How do you move from regulatory expectation to a practical framework made for defensible execution, especially in complex clinical development programs?
Discover the science and art of operationalizing risk-based quality, aligning with both evolving regulatory expectations and trial success metrics.
Presenters
- Piran Sucindran
Head of Quality, Blue Earth Therapeutics - Fatma Guermazi
Senior Manager, Risk-Based and Centralized Monitoring, PSI
WEBINAR
Painting by Numbers: QTLs, KRIs, and Quality by Design
Piran Sucindran
Head of Quality
Blue Earth Therapeutics
Fatma Guermazi
Senior Manager, Risk-Based and Centralized Monitoring
PSI
A practical framework to operationalize risk-based quality in complex studies
As regulatory authorities sharpen expectations around inspection readiness and data integrity, sponsors face mounting pressure to deliver pivotal trial outcomes without operational blind spots. These challenges are especially pronounced in complex modalities, where multifaceted logistics, regulatory complexity, and site coordination heighten the stakes for quality oversight – a scenario well known to experts in radiopharmaceutical development.
The quality-by-design (QbD) paradigm promises a path to proactive risk management, but translating theory into practice presents persistent challenges. Join experts from Blue Earth Therapeutics, a clinical-stage company advancing targeted radiopharmaceutical therapies, and PSI, the leading pivotal-stage radiopharmaceutical CRO, for a candid discussion on structuring QbD, quality tolerance limits (QTLs), and key risk indicators (KRIs) to drive measurable quality and collaborative accountability in pivotal trials of any therapeutic area.
What You’ll Learn
- Apply a risk-based quality-by-design framework tailored for trials in any therapeutic area, aligning with current regulatory guidance and inspection trends
- Identify and operationalize critical-to-quality factors, QTLs, and KRIs through wise, data-driven risk assessment
- Leverage centralized monitoring and RBM tools to anticipate and control high-impact risks – before they escalate
- Navigate common implementation hurdles, from cross-functional buy-in to operationalizing oversight
About Blue Earth Therapeutics
Blue Earth Therapeutics is a clinical-stage radiopharmaceutical company advancing targeted radiopharmaceutical therapies with the aim of transforming the treatment of cancer.
Blue Earth Therapeutic’s mission is to develop radiopharmaceutical therapies that result in improved patient outcomes by delivering high radiation doses to tumours, without compromising on normal organ safety.
Founded in 2021 as a subsidiary of Bracco Imaging, the company was then partly spun out with Series A financing in 2024. Blue Earth Therapeutics unites a UK/US-based team with deep expertise across radiopharmaceutical development, oncology, and operations.
With a strong foundation of proven leadership, scientific innovation, and strategic partnerships, Blue Earth Therapeutics is shaping the future of precision radiopharmaceutical therapies. The initial focus is on prostate cancer, where we are advancing a pipeline of PSMA-targeted radiohybrid assets. Blue Earth Therapeutics operates through a reliable supply chain, leveraging a trusted network of external partners to ensure consistent manufacturing and global access while maintaining operational agility.
For more information, please visit: https://www.blueearththerapeutics.com.
Speakers
Piran Sucindran
Head of Quality, Blue Earth Therapeutics
Piran is the Head of Quality at Blue Earth Therapeutics. With a background in biotechs, Imaging CROs, and NHS investigator sites, Piran has a broad range of experience in GCP, as well as Radiopharmaceutical GMP, previously leading a multi-faceted global quality team. He has been a member of the RQA GCP Committee since 2018. His key interests are in data governance, oversight of computerised systems, and scalability of quality systems.
Fatma Guermazi
Senior Manager, Risk-Based and Centralized Monitoring, PSI
With more than 15 years of expertise in the clinical trials sector, Fatma Guermazi specializes in conducting clinical trials and providing strategic oversight for Risk Management and Centralized Monitoring. Her education as a pharmacist, alongside a Master’s degree in Quality Assurance of Health Products, equips her with a solid foundation for ensuring data integrity, patient safety, and study quality.
Over her career, Fatma has advanced from field monitoring positions as a Senior/Lead CRA to Senior Manager, Risk-Based and Centralized Monitoring. She is currently engaged in comprehensive risk management for clinical trials. Fatma is committed to promoting a culture of continuous improvement, regularly conducting lessons-learned sessions, and working with clinical research professionals to enhance trial quality and efficiency by focusing efforts on key areas.
