Patient safety doesn’t end with regulatory approval. In many ways, approval is just the beginning.
Pharmacovigilance activities conducted after regulatory approval are every bit as important as those conducted during clinical trials. Sponsors know this, but many are nevertheless unprepared for just how much work is involved.
A smaller emerging biopharmaceutical company faces identical post-approval safety and pharmacovigilance requirements as a top-5 pharmaceutical company. The difference is that the larger companies typically have large pharmacovigilance systems in place. However, for an emerging biopharma that may be bringing its first product to market, post-approval pharmacovigilance can be overwhelming.
If you’re an emerging biopharma company, you may have been able to manage your pharmacovigilance activities during the clinical trials, but now that the therapy is approved, there may be hundreds of thousands more people taking the drug. Moreover, now there cannot be such a tight control over prescribing, many of the populations now using the drug may not have been fully studied in the clinical trials.
Pharmacovigilance requirements may seem as if they should be simpler once your drug is approved. The data is just as important, but the scope is so much greater, as is the operational burden. Once a drug enters the market, it requires a robust safety system equipped to take a much larger scale of reports—safety reports from wherever in the world the drug is sold as well as from literature surveillance, patient programs and other sources.
This dramatically increases the workload, and smaller companies can’t afford a major infrastructure expenditure.
The post-approval pharmacovigilance process is focused on carefully collecting data. But you also need to manage what you’re seeing and analyze any safety issues that arise.
Beyond Vigilance: Action
For many sponsors, it makes sense to establish a post-approval safety committee. And again, although larger pharmaceutical companies generally handle this in house, smaller biotech companies may need outside help.
Interpreting inquiries and complaints—with an eye to identifying adverse events that may indicate a rare effect—remains vital especially after approval. Product safety, regulatory compliance and brand integrity are all at stake.
In fact, you may not find rare adverse events until you’re in a post-approval setting where many, many more people are taking the drug.
A post-approval safety committee can analyze data in certain populations. If you see something unusual, you can capture it and analyze it before it develops into a serious issue.
It’s all part of lifecycle risk management. You need to continue to build the safety profile of your product for the entire time it is on the market. It’s a heavy lift, but we can help.
Scalable, Comprehensive, Trusted
Small and emerging biopharmaceutical companies need a customized, scalable turnkey solution that allows them to manage product inquiries from patients and clinicians.
A specialized pharmacovigilance provider such as WCG can provide end-to-end services to support you along the entire lifecycle of your drug. We establish and staff the phone centers, write scripts, design webchats and create automated email responses.
We provide an array of other related services, all of which can be customized to a client’s specific situation. Among them:
- Implement and maintain a fully validated global safety database for all reports.
- Conduct literature surveillance.
- Create a full suite of medical information communications.
- Review adverse reports from all sources and make the appropriate reports.
- Set up safety committees to analyze and assess the data.
Our pharmacovigilance team brings a wealth of combined experience. This means we have the expertise to put processes in place on day 1 and the agility to adapt to a client’s changing needs.
To find out more about our pharmacovigilance services, please fill out this form
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About the Author
Ms. Pitwood is responsible for the ongoing development and management of WCG’s pharmacovigilance operations. With over 20 years of experience in the pharmaceutical industry, Ms. Pitwood is a healthcare professional who offers her clients the assurance that their safety and pharmacovigilance programs are being managed by a seasoned pharmacovigilance executive with experience in developing, implementing, and leading global safety operations.
Ms. Pitwood has both industry and CRO experience and was formerly Vice President of Drug Safety Surveillance at Pfizer Inc., where she successfully developed and led multiple therapeutic area teams and support functions for the management of adverse event reporting for human health, including all phases of a product life cycle (drugs, vaccines and devices). Ms. Pitwood developed and led these activities using a combination model of in-house staff at three global locations – U.S., Europe, and Asia and three off-shored safety operations vendor sites in the US and Asia.