Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

Volumn , Issue , 2008, Pages 1-283

  Tobin, John J ^a   Walsh, Gary ^b  

^a ChemHaz Solutions Ltd   (Ireland)

^b UNIVERSITY OF LIMERICK   (Ireland)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84884309043     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9783527623037     Document Type: Book

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111. Labelling 21 CFR Parts 801 & 809
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115. Quality System Regulations - 21 CFR Part 820
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144. European Regulations
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149. Human Medicines Directive 2001/83/EC
150. TTitle IV: Manufacture and imports
151. TTitle VIII: Advertising, Title IX: Pharmacovigilance
152. TTitle XI: Supervision and sanctions
153. Medicinal Products Regulation (EC) No. 726/2004
154. TTitle II, Chapter 2 Supervision and penalties; Chapter 3, Pharmacovigilance
155. TTitle III, Chapter 2 Supervision and penalties; Chapter 3, Pharmacovigilance
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157. Active Implantable Medical Devices Directive 90/385 EEC Article 8 (Competent Authority Vigilance procedure), Annex II 3.1 (manufacturer's vigilance and reporting duties)
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163. Drug Reporting requirements: 21 CFR Parts 314.80, 314.81, 514.80, 600.80, 600.81, 601.28
164. Medical Devices: 21 CFR 803, Medical Device Reporting, 21 CFR 806, Reports of
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