Well-defined pharmacovigilance systems and transparent data analysis need no deeper diggings and is self-explanatory!
There are always two ways of looking into a situation. pessimistic and optimistic, the pros and cons or in terms of revenue generation, the profitable and non-profitable.
Likewise, pharmacovigilance can be looked upon as a fulfillment of an imposed obligation or an opportunity to drive pharmacovigilance with an attempt to adhere to authorization country guidelines.
Other related stakeholders may see it as a futile activity of unending continuous reporting or a methodology to Safer existence of a molecule after investing largely in the pre-clinical and clinical phases!
The Marketing Authorization Holder (MAH) shall make all possible efforts to monitor the risk-benefit assessment and document pharmacovigilance system to ensure strategies for risk management, as and when safety issues arise.
Considering the need to expedited reporting in stipulated time, are we still struggling to decide about Manual versus Electronic system of safety submissions!
The following five valid points highlight why electronic-safety reporting is inevitable; it comprises many unique advantages once in the run!
- Going global-Sky is the limit: To widen horizons internationally, pharmacovigilance reporting electronically is but an urgent prerequisite. Most of the Regulatory authorities outside India have already tuned into digital mode.
- Workload: Why not to have a friendly solution that shares your burden and does it for you, as per your command!
- Unbeatable Memory: What if there is a system to remember all the set of guidelines and even the newer, revised ones that you can integrate and apply to capture current data or modify your database?
It is cent percent more convincing than relying on human memory to accomplish deadlines and have a ‘no non-compliance’ brand image in the Industry
- Requirements beyond human scope of fulfillment: It is unattainable task to think of a signal detection model by MAH successfully warning us of a Safety signal, without a technology solution clubbed with statistical intervention.
- Regulatory driven-industry: Pharma industry is more than dependent on the regulatory norms to maintain its remarkable presence in market. This is because drug (both human and veterinary) and medical devices necessitate continued monitoring to confirm its evolving safety profile when administered for long term.
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