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BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250417T160000
DTEND;TZID=America/Los_Angeles:20250417T200000
DTSTAMP:20260404T075309
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:20250414T180000
DTEND;TZID=America/Los_Angeles:20250417T200000
DTSTAMP:20260404T075309
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:20250402T183000
DTEND;TZID=America/Los_Angeles:20250402T200000
DTSTAMP:20260404T075309
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:20250320T120000
DTEND;TZID=America/Los_Angeles:20250320T130000
DTSTAMP:20260404T075309
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:20250314T183000
DTEND;TZID=America/Los_Angeles:20250314T203000
DTSTAMP:20260404T075309
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:20250313T120000
DTEND;TZID=America/Los_Angeles:20250313T130000
DTSTAMP:20260404T075309
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:20250213T080000
DTEND;TZID=America/Los_Angeles:20250213T130000
DTSTAMP:20260404T075309
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:20250131T180000
DTEND;TZID=America/Los_Angeles:20250131T200000
DTSTAMP:20260404T075309
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:20241114T183000
DTEND;TZID=America/Los_Angeles:20241114T183000
DTSTAMP:20260404T075309
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:20241030T120000
DTEND;TZID=America/Los_Angeles:20241030T130000
DTSTAMP:20260404T075309
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:20241014T120000
DTEND;TZID=America/Los_Angeles:20241014T131500
DTSTAMP:20260404T075309
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;VALUE=DATE:20240917
DTEND;VALUE=DATE:20240920
DTSTAMP:20260404T075309
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:20240912T120000
DTEND;TZID=America/Los_Angeles:20240912T131500
DTSTAMP:20260404T075309
CREATED:20240827T060539Z
LAST-MODIFIED:20240828T054722Z
UID:30236-1726142400-1726146900@ocra-dg.org
SUMMARY:Navigating EU MDR Compliance for CE Marking
DESCRIPTION:Navigating EU MDR Compliance for CE Marking \nDate: Thursday\, September 12\nTime: 12pm-1:15pm PT\nAudience: This webinar is recommended for professionals with some familiarity with EU MDR or the previous Medical Device Directive (MDD).\nPlatform: Zoom \nThis webinar aims to provide an overall understanding of the critical aspects of EU MDR compliance. Whether you’re preparing for the application (deadline is coming up!) or looking to enhance your knowledge\, this session is designed to equip you with the necessary insights. \nKey Topics to be Covered:\n– EUDAMED and Quality Management System requirements under EU MDR\n– Technical documentation requirements for a CE marking submission and how to avoid common pitfalls\n– Post-market lifecycle management and reporting \nProgram Synopsis:\nRegulation (EU) 2017/745 (“EU MDR”) has been in force since May 2021\, requiring manufacturers of legacy devices to update their quality management systems (QMS) and technical documentation. This webinar will provide a detailed overview of the steps necessary for a successful transition to EU MDR and CE marking. Key topics include interactions with Notified Bodies\, project planning\, EUDAMED implementation\, and QMS and technical documentation requirements\, both pre- and post-approval. \nWith a special focus on the upgrade of legacy devices to MDR\, our expert\, Dr. Artemis Ailianou\, will share case studies and real-life scenarios to illustrate practical strategies and tactics. This will be an invaluable session for anyone looking to understand the intricacies of EU MDR compliance and avoid common pitfalls. \nLearning Objectives:\nGain a clear understanding of EUDAMED and QMS requirements under EU MDR.\nLearn about technical documentation requirements for CE marking submissions.\nUnderstand the essentials of post-market lifecycle management and reporting.\nDon’t miss this opportunity to enhance your knowledge and stay ahead in the ever-evolving regulatory landscape! \n  \n\n\nAbout the Speaker:\n  \nArtemis Ailianou\, PhD\, MBA\, President\, ARTIA RA/QA Consulting Inc \nDr Ailianou is a regulatory affairs and quality system consultant specializing in CE marking and clinical trial applications. She previously worked for a European startup in the ophthalmic space where she led CE marking submission activities for Class IIb implantable devices\, approved in 2021 and 2023. She has also managed clinical trial applications in Europe\, Canada\, and US\, securing approvals from competent authorities and ethics committees. Prior to her career in regulatory affairs\, she worked in product R&D for novel polymeric materials. Dr. Ailianou earned her BSc in Chemical Engineering from the University of Texas at Austin; her PhD\, also in Chemical Engineering\, from California Institute of Technology; and her MBA from INSEAD in France. \n\n  \nFree for Member\n$20 for Nonmember \nRegister Now! \nRegistering for your team of 5+ participants? Please email programs@ocra-dg.org. \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/navigating-eu-mdr-compliance-for-ce-marking/
LOCATION:Online
CATEGORIES:Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240802T080000
DTEND;TZID=America/Los_Angeles:20240802T170000
DTSTAMP:20260404T075309
CREATED:20230228T154326Z
LAST-MODIFIED:20240505T053121Z
UID:27134-1722585600-1722618000@ocra-dg.org
SUMMARY:2024 OCRA 30th Anniversary Annual Conference
DESCRIPTION:See https://ocra-dg.org/2024-annual-conference/ for event details!
URL:https://ocra-dg.org/2024-annual-conference/
CATEGORIES:Events,In Person,Networking,OCRA Meetings
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240712T160000
DTEND;TZID=America/Los_Angeles:20240712T200000
DTSTAMP:20260404T075309
CREATED:20240608T194037Z
LAST-MODIFIED:20240630T164541Z
UID:29800-1720800000-1720814400@ocra-dg.org
SUMMARY:Summer Social
DESCRIPTION:Social Summer \nDate: Friday\, July 12\, 2024\nTime: 4 – 8pm PT\nLocation: Bosscat Kitchen & Libations\n18169 Von Karman Ave\, Irvine\, CA 92612 \n  \nFree for Member\n$10 for Nonmember \nRegister Now! \n 
URL:https://ocra-dg.org/event/summer-social/
LOCATION:Bosscat Kitchen & Libations\, 8169 Von Karman Ave\,\, Irvine\, CA\, 92612\, United States
CATEGORIES:Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240626T120000
DTEND;TZID=America/Los_Angeles:20240626T130000
DTSTAMP:20260404T075309
CREATED:20240521T052609Z
LAST-MODIFIED:20240622T081446Z
UID:29309-1719403200-1719406800@ocra-dg.org
SUMMARY:What's New in FDA 510(k) & eSTAR Best Practice
DESCRIPTION:What’s New in FDA 510(k) & eSTAR Best Practice \nDate: Wednesday\, June 26\, 2024\nTime: 12 noon – 1pm PT\nAudience: Medical device regulatory affairs professionals who are involved in the 510(k) submission process.\nPlatform: Zoom \nThe panel will provide an overview of the recent updates and changes in FDA 510(k) program and guide the participants through best practices for preparing a 510(k) submission in the eSTAR system and share useful tips through case scenarios. \nSubmit your questions after registration and have them answered at the event! \nLearning Objectives: \n\nUnderstand the recent updates and changes in FDA 510(k) program\nLearn best practices for submitting 510(k) applications in the eSTAR system\n\nRegister now to secure your spot and empower your team for success! \n  \n\n\nAbout the Speakers:\n \nHeather Rosecrans\, F.R.A.P.S.\, EVP\, Medical Devices & Combination Products at Eliquent Life Sciences\n \nHeather boasts over 45 years of public health and medical device expertise. Formerly the Director of the 510(k) Premarket Notification Staff at the FDA CDRH\, she spearheaded regulatory policy implementation and led key programs. Heather’s significant contributions include drafting guidance documents and regulations of the 510(k)\, training FDA staff and other stakeholders\, and shaping pivotal legislation. Her unparalleled experience has established her as a foremost expert in FDA 510(k) processes. With a B.S. in biology from Pfeiffer College\, Heather now leverages her knowledge to consult and facilitate innovative device entry into the U.S. \n  \nSamantha Eakes\, MPH\, VP\, Regulatory Affairs at Eliquent Life Sciences\n \nSamantha brings over seven years of FDA regulatory consulting experience. With a background in public health\, policy\, and nonprofits\, she offers strategic insight into regulatory challenges. Her expertise spans various FDA submissions\, including 510(k) Premarket Notifications and Emergency Use Authorizations. Samantha has published articles on medical device topics and previously contributed to policy and advocacy at Management Sciences for Health. She holds a B.A. in psychology and an M.P.H. from Boston University. \n  \n\n  \nFree for Member\n$20 for Nonmember \nRegister Now! \nRegistering for your team of 5+ participants? Please email programs@ocra-dg.org. \n\n  \nThank you to our Sponsors!\n \n  \n  \n  \n  \n  \n  \n  \n \n  \n                          
URL:https://ocra-dg.org/event/whats-new-fda-510k-estar-best-practice/
LOCATION:Online
CATEGORIES:Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240606T080000
DTEND;TZID=America/Los_Angeles:20240606T090000
DTSTAMP:20260404T075309
CREATED:20240404T044408Z
LAST-MODIFIED:20240516T065820Z
UID:29012-1717660800-1717664400@ocra-dg.org
SUMMARY:China Medical Device Registration Clinical Pathways Latest Updates
DESCRIPTION:China Medical Device Registration Clinical Pathways Latest Updates \nDate: Wednesday\, June 6\, 2024\nTime: 8am – 9am PT\nAudience: Regulatory and clinical professionals in medical device industry\nPlatform: Zoom \nStruggling with determining the regulatory pathways for your device in China? Which pathway needs clinical evidence? Is clinical trial needed to support your device registration in China? \nThis webinar provides an overview of the critical elements of China’s registration and clinical pathways\, focusing on the China regulatory and clinical framework and finds the least burdensome pathway with the latest China NMPA (National Medical Products Administration) updates.\nSubmit your questions after registration and have them answered at the event! \nLearning Objectives: \n\nOverview of key pathways for medical device and IVD registration\nExplore the clinical evaluation requirement for product registration in China\nLearn about the key requirements and criteria to determine the different clinical pathways\nUnderstand the role of RWE in clinical evidence to support product registration\n\nRegister now to secure your spot and empower your team for success! \n  \n\n\nAbout the Speakers:\n \nGrace Fu Palma\, Principal at China Med Device\, LLC/Accel Groups \nGrace spearheads China Med Device\, a sector of Accel Groups\, streamlining market access for medical device firms. With three decades’ experience in global business strategy\, regulatory affairs\, and clinical trials\, she’s bilingual and a recognized expert in China and US MedTech. She’s also founded the Chinese American Heart Association\, strengthening connections between clinical communities in the US and China. A member of prominent physician communities like ANACP and CAP\, Grace is deeply entrenched in clinical networks bridging the US and China. Raised in Beijing\, she holds a BA/BS from Peking University and an MBA from Yale University. \n  \nYan Sheng\, PhD\, Project Manager at China Med Device\, LLC/Accel Groups\n \nYan has extensive experience in the life science industry\, having worked in both the United States and China. With over four years as a project manager at China Med Device/Accel Groups\, her expertise extends to a diverse range of areas\, including IVD and CDx products\, combination products\, as well as medical devices such as implants\, aesthetics devices\, etc. Yan holds a PhD degree in Pharmaceutical Sciences and has a rich history of working with cutting-edge technologies in the realms of both chemistry and microbiology prior to her entry into the life science industry. \n  \n\n  \nFree for Member\n$20 for Nonmember \nRegister Now! \nRegistering for your team of 5+ participants? Please email programs@ocra-dg.org. \n\n  \nThank you to our Sponsors!\n  \n  \n  \n  \n  \n  \n             
URL:https://ocra-dg.org/event/china-medical-devices-updates/
LOCATION:Online
CATEGORIES:Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240530T173000
DTEND;TZID=America/Los_Angeles:20240530T193000
DTSTAMP:20260404T075309
CREATED:20240221T193321Z
LAST-MODIFIED:20240521T064851Z
UID:28019-1717090200-1717097400@ocra-dg.org
SUMMARY:IDE Submission Best Practice\, and Pitfalls to Avoid - from Both Regulatory & Clinical Perspectives
DESCRIPTION:IDE Submission Best Practice\, and Pitfalls to Avoid – from Both Regulatory & Clinical Perspectives \nDate: Thursday\, May 30\, 2024 (New Date!)\nTime: 5:30pm – 7:30pm PT\nAudience: Regulatory and clinical affairs professionals in medical device industry\nLocation: Alcon Laboratories\, 20511 Lake Forest Dr\, Lake Forest\, CA 92630 (New Location!) \nThis panel discussion provides an overview of the critical elements for a successful IDE strategy and submission\, focusing on best practices from both regulatory and clinical perspectives. The discussion will focus on case scenarios and pitfalls to avoid\, facilitating the understanding of the content. Attendees will have the opportunity to learn from the discussions and ask questions.\nSubmit your questions after registration and have them answered at the event! \nLearning Objectives: \n\nOverview of IDE submission process\nBest practices of IDE submission and common pitfalls to avoid\nNavigating the review process\nNow you’re approved…what to expect.\n\nAgenda: \n\n17:30   Check in\, light dinner & social networking\n18:00  Introducing OCRA and speakers\n18:10   Panel Presentation and Q&A\n19:10   Open discussion & social networking\, other announcements\n19:30   Adjourn\n\nRegister now to secure your spot and empower your team for success! \n  \n\n\nAbout the Speakers:\n \nMagda Michna\, Ph.D.\, Chief Clinical\, Regulatory and Medical Affairs Officer at STAAR Surgical Company\n \nDr. Michna brings extensive expertise in global clinical\, regulatory\, and medical affairs. Previously\, she held key leadership roles at AcuFocus Inc. (a subsidiary of Bausch & Lomb)\, Presbia LLC\, and within Alcon’s surgical franchise. With a focus on accelerating market entry and driving adoption\, Dr. Michna has spearheaded the development of premium intraocular lens and surgical device technologies. Her strategic leadership and deep understanding of regulatory landscapes have facilitated successful market introductions. \n  \nLaura Schall\, Director\, Clinical Affairs at STAAR Surgical Company\n \nLaura Schall brings extensive experience in clinical research that spans the sponsor and clinical investigator perspectives. Laura started her research career as a Clinical Research Coordinator at a private medical practice\, where she was responsible for the execution of clinical studies. Laura transitioned to the sponsor side\, first as part of a Clinical Research Organization (CRO) before she made the leap into industry\, where she has led the strategy and execution of multiple registration and post-market clinical trials. Laura’s extensive knowledge of clinical research has led to multiple successful product registrations. \n  \n\n  \n\n\nIn-Person Ticket\n$20 for Member\n$35 for Nonmember \nLight fare & beverage provided at 5:30pm PST. \nRegister Now! \n\n\nVirtual Ticket\nFREE for Member\n$20 for Nonmember \nEvent starts at 6pm PST. \nRegister Now! \n\n\nRegister for your team of 5+ participants? Please email programs@ocra-dg.org. \n\n  \nThank you to our Sponsors!\n  \n  \n  \n  \n  \n  \n             
URL:https://ocra-dg.org/event/ide-submission-best-practice-and-pitfalls-to-avoid-from-both-regulatory-clinical-perspectives/
LOCATION:Alcon Laboratories\, 20511 Lake Forest Dr\, Lake Forest\, CA\, 92630
CATEGORIES:Events,In Person
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240522T120000
DTEND;TZID=America/Los_Angeles:20240522T130000
DTSTAMP:20260404T075309
CREATED:20240221T193357Z
LAST-MODIFIED:20240508T052647Z
UID:28020-1716379200-1716382800@ocra-dg.org
SUMMARY:FDA’s Predetermined Change Control Plan (PCCP) Draft Guidance for AI/ML-Enabled Device: Implications and Insights for Regulatory Compliance
DESCRIPTION:FDA’s Predetermined Change Control Plan (PCCP) Draft Guidance for AI/ML-Enabled Device: Implications and Insights for Regulatory Compliance \nDate: Wednesday\, May 22\, 2024\nTime: 12pm – 1pm PT\nAudience: Medical device quality assurance\, regulatory affairs\, and R&D leaders and practitioners.\nPlatform: Zoom \nIn April 2023 FDA published its Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions Draft Guidance. There has been much discussion regarding the scope and implications of the draft guidance\, and FDA has been actively reviewing PCCPs in submission prior to and since the publication of this document. This session will walk through the contents of the draft guidance highlighting specific recommendations\, implications to industry and FDA\, and how this guidance might help or hinder an effective regulatory framework for incorporating AI/ML functionality into medical devices. \nLearning Objectives: \n\nUnderstanding the requirements of FDA’s PCCP for AI/ML draft guidance\nUnderstanding of the implications of PCCPs for AI/ML-enabled product modifications and submissions\nHow the draft guidance may impact FDA’s efforts to establish a regulatory framework for AI/ML-enabled medical devices\n\nRegister now to secure your spot and empower your team for success! \n  \n\n\nAbout the Speaker:\n \nEric Henry\, Sr. Quality Systems & Compliance Advisor at King & Spalding LLP\n \nEric is a Senior Quality Systems and Compliance Advisor in the FDA & Life Sciences Practice of the law firm King & Spalding.  He is a 35-year industry veteran and since 2018 has provided advisory and consulting services focused on regulatory compliance\, enforcement\, and policy matters for industries regulated by the FDA. Eric’s guidance focuses on FDA requirements to professionals in medical device manufacturing\, including but not limited to quality systems requirements\, inspection preparedness and post-market obligations. He also advises corporate management and boards on their responsibilities and expectations of the FDA. \n  \n  \n\n  \nFree to Members\n$20 for Nonmembers \nRegister Now! \nRegister for your team of 5+ participants? Please email programs@ocra-dg.org. \n\n  \nOCRA Gold Sponsors:
URL:https://ocra-dg.org/event/fda-pccp/
CATEGORIES:Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240415T160000
DTEND;TZID=America/Los_Angeles:20240415T170000
DTSTAMP:20260404T075309
CREATED:20240221T193245Z
LAST-MODIFIED:20240321T215844Z
UID:28018-1713196800-1713200400@ocra-dg.org
SUMMARY:Quality System Audit Best Practice\, Tips & Tricks for Finding Mitigation
DESCRIPTION:Mastering QMS Audit Readiness: Strategies for Preparation\, Conduct\, and Mitigation\nMastering QMS Audit Readiness: Strategies for Preparation\, Conduct\, and Mitigation Webinar \nJoin us for an insightful webinar where we’ll delve into comprehensive strategies and tactics to help ensure your organization is prepared for your next audit. \nDate: Monday\, April 15\, 2024\nTime: 4pm to 5pm PT\nPlatform: Zoom \nIn this dynamic session\, our expert speaker will guide you through the entire audit lifecycle\, covering crucial aspects such as: \n\n Pre-Audit Preparation: Gain actionable insights into preparing your facility and personnel for a successful quality system audit. Learn how to ensure readiness\, establish best practices\, and optimize cross-functional team collaboration to streamline audit preparations.\n Front Room and Back Room Management: Discover effective strategies for managing interactions with auditors (front room) and coordinating behind-the-scenes operations (back room) during the audit process. From responding to inquiries to retrieving requested documents\, you’ll learn how to maintain professionalism and efficiency throughout.\n Audit Finding Mitigation: Explore proactive approaches to mitigate audit findings and enhance audit outcomes. Learn how to identify potential issues\, address auditor questions with confidence\, and implement strategies that helps to mitigate/de-escalate findings and observations. The speaker will share real-life cases and scenarios to facilitate your understanding.\n\nThis webinar is essential for Quality & Regulatory Directors and Managers\, Quality & Regulatory personnel supporting a QMS audit\, as well as any job functions that are involved in a QMS audit. Don’t miss this opportunity to gain invaluable insights and actionable strategies to elevate your organization’s audit readiness and effectiveness. \nRegister now to secure your spot and empower your team for audit success! \nAbout the Speaker:\nJulie Manchester\, Senior Director Quality Assurance & Regulatory Affairs\, The HydraFacial Company \nJulie Manchester is a seasoned leader with over 15 years of experience in quality and regulatory affairs across biotech\, medical devices\, pharmaceuticals\, and other industries. Holding a Bachelor of Science from UC Riverside\, she is an ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) and holds a RAPS Device certification. Julie is deeply engaged in community and industry leadership roles\, serving as committee members for OCRA\, RAPS\, and ASQ\, contributing to industry standards and best practices. She also serves the board of the VietNam Scholarship Foundation\, and as an Advisory Committee Member for the Women of Leadership Program at the University of Richmond. Throughout her career\, Julie has excelled in building\, leading\, and executing quality management and regulatory programs\, ensuring adherence to quality standards and regulatory compliance in international markets\, and has hosted over 250 audits including regulatory body audits and inspections\, such as the FDA and Notified Bodies\, technical/safety audits\, customer audits and more. \nRegister Now! \nFree to OCRA member\n$20 for nonmember\nRegister for your team of 5+ participants? Please email programs@ocra-dg.org. \n\nThank you to our Silver Sponsors!
URL:https://ocra-dg.org/event/quality-system-audit-best-practice-tips-tricks-for-finding-mitigation/
CATEGORIES:Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240409T180000
DTEND;TZID=America/Los_Angeles:20240409T200000
DTSTAMP:20260404T075309
CREATED:20240221T193125Z
LAST-MODIFIED:20240404T044955Z
UID:28017-1712685600-1712692800@ocra-dg.org
SUMMARY:Job Interview Virtual Workshop
DESCRIPTION:Job Interview Techniques & Practical Role-playing with Industry Experts\nJoin us at this special virtual event that aims to assist participants in navigating effective job interview strategies and techniques\, offering invaluable advice from a panel of seasoned regulatory/quality and human resources experts. Gain insider tips on interview preparation\, learn the dos and don’ts\, and uncover strategies for standing out in a competitive job market. \nThe highlight of this virtual event is the interactive mock interview session. Participants will have the opportunity to engage in role-play scenarios\, simulating responses to real-world interview questions in breakout rooms facilitated by industry experts. \nThis hands-on experience allows participants to refine their interview skills\, receive personalized feedback\, and build confidence for their upcoming job interviews in the relevant fields. \nParticipants must turn on their camera and microphone for the mock interview session. \n  \nPanel: \nSara Yazdanfar\, Scientific Recruiting Team Lead at Applied Medical \nSara Yazdanfar has been in the recruiting field for 5 years. Currently\, Sara is the Scientific Recruiting Team Lead at Applied Medical\, a rapidly growing global organization with approximately 5\,000 team members. Sara studied at USC in her Master’s in Applied Psychology\, emphasis in Organizational Psychology. Her joy in life is connecting with people\, learning about their experiences\, and hopefully\, finding the right career for them\, and supporting them through the process! \n  \n  \nRichard DeRisio\, Training Program Developer and Presenter at DeRisio Group\, LLC \nRichard DeRisio is a seasoned professional in regulatory affairs and quality systems\, with a wealth of experience in the pharmaceuticals\, diagnostics\, and medical devices industries. Beginning his career at the FDA’s Washington-area headquarters\, Richard managed foreign inspections\, conducted compliance actions\, and served as an expert in sterilization sciences. Throughout his career\, he has held leadership positions at major companies including Abbott\, J&J\, Covidien\, and Pfizer\, overseeing global and divisional clinical\, quality\, regulatory\, government affairs\, and operations functions. Richard also led the Americas Region for the German Notified Body TÜV SÜD\, responsible for CE-Mark approval of medical devices manufactured in North America. He holds a B.S. degree in chemical engineering and an M.S. degree in food science and technology from Cornell University. Richard has been actively involved in industry organizations\, serving on the Association for the Advancement of Medical Instrumentation Board of Directors and co-chairing multiple standards committees. He has presented at regulatory programs at USC and Chapman University\, published in Medical Device & Diagnostic Industry magazine\, and spoken at UBM/Canon Medical Design and Manufacturing Conferences\, among others. \n  \nRonald Kao\, Principal Recruitment Consultant\, Real Staffing \nRonald is a seasoned Principal Recruitment Consultant based in San Diego\, who focuses on Direct-Hire placement within the Medical Device and Diagnostic industry across the West Coast. He has over 5 years of recruiting experience placing and consulting with executives\, senior leadership\, and senior/principal level professionals. Having a degree in psychology and social behavior\, Ronald has a strong ability to understand people and uses that to connect them to their dream jobs and opportunities. A tennis\, yoga\, and escape room enthusiast\, he is driven by bringing skilled people together to create a win-win situation. \n  \nHuong Huynh\, PhD\, Director of Regulatory Science at Critical Path Institute \nHuong Huynh\, PhD is Director of Regulatory Science at Critical Path Institute (C-Path) and Professor of Practice at The University of Arizona James E. Rogers College of Law. At C-Path\, Huong leads the development of regulatory strategies for the organization and bridges communication with regulatory authorities; she has contributed to the standup of 3 new public-private partnerships to address rare neurodegenerative diseases and for research on unmet medical needs in alpha-1 antitrypsin deficiency and lysosomal diseases. At The University of Arizona\, Huong is a lead instructor as part of the Graduate Certificate in Regulatory Science. Prior to joining C-Path\, Huong was a review pharmacologist at FDA\, where she contributed to the assessment of the approvability of over 300 regulatory submissions\, leading to the approval of over 50 generic drug products. \n  \nDate: Tuesday\, April 9th \nTime: 6pm to 8pm \nCost: $10 Members – $20 Non-members \nMembers: be sure to log in to get the member discount! \nNote: Space is limited in order to maintain a good interviewer-interviewee ratio. We respectfully ask you to email programs@ocra-dg.org at least 3 days in advance if you cannot attend the event so the space can be released to others on the waitlist. Priorities will be given to OCRA members. \nRegister Now! \n\nThank you to our Silver Sponsors!
URL:https://ocra-dg.org/event/regulatory-affairs-job-interview-prep-mock-interview/
CATEGORIES:Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240328T120000
DTEND;TZID=America/Los_Angeles:20240328T130000
DTSTAMP:20260404T075309
CREATED:20240221T193018Z
LAST-MODIFIED:20240321T215938Z
UID:28016-1711627200-1711630800@ocra-dg.org
SUMMARY:Artificial Intelligence in Drug Development
DESCRIPTION:Date: Thursday | March 28\, 2024 \nTime: 12 noon to 1pm PT \nLocation: Zoom \nRegistration: Free for OCRA-DG members; $20 for nonmembers \nArtificial intelligence (AI) and machine learning (ML) technologies have the potential to advance drug development in multiple areas\, including candidate identification and refinement\, nonclinical and clinical research\, manufacturing\, and post market surveillance. The Food and Drug Administration (FDA) has recognized this potential\, and is actively seeking feedback and engagement from stakeholders in this area as the agency works towards building a regulatory framework.  In this program\, we will review FDA’s current thinking on the use of artificial intelligence and machine learning in drug development\, and explore ways in which drug companies are using these technologies to improve their business. \nLearning Objectives: \n\nUnderstanding of FDA’s current thinking on the use of artificial intelligence and machine learning in drug development\nExamples of ways in which drug companies are using artificial intelligence and machine learning to improve their business\n\nWho Should Attend: \n\nPharmaceutical regulatory affairs professional\nPharmaceutical executives\, entrepreneurs\, and business owners\nAnyone keen on the future of healthcare innovation!\n\nRegister Now! \n\nAbout the Speaker: \n  \n \nBert Lao\, JD\, PhD\nCounsel\, Hogan Lovells \nBert Lao\, JD\, PhD\, serves as Counsel at Hogan Lovells\, bringing over a decade of experience in pharmaceutical law. His expertise lies in assisting drug companies in navigating regulatory requirements and legal challenges. Throughout his career\, he has provided guidance to clients across various stages of product development\, including clinical trials\, FDA interactions\, and approval processes. \nIn addition to his involvement in product development\, Bert supports drug companies in maintaining regulatory compliance and addressing legal issues. His services encompass a range of activities such as assisting with securities filings\, conducting internal investigations\, drafting trade complaint letters\, and reviewing promotional materials for pharmaceuticals\, over-the-counter drugs\, and cosmetics. \nBert Lao holds a JD from UC Berkeley School of Law and a PhD in Biomedical Engineering from UCLA. \n  \n  \n  \n  \n\n\nThank you to our Silver Sponsors!
URL:https://ocra-dg.org/event/artificial-intelligence-in-drug-development/
CATEGORIES:Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240311T160000
DTEND;TZID=America/Los_Angeles:20240311T170000
DTSTAMP:20260404T075309
CREATED:20230228T162106Z
LAST-MODIFIED:20240305T152827Z
UID:27145-1710172800-1710176400@ocra-dg.org
SUMMARY:Overview of China NMPA and Pharmaceutical GMP Regulations
DESCRIPTION:To succeed in China’s dynamic pharmaceutical landscape\, you must first have a good understanding of the China National Medical Products Administration (NMPA)\, how China regulates drugs\, and China’s pharmaceutical Good Manufacturing Practices (GMP) regulations. \nSpeaker: Andrew Chen\, J.D. \nChief Representative\, Shanghai Office of Arnold & Porter LLP. Mr. Chen is a seasoned expert with over two decades of experience\, including serving at the US FDA and Amgen. \n \nIn this webinar\, you can expect to learn about: \n\nThe NMPA as a government agency.\nChinese approach to drug approval and oversight.\nChinese pharmaceutical GMP regulations.\n\nDuring the presentation\, the speaker will draw comparisons between China’s NMPA and the US FDA\, aiming to enhance comprehension for individuals familiar with the US FDA. With the speaker’s distinctive expertise in both US and Chinese law\, he has the capacity to distill complex topics into a simple\, organized\, and easily understandable presentation. \nWho Should Attend: \n\nPharmaceutical professionals whose job responsibilities or professional interests involve China.\nPharmaceutical professionals in RA\, QA\, medical\, commercial\, business development\, and legal functions.\nPharmaceutical professionals at all levels of experience\, from entry to executive levels.\n\nRegister Now!
URL:https://ocra-dg.org/event/china-nmpa/
CATEGORIES:Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240305T180000
DTEND;TZID=America/Los_Angeles:20240305T191500
DTSTAMP:20260404T075309
CREATED:20230228T162147Z
LAST-MODIFIED:20240221T193648Z
UID:27146-1709661600-1709666100@ocra-dg.org
SUMMARY:OCRA/USC Joint Career Program: Landing Your First Job in Regulatory Affairs
DESCRIPTION:
URL:https://ocra-dg.org/event/ocra-usc-joint-career-program/
CATEGORIES:Joint Meetings,Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240226T170000
DTEND;TZID=America/Los_Angeles:20240226T210000
DTSTAMP:20260404T075309
CREATED:20240111T170550Z
LAST-MODIFIED:20240130T190244Z
UID:27930-1708966800-1708981200@ocra-dg.org
SUMMARY:OCRA Open House
DESCRIPTION:JOIN US FOR AN OCRA OPEN HOUSE – NEW DATE & LOCATION\nNetwork\, Engage\, and Socialize \nFebruary 26\, 2024 5:00 PM – 9:00 PM \nProgram: \n\nIntroduce the 2024 Board\nVolunteers & strategic partners appreciation\nMembership appreciation\nMembership drive\n\n\nLocation: \nLocation: “Be Good” restaurant in Huntington Beach \nBest Experiences in Huntington Beach\, CA | BeGood Restaurants \nHors D’oeuvres provided. Cash bar. \nParking: Garage next to the restaurant. validation for 2 hours\nCOST: Free to all\, but registration is required. \nRSVP Now!
URL:https://ocra-dg.org/event/ocra-open-house/
CATEGORIES:Events,In Person,Networking,OCRA Meetings
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240220T160000
DTEND;TZID=America/Los_Angeles:20240220T170000
DTSTAMP:20260404T075309
CREATED:20240207T210455Z
LAST-MODIFIED:20240208T165759Z
UID:27975-1708444800-1708448400@ocra-dg.org
SUMMARY:Webinar: Drug Development Overview
DESCRIPTION:From Discovery to Market: Decoding Drug Development’s Journey\n\n\n\n\n\n\n\nWhat are the Key Milestones\, Challenges\, and Innovations in the intricate development process? \nThis webinar provides an insightful view of the intricate process involved in developing pharmaceutical drugs and delves into the multifaceted stages shaping the landscape of modern medicine. From initial discovery to market launch\, this presentation will take you on a journey through key milestones\, challenges\, and innovations that define the pharmaceutical industry today. \nDate: Tue\, Feb 20\, 2024 \nTime: 4:00 PM- 5:00 PM PT \nLocation: Zoom \nRegistration: Free for OCRA members\, $20 for nonmembers \nThis presentation will use the real-world case scenario approach to provide a look at the drug development process\, covering:  \n\nDrug Discovery Milestones: Understand the critical importance of milestones in drug discovery.\nNonclinical Testing: How nonclinical testing lays the groundwork for successful drug development\, ensuring safety and efficacy are at the forefront.\nChemistry\, Manufacturing\, and Controls (CMC): Gain insights into the necessity of a clear understanding of CMC\, a foundational element in the development process that ensures the quality and consistency of pharmaceutical products.\nRegulatory Path for IND Application Submission: Explore innovative approaches to identifying the most successful regulatory path for Investigational New Drug (IND) Application.\nPhases of Clinical Trials: Navigate through the phases of clinical trials\, from initiation to completion\, understanding the challenges and triumphs that accompany each stage.\nNew Drug Application (NDA) and FDA Inspections: Understanding the crucial steps that determine a drug’s eligibility for market launch.\nPost Marketing Requirements: Uncover the ongoing responsibilities that pharmaceutical companies face after a drug is introduced to the market.\n\nWho Should Attend: \n\nRegulatory professionals\nPharmaceutical researchers and scientists\nHealthcare professionals\nStudents and academics\n\nRegister Now! \nAbout the speaker:\nBani Tchekanova\, PhDSVP of Global Regulatory AffairsClinReg PartnersMember of FDA Advisory Committee\n  \n\n\n\n\n\n\n\n  \nDr. Tchekanova has over 25 years of extensive industry expertise spanning diverse therapeutic areas\, including oncology\, dermatology\, infectious disease\, ophthalmology\, cardiovascular\, and neuroscience. A seasoned Strategic Global Regulatory Affairs Professional\, Dr. Tchekanova’s proficiency extends to various pharmaceutical domains such as IND\, NDA\, BLA\, and MAA encompassing CMC\, nonclinical\, clinical\, biologics (BLA)\, medical devices (510k)\, OTC\, and cosmetics. \n  \n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nThank you to our platinum Sponsor!
URL:https://ocra-dg.org/event/webinar-drug-development-overview/
CATEGORIES:Online
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BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20231109T170000
DTEND;TZID=America/Los_Angeles:20231109T200000
DTSTAMP:20260404T075309
CREATED:20230929T125143Z
LAST-MODIFIED:20231026T172205Z
UID:27764-1699549200-1699560000@ocra-dg.org
SUMMARY:Best practices for CLIA lab setup and certification
DESCRIPTION:How to be agile in the dynamic regulatory environment without sacrificing quality – Best practices for CLIA lab setup and certification\nThe Clinical Laboratory Improvement Amendments require that clinical laboratories\, including those in healthcare facilities\, reference labs\, public health labs\, and some research labs need to be certified. Many practices for developing Laboratory Tests (LDTs) and establishing a new functioning laboratory are common to CLIA certification and FDA approval. CLIA certification is a first step toward FDA companion diagnostic kit approval. During this session\, you will learn:  \n\nHow to set up a CLIA laboratory that meets CLIA standards\nActions to take to be prepared for an inspection\nBest practices for laboratories to implement that will enable them to be ready for regulatory changes\n\nMeeting Details: \nNov. 9\, 2023 \n 5:00 – 8:00 pm  \n 2400 Barranca Parkway\, Irvine CA  \nRefreshments and soft drinks will be provided \nCOST: Free for OCRA Members & Students\, $15 Non-Members \n\nFeatured Speaker\nLinda Castle\, Senior Consultant \nIntegrated Project Management Company\, Inc \nLinda Castle is a Senior Consultant with Integrated Project Management Company\, Inc. (IPM)\, a national consulting firm focused on providing solutions to complex problems and ensuring strategy realization through disciplined project leadership. She has a long career as a scientist and manager in Life Sciences\, leading discovery\, new technologies\, and product development biotech laboratory teams. She has been a certified project manager focusing on CLIA laboratories for the past seven years\, where she has led LDT development and launch\, tech transfers\, lab construction\, operational efficiency\, and fast-paced laboratory stand-up projects.  \nLinda has bachelor’s degrees in math and forest science and a PhD in genetics. She is a certified Project Manager (PMP)\, a SAFe Agile Scrum Master\, and a Six Sigma/LEAN Greenbelt. \n\nQuestions? Contact Fawn Zhang: (206) 639-1311; fawnzhang0@gmail.com \n\nRegister Now!
URL:https://ocra-dg.org/event/best-practices-for-clia-lab-setup-and-certification/
CATEGORIES:Events,In Person,OCRA Meetings
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BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20231010T170000
DTEND;TZID=America/Los_Angeles:20231010T200000
DTSTAMP:20260404T075309
CREATED:20230822T180902Z
LAST-MODIFIED:20231003T114621Z
UID:27720-1696957200-1696968000@ocra-dg.org
SUMMARY:A.I. Is Coming\, Are You Ready? Navigating the Ethical Landscape of Advanced Technologies
DESCRIPTION:Speaker: Steven Thompson  \nTopic: Advancements vs Ethics – How to safely use advanced technologies and avoid a catastrophe \nSynopsis: Technology is advancing exponentially especially with significant progress in Artificial Intelligence\, Machine Learning\, and Generative AI. But with the advancement comes challenges because technology often outpaces ethics. \nToday the security of medical devices is being threatened. AI is or will be solving many security and other issues. During the session\, you will have the opportunity to learn about the recent advancements in AI\, including: \n\nWays the security of medical devices is being threatened\nHow machine learning algorithms can be used for product and process innovation and to identify potential cyber-attacks\nExamples of blockchain technology that is being used to stop systems from being hacked\nHow cloud computing is helping automate routine processes and streamline workloads\nChallenges with AI including violating people’s rights to privacy and eliminating human participation in the R&D and other processes\n\nLocation: 2400 Barranca Pkwy\, Irvine \n5-8pm  \nCost: FREE for members\, $15 nonmember\, parking free\, refreshments & soft drinks are provided \nQuestions? Contact Anand Parikh: anandparikh27@gmail.com \nRegister Now!
URL:https://ocra-dg.org/event/advancements-vs-ethics-how-to-safely-use-advanced-technologies/
CATEGORIES:Events,In Person,OCRA Meetings
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BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20230915T120000
DTEND;TZID=America/Los_Angeles:20230915T130000
DTSTAMP:20260404T075309
CREATED:20230906T183726Z
LAST-MODIFIED:20230906T183726Z
UID:27740-1694779200-1694782800@ocra-dg.org
SUMMARY:OCRA Leadership Circle Meeting
DESCRIPTION:The first meeting of the OCRA Leadership Circle will be Friday\, Sept 15th\, from 12:00-1:00pm PT\, via Zoom. \nFor more information\, please contact Huong Huynh at membership@ocra-online.org \nFor Members Only \n  \n\n  \nDo you have mentors\, sponsors\, and allies? Learn about these important supporters to your career journey. \nThe OCRA Leadership Circle is a new initiative for members only with\nan objective of helping develop future regulatory professional leaders and\nmanagers. Our goal is to learn from each other through peer-to-peer learning\,\nto recognize different types of leadership styles\, which leadership style works\nbest for us and how to adapt leadership styles for various situations. \nThe OCRA Leadership Circle is envisioned as a discussion group and will meet monthly to share learnings from short readings (articles or book chapters) or video vignettes\, and how we can each develop and improve our skills to lead people and manage projects.
URL:https://ocra-dg.org/event/ocra-leadership-circle-meeting/
LOCATION:Online
CATEGORIES:OCRA Meetings,Online
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BEGIN:VEVENT
DTSTART;VALUE=DATE:20230909
DTEND;VALUE=DATE:20230910
DTSTAMP:20260404T075309
CREATED:20230807T174446Z
LAST-MODIFIED:20230905T141233Z
UID:27452-1694217600-1694303999@ocra-dg.org
SUMMARY:Team OCRA: Relay for Life
DESCRIPTION:JOIN TEAM OCRA FOR THE RELAY FOR LIFE\nDate: Saturday\, Sep 9\, 2023\nTime: Team OCRA will meet at 9:30am\, walk starts at 10am\nLocation: Team OCRA will meet in the parking lot at Santa Ana College\, 1530 W. 17th St\, Santa Ana\n\nAs part of this event\, OCRA will be raffling off tickets to five upcoming OCRA events or webinars!\n\n\nIf you can’t make it to the relay but you’d like to donate to this cause\, please see the OCRA donation page for Relay for Life:\nRelay For Life of North Orange County: OCRA | Relay For Life (acsevents.org)\n\n\nReady to join Team OCRA?\n\nRSVP NOW \n\nQuestions? contact fawnzhang0@gmail.com \n  \nA life changing experience! \n \n  \n 
URL:https://ocra-dg.org/event/team-ocra-relay-for-life/
CATEGORIES:Events,In Person,OCRA Meetings,Other Meetings
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