15 March - 12:00 -13:00 GMT / 13:00 – 14:00 CET
Integrated Pharma Regulatory Strategy as the Key to Market Advantage.
Why attend?
• 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!
Speakers
Jayne Hunt, Principal Consultant, Regulatory Affairs, Arriello
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 Coleman, VP of Quality and Compliance (Principal Consultant), Arriello
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.
Disclaimer: Whilst TOPRA is running this webinar for Arriello this is not an endorsement of Arriello, Arriello's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.
How do I register?
Simply log in or create an account and register below.
Pricing
- Members: free
- Non-members: free
Terms and Conditions
By purchasing this webinar, you are agreeing to TOPRA's training terms and conditions.