The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK plays a critical role in ensuring the safety, quality, and efficacy of medicines and medical devices. MHRA inspections are often a key step in bringing new therapies to market — but poor preparation can result in delays or regulatory setbacks. 

A well-run inspection demonstrates operational excellence, while disorganization can damage your credibility with regulators, investors, and partners. 

Join this webinar to gain practical insights from Cytel’s MHRA inspection experience. Learn how to prepare thoroughly, execute precisely, and turn post-inspection feedback into innovation.

Key Topics 

• Real-world strategies from Cytel’s MHRA inspection journey, covering logistics, personnel management, communication, and documentation. 

• Best practices for dossier preparation, handling pre-inspection requests, training staff (including interviewees), managing concurrent sessions, and more. 

• A robust framework with defined roles and live demonstrations to foster productive dialogue and collaborative engagement with MHRA inspectors. 

• How post-inspection discussions led to innovative solutions for continuous improvement.
   

Speakers 

• Nicolas Rouillé, Senior Director, Statistical Programming 

• Stephanie Dontenville, Director, Quality Assurance