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X-ORIGINAL-URL:https://ocra-dg.org
X-WR-CALDESC:Events for OCRA-DG - Regulatory Affairs
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DTSTART;TZID=America/Los_Angeles:20240220T160000
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DTSTAMP:20260419T041740
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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:20240226T170000
DTEND;TZID=America/Los_Angeles:20240226T210000
DTSTAMP:20260419T041740
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
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