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Swiss Life Sciences Briefing
Global Life Sciences in Switzerland
Recommended Reading
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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
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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
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WatchFemTech in the Spotlight – An Interview With the DTA’s Megan CoderNovember 1, 2022
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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
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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Quick Guide for Management of Data Integrity Breaches in a Clinical TrialFebruary 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 -
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Future Developments in Clinical Studies: Clinical Trials in Countries with Emerging EconomiesApril 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Future Developments in Clinical Studies: Big Data AnalysisMarch 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Contract Research Organizations: Ensuring That Sponsors of Clinical Studies Meet Their Oversight ObligationFebruary 2020
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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
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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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Editor
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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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