Investigational Medicinal Products Imp

2009 06 annex13 - ECA Academy

PRINCIPLE Investigational medicinal products should be produced in accordance with the principles and the detailed guidelines of Good Manufacturing Practice for Medicinal Products (The Rules

  Product, 2009, Medicinal, Investigational, Medicinal products, 2009 06 annex13, Annex13, Investigational medicinal product

Labelling Requirements for Investigational …

Labelling Requirements for Investigational Medicinal Products in Multinational Clinical Trials: Bureaucratic Cost Driver or Added Value? Wissenschaftliche Prüfungsarbeit

  Product, Medicinal, Investigational, Investigational medicinal product

Guideline on the requirements for quality …

Guidelineontherequirementsforqualitydocumentationconcerningbiological investigationalmedicinalproductsinclinicaltrials EMA/CHMP/BWP/534898/2008 Page 3/17

  Quality, Requirements, The requirements for quality

DIRECTIVE FOR IMPORTATION AND RELEASE OF …

draft template document [name of national regulatory authority] directive for importation and release of investigational medicinal products for clinical trials to be conducted in (name of the country)

  Product, Release, Medicinal, Investigational, Importation, Importation and release of, Importation and release of investigational medicinal products

Thomas Sudhop, MD - AGAH

2 3 Required IMP related Data Investigator’s brochure Trial Protocol Investigational Medicinal Product Dossier (IMPD) Examples of the label in the national language

  Medicinal, Thomas, Investigational, Investigational medicinal, Thomas sudhop, Sudhop

Guideline on strategies to identify and mitigate …

The purpose of FIH trials is to evaluate an investigational medicinal product ( IMP) in humans for the first time, to study the human pharmacology , tolerability and safety of the IMP and to compare how

  Guidelines, Medicinal, Investigational, Investigational medicinal

swissethics

Study ID, Version xx of date (DD/MM/YYYY) Page 3 of 45 <<Protocol template: Interventional study with investigational medicinal product (IMP) / medical device (MD)>> Clinical Study Protocol

  Medicinal, Investigational, Investigational medicinal

First in Human Studies - ABPI

Introduction First in Human (FIH) clinical trials are part of the exploratory phase of drug development and represent a significant milestone in the clinical development of new

The new Clinical Trial Regulation and corresponding …

TITLE PAGE The new Clinical Trial Regulation and corresponding new EU portal and database: an opportunity to enhance standardisation and interoperability in …