by chuck_ltd | 29 Aug, 2017 | CHCUK News & Articles, PASS
GVP Module VI, which deals with the collection, management and submission of reports of suspected adverse reactions to medicinal products has been amended. Revision 2 comes into effect on the 22 November 2017. Revision 2 boasts 144 pages versus the 90 pages of...
by chuck_ltd | 10 Aug, 2016 | CHCUK News & Articles, Consultation, GVP, News, NIS
Draft guideline on good pharmacovigilance practices (GVP) – Module VI – Management and reporting of adverse reactions to medicinal products (Rev. 2) This Module of GVP addresses the legal requirements detailed in Title IX of Directive 2001/83/EC 183 and Chapter...