BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//OCRA-DG - Regulatory Affairs - ECPv6.11.2.1//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:OCRA-DG - Regulatory Affairs
X-ORIGINAL-URL:https://ocra-dg.org
X-WR-CALDESC:Events for OCRA-DG - Regulatory Affairs
REFRESH-INTERVAL;VALUE=DURATION:PT1H
X-Robots-Tag:noindex
X-PUBLISHED-TTL:PT1H
BEGIN:VTIMEZONE
TZID:America/Los_Angeles
BEGIN:DAYLIGHT
TZOFFSETFROM:-0800
TZOFFSETTO:-0700
TZNAME:PDT
DTSTART:20250309T100000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0700
TZOFFSETTO:-0800
TZNAME:PST
DTSTART:20251102T090000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250402T183000
DTEND;TZID=America/Los_Angeles:20250402T200000
DTSTAMP:20260404T074959
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:20260404T074959
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:20260404T074959
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:20260404T074959
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:20260404T074959
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:20260404T074959
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:20260404T074959
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:20260404T074959
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:20260404T074959
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:20260404T074959
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