April Edition - Warning Letter Wednesday

​Tracking guidance updates and enforcement actions is table stakes. The harder problem is knowing what to do with them.

​In this session, GKS and A-Reg Solutions work through both sides of regulatory intelligence (pre-market and post-market) and focus on the step most teams underinvest in: turning a signal into a decision.

​What we'll cover:

• ​Why surveillance is only half the job, and what the second half actually looks like

• ​Monitoring competitor activity, EPARs, and public assessment reports

• ​The specific challenge of interpreting blinded regulatory data before a product reaches market

• ​FDA enforcement trends, warning letters, and inspection patterns post-market

• ​How KeyPedia™ automates regulatory monitoring at scale

• ​Moving from "something changed" to "here's what we do about it"

​Speakers:

• ​Anna Hanzlíková - Founder & CEO, A-Reg Solutions

• ​Lucie Svobodova - Founder & COO, A-Reg Solutions

• ​George Kwiecinski - Founder & CEO, Global Key Solutions

​45-minute presentation, followed by 15 minutes of Q&A.

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​Join Global Key Solutions Corp. for an engaging Warning letter on Wednesday.