Guideline for good clinical practice E6(R2)
Guideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995 Page 2/75 10 Document History 11 First Codification History Date New Codification November
Guidelines, Good, Practices, Clinical, Good clinical practice e6
Download Guideline for good clinical practice E6(R2)
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document:
Documents from same domain
Q12 Step 2b Technical and regulatory …
www.ema.europa.euICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management EMA/CHMP/ICH/804273/2017 Page 3/36
Product, Management, Lifecycle, Product lifecycle management
Guideline on good pharmacovigilance practices …
www.ema.europa.eu9 December 2013 . EMA/816292/2011 Rev 1* Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report (Rev 1)
Guidelines, Good, Practices, Guideline on good pharmacovigilance practices, Pharmacovigilance
Guideline on good pharmacovigilance practices (GVP)
www.ema.europa.euGuideline on good pharmacovigilance practices (GVP) – Module IX (Rev 1) EMA/827661/2011 Rev 1 Page 2/25
Guideline on good pharmacovigilance practices …
www.ema.europa.euGuideline on good pharmacovigilance practices (GVP) – Module VIII (Rev 3) EMA/813938/2011 Rev 3 Page 2/28
Guidelines, Good, Practices, Guideline on good pharmacovigilance practices, Pharmacovigilance
Guideline for good clinical practice E6(R2)
www.ema.europa.euGuideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995 Page 2/70 Document History First Codification History Date New Codification
Guideline on good pharmacovigilance practices …
www.ema.europa.euharmful physical or psychological effects [DIR 2001/83/EC Art 1(1 6)]. 74 Adverse event (AE); synonym: Adverse experience 75 Any untoward medical occurrence in a patient or clinical- trial subject administered a medicinal product
Guidelines, Good, Practices, Guideline on good pharmacovigilance practices, Pharmacovigilance
European Medicines Agency
www.ema.europa.eu© EMEA 2006 2 SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS ICH Harmonised Tripartite Guideline
Guidelines, European, Agency, Medicine, Harmonised, European medicines agency, Ich harmonised
products1/traditional herbal medicinal products
www.ema.europa.euThere is no expectation that existing herbal medicinal products on the market will be affected by this guideline, with the exception of traditional herbal medicinal products for human use that were already
Product, Medicinal, Traditional, Herbal, Products1 traditional herbal medicinal products, Products1
Q7 Q&A - good manufacturing practice for active ...
www.ema.europa.euICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients – questions and answers EMA/CHMP/ICH/468930/2015 Page 2/37
Good, Practices, Pharmaceutical, Manufacturing, Active, Ingredients, Good manufacturing practice for active, Good manufacturing practice for active pharmaceutical ingredients
Electronic submission of Article 57(2) data …
www.ema.europa.euElectronic submission of Article 57(2) data EMA/159776/2013 Page 3/75 3.5. Submission of medicinal products with different authorisation number for each package
Product, Electronic, Article, Medicinal, Submissions, Electronic submission of article 57, Medicinal products
Related documents
Guideline for good clinical practice E6(R2)
www.ema.europa.euGuideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995 Page 2/70 Document History First Codification History Date New Codification
GUIDELINE FOR GOOD CLINICAL PRACTICE
www.ich.orgGUIDELINE FOR GOOD CLINICAL PRACTICE INTRODUCTION Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the
South African good clinical practice guidelines. …
www.kznhealth.gov.zaSOUTH AFRICAN GOOD CLINICAL PRACTICE GUIDELINES SECOND EDITION Suggested Citation: Department of Health, 2006. Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa.
Guidelines, Good, Practices, Clinical, Good practices, South, African, South african good clinical practice guidelines
ICH Topic E 6 (R1) Guideline for Good Clinical …
www.pdexternal-roche.comICH Topic E 6 (R1) Guideline for Good Clinical Practice 1. GLOSSARY 1.1 Adverse Drug Reaction (ADR) In the pre-approval clinical experience with a new medicinal product or its new usages, particularly
Guidelines, Good, Practices, Clinical, Guideline for good clinical, Guideline for good clinical practice
GOOD CLINICAL LABORATORY PRACTICE (GCLP)
www.who.int2 | Good Clinical Laboratory Practice (GCLP)/08 FOREWORD For some years, it has been internationally recognized that clinical laboratories processing specimens from clinical trials require an appropriate set of standards
Good, Practices, Laboratory, Clinical, Good clinical laboratory practice
H A N D B O O K - WHO
www.who.intH A N D B O O K GOOD LABORATORY PRACTICE (GLP) Quality practices for regulated non-clinical research and development Special Programme for Research & Training in Tropical Diseases (TDR) sponsored by
Good, Practices, Laboratory, Clinical, H a n d b o o k, H a n d b o o k good laboratory practice