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EU Clinical Trials Register Glossary | Search for Clinical ...
www.clinicaltrialsregister.euEU Clinical Trials Register . Disclaimer: The explanations are provided for the benefit of public users of the system and to enhance general understanding of terms used.
EU Clinical Trials Register – FAQs
www.clinicaltrialsregister.eu7 March 2014 . EMA/199793/2011 . EU Clinical Trials Register – FAQs . Questions and answers relating to practical and technical aspects of the EU
EASL Clinical Practice Guidelines: Autoimmune hepatitisq
www.easl.euEASL Clinical Practice Guidelines: Autoimmune hepatitisq European Association for the Study of the Liver⇑ Introduction Autoimmune hepatitis (AIH) was the first liver disease for which
European Medicines Agency Inspections
ec.europa.euguideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials
Guideline for the notification of serious breaches of ...
www.ema.europa.eu33 . 1. Legal requirement 34 Management of serious breaches of clinical trials authorised in the Europe Union (EU)/ European 35 . Economic Area (EEA) is defined by Regulation (EU) No 536/2014, which states in Article 52:
Clinical Trials Directive (2001/20/EC) - eortc.be
www.eortc.beL121/38 EN OfficialJournaloftheEuropeanCommunities 1.5.2001 Article 4 Clinical trials on minors Inadditiontoanyotherrelevantrestriction,aclinicaltrialon minors may be ...
SYSTEMIC LUPUS ERYTH EMATOSUS: PATHOGENESIS, …
www.eular-onlinecourse.orgThere are many epidemiological studies on SLE from around the world and there is extensive data from the European Union (EU) and the United States of America (USA) (2-14).