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Life Sciences European Medicines Agency (EMA) Confidential Information

Hogan Lovells

New transparency rules for EMA’s Clinical Trials Information System (CTIS) - Clinical trial data disclosure in the EU

Hogan Lovells on

As of 18 June 2024, the Revised CTIS Transparency Rules as adopted by the European Medicines Agency (EMA) apply, and will impact patients, health care professionals and sponsors. Also as of 18 June, a revised version of the...more

Nelson Mullins Riley & Scarborough LLP

EMA Releases Official Guidance for Protecting PPD and CCI in Clinical Trial Filings within the European Economic Area (EEA)

Version 1.1 of the European Medicines Agency's (EMA) “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical Trials...more

Nelson Mullins Riley & Scarborough LLP

EMA Finalizes Guidance on Safeguarding PPD and CCI in Clinical Trial Filings in the European Economic Area (EEA)

The European Medicines Agency (EMA) published Version 1.1 of its “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical...more

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