Pharmacovigilance discipline merger with IT would witness major electronic transformation

June 16, 2015

Pharmacovigilance discipline merger with IT would witness major electronic transformationE2B XML was a remarkable turning point in pharmacovigilance for electronic reporting of expedited adverse reactions. A standard language format was used to configure the functional case processing (Individual case safety report) aspects of product safety.

Regulatory provided us with a unified platform to transmit messages using globally acceptable electronic format ‘Extensible Markup Language’!

The journey has just begun and we are moving on to cover major milestones that would ensure technical compatibility for global conformance to expedited adverse reaction reporting, electronic submission of medicinal product information, aggregate reporting, different report formats etc.
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Branded softwares in Pharmacovigilance: Are we being unduly ‘overgenerous’ in name of Regulatory compliance!

June 2, 2015

Branded softwares in Pharmacovigilance: Are we being unduly ‘overgenerous’ in name of Regulatory compliance!This blog presents Industry expert’s views and expresses their opinions on the utility of ‘Branded software’ as a preferred solution under the misconception that only those softwares can ensure regulatory compliance.

Views of Quality assurance officer

QA Officer of a reputed CRO who faces various audits frequently said “as far as audit approach is concerned, there is huge difference when one is facing audit of Regulatory bodies like FDA, MHRA against that of Sponsors audits. Generally regulatory audits are conceptual and broad based on actual validation documentation, SOP and processes followed within the PvNET.

We ought to believe what we see or are made to see. Influence is a double-edged sword if lacks introspection!
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Gearing up for a smooth transition to ISO-IDMP standards: Planning step-wise

May 26, 2015

Gearing up for a smooth transition to ISO-IDMP standards: Planning step-wiseIn pharmacovigilance and in this industry largely, striking a regulatory balance undeniably precedes over anything else. If you are not regulatory compliant, you might be outmoded.

Industry’s competence parameter is not only the quality of the products they are marketing but also how well and how quick they are taking a call for regulatory compliance!

Transition that needs to be addressed…

Industry was just trying to overcome and streamline the gigantic revolution of xEVMPD. As if it was just the beginning of yet another principal leap, Regulator’s announcement of transition to ISO standards became the next breaking news for Industry.

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PvNET breaks the monopoly- A reputed Indian CRO opted PvNET over Oracle based safety database

May 13, 2015

We live in a competitive era where only change is constant. Sarjen is proud to announce that PvNET was picked as a regulatory compliant safety database over one of the market competitors. We consider it to our credit and put across the points that stood strong in our favor.

PvNET breaks the monopoly- A reputed Indian CRO opted PvNET over Oracle based safety database

Few points that have indeed worked as table turners are discussed here:
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Pharma/Biotech Industries to modulate their operations to suit the massive pharmacovigilance headway

April 23, 2015

Pharma/Biotech Industries to modulate their operations to suit the massive pharmacovigilance headwayProduct safety has geared up to what we call ‘optimal’ compliance.
Thanks to all the regulations that define the futuristic vision of safe and complete reporting as well as the rat race wherein the industry wants to sustain their presence amidst growing pharmacovigilance services competition.

However, certain issues are still buried and need to dig up. These mainly are the areas that are either sub-sections of pharmacovigilance or are in its vicinity.

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