Keeping up with today’s regulatory landscape requires organizations to build a pharmaceutical quality system that can withstand increasing scrutiny from authorities such as the MHRA, EMA, and FDA.
In this UK-focused session in collaboration with our partner Rephine, Christopher Homan, Pharmaceutical Quality and CMC Expert and Consultant and Angel Buendía, Scilife’s Knowledge Manage will share practical insights for growing and mid-sized pharmaceutical and biotech organizations, covering current inspection trends, compliance challenges, and realistic strategies to strengthen inspection readiness without overcomplicating quality.
We will cover:
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UK and EU regulatory landscape and its impact on your quality system
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Key PQS considerations for growing pharma and biotech companies
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Current MHRA, FDA, and EMA inspection trends, including data integrity
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Practical strategies for maintaining inspection readiness
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Best practices for managing responses and avoiding post-inspection escalation
