
2022 Featured Presentations
FDA KEYNOTE: GCP INSPECTION UPDATE
Examine Recent BIMO Updates as well as GCP Inspection Trends, Metrics and Regulatory Actions

Chrissy J. Cochran, Ph.D.
Director, Office of Bioresearch Monitoring Operations, ORA
FDA
PROACTIVE QUALITY BRIEF
Maximize Transparency with Health Authorities through Submission of Proactive Quality Briefs to Streamline Approvals and Facilitate Inspections

Paula Walker
Quality Policy Chapter Lead, PDQ
ROCHE
Former Head of Compliance
MHRA

Achieve confidence that your company is GCP inspection ready by walking through every step of the inspection preparation and execution process. Leave having heard directly rom the regulators themselves about inspection trends, what you need to implement to ensure you are prepared, and understand how technology and effective training can be utilized to drive a culture of quality, and a continued state of GCP inspection readiness.

2022 SPEAKER HIGHLIGHTS
Thank you to our 2022 Sponsors and Partner
CONSORTIUM PARTNER
SPONSORSHIP OPPORTUNITIES
Sponsorship is a great way to enhance your brand’s visibility and help you connect with top-level decision-makers, innovators, and industry disruptors. There are a number of ways to maximize branding opportunities at the summit.
For more details on sponsorship and exhibition opportunities, please contact Michael Williams at michael@momentumevents.com
Top Reasons to Attend

Discuss quality culture as the heart of any successful inspection readiness plan



Understand the current regulatory environment and the impact on GCP inspections





WHO SHOULD ATTEND
This event is developed for professionals from pharmaceutical, biotechnology and medical device companies, CROs, clinical service and technology providers as well as those professionals from sites who have responsibilities in any the following areas:
- Inspection/Inspection Readiness
- Compliance/Clinical Compliance/Regulatory Compliance
- Auditing
- Quality Management/Clinical Quality Management
○ Clinical Quality Assurance/QA/CQA
○ Clinical Quality Control/QC/CQC - Quality Operations/Quality Systems/Quality Processes
- Regulatory Affairs
- Clinical Operations/Management/Research/Development
- Clinical Outsourcing/Vendor Oversight and Management/Strategic Partnerships/Third-Party Management and Oversight
- Clinical Risk/Quality Risk/Risk Assessment/Risk Management
- Site Monitoring/Site Management/Study Management/Trial Management
- Good Clinical Practice/GCP
- Clinical Data