRA Meetings,Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250414T180000
DTEND;TZID=America/Los_Angeles:20250417T200000
DTSTAMP:20260415T090750
CREATED:20250225T083721Z
LAST-MODIFIED:20250415T000451Z
UID:30980-1744653600-1744920000@ocra-dg.org
SUMMARY:Ensuring IVD Success: Insights on latest MDCG Guidance\, Technical Documentation\, and Audit Challenges
DESCRIPTION:Date: Thursday | April 17\, 2025 \nTime: 6 pm to 8 pm PT \nLocation:  Alcon Laboratories\, 20511 Lake Forest Dr\, Lake Forest\, CA 92630 \nRegistration: New Price! Free for OCRA-DG members; $20 for nonmembers \nTopic: Ensuring IVD Success: Insights on the latest MDCG Guidance\, Technical Documentation\, and Audit Challenges \n\nLearning Objectives: \n 1. Understand the EU IVDR requirements \n 2. Identify the differences between IVDD and IVDR \n 3. Identify potential gaps in technical documentation and management systems \n 4. Understand the meaning of the latest MDCG guidances  \n\n\nSpeaker: \nDr. Julien Senac\, Senior Director – Medical and Health Services Americas at TUV SUD \nDr. Julien Senac is currently Senior Director of Medical and Health Services at TÜV SÜD America\, overlooking certification and testing services for medical devices manufacturers. Prior to this\, he has many years of experience with quality and regulatory affairs\, through various notified bodies\, where he participated to the implementation of IVDR\, performed Design Dossier assessment of in vitro diagnostic devices and high risk cardiovascular medical devices. \nDr. Senac has a Ph.D. in Molecular and Human Genetics and more than 10 years of experience in biomedical research. He worked in top research/medical institutions in the United States such as Mayo Clinic and the National Institutes of Health. Dr. Senac has also participated  to the development of multiple biotechstart-up companies in oncology and gene therapy.\n\n\nRefreshments and beverages will be provided! Don’t miss out—two raffle tickets will be up for grabs for the 2025 OCRA Annual Conference! \nRegister now to secure your spot and empower your team for success! \n  \n\n 
URL:https://ocra-dg.org/event/webinar-series-ensuring-ivd-success/
LOCATION:Alcon Laboratories\, 20511 Lake Forest Dr\, Lake Forest\, CA\, 92630
CATEGORIES:Events,In Person,Networking,OCRA Meetings
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250417T160000
DTEND;TZID=America/Los_Angeles:20250417T200000
DTSTAMP:20260415T090750
CREATED:20250304T180608Z
LAST-MODIFIED:20250414T041611Z
UID:31013-1744905600-1744920000@ocra-dg.org
SUMMARY:Leadership Circle
DESCRIPTION:Content is protected.
URL:https://ocra-dg.org/event/leadership-circle/
LOCATION:Fogo de Chao\, 623 Spectrum Drive\, Irvine\, CA\, 92618\, United States
CATEGORIES:Events,In Person,Networking,OCRA Meetings
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250506T120000
DTEND;TZID=America/Los_Angeles:20250506T130000
DTSTAMP:20260415T090750
CREATED:20250409T222201Z
LAST-MODIFIED:20250415T002859Z
UID:31335-1746532800-1746536400@ocra-dg.org
SUMMARY:NAVIGATING THE CURRENT REGULATORY CHANGES IN THE EUROPEAN MEDICAL DEVICE INDUSTRY
DESCRIPTION:Date: Tuesday | May 6\, 2025\nTime: 12 noon to 1pm PT\nLocation: Zoom\nRegistration: Free for OCRA-DG members and nonmembers\nSpeaker: Mizanu Kebede\, Chief Quality & Regulatory Officer Smith & Nephew \nRegister Now
URL:https://ocra-dg.org/event/navigating-the-current-regulatory-changes-in-the-european-medical-device-industry/
LOCATION:Webinar
CATEGORIES:Events,Networking,OCRA Meetings,Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250515T180000
DTEND;TZID=America/Los_Angeles:20250515T200000
DTSTAMP:20260415T090750
CREATED:20241105T055103Z
LAST-MODIFIED:20250501T011130Z
UID:30558-1747332000-1747339200@ocra-dg.org
SUMMARY:May 15 Happy Hour
DESCRIPTION:OCRA-DG May 15th Happy Hour\nDate & Time: Thursday\, May 15th – 6pm\nEvent: Inviting members and nonmembers of the SoCal Regulatory Affairs community to socialize and network.\nLocation:\nPostino Park Place\n2981 Michelson Dr.\nSuite E\nIrvine\, CA 92612 \nRegister Now \n 
URL:https://ocra-dg.org/event/may-15-happy-hour/
CATEGORIES:Events,In Person,Networking,OCRA Meetings
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250711T174500
DTEND;TZID=America/Los_Angeles:20250711T203000
DTSTAMP:20260415T090750
CREATED:20241105T055333Z
LAST-MODIFIED:20250702T052843Z
UID:30559-1752255900-1752265800@ocra-dg.org
SUMMARY:July 11 Happy Hour
DESCRIPTION:OCRA-DG July 11 Happy Hour\nDate: Friday | July 11\, 2025 \nTime: 6:00pm-8:30pm PT\, (Doors open at 5:45pm) \nLocation: PRN Medical Solutions – 17592 E. 17th St. Suite 225\, Tustin\, California \nRegistration: Free! \nEvent: Inviting members and nonmembers of the SoCal Regulatory Affairs community to socialize and network. \n  \nRegister Now \n  \n 
URL:https://ocra-dg.org/event/july-11th-happy-hour/
CATEGORIES:Events,In Person,Networking,OCRA Meetings
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250806T120000
DTEND;TZID=America/Los_Angeles:20250806T130000
DTSTAMP:20260415T090750
CREATED:20250701T063812Z
LAST-MODIFIED:20250701T065141Z
UID:31738-1754481600-1754485200@ocra-dg.org
SUMMARY:Webinar Series - A.I. in Regulatory Affairs
DESCRIPTION:Date: Wednesday | August 6\, 2025 \nTime: 12 noon to 1pm PT \nLocation: Zoom \nRegistration: Free for OCRA-DG members and nonmembers  \nSpeaker: Kamayani Gupta\, CEO\, KAMI Think Tank \nRegister Now \n  \n\nKamayani Gupta is a life sciences expert who uses data-centric approaches to optimize complex business processes. Over the past decade\, she has enjoyed working with new technologies to reduce redundant workflows and biases in the drug discovery to commercialization pipeline. She was one of the first members of Watson for Drug Discovery\, and the former Head of HCLS R&D at Slalom.
URL:https://ocra-dg.org/event/webinar-series-a-i-in-regulatory-affairs/
LOCATION:Webinar
CATEGORIES:Events,Networking,OCRA Meetings,Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250912T181500
DTEND;TZID=America/Los_Angeles:20250912T203000
DTSTAMP:20260415T090750
CREATED:20250830T211106Z
LAST-MODIFIED:20250830T211905Z
UID:31924-1757700900-1757709000@ocra-dg.org
SUMMARY:September 12th Happy Hour at PRN Medical Solutions
DESCRIPTION:OCRA-DG July 11 Happy Hour\nDate: Friday | September 12\, 2025 \nTime: 6:30pm-8:30pm PT\, (Doors open at 6:15pm) \nLocation: PRN Medical Solutions – 17592 E. 17th St. Suite 225\, Tustin\, California \nRegistration: Free! \nEvent: Inviting members and nonmembers of the SoCal Regulatory Affairs community to socialize and network. \n  \nRegister Now \n  \n 
URL:https://ocra-dg.org/event/sept-12-2025-happy-hour/
CATEGORIES:Events,In Person,Networking,OCRA Meetings
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20251028T123000
DTEND;TZID=America/Los_Angeles:20251028T183000
DTSTAMP:20260415T090750
CREATED:20250711T064858Z
LAST-MODIFIED:20251004T033426Z
UID:31832-1761654600-1761676200@ocra-dg.org
SUMMARY:Fall Symposium - Tuesday\, October 28th
DESCRIPTION:Join us for another premier event\, an inspiring symposium focused on best practices\, practical insights\, an meaningful networking opportunities you won’t want to miss. \nCo-Sponsored by IPM\nReception Sponsored by 4C Pharma Solutions\nDate: Oct 28\, 2025\, Tuesday\nTime: 12:30 – 6:30 pm PT\nLocation: University Club: Secret\, Sophisticated Irvine\, CA Wedding Venue\n801 E Peltason Dr\, Irvine\, CA 92617\nDinner: Included\nPrice: $75 non-member\, $50 member and early bird (end Sep 1)\nParking: Free \nRegister Now \n2025 OCRA Fall Symposium Agenda\n\n\n\n\n12:00-1:00\nRegistration\n\n\n\nPharma\nDevice\n\n\n1:00-1:45\nSpeaker: Peder Seglund\, PhD\nTopic: Increasing Efficiencies\nand Reducing Costs by\nImplementing Artificial\nIntelligence and Outsourcing for\nRegulatory Affairs and\nPharmacovigilance\nSpeaker: Heinz Steneberg\nTopic: EUDAMED updates\n\n\n1:45-2:00\nBreak\n\n\n2:00-2:45\nSpeaker: Natalie Pripuzova\,PhD\nTopic: Navigating Regulatory\nExpectations and the\nComplexity of Control Strategy\nin Allogeneic Cell and Gene\nTherapies\nSpeaker: Bryant Foster\nTopic: Finding the Right Dose of\nHuman Factors for Your Medical\nDevice or Combination Product\n\n\n2:45-3:00\nBreak\n\n\n3:00-3:45\nPlenary Session\nTopic: Preparing for Inspections (FDB)\n\n\n3:45-4:00\nBreak\n\n\n4:00-4:45\nSpeaker:Jon Mann\nTopic: Compliance Circling Calibrations\n\n\n4:45-7:00\nDinner\n\n\n\n\n 
URL:https://ocra-dg.org/event/fall-symposium-tuesday-october-28th/
CATEGORIES:Events,In Person
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20251204T180000
DTEND;TZID=America/Los_Angeles:20251204T200000
DTSTAMP:20260415T090750
CREATED:20251112T012825Z
LAST-MODIFIED:20251112T012825Z
UID:32023-1764871200-1764878400@ocra-dg.org
SUMMARY:Community Holiday Appreciation Dinner - Thursday\, December 4th
DESCRIPTION:Date: Dec 4th\, 2025\, Tuesday\nTime: 6:00 pm – 8:00 pm PT\nLocation: Fogo de Chão – 623 Spectrum Center Dr\, Irvine\, CA 92618\nPrice: FREE for Current OCRA-DG Members \nRegister Now
URL:https://ocra-dg.org/event/community-holiday-dinner-members-december-4th/
CATEGORIES:Events,In Person
END:VEVENT
END:VCALENDAR