Sidley Resource
Swiss Life Sciences Briefing
Global Life Sciences in Switzerland
Recommended Reading
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PublicationsU.S.–Swiss Mutual Recognition Agreement on Good Manufacturing PracticesAugust 6, 2024
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PublicationsHow to Ensure the Safe and Compliant Use of AI in Drug ManufacturingAugust 6, 2024
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PublicationsEngaging 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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PublicationsRegulating the Future: Navigating Ethical and Legal Pathways in Brain-Computer Interface TechnologyApril 4, 2024
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PublicationsSwiss Life Sciences Companies With International Supply Chains Face New ESG Obligations With First Reports Due in 2024April 3, 2024
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PublicationsRegulatory Consideration for Software Hardware Medical DeviceApril 3, 2024
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PublicationsTemporary Marketing Authorization – Swissmedic Guidance RevisedApril 3, 2024
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PublicationsSimultaneous Review of Veterinary Medicinal Product Applications in Switzerland and the UK Offers Potential for New EfficienciesSeptember 19, 2023
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PublicationsFood Supplements: Under Higher Scrutiny Than EverJune 23, 2023
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PublicationsNew AI, Data, and Cyber Laws — State of PlayJune 9, 2023
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PublicationsIn-House Counsel Privilege – Soon to Arrive in SwitzerlandApril 26, 2023
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PublicationsInternational Dispute Resolution 2.0: Innovative Tools to Empower ClientsApril 20, 2023
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PublicationsUpdate on New Swiss Conflict Minerals and Child Labor Due Diligence ObligationsApril 19, 2023
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Publications3D Printing — Custom-Made vs. Adaptable Medical Devices and Their RequirementsFebruary 24, 2023
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PublicationsFemtech - Digital Health – Considerations in Early Stage Due DiligenceFebruary 16, 2023
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PublicationsPharmacovigilance Must Ready Itself for AIJanuary 30, 2023
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PublicationsU.S.–Swiss Mutual Recognition Agreement on Good Manufacturing PracticesJanuary 30, 2023
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PublicationsSerious Incident Reporting for Medical Devices — Serious Implications of NonreportingJanuary 30, 2023
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Sidley UpdatesSwitzerland Will Open Its Market for U.S. Food & Drug Administration (FDA) - Regulated Medical DevicesDecember 7, 2022 Global Life Sciences Update
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Sidley UpdatesImpact 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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PublicationsNew Swiss Data Protection Act – And a New Swiss-U.S. Trans-Atlantic Data Privacy Framework?October 25, 2022
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PublicationsReimbursement Pathways for Digital Health Tools and Software - How to Bring Your FemTech Solution to WomenSeptember 29, 2022
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PublicationsSwitzerland Fines SBM Offshore Over BriberySeptember 27, 2022
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PublicationsArtificial 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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PublicationsEU a Step Closer to Adopt Expansive New Rules Covering Batteries for Medical DevicesJuly 2022
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PublicationsFDA: Draft Bill to Eliminate Preannouncements for Foreign Drug InspectionsApril 2022
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PublicationsA Wakeup Call – The New Swiss Data Protection Act Enters Into Force on September 1, 2023April 2022
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PublicationsFemtech 2022: International Women’s Day - Putting Women’s Health in the SpotlightMarch 2022
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PublicationsThe 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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PublicationsThe Opportunities and Risks of Carbon Credits on the Pathway to Net ZeroMarch 2022
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PublicationsA New Era for Novel Therapies in Animal HealthJanuary 2022
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Sidley UpdatesGermany’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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PublicationsGetting to Know Eva Von Mühlenen: Our Latest Digital Health Thought LeaderNovember 2021
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Publications“Mission-Critical Risks” and the Fiduciary Duties of Directors of Life Sciences CompaniesNovember 2021
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PublicationsHerring or Cheese? The Swiss/European Union Relationship Without an Institutional Framework AgreementSeptember 2021
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PublicationsUK Supreme Court Unanimously Upholds Judgment in Favor of Servier in “Unlawful Means” CaseSeptember 2021
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PublicationsForeign Fines Tax-deductible Only in Exceptional Cases under New Swiss Law from 2022June 2021
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PublicationsTakeaways From the New EU Animal Health RegulationJune 2021
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PublicationsCOVID Passports in the EU and SwitzerlandJune 2021
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PublicationsBest Recall Practices – Part 3 – Consumer GoodsJune 2021
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PublicationsSwitzerland: Unequal Treatment of Patients With Rare DiseasesMay 2021
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PublicationsSwitzerland: Public Consultation on Draft of New In Vitro Diagnostic OrdinanceMay 2021
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PublicationsSwiss Medical Devices Regulation: Federal Council Issues Last-Minute ChangesMay 2021
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PublicationsPharma Opportunities in Post-Brexit UKMay 2021
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PublicationsSwiss Data Protection Act — New Guidance by the Swiss RegulatorApril 2021
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PublicationsBest Recall Practices Guidelines — Part 2 — Food ProductsApril 2021
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PublicationsBest Recall Practices Guidelines — Part 1 — Medical DevicesFebruary 2021
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PublicationsPart 2: Revised to Match the EU General Data Protection Regulation — or AlmostFebruary 2021
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PublicationsNational Institute for Health and Care Excellence Reinvented: Eyes on Innovation and Enhanced Patient AccessFebruary 2021
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PublicationsRise of Environmental, Social, and Governance Due Diligence in EuropeFebruary 2021
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PublicationsExport Restrictions on Medical Supply Amidst a PandemicFebruary 2021
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PublicationsBrexit: Key Considerations for Swiss Pharmaceutical CompaniesDecember 2020
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PublicationsSwiss Data Protection Act - Part 1: Revised to Live Up to the Digital AgeDecember 2020
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Publications2020 – the Year of SPACsDecember 2020
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PublicationsThe Nagoya Protocol's Impact on Research and DevelopmentNovember 2020
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PublicationsCross-Border Data Flows and the Life Sciences Industry: How Trade Law Can HelpNovember 2020
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PublicationsAdvertising by Mail-Order Pharmacies: Free Movement Rules of e-Commerce Directive Apply, Says European Court of JusticeOctober 2020
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PublicationsInvestment Screening: Recent Developments With Implications for the Healthcare SectorOctober 2020
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PublicationsThe End of the Swiss-U.S. Privacy Shield?September 2020
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PublicationsSwitzerland: Update on Life Sciences Regulations — It’s Not All About COVID-19September 2020
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PublicationsFacilitating Trade in Healthcare Products: the EU’s ProposalSeptember 2020
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PublicationsLegality of Patent Settlement Agreements: The Jury’s Still OutJuly 2020
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PublicationsChange of Control?July 2020
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PublicationsNew European Medicines Agency Guidance on Use of Software Tools in Clinical TrialsMay 2020
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PublicationsSwitzerland: COVID-19 Disrupts Well-Established Safeguards for Medicinal ProductsApril 2020
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PublicationsClinical Trials in the EU: Ongoing Uncertainty Around Data Protection Compliance for SponsorsApril 2020
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PublicationsOxygen for the Industry Providing Ventilators: EU Commission to Propose New Date for MDR ImplementationMarch 2020
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PublicationsEU Whistleblowing Directive: What Life Sciences Companies Need to KnowMarch 2020
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PublicationsProducts With Non-Medical Purpose — MDR Annex XVI Is LoomingFebruary 2020
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PublicationsUnderstanding What Constitutes “Significant Changes” in Design and Intended Purpose of Medical Devices in the EUFebruary 2020
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PublicationsData Integrity: Discover Anomalies Before Your Regulator DoesJanuary 2020
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PublicationsReplacement Compounding: A Major Threat to the Marketing Authorization SystemDecember 2019
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PublicationsSoftware as Medical Device: New European Commission GuidanceDecember 2019
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PublicationsNitrosamines: Swissmedic Guidance Requires New GMP/API FocusNovember 2019
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PublicationsNew Swiss Rules on Clinical Evaluations and Investigations of Medical Devices: Important Changes Around the CornerNovember 2019
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PublicationsWHO May Affect the National Pricing of Therapeutic ProductsNovember 2019
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PublicationsTransparency vs. Confidentiality of Commercially Sensitive Information — A New Chapter Before EU CourtsNovember 2019
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PublicationsWhen Pharma Met Medtech: Better and Faster Drug DiscoveryOctober 2019
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PublicationsCould Private Equity Firms Help You Stay Competitive Following the New Swiss Medical Devices Regulation?October 2019
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PublicationsTraveling Healthily on the Belt and RoadSeptember 2019
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PublicationsSwiss Medical Devices Manufacturers to Be Blocked by Missing Framework Agreement?September 2019
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PublicationsEuropean Commission Issues Additional Medtech Vigilance GuidanceSeptember 2019
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PublicationsThe Extra-Territorial Reach of EU Data Protection LawJuly 2019
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PublicationsEU Challenges Turkey with WTO Pharma DisputeJune 2019
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PublicationsYour Life Sciences Investments in Cuba: A Time Bomb?June 2019
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PublicationsTo 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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PublicationsThe 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:
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Senior Advisorabalsiger@sidley.com +41 22 308 0051Geneva*Admitted at the Swiss Bar but not registered at the Cantonal Attorney Register. -
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