The 10th Clinical Quality Oversight Forum
focuses on ensuring trial integrity by effectively assessing, optimizing and managing the quality of clinical vendors and sites. This Forum acts as the annual gathering for clinical quality, operations, management and audit professionals to engage and candidly share their experiences, struggles, obstacles, and achievements when working with varying clinical partners including CROs and investigator sites. Learn from this experienced group and take away proven, results-driven, risk-based strategies for optimizing your company's clinical vendor and site oversight approach.
Top Five Reasons to Attend:
- Learn from the industry's leading clinical operations and quality experts as they candidly share their experiences, strategies, and guidance for selecting and managing your clinical partners to ensure compliance and maximize performance.
- Benchmark your clinical quality oversight strategy against other similar-sized companies to ensure your approach is optimal and effective.
- Integrate a risk-based, resource-optimizing approach for effective selection, monitoring and long-term management of your clinical vendors and sites.
- Position your trial for success by ensuring your clinical vendors and sites are inspection ready with the latest tools, technologies and audit strategies.
- Design your own agenda and choose your preferred learning environment with the selection of interactive workshops, session tracks, educational presentations, dynamic panels, interactive roundtables, and ample networking opportunities.
Who Should Attend
This event is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinical service providers who have responsibilities in the following areas:
- Quality Management/Clinical Quality Management
- Clinical Quality Assurance/QA/CQA
- Clinical Quality Control/QC/CQC
- Clinical Operations/Management/Research/Development
- Compliance/Clinical Compliance/Regulatory Compliance
- Monitoring/Site Management/Study Management
- Clinical Outsourcing/Vendor Management/Third-Party Management
- Good Clinical Practice/GCP
- Clinical Risk/Risk Assessment
- Regulatory Affairs
- Medical Affairs
The event is also of interest to:
- Investigative Sites
- Academic Research Organizations
- Central, Imaging and ECG Labs
- IVRS Companies
- EDC Companies
- Other Clinical Service Providers
- Kenneth A. Getz, MBA, Chairman, CISCRP, Director of Sponsored Research, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT
- Kathy Goldstein, Sr. Director, Quality Management Lead, REGENERON PHARMACEUTICALS
- Sheila Gwizdak, Principal Consultant , HALLORAN CONSULTING GROUP
- Blake Jensen, Vice President, Quality and Compliance , G1 THERAPEUTICS, INC.
- Miah Jung, Pharm.D., M.S., Pharmacologist, Office of Scientific Investigations, Office of Compliance, CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), FDA
- Maryann Livolsi, MSN, RN, Senior Director, GCP Quality Assurance, BILL & MELINDA GATES MEDICAL RESEARCH INSTITUTE
- Marion Mays, VP Client Solutions and Quality Assurance, PHLEX GLOBAL
- Cheryl McCarthy, RQAP-GCP, CQA, CBA, Director, Research Quality Assurance, IRONWOOD PHARMACEUTICALS
- Dawn M. Niccum, M.S., RN, PMP, CCRA, RQAP-GCP, Senior Director, Quality Assurance and Compliance, INSEPTION GROUP
- Jonathan Rowe, Ph.D., M.S., M.A., Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER
- Christine Sahagian, Head of Registries and Late Phase QA and Compliance, SHIRE
- Dennis Salotti, M.S., MBA, CCRA, Chief Operating Officer, THE AVOCA GROUP
- Stacy St. John, Director, Clinical Development Quality - Vendor Quality and Quality Culture, PFIZER
- Krista Tibbs, Specialist, Clinical Development, HALLORAN CONSULTING GROUP
- Michael Torok, Ph.D., Clinical Quality Assurance Head, ASTELLAS
- Shelly Weeks-Townsend, M.S., CQA, Director, Quality Assurance, ZYNERBA PHARMACEUTICALS
- Jane Wood, Quality Center of Excellence Lead, YOUR ENCORE, Former Vice President and Head, BioResearch and Quality Compliance, JOHNSON & JOHNSON
- Liz Wool, President, WOOL CONSULTING GROUP, INC.
- Steve Young, Chief Operations Officer, CLUEPOINTS
VenueSonesta Philadelphia Downtown Rittenhouse Square
1800 Market St.
Philadelphia, PA 19103
To make reservations, guests can call 1-800-SONESTA (766-3782) and request the group rate for ExL's October Meetings
The group rate is available until September 25, 2019. Please book your room early, as rooms available at this rate are limited.