ONLINE WEBINAR · March 30, 2023, 08:00 AM PDT | 11:00 AM EST | 17:00 CET | 21:30 IST
Quality by Design - Integrating this into your technology platforms
Session Overview: An often-discussed topic Quality by
Design (QbD), can be understood and yet partially implemented. Data leaks and loss, quality and compliance challenges, and
managing data collection, cleaning, and analysis when the quantum is very large are yet unsolved issues. When QbD is integrated into the intelligence of your technology, the quality journey can be simpler and stress-free.
OverviewAn often-discussed topic Quality by Design (QbD), can be understood and yet partially implemented. Data leaks and loss, quality and compliance challenges, and managing data collection, cleaning, and analysis when the quantum is very large are yet unsolved issues. When QbD is integrated into the intelligence of your technology, the quality journey can be simpler and stress-free.
Most biopharma companies are focused on their clinical strategy but often think of their data right at the end of the road-right before the submission. The scramble for data at the end is in famous and very avoidable. But how?
Centralizing your data holds the key to a strong data strategy and execution. No matter how many CRO partners are involved, and how many systems are used, the heart of your clinical trial which is the data should be completely visible and in your control. The conversation today is centered around increasing automation and leveraging AI/ML, but the role of “human intelligence” in “expertise-driven” areas must be clearly understood. While we try to reduce human intervention to the extent possible, there are areas where technology and data needs have to keep the “human” aspect in mind and this makes all the difference to how technology is consumed.
What You'll Learn
- Understand the role of expertise-driven roles in a technology-driven industry
- Understand the benefits of centralizing clinical data and how one can go about this
- Identify challenges and opportunities in the current QbD ecosystem and foresee improvements
- Observe and understand the technology needs of the future and prepare for it
Who Should AttendThis course is appropriate to:
1.Data Sciences Professionals
2.Senior Technology Experts
3.Clinical Development Leaders
4.Clinical Data Managers
6.Data Monitoring and Management Professionals
Meet the Speaker
CEO, Algorics IncNithiya is a passionate life science professional with 20 years of experience in the areas of clinical technologies & data science.
He is currently CEO of Algorics, a fast-growing, clinical data science company focused on data management, biostatistics, data standardization, and advanced data analytics.
Prior to Algorics, Nithiya was associated with ICON clinical research and Cognizant technology solutions in various management roles including leading large, diverse cross-functional groups in clinical technologies and statistical programming.
He is a proud recipient of the PharmaVOICE 100 award in 2017 and a recognized industry thought leader associated with and presenting in various industry associations and life science forums.
Principal Consultant, Biotex ConsultingNicole has 30 years of experience in the industry beginning as a study coordinator in a multi-therapeutic site followed by 25 years at large, global CROs where she spent several years as a Clinical Research Associate (CRA) and Project Manager (PM) before moving into leadership roles. Nicole’s leadership roles included Head of Clinical Trial Management, Head of Central Monitoring and Head of Global Clinical Performance, a group responsible for clinical metrics, systems, process and quality. Nicole has led the development of the risk-based monitoring (RBM) strategy, process and tools at 2 large CROs and has experience managing CTMs, CRAs and administrative staff. Nicole has supported training development and delivery ranging from CRA training, project management training on metrics and reporting, project management financial training and risk management training. Nicole has consulted with biotech companies on organizational structure, resourcing optimization, budget management, ICH E6 R2 compliance, risk management and technology selection and optimization.
Earn CEUsSCDM is authorized by IACET to offer 0.2 CEUs for this program. Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assessment deadline.
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