Clinical quality oversight has been significantly impacted by the forced change and rapid technology adoption catalyzed by the pandemic, as well as new regulations driving quality cultures and quality by design. This is a critical time in clinical research and an opportunity to adopt risk-based oversight approaches that ensure quality and mitigate risk.
This interactive gathering of senior-level clinical quality, compliance and operations professionals offers an opportunity to engage in-person with like-minded peers often struggling with the same challenges. Learn together through presentations, panels, roundtables and instructional workshops and be part of our clinical quality community.
Top Reasons to Attend
- Identify leading practices from the industry's premier clinical quality experts as they candidly share innovative approaches and strategies for managing risk across the trial.
- Understand the critical components of new regulatory guidance, including ICH E6 R3 and ICH E8 R1, and their impact on clinical oversight and quality risk management.
- Optimize rapidly adopted remote technologies and processes to effectively oversee clinical quality.
- Benchmark your clinical oversight strategy against those of similar companies to ensure you are on pace with the industry.
- Integrate an effective risk-based, resource-optimizing approach for the selection, monitoring and management of clinical vendors and sites.
- Ensuring your clinical vendors and sites are inspection ready with the latest tools, technologies and auditing strategies.
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:
- Quality Management/ Clinical Quality Management
- Clinical Quality Assurance/ QA/ CQA
- Clinical Quality Control/ QC/ CQC
- Quality Operations/ Quality Systems/ Quality Processes
- Clinical Operations/ Management/ Research/ Development
- Compliance/ Clinical Compliance/ Regulatory Compliance
- Auditing
- Inspection/ Inspection Readiness
- 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
- Regulatory Affairs
A Hybrid Event - Choose Your Experience
The In-Person Experience - FULL ACCESS
- This Event is Designed for the In-Person Experience
- Access to All Offered Content and Networking Opportunities
- Option to Add-On Pre-Conference Workshops
The Virtual Experience - PARTIAL ACCESS
- Select Main Conference Sessions Accessible Virtually - See Agenda
- NO ACCESS to Networking Opportunities, Roundtable Discussions, Pre-Conference Workshops, and Sessions NOT Indicated as Accessible Virtually in the Agenda
Conference Chair
- David Fryrear, Executive Vice President and Head of Quality Assurance, ASTELLAS
Speakers
- Priya Chaturvedi, PhD, Vice President, Head of Global Quality, EISAI
- Fran DeGennaro-Culver, President, FDC CONSULTING, LLC
- Allison Duran, Associate Director, Clinical Oversight and Optimization, SANGAMO THERAPEUTICS
- Celeste M. Gonzalez, BS, CVT, RQAP-GCP, CCRP, Principal, CLINICAL QA INTERNATIONAL, LLC
- Sheila Gwizdak, M.S., Vice President, Quality, HALLORAN CONSULTING GROUP
- Paul Houri, Vice President, Head of BioResearch Quality Assurance, JOHNSON & JOHNSON
- Maryann Livolsi, Senior Director, GCP Quality Assurance, BILL AND MELINDA GATES MEDICAL RESEARCH INSTITUTE
- Dawn Lundin, Head of Global Quality, MAPS PBC
- Cristin MacDonald, PhD, Vice President, Client Delivery, WCG AVOCA
- Dawn Niccum, Executive Director, Clinical Quality and Compliance, INSEPTION GROUP
- Sharon Reinhard, Vice President, Global Quality, AVROBIO
- Tim Stoddard, Quality Consultant/Advisor; Previous Head of Quality,FLATIRON HEALTH, Previous Clinical Quality Leader, SPARK THERAPEUTICS
- Michelle Webb, Vice President, AVOCA QUALITY CONSORTIUM
- Michele Weitz, Executive Director, Clinical Standards and Innovation, CLOVIS ONCOLOGY
- Michael Wieczerzak, MS, MBA, CCRP, Associate Director, Clinical Quality Management Lead, EMD SERONO
- Liz Wool, Principal, WOOL CONSULTING GROUP, INC.; Virtual Training WHIZ
Please fill in your name and email to receive the Conference Agenda of this event.
Venue
The Notary Hotel, Autograph Collection
21 N. Juniper Street, 19107
Philadelphia, PA, USA
A limited and exclusive room block is available for the
Clinical Quality Oversight Summit. To take advantage of our discounted room rate of $260++ please use this link:
https://book.passkey.com/event/50308463/owner/12526/landing or call the venue 888-887-8130. The group rate is available until June 7, 2022.
Please note there is only one official, exclusive housing block for this event. Any other channels for booking reservations are not authorized. If you are contacted by a 3rd party housing company claiming to have a relationship with us, our event and/or The Notary; these companies and others like it are not in any way affiliated with us.
