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Clinical trials - Public Health
- https://health.ec.europa.eu/medicinal-products/clinical-trials_en
- The Clinical Trials Regulation (CTR) aims to ensure greater harmonisation of the rules of conducting clinical trials in the EU. It features: A streamlined application procedure for all clinical trials conducted in Europe in a single EU portal and database. All applicants must register before submitting any … See more
Medical devices | European Medicines Agency
- https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
- The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It …
Clinical Trials in the European Union - EMA
- https://euclinicaltrials.eu/
- This website supports the undertaking and oversight of clinical trials in the European Union (EU) and European Economic Area (EEA). It is part of a broad initiative to …
MDCG 2021-6 Regulation (EU) 2017/745 – Questions
- https://health.ec.europa.eu/system/files/2021-04/mdcg_2021-6_en_0.pdf
- Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation April 2021 This document has been endorsed by the Medical Device Coordination Group (MDCG) …
Outsourcing in Clinical Trials: Medical Devices Europe 2023
- https://www.arena-international.com/event/omdteurope/
- CCRC is committed to providing end-to-end services including innovative medical device application, regulatory and clinical strategy consulting, preclinical study design and …
EU Clinical Trials Register - Update
- https://www.clinicaltrialsregister.eu/
- EU CTR continues to display information on EudraCT trials. EudraCT remains available for amendments to EudraCT trials, creation of PIP/Art 46 third country files (see FAQs ), …
Medical Device Clinical Trials: Regulatory …
- https://www.greenlight.guru/blog/medical-device-clinical-trials
- The processes for getting approval and initiating a clinical trial in the EU and US are different, so let’s take a look at each. Clinical trial regulatory …
Outsourcing in Clinical Trials: Medical Devices Europe 2023
- https://www.iqvia.com/events/2023/02/outsourcing-in-clinical-trials-medical-devices-europe-2023
- The Outsourcing in Clinical Trials: Medical Devices Europe will be held in Munich Germany. Learn how IQVIA MedTech can support you across the submission pathway …
Medical Device Clinical Trials in Europe - Global …
- https://globalresearchonline.net/journalcontents/v62-1/33.pdf
- An EU wide coordinated procedure in multi center clinical studies on medical devices Reinforced requirements for manufacturer to collect data. Improved coordination post …
Outsourcing in Clinical Trials: Medical Devices Europe 2023
- https://eventually.com/events/outsourcing-in-clinical-trials-medical-devices-europe-2023
- We are excited to welcome you back to the annual Outsourcing in Clinical Trials conference for Medical Devices. This years programme offers a fresh insight into the …
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