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

Headshot of Lina Kim

Lina Kim

Position: Director, Clinical Quality Assurance
PURETECH HEALTH
Categories: Speakers
Location: Speakers

Lina Kim

Director, Clinical Quality Assurance
PURETECH HEALTH

John Sikora

Position: Associate Principal Consultant, Organizational & Quality Solutions
HALLORAN
Categories: Speakers
Location: Speakers

John Sikora

Associate Principal Consultant, Organizational & Quality Solutions
HALLORAN

Headshot of Hannah Yee

Hannah Yee

Position: Consultant
HALLORAN
Categories: Speakers
Location: Speakers

Hannah Yee

Consultant
HALLORAN

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

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

PRICING

PHARMACEUTICAL / MEDICAL DEVICE / BIOTECH COMPANIES

SOLUTION PROVIDERS / VENDORS

GROUP RATES 
Training is best done across departments, so bring your clinical, quality, and biometrics teams and take advantage of our discounted group rate. For more information contact Frank Fernandez at frank@momentumevents.com

SPONSOR

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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.

NETWORKING CAPABILITIES

✔ Virtual Matchmaking: Visit our virtual lobby and connect with fellow attendees using our platform’s matchmaking technology. You can chat, video, and even make a list of the people you want to meet and the knowledge you’re looking to gain through our bespoke 1:1 match-making services

✔ Roundtable Networking throughout the Summit will give you the chance to connect and meet in-depth your fellow attendees as well as our Sponsors and Speakers

✔ The platform we use allows us to make polls, QA, and chat during the sessions.

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How Will The Virtual Event Work

Designed to provide a fully immersive experience that expands beyond the traditional video conferencing platform, Momemtum Virtual Events take place on a platform that includes the latest advancements to deliver a seamless and simple user interface to increase engagement across all participants.

Virtual Meeting Feature of Momentum
  • Exclusive event hub page accessible via desktop, tablet or mobile device
  • Virtual lobby with topic streams that creates a “community” atmosphere
  • Dedicated live stream session content
  • Live Q&A & Interactive Polling
  • Embedded AI powered match-making 1:1 meeting facilitation
  • Embedded video and/ or audio chat
  • Direct messaging
  • And much more…