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X-WR-CALDESC:Events for OCRA-DG - Regulatory Affairs
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DTSTART;TZID=America/Los_Angeles:20240305T180000
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DTSTAMP:20260419T023242
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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
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BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240311T160000
DTEND;TZID=America/Los_Angeles:20240311T170000
DTSTAMP:20260419T023242
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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
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DTSTART;TZID=America/Los_Angeles:20240328T120000
DTEND;TZID=America/Los_Angeles:20240328T130000
DTSTAMP:20260419T023242
CREATED:20240221T193018Z
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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
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