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. Speaker: Andrew Chen, J.D. Chief Representative, Shanghai Office of Arnold &...
Date: Thursday | March 28, 2024 Time: 12 noon to 1pm PT Location: Zoom Registration: Free for OCRA-DG members; $20 for nonmembers Artificial intelligence (AI) and machine learning (ML) technologies have the potential to advance drug development in multiple areas, including candidate identification and refinement,...
Job Interview Techniques & Practical Role-playing with Industry Experts Join 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...
Mastering QMS Audit Readiness: Strategies for Preparation, Conduct, and Mitigation Mastering QMS Audit Readiness: Strategies for Preparation, Conduct, and Mitigation Webinar Join us for an insightful webinar where we'll delve into comprehensive strategies and tactics to help ensure your organization is prepared for your next...
FDA’s Predetermined Change Control Plan (PCCP) Draft Guidance for AI/ML-Enabled Device: Implications and Insights for Regulatory Compliance Date: Wednesday, May 22, 2024 Time: 12pm – 1pm PT Audience: Medical device quality assurance, regulatory affairs, and R&D leaders and practitioners. Platform: Zoom In April 2023 FDA...
IDE Submission Best Practice, and Pitfalls to Avoid - from Both Regulatory & Clinical Perspectives Date: Thursday, May 30, 2024 (New Date!) Time: 5:30pm – 7:30pm PT Audience: Regulatory and clinical affairs professionals in medical device industry Location: Alcon Laboratories, 20511 Lake Forest Dr, Lake...
China Medical Device Registration Clinical Pathways Latest Updates Date: Wednesday, June 6, 2024 Time: 8am – 9am PT Audience: Regulatory and clinical professionals in medical device industry Platform: Zoom Struggling with determining the regulatory pathways for your device in China? Which pathway needs clinical evidence?...
What's New in FDA 510(k) & eSTAR Best Practice Date: Wednesday, June 26, 2024 Time: 12 noon – 1pm PT Audience: Medical device regulatory affairs professionals who are involved in the 510(k) submission process. Platform: Zoom The panel will provide an overview of the recent...
Social Summer Date: Friday, July 12, 2024 Time: 4 – 8pm PT Location: Bosscat Kitchen & Libations 18169 Von Karman Ave, Irvine, CA 92612 Free for Member $10 for Nonmember Register Now!
See https://ocra-dg.org/2024-annual-conference/ for event details!
Navigating EU MDR Compliance for CE Marking Date: Thursday, September 12 Time: 12pm-1:15pm PT Audience: This webinar is recommended for professionals with some familiarity with EU MDR or the previous Medical Device Directive (MDD). Platform: Zoom This webinar aims to provide an overall understanding of...
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. OCRA Members receive 10% off RAPS Convergence registration rate! Contact Membership@ocra-dg.org to obtain the special promo code!
Inherently Safer Design Date: Monday, October 14, 2024 Time: 12pm – 1:15m PT Audience: - Medical device and IVD regulatory affairs professionals - Risk Management professionals - Systems Engineers - Engineering management and design engineers - Clinical Affairs professionals Platform: Zoom Control of risk is...
Clinical Trial Management in Academic Medical Centers Date: Wednesday, October 30 Time: 12:00pm-1:00pm PT Audience: Audiences interested in clinical trial management. Platform: Zoom Clinical trials are crucial for the development of safe and effective medical products and enhancing the quality of patient care worldwide. Effective...
End-of-year Holiday Party/Member & Sponsor Appreciation Dinner Date: Thursday, November 14, 2024 Time: 6:30pm – 9:30m PT Event: A thank you to our members and sponsors. Free for Members, Sponsors and Guests Register Now!
OCRA-DG Open House Date: Friday, January 10 2025 Event: Introducing OCRA members to the new 2025 board Check back soon for more info.
OCRA-DG March 14 Happy Hour Date: Friday, March 14th Event: Inviting members and nonmembers of the SoCal Regulatory Affairs community to socialize and network. Check back soon for more info.
OCRA-DG May 9 Happy Hour Date: Friday, May 9th Event: Inviting members and nonmembers of the SoCal Regulatory Affairs community to socialize and network. Check back soon for more info.
OCRA-DG July 11 Happy Hour Date: Friday, July 11th Event: Inviting members and nonmembers of the SoCal Regulatory Affairs community to socialize and network. Check back soon for more info.
OCRA-DG Sept 12 Happy Hour Date: Friday, September 12th Event: Inviting members and nonmembers of the SoCal Regulatory Affairs community to socialize and network. Check back soon for more info.
