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.
Unlocking the secrets of regulatory success: Stability study design webinar
Date: Wednesday 22nd of May 2024
Time: 2 pm (GMT)
In this engaging webinar, we’ll explore the critical aspects of stability study design and execution across the entire product lifecycle. Whether you’re an analytical expert, a quality specialist, or a regulatory professional, this session is tailored for you.
Here’s what we’ll cover:
- Regulatory requirements:
- Understand the specific stability requirements for clinical trial applications and marketing authorisation applications.
- Navigating manufacturing changes:
- Explore the challenges posed by manufacturing changes during clinical development.
- Discover strategies to maintain stability study integrity amidst these changes.
- Aligning commercial strategy with stability:
- Why is stability strategy alignment crucial for future commercial success?
- Practical insights on ensuring harmony between stability and commercial goals.
At the end of the webinar, you will have the opportunity to ask Kate Coleman your specific questions during a live Q&A session.
Meet our guest speaker: Kate Coleman
Kate Coleman 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.
Kate’s wealth of knowledge will illuminate the intricacies of stability study design and its impact on regulatory success.
Why join this webinar?
- Insights: Gain practical insights from an industry expert.
- Q&A Session: Have burning questions? Ask Kate Coleman during the live Q&A segment.
- Networking: Connect with fellow professionals managing stability studies.
How can Q1 Scientific support stability study design?
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.
You focus on breakthroughs, we handle the logistics. Your breakthroughs deserve the right conditions.
Talk to Q1 Scientific about stability storage
Register for the stability study design webinar
Don’t miss this opportunity to enhance your stability study expertise! Register now and be part of the regulatory journey toward excellence.