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Highest European Court Confirms: No Presumption of Confidentiality Over Documents Submitted in Marketing Authorization Dossier

Data Matters

On January 22, 2020, the Court of Justice of the European Union (CJEU) found that there is not a general presumption of confidentiality over documents containing clinical and preclinical data provided to the European Medicines Agency (EMA) to support a marketing authorization application. Background. Judgment and implications.

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2019 end-of-year review part 1: January to June

IT Governance

A royal baby, a fire at Notre-Dame, the highest grossing film of all time and more than 12 billion breached data records: 2019 has been quite a year. IT Governance is closing out the year by rounding up 2019’s biggest information security stories. Part one covers January to June, and will be followed by part in the coming days.

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Cryptoassets and Smart Contracts – UK Offers Legal Clarity

Data Matters

On November 18, 2019, the UK Jurisdiction Taskforce, which is part of The English Law Society’s LawTech Delivery Panel , published its Legal Statement on the status of cryptoassets and smart contracts (the Legal Statement). 5 The consequences of this are important, however.

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Cryptoassets and Smart Contracts – UK Offers Legal Clarity

Data Matters

On November 18, 2019, the UK Jurisdiction Taskforce, which is part of The English Law Society’s LawTech Delivery Panel , published its Legal Statement on the status of cryptoassets and smart contracts (the Legal Statement). 5 The consequences of this are important, however.

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Regulatory Update: NAIC Summer 2021 National Meeting

Data Matters

Highlights include, among others, adoption of revised risk-based capital bond factors for life insurers, amendments to SSAP No. NAIC Adopts Revised Risk-Based Capital Bond Factors for Life Insurers. NAIC Adopts FAQ Document to Facilitate Uniformity in State Adoption of Revised Suitability in Annuity Transactions Model Regulation .

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Regulatory Update: NAIC Summer 2018 National Meeting

Data Matters

While it has been determined that the GCC will utilize a risk-based capital (RBC) aggregation approach in order to leverage existing legal capital requirements, it is not clear which entities within any group will be subject to the GCC or how the GCC will apply to those entities within a group that do not have existing capital requirements.

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Regulatory Update: NAIC Fall 2020 National Meeting

Data Matters

The GCC uses a risk-based capital (RBC) aggregation approach intended to act as an additional group supervisory tool for regulators, in conjunction with the Form F Enterprise Risk Report, Own Risk and Solvency Assessment (ORSA) report, and the Corporate Governance Annual Disclosure. 43R —Loan-Backed and Structured Securities.