EMA revises guideline on first-in-human clinical trials
EU Clinical Trials Regulation (EU-CTR) enters application on 31 January 2022
EudraVigilance system overview | European Medicines Agency
The obligatory sharing of clinical trial data in the European Union - datenschutz notizen | News-Blog der datenschutz nord Gruppe
EMA's Clinical Trials Information System (CTIS) goes live – EJP RD – European Joint Programme on Rare Diseases
EMA: Points to consider on implications of COVID-19 on methodological aspects of ongoing clinical trials - Meditrial Helpline
Characteristics of Single Pivotal Trials Supporting Regulatory Approvals of Novel Non-orphan, Non-oncology Drugs in the European Union and United States from 2012-2016. - Abstract - Europe PMC
Assessment of the Regulatory Dialogue Between Pharmaceutical Companies and the European Medicines Agency on the Choice of Noninferiority Margins - Clinical Therapeutics
Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration | Journal of Law, Medicine & Ethics | Cambridge Core
Clinical Trial Regulation Update - PharSafer® - Specialists in Global Clinical and Post Marketing Drug Safety
EU clinical trial portal and database declared functional | RAPS
Comparative overview of Preclinical Data studies and Clinical Trials... | Download Scientific Diagram
Transparency of clinical trials and good governance should be included in the EMA extended mandate | European Alliance for Responsible R&D and Affordable Medicines
Patient involvement in EMA regulatory committees - EUPATI Toolbox
Good clinical practice | European Medicines Agency
Path to Better Clinical Trials for T1D Delay/Prevention | Insulin Nation
What are the EMA Guidelines for Clinical Trial Management? – pepgra
EMA sets out plan to accelerate clinical trials, reduce administrative burden | Fierce Biotech
Clinical trials for EMA-submitted medicines move away from US and Europe - PMLiVE
The EMA and Foreign Data_Part 2
COVID-19 vaccines: development, evaluation, approval and monitoring | European Medicines Agency
EMA calls for 'stakeholder' input on design of new clinical trials database
Correspondence with the European Medicines Agency | The BMJ
Positive outcome for ema's policy 0070, one year after the publication of the clinical trial results - Portolano Cavallo
