If you are attending and encounter any issues or have any questions, please contact Erika Banchs at erika@momentumevents.com
In accordance with ICH E6 (R2), the expectations for Quality Tolerance Limits (QTLs) when conducting clinical trials have generated a buzz in the industry. QTL parameters are absolutely critical to basic trial integrity, patient safety, and the study endpoints. As stated above, ICH E6 (R2) requires that Quality Tolerance Limits be set for each study. Additionally, organizations, their clinical teams, and relevant service providers (e.g CROs, high-risk technical providers) require alignment on the definitions, requirements, and utilization of QTLs to help establish the key parameters, associated Quality Tolerance Limits, tracking mechanisms/reports, and mitigation strategies for the conduct of clinical trials.
This one-day event will provide attendees the overall insight starting with basic-training knowledge behind QTLs to learning more about the implementation journey.
SPEAKER HIGHLIGHTS
Jacqueline Agostinelli, BSN
Principal Consultant
HALLORAN CONSULTING GROUP
Dawn Niccum
Executive Director, Quality Assurance & Compliance
INSEPTION GROUP
Kristin Stallcup
Director, Risk Based Quality Management Operations
TAKEDA
Melissa Suprin
Head of Quality Risk Management
PFIZER
Michele Weitz
Clinical Operational Excellence Quality Consultant
GCP VISION CONSULTING
Hannah Yee, MPH
Consultant, Organizational & Quality Solutions
HALLORAN CONSULTING GROUP
TOP REASONS TO ATTEND
Recognize the importance and value of QTLs
Establish a better understanding of ICH E6 R2 requirements for Quality Tolerance Limits (QTLs) as part of Clinical Quality Management
To learn guidance and considerations for QTL implementation in Clinical Development
Identify the biggest challenges when it comes to adopting QTLs
Discover practical solutions and tools to overcome inefficiencies in research and development
SILVER SPONSOR
SPONSOR
SPONSORSHIP OPPORTUNITIES
Momentum Events is building a community in the clinical quality space, offering educational and networking opportunities through in-person, hybrid and virtual offerings. To get involved and position your company as a thought leader in this space, contact Michael Williams at Michael@momentumevents.com.
WHO SHOULD ATTEND
Pharmaceutical, Biotech, and Medical Device Professionals with responsibilities in the Following Areas:
- Clinical Operations
- Clinical Compliance
- Clinical Quality Assurance
- Clinical Quality Control
- Data Management Medical Affairs
- Quality Risk Management
- Compliance and Operations
- Inspection/ Inspection Readiness
- Regulatory Affairs
- Safety and Risk Management
- Good Clinical Practice/GCP
- Clinical Data