Mihaela Nosca

Mihaela Nosca

Director Clinical Compliance and Inspection Readiness Seqirus - A CSL Company
Mihaela Nosca

Conference 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

Conference Day Two

9:30 AM PANEL DISCUSSION: FORWARD THINKING SOLUTIONS TO BE DEFENSIBLE

PANEL DISCUSSION: FORWARD THINKING SOLUTIONS TO BE DEFENSIBLE

Adopting a risk-based approach to TMF by inculcating forward thinking solutions that encourage reasonable rationale for operations, actions and approaches

-        How risk-based approaches to TMF management can simplify and modernise operations without compromising inspection readiness

-        Highlight what a risk-based approach actually entails, the benefits that can be gained and how it impacts, time, cost and process

-        Enable better delegation of responsibility by effectively prioritising to truly understand risks involved in operations

-        Is it always possible to set framework ahead of time?

Check out the incredible speaker line-up to see who will be joining Mihaela.

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