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Clinical trial authorisation framework in Europe - overview
quality documentation (EMA - 2006) -For biologicals (public consultation) 5 5 The clinical trials directive and guidances Medicinal products (gene and cell therapies included) Harmonisation in 27 ... process • Avoid : • National CTA requirements • National divergent decisions •
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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 E6(R2)
www.ema.europa.euGuideline 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
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
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
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)
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
European Medicines Agency
www.ema.europa.eu© EMEA 2006 2 SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS ICH Harmonised Tripartite Guideline
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
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
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www.patientsafety.va.govThis Directive clarifies the process for obtaining privileges to ... of the adequacy of pulmonary ventilation by continual observation of qualitative clinical signs is required. VHA DIRECTIVE 1073 December 30, 2014 4 (4) Procedural Documentation. (a) The use of moderate sedation must be documented in the patient’s medical record; (b ...
Guideline on the requirements for quality documentation ...
www.ema.europa.eu60 on medicinal products for human use, and repealing Directive 2001/20/EC , which came into force on 61 . June 20, 2014 62 Since clinical trials can be designed as multi-centre studies potentially involving different Member 63 States, it is the aim of this guideline to define harmonised require ments for the documentation to be 64
Medical Device Directive (MDD)
www.medicaldevicesgroup.netClinical • Article 16 . Notified bodies • Article 17 . CE marking • Article 18 . Wrongly affixed CE marking • Article 19 . Decision in respect of refusal or restriction • Article 20 . Confidentiality • Article 21 . Repeal and amendment of directives • Article 22 . Implementation, transitional provisions • Article 23 . Directive ...
Structure of Technical Documentation (Medical Devices)
www.mdc-ce.deStructure of Technical Documentation 004/08.2021 (Medical Devices) ID: 2379 Page 3 of 4 6.4.Software verification and validation (if applicable) 6.4.1.Description of the software lifecycle (e.g. according to EN 62304)