Search results with tag "Guideline on good pharmacovigilance practices"
Guideline on good pharmacovigilance practices (GVP)
www.ema.europa.euGuideline on good pharmacovigilance practices (GVP) – Module VIII Add I (Rev 3) EMA/395730/2012 Rev 3 Page 2 /3 VIII.Add.I.1. Introduction This Addendum provides additional information on legal requirements (identifiable by the modal verb “shall”) and recommendations (identifiable by the modal verb “should”) for the submission of study
Guideline on good pharmacovigilance practices (GVP)
www.ema.europa.euGuideline on good pharmacovigilance practices (GVP) – Module II (Rev 2) EMA/816573/2011 Rev 2 Page 2/20 This revision of the Module was not subject to public consultation because it concerns only updates and clarifications
Guideline on good pharmacovigilance practices (GVP)
www.ema.europa.eucommunication e.g. on the resolution of a safety concern or updated recommendations. • The effectiveness of safety communication should be evaluated where appropriate and possible (see XV.B.7.). • Safety communications should comply with relevant requirements relating to individual data protection and confidentiality.
Guideline on good pharmacovigilance practices (GVP)
www.ema.europa.euGuideline on good pharmacovigilance practices (GVP) ... the guidance in this Addendum to GVP Module XVI should be followed together with national guidelines. This Addendum is applicable to both centrally and nationally authorised products, including those ... and provide clear statements and concise
Guideline on good pharmacovigilance practices (GVP)
www.ema.europa.eu22 June 2012 . EMA/873138/2011 (superseded version) Guideline on good pharmacovigilance practices (GVP) Module VI – Management and reporting of adverse reactions to medicinal
Guideline on good pharmacovigilance practices …
jfda.joVersion 2 The League of Arab States Guideline on good pharmacovigilance practices (GVP) for Arab Countries Page 4 / 532 ―Summary of activities in the RMP by
Guideline on good pharmacovigilance practices (GVP)
www.ema.europa.euModule XVI – Risk minimisation measures: selection of tools and effectiveness indicators (Rev 2) Date for coming into effect of first version 1 March 2014 Date for coming into effect of Revision 1 28 April 2014 Draft Revision 2* finalised by the Agency in …
Guideline on good pharmacovigilance practices (GVP)
www.ema.europa.euInternal Control: Internal control is an integral process that is effected by an entity’s management and personnel and is designed to address risk and provide reasonable assurance that in pursuit of the entity’s mission, the following general objectives are …
Guideline on good pharmacovigilance practices (GVP)
www.ema.europa.euGuideline on good pharmacovigilance practices (GVP) – Module VIII (Rev 3) EMA/813938/2011 Rev 3 Page 2/28
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.eu- Addition of an explanatory note for Audit to clarify what is not regarded as audit in accordance with GVP Module IV Rev 1; - Addition of the definition of Biological medicinal product as defined in Directive 2001/83/EC, Annex 1, Part I,
Guideline on good pharmacovigilance practices (GVP)
www.ema.europa.euClinical trial 92 Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or 93 other pharmacodynamic effects of one or more investigationa l medicinal product(s), and/or to identify
Guideline on good pharmacovigilance practices (GVP)
www.ema.europa.euEU competent authority for the protocol oversight and reporting of results ( VIII.C.2.) and for subsequent changes to the marketing authorisation ( VIII.C.3.). Legal requirements are identifiable by the modal verb “shall”. Recommendations that are not legal requirements are.