Articles

Latest blogs and articles

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E2B (R2) to E2B (R3) backwards and forwards compatibility (BFC)

ICSRs of adverse drug reactions (ADR) have to be transmitted from identified reporting sources to pharmaceutical companies, between regulatory agencies, between pharmaceutical companies, between pharmaceutical companies to regulatory agencies, within pharmaceutical companies or regulatory agencies, from clinical investigators via the sponsor to ethic committees, from regulatory agencies to WHO.

02

Evolving patient safety with standards such as E2B R3, IDMP

Safety information is exchanged using mostly electronic and some paper formats. As the product and safety information is exchanged globally there has to be a common vocabulary so as to have consistent data which is interpreted and exchanged the same way across the globe. These requirement leads regulators to develop data, data dictionary and data exchange standards.

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Managing challenging projects

Survey feedback related to challenge projects puts the statistics at an alarmingly high percentage i.e. 50%. Challenged projects are over-budget, late, or partially delivers against the expectations.

What a waste!!!

To get around this one of the critical success factors is how we manage project risks, which can then lay the right foundation.

Keep tabs on your project

With internet of things it would seem that everything and everyone is connected yet some projects, especially the large engagements, do not meet their desired fate.

Projects are initiated with the intended business benefits, requirements are drawn, solution design is meticulously drafted, configurations and customizations are carried out, testing is done etc. yet the project is nowhere near the finish line and business benefits seem like a distant dream.

Drug safety system landscape

A drug safety department performs many functions within a pharmaceutical company. Primary purpose of a safety department is to reports adverse events to authorities (FDA, EMA, PMDA etc.) in accordance with published regulations.