April 2018 - Intuvigilance

QPPV

Author: Nimisha Kotecha | Apr 21, 2018

Where does LQPPV Stop and NSC Start?

Anyone working in Pharmacovigilance these days knows that some (not all) EU Member States stipulate a requirement for a local QPPV (LQPPV). Some say that the presence of a EU QPPV will suffice. Others mention a ‘Responsible Person’ for PV; Germany needs a ‘Stufenplanbeauftragter’. Regardless of nomenclature, wherever stipulated, broadly speaking this tends to align with the qualifications and responsibilities assigned to the LQPPV. Other countries in turn,

QA and Compliance

Author: Nimisha Kotecha | Apr 11, 2018

Audits and Inspections

Audits and Inspections in the PV universe is not a new concept with the MHRA PV Inspectorate being established in 2004, although, the focus on the PV quality system has increased in the introduction of the new GVP modules in 2012 making the risk-based approach now part of legislation. From the most recent MHRA metrics (2015/16) it can be established that from the five overall the topic areas representing the largest proportion of inspection findings in this period one area that

Brexit

Author: Nimisha Kotecha | Apr 8, 2018

Brexit: Definitely Time for Plan B

For those of you who have followed our conversations, podcasts, interviews, petitions, submissions to the House of Commons, are members of our LinkedIn group ‘UK QPPVS for the EU’ and have had an opportunity to view our video conference on Brexit, will know how hard we have lobbied and what immense support we have had from peers, of our persistent hammering-on about the tangible impact of Brexit on the role of EU