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 site is crisp, colourful, focussed on our service offering and most importantly of all, showcases our client testimonials. Following on from our recent IAE Award in Compliance and Quality Assurance, we are certain that you will find everything you need on our site. We look forward to being of continued service to the drug safety and Pharmacovigilance community.

Why not drop us an email or give us a call to find out how we can provide you with our Award Winning pharmacovigilance services.

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, refer to a need for a named safety contact (NSC) i.e. a safety contact who doesn’t carry legal liability for the product however must be the main safety contact in the country for the regulatory authority. In some countries, a NSC performs most of the safety tasks designated to the LQPPV, however is not legally liable for the safety of a given product in a given country.

At first glance, 53 global countries (and counting) stipulate either a NSC or a LQPPV requirement. Interestingly, legislated
requirements for a LQPPV also exist in countries outside of the EU member states. However their responsibilities and qualifications seem to vary enormously. Whilst some countries stipulate a physician, others want a pharmacist. Whilst some have a list of responsibilities for their LQPPV or NSC, others tend to dilute their requirements to ‘supporting the EU QPPV’.

Regardless of how the roles are described within specific legislation, notwithstanding the fact that NSCs appear to carry far less legal responsibility than LQPPVs, and aside from the fact that these days ROW countries are also stipulating the need for these persons to be resident in the country, it does appear prudent to appoint a NSC in any country that doesn’t stipulate a LQPPV regardless of country legislation. But is it really?

It goes without saying (so I will say it) that it is challenging for the EU QPPV to maintain oversight of their local QPPVs across all territories EU and/or otherwise. Should we now extend that oversight to include NSCs? After all, a NSC within a given country is the point person for the authority regarding a given product in that territory. Should NSCs have a more defined role such as that of the LQPPV? Is there a need to align global PV requirements around NSCs? If a country doesn’t stipulate a LQPPV or NSC does it mean that there is no need for oversight in that country? Should companies appoint an NSC in affiliate territories regardless of a requirement in the country? Does it matter if a NSC within one of our affiliates is a Sales or Logistics person? Where does the EU QPPVs oversight stop regarding local responsibilities of an NSC?

Some food for thought.

The ‘Oscars’ of the pharma industry were held on the 22nd of May in Kensington, London and Intuvigilance picked up the coveted award for the Best Compliance and Quality Assurance company 2018.

The International Award of Excellence Pharma Awards are awarded to International Pharmaceutical and Biotechnology Companies, Scientists, Auditors, C-Level Executives, Pharma Leaders and Solution Providers with proven State of Excellence and Recognising Individuals / Organisations for their Outstanding Achievements & Dedication towards Pharmaceutical Research, Development, Safety and Monitoring.

The IAE is the only Award which brings together Top International Professionals and Pharma Leaders under one roof from around the globe to recognise excellence and the IntuVigilance team were on hand to collect the prestigious award on the night.

The votes and generous support of our esteemed colleagues and amazing clients helped to catapult us into first place. To be nominated for an award in the Pharmacovigilance Industry is precious enough for a humble group like IntuVigilance, but to be selected as winners within a category that forms the pillars on which Pharmacovigilance resides, is high praise indeed. The Team are humbled to receive this award, and we wish to thank all our clients, friends and colleagues for your kind words and support.

IntuVigilance boasts a plethora of subject matter experts to suit your Drug Safety and PV needs. Our team is dedicated to providing innovative and diligent solutions that are synonymous with the ethos and values of IntuVigilance.

During this time we also upgraded to RapidLive Argus SaaS and its E2B R3 capabilities. This has ensured that IntuVigilance was ahead of the curve way before any of our competitors. We have been producing R3 ready reports for the last 1.5 years and are in a very good place to support customer needs in line with the mandatory change to E2B R3 in June 2022, as announced by the EMA.

ikyzen is IntuVigilance’s Regulatory Intellgence Collection System which provides the Industry with PV regulatory updates across ISO countries.

ikyzen has been developed to allow vigilance departments access to regulatory requirements at their fingertips.

Gone are the days of trawling through websites for information. ikyzen does the hard work for you.

For more on ikyzen please visit or email us at [email protected] for a quote