Risk to Reward: The Late-Phase Challenges Webinar Series
Tuesday, October 10th
10am ET | 3pm GMT | 7am PT
Register now →Embracing Risk to Succeed in Biologics Development
Gain a holistic understanding of the role of risk in late-phase biologics development in this comprehensive, three-part webinar series from Citeline, presented in partnership with Thermo Fisher Scientific. Tap into expert perspectives on managing late-phase risk, overcoming the specific challenges of PPQ prep, and optimizing analytical methodologies to ensure a successful PPQ.
OnDemand: Late-Phase Biologics Development: Embracing risk for competitive advantage
OnDemand: Pitfalls of PPQ: Top Risks and How to Mitigate Them To Ensure Successful Commercialization
Webinar 3: Mastering Analytical Methods For Fail-Safe PPQ
Webinar 3: Mastering Analytical Methods For Fail-Safe PPQ
Register now to secure your spot!
Webinar 1: “Late-Phase Biologics Development: Embracing risk for competitive advantage”
Watch now on Demand
- Delve into common technical, program, and business risks in scale-up and production.
- Explore solutions for integrating the risk management into strategy development.
- Understand how embracing risk can result in major competitive advantage.
Meet the Speakers
Dan Baskind
Global CMC lead, Biologics Thermo Fisher Scientific, Pharma Services
Christy Eatmon
DP + Integrated Offering at Thermo Fisher Scientific
Webinar 2: “Pitfalls of PPQ: Top Risks and How to Mitigate Them To Ensure Successful Commercialization”
Watch now on Demand
10am ET | 3pm GMT | 7am PT
- Identify PPQ complications and learn strategies for identifying and addressing risks and allocating resources.
- Understand documentation and data integrity requirements.
- ID partnership traits to optimize CDMO/sponsor collaboration and streamline PPQ.
Meet the Speakers
Daniela Decina
Senior Director, Regulatory Affairs and Head of the North America Regulatory Affairs function at Thermo Fisher Scientific
Christy Eatmon
DP + Integrated Offering at Thermo Fisher Scientific
Sabine Zollner
Global CMC and Process Validation Lead in the Pharma Services Group at Thermo Fisher Scientific
Webinar 3: “Mastering Analytical Methods For Fail-Safe PPQ”
October 10
Watch now on Demand
- Gain a comprehensive understanding of laboratory methods in PPQ.
- Develop and validate robust analytical methodologies for reliable results.
- Explore the significance of container closure integrity.
- Optimize resources with phase-appropriate methods for analytics.
Meet the Speakers
Nolan Dean
R&D and Manufacturing Scientist at Thermo Fisher Scientific
Ryan Uding
Manager, Analytical and Formulation Sciences at Thermo Fisher Scientific
Christy Eatmon
DP + Integrated Offering at Thermo Fisher Scientific
Katherine Hanson, Ph.D.
Associate Director, GMP Laboratory Services Clinical Research Group PPD, part of Thermo Fisher
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