Cambrex provides end-to-end services from preclinical to commercial supply for drug substance and drug product, supported by our analytical and testing services.
presents
Stability study design for optimised regulatory approvalWebinar Date & Time
Wednesday, 22nd of May, 2024
2:00 pm GMT
How do you optimise stability study design for regulatory approval? Join us for a webinar featuring guest speaker Kate Coleman, VP Regulatory Affairs, Quality and Compliance (Principal Consultant) at Arriello to unlock 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.
Followed by a Q&A session with Kate Coleman.
About Q1 Scientific
This webinar is hosted by Q1 Scientific. If you are looking for a secure, reliable and cost-effective way to store your pharmaceutical and medical device products under various environmental conditions, you need Q1 Scientific, the leader in outsourced stability storage. Operating from state-of-the-art facilities in Ireland and Belgium, Q1 Scientific helps improve the speed of new drugs and medical devices reaching the marketplace along with saving companies the expense of building and monitoring their own storage chambers. With full equipment validation, tightly controlled conditions and continuous sample monitoring Q1 Scientific is not just a storage provider, it is your trusted partner for stability storage excellence.
Speaker
Kate Coleman
VP Regulatory Affairs, Quality and Compliance (Principal Consultant)
Kate is the VP of Regulatory Affairs, Quality and Compliance at Arriello and has over 20 years of experience in the Pharmaceutical Industry across several platforms including Biologics, Sterile Fill Finish, Vaccines, and Oral Dose. Kate is a Qualified Person, Principal Consultant, Lead Auditor and an SME in several areas including Quality Control and Stability.
