May 2018 - Intuvigilance

Pharmacovigilance, QA and Compliance, QPPV, Regulatory Intelligence

Author: Nimisha Kotecha | May 30, 2018

Welcome to the New IntuVigilance Website

IntuVigilance is pleased to announce the launch of its brand new website. Many of you have visited our previous site and found it to be straight forward, clean and factual. All the things that embody IntuVigilance. Our new www.intuvigilance.com site is crisp, colourful, focussed on our service offering and most importantly of all, showcases our client testimonials. Following on from our recent

Brexit, Pharmacovigilance, QPPV

Author: Nimisha Kotecha | May 17, 2018

Brexit and the UK QPPV: Quo Vadis?

On June 23rd 2016, the UK public voted by referendum to leave the European Union aHer 43 years. Roughly 48% Remain, 52% Leave. This was not legally mandatory but has been politically interpreted as ‘Brexit meaning Brexit’. The next step is a decision to trigger Article 50 of the Lisbon Treaty which triggers a legal process for withdrawal. This step rests with the Government. Huge discussion about how this should be done properly. A possibility of full debate and vote

Regulatory Intelligence

Author: Nimisha Kotecha | May 5, 2018

Global PV Requirements Collection – To Collect or Not to Collect?

Having worked within Pharmacovigilance (PV) for close to a couple of decades now, I have witnessed an assortment of creative methods for gathering global PV intelligence information from country specific legislation. Whilst we all understand the significance of having the most current PV legislation to hand, we know full well the intense pressure

Brexit

Author: Nimisha Kotecha | May 1, 2018

Brexit: Health and Social Care inquiry

Pharmacovigilance: (World Health Organization): the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug- related problem. (See Section 1 below). Legal basis of the EU QPPV: As defined by EU Directive 2010/84/EU and Regulation 1235/20101 and outlined within Module 1 of Good Pharmacovigilance Practices2. As a key leader in the PV system, the EU/EEA QPPV has a very important role for Market Authorisation