Navitas Principal Jeffrey Ho will present “Efficient content management for the compilation and management of the PSMF” at the DIA 10th Annual Forum , ...

October 05, 2016 Princeton, New Jersey: Navitas at DIA’s 10th Annual Forum for Qualified Persons in Pharmacovigilance conference in the United Kingdom

Navitas Principal Jeffrey Ho will present “Efficient content management for the compilation and management of the PSMF” at the DIA 10th Annual Forum for Qualified Persons in Pharmacovigilance conference in the United Kingdom October 5th. The conference will be attended by EU QPPV’s and Deputies of all company sizes, as well as Pharmacovigilance regulators and inspectors, CRO’s that provide QPPV services and National Responsible Persons for Pharmacovigilance, among others.

The poster session will be an opportunity to learn more about a case study on efficient management of PV System Master File content, compilation and management. Methods include a phased implementation of a data warehouse to consolidate data presented in the source of safety information annex of the PSMF, the adoption of this model for other parts of the PSMF, and an evaluation of the potential to expand the usage of PSMF content.

The PSMF reflects the complicated, cross-functional, multi-entity nature of a PV system and consolidating data sourced from across the MAH’s business is challenging. Establishing shared repositories has proven to be an effective approach to efficient content management for maintaining an accurate and up to date PSMF and has reduced its administrative burden. Efficient methods are available to replicate information from source systems to a data warehouse followed by use of a data analytics tool to generate PSMF-ready extracts. Structuring the input while having configurable output structure enables PSMF content to be employed for different markets and uses. Taken further, Navitas envisions a dynamic PSMF based on live data from multiple business systems that ultimately transform the PSMF to a versatile database, rather than a static document, and addresses the requirements for QPPV oversight, while also generating additional business value.

Please come by the Crowne Plaza London – Docklands between 17:30 and 19:30 on October 5th to meet Jeffrey Ho and learn more!

About Navitas:
The Navitas team has been assembled bringing together the proven expert teams of TAKE Life Sciences and WCI Consulting and, adding to this core, a range of experts from the worlds of Clinical Development, Regulatory, Technology, and Consulting. We have built the Navitas team specifically to deliver insight to our clients, to develop pragmatic solutions together, and to support their deployment and operation. We deliver advise, solutions, and services in Clinical, Regulatory, Safety, and Content Management. We are proud that our legacy businesses have served the sector for some 20 years and have allowed us to work with 100 of the top Life Science companies. Our team have now grown to over 400 staff.

We pride ourselves in our role as Expert Navigators. Interpreting market and regulatory change; driving collaboration across companies; seeking the simple solution to the complex problem; investing to enable the changes. Motivated by the success of our clients, we thrive on working together with clients, partners, and each other, across geographies, time zones, and cultures. For more information, visit www.navitas.net.

 

02
Nov2016

BioVectra chooses pharmaREADY for eCTD Solution

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

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 management of the...

12
Jul2016

Navitas Celebrates 100th pharmaREADY customer

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

16
Oct2015

Navitas Introduces Innovative Regulatory Process Outsourcing Model

The workload for regulatory functions of pharmaceutical companies has continued to increase in recent years ...