Our 9th
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
- Auditing/Auditor
- 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
Speakers
- Katie Alberta, Global Head, QA, GLP, GCP, GPvP and PDMA, ALKERMES
- Angela Berns, Director and Head of Vendor Management, UCB BIOSCIENCES INC.
- JoAnna Brodie, Director, Clinical Development Quality Assurance - Third Party Resourcing, GLAXOSMITHKLINE
- Frances DeGennaro-Culver, Clinical Research, Head Quarters Clinical Quality Management, MERCK
- Donna-Lee Destouche, M.Sc., CCRP, Senior Clinical Trial Manager, Clinical Development, IMMUNOGEN, INC.
- Greg Dombal, Chief Operating Officer, HALLORAN CONSULTING GROUP
- Kira Drummond, Head of R&D Quality and Compliance, ALEXION PHARMACEUTICALS, INC.
- Federico, A. Feldstein, J.D., Vice President, Head of R&D Quality and Compliance, JOHNSON & JOHNSON
- Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC
- Beth Harper, President, CLINICAL PERFORMANCE PARTNERS, INC.
- Ryan Jones, CEO, FLORENCE
- Karine Julien, Executive Director, Therapeutic Area Head, Primary Care, and Interim Pharmacovigilance Head, MRL Quality Assurance, MERCK
- Miah Jung, Pharm.D., M.S., Pharmacologist, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research (CDER), FDA
- Larry Kennedy, Ph.D., Vice President, Quality Management Systems, Chief Quality Officer, ALLIANCE FOR CLINICAL RESEARCH EXCELLENCE AND SAFETY (ACRES), CEO, QUALITY MANAGEMENT INSTITUTE
- Sheri Kuss, Director, Clinical Quality Lead, PFIZER
- Melissa Mudrick, Vice President and Global Head, R&D Quality and Compliance, BIOGEN
- Dawn Niccum, Quality Manager, ENDOCYTE, INC., Dawn M. Niccum, M.S., RN, PMP, CCRA, RQAP-GCP, Director, Quality Assurance, INSEPTION GROUP
- Sharon Reinhard, M.S., Clinical Compliance Solutions, Consultant on Assignment, MERCK
- Karen Rezzonico, Associate Director, Clinical Quality Compliance, INSEPTION GROUP
- Christina Salerno, Executive Director, Head, Clinical Sciences and Study Management, Primary Care, MERCK, Interim Head, HQ Clinical Quality Management, MERCK
- Melissa Suprin, Head, Clinical Quality Risk Management, PFIZER
- Steven Whittaker, Senior Consultant, THE AVOCA GROUP
- Cheri Wilczek, President, CLINAUDITS, LLC
- Michael Wilkinson, Senior Research Analyst, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT
- Liz Wool, President, WOOL CONSULTING GROUP, INC.
- Steve Young, Chief Operations Officer, CLUEPOINTS
Please fill in your name and email to receive the conference agenda of this event.
Workshop Day - Wednesday, October 10, 2018
Conference Day One - Thursday, October 11, 2018
Conference Day Two - Friday, October 12, 2018
Venue
The venue is not yet available for this event.
Follow this event to be informed when the venue is available and stay informed on other changes.
Venue
Sonesta Hotel Philadelphia1800 Market St.
Philadelphia, PA 19103
Explore the comfort and fresh, contemporary vibe at the all-new Sonesta Philadelphia. A premier choice among hotels in Philadelphia, enjoy spacious, modern accommodations and luxurious amenities while staying in the heart of downtown and only steps away from Rittenhouse Square.
To make reservations over the phone, please call 1-800-SONESTA and request the negotiated rate for ExL's October Meetings. To make reservations online
Click HereYou must book your room by September 18, 2018 in order to receive the group rate. Please book your room early, as rooms available at this rate are limited.
