Webinar Q1 scientific BALANCE

Upcoming webinar:
Stability study design for optimized regulatory approval

In collaboration with:

Q1 Scientific

 

Speakers:
Kate Coleman from Arriello

Date of webinar:
Wednesday, 22nd of May, 2024
14:00 GMT

How do you optimize stability study design for regulatory approval? This webinar will feature Kate Coleman, VP Regulatory Affairs, Quality and Compliance (Principal Consultant) who will discuss methods to unlocking the secrets of regulatory success.

This webinar will consider the elements to consider in stability study design and execution throughout the product lifecycle including the regulatory requirements for stability for clinical trial applications and marketing authorisation applications. Kate will also discuss challenges related to manufacturing changes during clinical development and their impact on stability studies and how to ensure that the future commercial strategy is aligned with the stability strategy.

Register here

 

Connect with Arriello:

To understand more about how we might help or have a meeting with the team, contact the team directly:

via LinkedIn,

e-mail: solutions@arriello.com

Our Speaker.

Kate Coleman Official
Kate Coleman
VP Regulatory Affairs, Quality and Compliance (Principal Consultant)

Kate has over 20 years’ experience in Quality Assurance, Sterility Assurance, Microbiology and Quality Control, and has worked across ATMPs, Biologics, Sterile Fill Finish, Vaccines, APIs and Oral Dose platforms.

Over her career to date, Kate has served as a practicing QP, Principal Consultant, and qualified Lead Auditor.

She is also a subject matter expert in Commercialization readiness, Supply Chain GDP, MAH Compliance, Quality Risk Management, New Facility Design/Start Up, Quality Control and Sterility Assurance. In her previous role before joining Arriello, she was Senior Director for Quality Management and Compliance, and Head of QMC for Ireland and UK.

Kate is particularly passionate about the management of risk and the interdependence of Regulatory and Quality, as companies develop their strategies and processes and look more holistically at what they need, rather than operating in silos.

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Arriello at Regulatory Affairs event TOPRA in Lisbon.
Arriello at Regulatory Affairs event TOPRA in Lisbon.
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