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Classification and analysis of the GCP inspection …
01 December 2014 INS/GCP/46309/2012 Compliance and Inspections Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP ( inspection reports to EMA 2000-2012) 30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5505 Send a question via our website European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged. TABLE OF CONTENTS 1. GLOSSARY .. 3 2. INTRODUCTION .. 4 3. SCOPE AND AIMS .. 6 4. METHOD .. 6 INFORMATION ABOUT FINDINGS .. 6 INFORMATION ABOUT THE APPLICATIONS .. 7 INFORMATION ABOUT THE CLINICAL TRIAL(S) INSPECTED .. 8 INFORMATION ABOUT THE INSPECTIONS .. 8 INFORMATION ABOUT THE inspection OUTCOME .. 8 5.
01 December 2014 . INS/GCP/46309/2012 . Compliance and Inspections . Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP
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