Webinars

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A Pragmatic Way to Navigate the Safety-Regulatory Continuum for Mature Products


David Balderson

In the face of dwindling drug pipelines, stringent drug regulations, and block-busters crossing their patent exclusivity, mature and established products offer an opportunity for companies to sustain their revenues and bottom lines in the increasingly challenging pharmaceutical market. Compared to new products,...

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Safety Operations Expert Panel Discussion: A New Approach to Ensuring Quality Safety Submissions the First Time


David Balderson

Poor quality ICSR data impacts the ability to conduct safety surveillance activities and forces regulators and independent groups to question the overall quality of the pharmacovigilance system. Learn best practices and recommendations that can be employed to improve case quality, avoid feedback...

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Optimizing Global Labeling Operations: A Best Practice Panel Discussion


Beth A, Lage (Baxter), Griha Mangru (Pfizer), Boris Jankowski (Sciformix), and Craig Trautman (Intagras)

Product labeling teams are accountable for driving both timely and accurate benefit: risk communications and ensuring demonstrable process performance. To do this, they must be adept at providing a critical link between upstream information providers (e.g. clinical development, pharmacovigilance) and downstream implementers...

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Trends & Best Practices in Global Drug Product Labeling Management: Taking Control of the End-to-End Labeling Process


Bindu Narang (Sciformix), Boris Jankowski (Sciformix), and Craig Trautman (Intagras)

Drug product labeling is continuing to grow both in complexity and strategic importance as the key document for communication of benefit: risk to health care professionals and patients. Life science companies not only have to ensure harmony of messaging from Core Data...

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