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SUMMARY:Life Sciences Regulatory Bootcamp
DESCRIPTION:Building a foundation for success in the medical products industry\n\nJoin us for an afternoon of discussions designed to provide a foundation in FDA\, healthcare\, and securities issues arising in the development of medical products. Whether you are relatively new to counseling and risk mitigation in these areas or more experienced counsel looking for an efficient way to focus on their application in pre-commercial contexts\, this event is for you. Learn from Sidley’s experienced regulatory and disclosure lawyers and get answers to your most pressing questions. \n \nWho Should Attend: Lawyers needing a practical introduction to legal and regulatory issues arising in the development of medical products. \nFEATURED PANELS \nEssential FDA Concepts and Strategic Considerations for Drug Development \n\nFDA’s expectations of drug developers\nFDA programs to expedite development and regulatory review\nNon-patent exclusivities administered by FDA: considerations for lifecycle management and mitigating litigation risks\nDisputing FDA Actions\n\nProcedural options and definition of success\nKey factors predicting outcomes\nAppropriate means of influencing FDA\n\n\n\nEngagement with Patients and HCPs\, Including Compliance Considerations for Pre-Commercial Products \n\nObtaining coding\, coverage\, and reimbursement\nPricing considerations\nMarket access strategies\, including expanded/post-trial access\nArrangements with HCPs and patients\nRight-sized compliance infrastructure\n\nPractical Approaches to SEC\, Shareholder Litigation\, and FDA Risks in Pre-Approval Communications \n\nSEC and FDA requirements/coordination with respect to pre-approval communications and disclosures for public life science companies\nIssues and trends in shareholder litigation\nPractical approaches to mitigating regulatory\, enforcement\, and litigation risks\n\nRSVP HERE \n1:30 p.m. – 5:30 p.m. PT | Cocktail Reception: 5:30 p.m. – 6:30 p.m. PT \n\nCLE credit for this program is pending. \nFor more information\, contact Sidley Global Life Sciences.
URL:https://goodlifesci.sidley.com/event/life-sciences-regulatory-bootcamp/
LOCATION:Sharon Heights Country Club\, 2900 Sand Hill Rd\, Menlo Park\, CA\, United States
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