In collaboration with TOPRA – The Organization for Professionals in Regulatory Affairs
Jayne Hunt and Kate Coleman from Arriello
Date of webinar:
Friday, March 15th, 2024, 13.00–14.00 CET / 12.00–13.00 GMT
During this webinar, our experts will describe how integrating all functions into a comprehensive and holistic regulatory strategy is the key for optimizing regulatory frameworks, removing risk along the strategic regulatory pathway and ultimately reducing time to market for key innovative therapies.
- Gain strategic insights for navigating regulatory and commercialization challenges for both innovative and traditional therapies.
- Maximize the potential for regulatory success through holistic stakeholder engagement – reduce the siloed and atomistic nature of submission collation for submission success!
- Discover proven risk mitigation strategies and solutions to minimize delays and achieve a faster path to market, ultimately ensuring patient access to vital therapies.
This webinar is ideal for:
- Regulatory professionals: From early development to marketing authorization and launch support.
- Product development team members: Gain insights into the regulatory landscape and its impact on patient access.
- Regulatory professionals or colleagues who support product import and distribution from the maintenance of manufacturing and wholesale distribution licenses through to supply chain considerations.
- Don’t miss this opportunity to gain the knowledge and strategies you need to navigate the regulatory and commercialization landscape with confidence. Register today!
Jayne has over 30 years strategic & operational Regulatory Affairs expertise in pre & post marketing across the EU, UK, US, and other territories.
She has experience in multiple areas including ATMPs, biologics, small molecules, marketing authorizations and pre-marketing development activities.
This includes supporting interactions and meetings with regulatory agencies in Europe (National and EMA) as well as with the FDA & Health Canada.
Jayne holds a PhD in Biochemistry from the University of London.
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.