Sidley Resource
Swiss Life Sciences Briefing
Global Life Sciences in Switzerland
Recommended Reading
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著書U.S.–Swiss Mutual Recognition Agreement on Good Manufacturing PracticesAugust 6, 2024
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著書How to Ensure the Safe and Compliant Use of AI in Drug ManufacturingAugust 6, 2024
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著書Engaging in Foreign Trade by a Swiss-Based Entity? Be Sure the Required Swiss Establishment License for Foreign Trade Is in PlaceAugust 6, 2024
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著書Regulating the Future: Navigating Ethical and Legal Pathways in Brain-Computer Interface TechnologyApril 4, 2024
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著書Swiss Life Sciences Companies With International Supply Chains Face New ESG Obligations With First Reports Due in 2024April 3, 2024
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著書Regulatory Consideration for Software Hardware Medical DeviceApril 3, 2024
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著書Temporary Marketing Authorization – Swissmedic Guidance RevisedApril 3, 2024
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著書Simultaneous Review of Veterinary Medicinal Product Applications in Switzerland and the UK Offers Potential for New EfficienciesSeptember 19, 2023
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著書Food Supplements: Under Higher Scrutiny Than EverJune 23, 2023
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著書New AI, Data, and Cyber Laws — State of PlayJune 9, 2023
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著書In-House Counsel Privilege – Soon to Arrive in SwitzerlandApril 26, 2023
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著書International Dispute Resolution 2.0: Innovative Tools to Empower ClientsApril 20, 2023
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著書Update on New Swiss Conflict Minerals and Child Labor Due Diligence ObligationsApril 19, 2023
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著書3D Printing — Custom-Made vs. Adaptable Medical Devices and Their RequirementsFebruary 24, 2023
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著書Femtech - Digital Health – Considerations in Early Stage Due DiligenceFebruary 16, 2023
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著書Pharmacovigilance Must Ready Itself for AIJanuary 30, 2023
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著書U.S.–Swiss Mutual Recognition Agreement on Good Manufacturing PracticesJanuary 30, 2023
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著書Serious Incident Reporting for Medical Devices — Serious Implications of NonreportingJanuary 30, 2023
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シドリー最新情報Switzerland Will Open Its Market for U.S. Food & Drug Administration (FDA) - Regulated Medical DevicesDecember 7, 2022 Global Life Sciences Update
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シドリー最新情報Impact of the Recent Judgment on Food for Special Medical Purposes in the EUNovember 15, 2022 Global Life Sciences Update
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WatchFemTech in the Spotlight – An Interview With the DTA’s Megan CoderNovember 1, 2022 Sidley Webinar
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著書New Swiss Data Protection Act – And a New Swiss-U.S. Trans-Atlantic Data Privacy Framework?October 25, 2022
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著書Reimbursement Pathways for Digital Health Tools and Software - How to Bring Your FemTech Solution to WomenSeptember 29, 2022
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著書Switzerland Fines SBM Offshore Over BriberySeptember 27, 2022
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著書Artificial Intelligence Considerations for Femtech and BeyondJuly 2022
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WatchFemtech in the Spotlight — An Interview with Wolfgang Hackl — Founder and CEO of OncoGenomXJuly 11, 2022
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著書EU a Step Closer to Adopt Expansive New Rules Covering Batteries for Medical DevicesJuly 2022
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著書FDA: Draft Bill to Eliminate Preannouncements for Foreign Drug InspectionsApril 2022
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著書A Wakeup Call – The New Swiss Data Protection Act Enters Into Force on September 1, 2023April 2022
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著書Femtech 2022: International Women’s Day - Putting Women’s Health in the SpotlightMarch 2022
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著書The NICE HST Manuals: A Model for the Swiss Federal Office of Public Health?March 2022
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WatchFemTech in the Spotlight - An Interview with REA Co-FoundersMarch 7, 2022
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著書The Opportunities and Risks of Carbon Credits on the Pathway to Net ZeroMarch 2022
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著書A New Era for Novel Therapies in Animal HealthJanuary 2022
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シドリー最新情報Germany’s “DiGA” Digital Health Fast Track Process Is Modeling a New Way To Regulate Market Access and ReimbursementDecember 10, 2021 Global Life Sciences Update
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著書Getting to Know Eva Von Mühlenen: Our Latest Digital Health Thought LeaderNovember 2021
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著書“Mission-Critical Risks” and the Fiduciary Duties of Directors of Life Sciences CompaniesNovember 2021
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著書Herring or Cheese? The Swiss/European Union Relationship Without an Institutional Framework AgreementSeptember 2021
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著書UK Supreme Court Unanimously Upholds Judgment in Favor of Servier in “Unlawful Means” CaseSeptember 2021
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著書Foreign Fines Tax-deductible Only in Exceptional Cases under New Swiss Law from 2022June 2021
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著書Takeaways From the New EU Animal Health RegulationJune 2021
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著書COVID Passports in the EU and SwitzerlandJune 2021
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著書Best Recall Practices – Part 3 – Consumer GoodsJune 2021
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著書Switzerland: Unequal Treatment of Patients With Rare DiseasesMay 2021
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著書Switzerland: Public Consultation on Draft of New In Vitro Diagnostic OrdinanceMay 2021
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著書Swiss Medical Devices Regulation: Federal Council Issues Last-Minute ChangesMay 2021
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著書Pharma Opportunities in Post-Brexit UKMay 2021
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著書Swiss Data Protection Act — New Guidance by the Swiss RegulatorApril 2021
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著書Best Recall Practices Guidelines — Part 2 — Food ProductsApril 2021
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著書Best Recall Practices Guidelines — Part 1 — Medical DevicesFebruary 2021
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著書Part 2: Revised to Match the EU General Data Protection Regulation — or AlmostFebruary 2021
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著書National Institute for Health and Care Excellence Reinvented: Eyes on Innovation and Enhanced Patient AccessFebruary 2021
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著書Rise of Environmental, Social, and Governance Due Diligence in EuropeFebruary 2021
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著書Export Restrictions on Medical Supply Amidst a PandemicFebruary 2021
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著書Brexit: Key Considerations for Swiss Pharmaceutical CompaniesDecember 2020
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著書Swiss Data Protection Act - Part 1: Revised to Live Up to the Digital AgeDecember 2020
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著書2020 – the Year of SPACsDecember 2020
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著書The Nagoya Protocol's Impact on Research and DevelopmentNovember 2020
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著書Cross-Border Data Flows and the Life Sciences Industry: How Trade Law Can HelpNovember 2020
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著書Advertising by Mail-Order Pharmacies: Free Movement Rules of e-Commerce Directive Apply, Says European Court of JusticeOctober 2020
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著書Investment Screening: Recent Developments With Implications for the Healthcare SectorOctober 2020
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著書The End of the Swiss-U.S. Privacy Shield?September 2020
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著書Switzerland: Update on Life Sciences Regulations — It’s Not All About COVID-19September 2020
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著書Facilitating Trade in Healthcare Products: the EU’s ProposalSeptember 2020
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著書Legality of Patent Settlement Agreements: The Jury’s Still OutJuly 2020
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著書Change of Control?July 2020
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著書New European Medicines Agency Guidance on Use of Software Tools in Clinical TrialsMay 2020
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著書Switzerland: COVID-19 Disrupts Well-Established Safeguards for Medicinal ProductsApril 2020
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著書Clinical Trials in the EU: Ongoing Uncertainty Around Data Protection Compliance for SponsorsApril 2020
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著書Oxygen for the Industry Providing Ventilators: EU Commission to Propose New Date for MDR ImplementationMarch 2020
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著書EU Whistleblowing Directive: What Life Sciences Companies Need to KnowMarch 2020
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著書非医療目的の製品 － 迫りくるEU医療機器規制（Annex XVI）2020年2月
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著書EUにおける医療機器の設計および意図する目的の「重要な変更」とは2020年2月
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著書データ完全性：規制当局よりも早く異常を発見せよ2020年1月
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著書代替的調製：販売承認システムに対する大きな脅威2019年12月
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著書Software as Medical Device: New European Commission GuidanceDecember 2019
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著書Nitrosamines: Swissmedic Guidance Requires New GMP/API FocusNovember 2019
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著書New Swiss Rules on Clinical Evaluations and Investigations of Medical Devices: Important Changes Around the CornerNovember 2019
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著書WHOによる医療製品の国内価格への影響の可能性2019年11月
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著書透明性 対 営業秘密（CCI）の保護―EU裁判所の新しい章2019年11月
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著書When Pharma Met Medtech: Better and Faster Drug DiscoveryOctober 2019
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著書Could Private Equity Firms Help You Stay Competitive Following the New Swiss Medical Devices Regulation?October 2019
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著書Traveling Healthily on the Belt and RoadSeptember 2019
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著書Swiss Medical Devices Manufacturers to Be Blocked by Missing Framework Agreement?September 2019
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著書European Commission Issues Additional Medtech Vigilance GuidanceSeptember 2019
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著書The Extra-Territorial Reach of EU Data Protection LawJuly 2019
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著書EU Challenges Turkey with WTO Pharma DisputeJune 2019
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著書Your Life Sciences Investments in Cuba: A Time Bomb?June 2019
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著書To Settle or Not To Settle? An Analysis of The Servier Patent Settlement Case and Its Practical ImplicationsMay 2019 CPI Antitrust Chronicle
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著書The Last Piece of the Puzzle: Preventing Financial Influences on Healthcare Professionals’ Therapeutic DecisionsMay 2019
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If you have any questions regarding the content of these articles or suggestions for topics to be covered in future issues, please contact the Sidley lawyer with whom you usually work, or:
Editors
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Senior Advisorabalsiger@sidley.com +41 22 308 0051ジュネーブ*Admitted at the Swiss Bar but not registered at the Cantonal Attorney Register. -
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