Trial Master File and Inspection Readiness Conference
Malgorzata Okrasa
Associate Director, Operational Excellence MSDConference Day One
10:10 AM PANEL DISCUSSION: THE SHIFT FROM REACTIONARY TO PREPARATORY TO MINIMISE INSPECTION FAILURE
Preparation is the key to allow successful operations that minimise stress and risk, and ensure all bases are covered, regardless of whether submissions are incorporated into final studies.
- Encouraging change within the industry to instil a preparatory approach throughout operations and processes to enable a work environment geared towards readiness
- Enable a culture of readiness that can effectively react to industry or regulatory changes
- Understand how to mitigate resistance to change by understanding key obstacles and effective solutions to overcome them
- Hear from speakers as they share experiences and tools used when regulations appear to be vague, as this presents a key issue holding the industry back from developing
- Take advantage of having a proactive approach which recognises and instils change before regulators enforce them to stay one step ahead of the game
Check out the incredible speaker line-up to see who will be joining Malgorzata.
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