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Track 11: Quality
With 10 sessions specific to Quality, this track provides a comprehensive view of quality across the product life cycle, including quality system approaches to address current issues resulting from accelerated development and review processes, increasing complexity of products, and globalization challenges. Exchange knowledge with top experts in clinical and CMC quality, including FDA staff from the Office of Pharmaceutical Quality, and participation in related “Engage and Exchange” peer-to-peer sessions will provide attendees with the resources they need to enhance their quality processes and improve product quality.
Highlights in Quality
- Managing acceleration and quality in product development
- Measuring and advancing the clinical quality management system (QMS)
- TPPs to support patient-centric development and assessment
- Developing clinically relevant quality specifications
- Pharmacovigilance inspections: hot topics and proactive approaches
- Quality standards in effective life cycle management approaches
- Impact of global harmonization on continuous improvement and optimization of manufacturing
- Featured Topics in Patient Centricity and Career Development
DIA recommends this track and associated sessions to professionals within sponsor, CRO, and regulatory agency organizations interested or working in clinical research, clinical quality, clinical monitoring, GCP, regulatory affairs, regulatory operations, compliance, pharmacovigilance, quality control/quality assurance, quality management systems, CMC, GMP, strategic planning, and legal affairs.
Sessions in Quality
Monday, June 19
The Evolution of Evidence Generation: Real-World Evidence and the Next Generation of Decision-Making
- Office of Pharmaceutical Quality Update
- Patient-Centric Development Assessment
- The Evolving International Landscape of FDA Inspections: Data Integrity Violations in Bioequivalence Studies in India
Tuesday, June 20
- Global Harmonization: Mutual Recognition
- Clinical Relevant Specifications: Leveraging Principles of QbD
- Comparison of Inspection Findings and Recommendations of Registration Trials Submitted in Support of Marketing Applications of New Drug Products to EMA and FDA
Wednesday, June 21
- Managing Acceleration and Quality in Product Development
- Measuring and Advancing the Clinical Quality Management System
- Life Cycle Management
- Quality Metrics: The Carrot or the Stick?
Need More on Quality?
DIA’s Learning portfolio offers multiple face-to-face and online opportunities. Our courses provide comprehensive coverage of the full discovery, development, and life cycle management of health care products. DIA’s unique multidisciplinary environment provides learning opportunities not only in participants’ respective fields, but also in related fields—lending new perspectives that help teams collaborate more efficiently and effectively. DIA wants to ensure you’re prepared with the knowledge, solutions, and strategies you need to be successful in today's complex global regulatory environment.
Upcoming Face-to-Face and Online Learning
- Interactions with the FDA During IND/NDA Phases
- How to Prepare for a Safety Inspection
- New Drug Product Development and Life Cycle Management
- Navigating Chemistry, Manufacturing, and Controls Through the Drug Development Process
Additionally, DIA’s CMC Workshop is offered April 24-26, in Rockville, MD. This workshop has a laser focus on regulatory applications and translations to technical and quality processes – the strategy behind the science.