Pharmacovigilance has evolved significantly over the past ten years and is business critical. Ensuring the safest possible use of drugs is a company mission that is required by regulators and markets alike. It is no longer enough to be able to report in a timely manner. Drug safety processes must be 100% reliable, cost efficient, and release management capability. The aim? To create and implement an effective Lifecycle Benefit-Risk Strategy to ensure patient safety, as well as to keep your products on the market. Navitas is able to define the future of drug safety and how to get there; transforming performance and compliance by improving processes. The focus of the Pharmacovigilance and Safety function has evolved beyond compliance and into three core areas of adding value, achieving operational efficiencies and maintaining compliance. We have helped our clients in all core areas to improve their approach to Pharmacovigilance and achieve operational excellence.

Within the EU, much expectation and responsibility has been put on the shoulders of the Qualified Person for Pharmacovigilance (QPPV). The dedication and commitment to the role has, in many organisations, established good oversight of operational processes across pharmacovigilance, for example, the requirement for a PV System Master File (PSMF) to support the QPPV oversight, submission process, and operational metrics to ensure compliance to regulatory requirements and inspections.

We have taken a proactive approach to drug safety and, in 2001, we founded pvnet, a membership based network for Heads of Safety of Top 25 pharmaceutical companies. Similarly, our pvconnect forum is for Heads of Safety from mid-sized life science companies. Recent changes in global regulations has catapulted the scope of Pharmacovigilance and indeed the Heads of Safety role. This network offers access for open discussions of challenges, best practices and Thought Leadership. As the global regulations, transparency, and healthcare demands increase, the focus on patient safety and public health is becoming critical, as is the need for emerging safety organisation. We continue to work with the PV leaders to shape the future direction of pharmacovigilance.

For more information about our pharmacovigilance forums, please visit pvnet and pvconnect

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Latest News

20
Apr2017

ICH Reflection on “GCP Renovation”: Modernization of ICH E8 and...

Navitas welcomes the opportunity to provide comments on this Reflection Paper... Navitas welcomes the opportunity...

13
Apr2017

Navitas Life Sciences Augments Global Executive Management Team

Navitas Life Sciences announced the appointment of Dr. Krishnan Rajagopalan as Chief Growth Officer....

24
Jan2017

Navitas Networks announce Forum dates for Spring, 2017

The Navitas Networks are pleased to confirm the dates for our upcoming Spring forums... ...

17
Jan2017

Navitas Launches Labeling Assessment Express

Regulators are changing the way they look at labeling. The emphasis is on ensuring...

02
Nov2016

BioVectra chooses pharmaREADY for eCTD Solution

BioVectra has chosen pharmaREADY for its eCTD requirements. BioVectra, located in Canada, manufactures...

05
Oct2016

Navitas at DIA's 10th Annual Forum for Qualified Persons...

Navitas Principal Jeffrey Ho will present "Efficient content management for the compilation and...

04
Oct2016

News 2016

[row id="1" class="ROW_CLASS"] [col class="span12"] 02 Nov 2016 AbbVie and Navitas Present Case Study on the Evolution...

27
Sep2016

Navitas releases paper on CDISC, the standards and why the...

The FDA (and eventually, regulatory agencies from around the world) will require clinical data...

13
Sep2016

AbbVie and Navitas Present Case Study on the Evolution and...

At 10:30a.m. (East Coast Time) on September 22nd, Navitas and AbbVie will...

29
Jul2016

Navitas Networks announce Forum dates for Autumn, 2016

The Navitas Networks are pleased to confirm the dates for our upcoming Autumn forums....

12
Jul2016

Navitas Celebrates 100th pharmaREADY customer

pharmaREADY is Navitas’ intuitive and easy to use, fully integrated, regulatory compliant, web-based suite...

28
Jun2016

Navitas' PVTech Summit Defines Future Success

Navitas’ PVTech Summit was held on June 15th at the Hudson Hotel in New...

18
May2016

Navitas Welcomes Tara Baer to Navitas

Navitas is pleased to welcome Tara Baer, who joins Navitas' Regulatory Practice. With over...

18
May2016

Navitas Speaks at Sparta Connection in Orlando

David Gwyn, Navitas' Technology Practice lead, will unveil idmpREADY at the Sparta Connection conference...

14
Mar2016

Navitas Earns Speaking Sessions at DIA’s 52nd Annual Meeting

In two different sessions, Subject Matter Experts from Navitas will address new challenges facing...

09
Mar2016

Navitas is pleased to announce the introduction of our networks...

Navitas' inaugural pvindia meeting took place in Mumbai on Thursday 03 March, 2016. ...

25
Jan2016

Navitas Announces the Inaugural pvindia Forum

Navitas will soon be adding to our portfolio of industry leading networks with the...

18
Jan2016

Navitas Relaunches pharmaREADY.com

pharmaREADY.com is Navitas' next generation website for its fully integrated, regulatory compliant document management,...

14
Dec2015

Steve Arlington, Navitas Advisor, Spoke on the Challenges, Opportunities and...

Steve Arlington, Navitas Advisor, Spoke on the Challenges, Opportunities and Future of the Pharmaceutical...

03
Nov2015

The changing trends in drivers of life sciences R D...

Outsourcing is not new in the life sciences sector. Clinical research outsourcing, contract sales...