Now in its ninth year, our Proactive GCP Compliance conference continues to act as the annual forum for both senior-level clinical quality and clinical operations executives to gather, learn and discuss strategies to achieve and maintain global GCP compliance. Join us to learn how to effectively build quality risk management approaches into your clinical operations to optimize research, maintain GCP compliance, contain costs and ensure patient safety.
Top Five Reasons to Attend
- This is the original GCP event and the only event with a longstanding history of delivering quality education and attracting a senior-level audience comprised of clinical quality, compliance, and operations professionals with the power to influence industry change.
- This influential event has become the annual gathering of senior-level clinical executives and acts as a candid forum to share experiences, conduct meaningful conversations and make valuable connections.
- Benefit from educational sessions on topics identified through intensive industry research to be the most critical issues surrounding and barriers to achieving GCP compliance, including identifying risk indicators, measuring compliance, risk-based monitoring, inspection readiness, quality by design, vendor oversight, clinical CAPAs, quality systems implementation and much more.
- Case study presentations from renowned industry leaders spearheading the development and implementation of proactive risk-based approaches to managing quality in clinical research, representing companies of all sizes.
- Customizable agenda allows you to choose your preferred topics and learning environment with interactive workshops, session tracks, educational presentations, interactive panels, intimate roundtables and ample networking opportunities.
Who Should Attend
This conference is designed for professionals
from pharmaceutical, biotechnology and medical device companies; CROs;
and other clinical trial service providers whose responsibilities
involve the following:
- Good Clinical Practice (GCP)
- Clinical Quality Assurance (CQA)
- Clinical Quality Control (CQC)
- Clinical Trial Operations/Management
- Clinical Research
- Quality Management/ Global Quality Management
- Audits/Inspections
- Compliance/Global Compliance
- Data Management/Systems Operations
- Clinical Monitoring
- Regulatory Affairs
- Safety and Risk Management/Operations
The event is also relevant to clinical QA, compliance and operations professionals from:
- Quality Service Providers and Consulting Companies
- CROs
- Central, Imaging and ECG Labs
- Investigative Sites
- IRBs
- Data Management and Software Vendors
- Safety Reporting Vendors
Speakers
- Katie Alberta, Global Head, QA, GLP, GCP, GPvP and PDMA, ALKERMES
- Catherine Arthey, President, DARCY CONSULTING
- Richard Azueta, Head, GxP Audit, NOVARTIS
- Peggy J. Berry, MBA, RAC, President and CEO, SYNERGY CONSULTING
- Nancy Bitters, Inspection Management Lead, Biopharma | Global Research and Development Quality, EMD SERONO
- Denise Calaprice, Ph.D., Senior Consultant, THE AVOCA GROUP
- Jennifer Clark, Director, Quality Systems, FERRING PHARMACEUTICALS, INC.
- Teresa DeVincentis, Senior Director, Clinical Quality Management, CELGENE
- Betsy Fallen, Regulatory and Clinical Process Consultant, BAFALLEN CONSULTING, LLC
- Karen Freid, Essential Document Lead, MERCK
- Dan Greenwood, Senior Director, Quality Assurance, TESARO
- Pamela Gustafson, Vice President, Clinical Research, PROTEON THERAPEUTICS, INC.
- Laurie Halloran, President and CEO, HALLORAN CONSULTING GROUP
- Paul Houri, Vice President, Head of BioResearch Quality Assurance, JOHNSON & JOHNSON
- Karine Julien, Executive Director, Quality Assurance Therapeutic Area Head, Primary Care, MERCK
- Maryann Livolsi, MSN, RN, RQAP-GCP, Senior Director, R&D Quality Assurance, ACADIA PHARMACEUTICALS
- Dawn Lundin, Director, Quality Assurance, MERCK
- Cheryl McCarthy, RQAP-GCP, CQA, CBA, Associate Director, R&D Quality and Compliance, BIOGEN
- Doreen McGirl, Director, Quality Assurance, CARDIOVASCULAR RESEARCH FOUNDATION
- April Rafkind, M.Sc., Director, Pharma Clinical Quality Assurance, NOVARTIS
Sharon Reinhard, M.S., Consultant, MERCK CONSULTANT
- Jonathan Rowe, Ph.D., M.S., M.A., Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER
- Mike Sobczyk, Senior Director, Regulatory Compliance, GILEAD SCIENCES
- Joanne Spallone, Global Development Quality Audit Head, NOVARTIS
- Steven Talerico, M.S., Director, GCP Inspection Management (GIM), Global Inspections Lead, Global Clinical Trial Operations (GCTO), MERCK
- Simon Trowell, Vice President, Quality and Risk Management, R&D Projects, Clinical Platforms and Sciences, GSK
- Stefan Van Den Akker, M.Sc., Director, R&D Quality and Risk Management, ACADIA PHARMACEUTICALS
- Cheri Wilczek, President, CLINAUDITS, LLC
- Shari Zeldin, B.S., CCRC, Clinical Research Compliance Officer, Department of Medicine, UNIVERSITY OF WISCONSIN
Please fill in your name and email to receive the conference agenda of this event.
Workshops - Monday March 19, 2018
Conference Day One - Tuesday March 20, 2018
Conference Day Two - Wenesday March 21, 2018
The agenda is available as PDF under downloads at the right side of the page.
Venue
Sheraton Philadelphia University City Hotel
3549 Chestnut St, 19104
Philadelphia, PA, USA
Venue
Sheraton Philadelphia University City Hotel3549 Chestnut Street
Philadelphia, PA 19104
Sheraton Philadelphia University City is a dynamic lifestyle hotel with a contemporary urban design and lifestyle amenities for business and leisure travelers. Our beautifully renovated hotel offers cutting-edge technology, warm hospitality and beautiful social spaces where you are free to relax, meet, work, dine and do your thing. Our hotel is immersed in the culture and history of Philadelphia, from museums that trace world civilizations to ethnic eateries and elite universities.
To make reservations, guests can call 1-888-627-7071 and request the group rate for ExL’s 9th Proactive GCP Compliance Meeting. To make reservations online Click Here
The group rate is available until February 26, 2018. Please book your room early, as rooms available at this rate are limited.
