Engage With Regulators and Discuss the Implementation of Risk-Based Approaches to Assess Optimise and Manage the Quality of Clinical Vendors and Sites
ExL Events is hosting the 3rd European Clinical Quality Oversight Forum on 25–26 February at the Hilton London Canary Wharf in London.
As we all strive to achieve a constant state of inspection-readiness, don’t miss this opportunity to engage directly with regulators to understand trends they’ve identified during inspections of clinical investigators and sponsors, so you can more effectively prepare for your next inspection. Through an interactive website, you’ll be able to ask questions anonymously and in real time, so come armed with your burning questions.
Featured Presentations:
REGULATORY UPDATE: MHRA INSPECTIONS
Understand What to Expect During an MHRA Inspection and Know How to Best Prepare
Paula Walker, Inspectorate Unit Manager for GCP/GPvP/GLP, MHRA
COMPLIANT CLINICAL DATA SYSTEMS
Develop Compliant, Secure and Inspection-Ready Clinical Data Systems
Philip Lange Møller, Former Medicines Inspector, DANISH MEDICINES AGENCY
REGULATORY PANEL: COMMON CHALLENGES TO GLOBAL COMPLIANCE
Discuss Common Questions and Challenges When Navigating Global Regulations and Share Recommendations for Overcoming Them Panellists
Philip Lange Moller, Former Medicines Inspector,DANISH MEDICINES AGENCY
Florinda Mihaescu, Senior GCP Auditor, R&DGCP Quality Assurance, ABBVIE DEUTCHLAND
Paula Walker, Inspectorate Unit Manager for GCP/GPvP/GLP, MHRA
GCP RENOVATION — MODERNISATION OF ICH E8 AND E6
Evaluate the Revision of ICH E8 and E6 to Address Evolved Quality Concepts and Critical to Quality Factors
Melissa Mudrick, Vice President, Global Safety and Regulatory Business Integration Lead, BIOGEN
In addition to regulatory topics, the forum also provides the industry perspective on the following issues:
SENIOR LEADERS PANEL:
DRIVING A GLOBAL QUALITY CULTURE Develop a Culture of Qualityto Drive a Proactive Risk Management Approach Panellists
Muriel Cottard, Global Head Pharma Clinical Development Quality,NOVARTIS Melissa Mudrick, Vice President, Global Safety and Regulatory Business Integration Lead, BIOGEN
Kevin Robinson, Senior Director, Clinical Quality Assurance, GSK
MIDSIZED COMPANY CASE STUDY: VENDOR SELECTION AND QUALIFICATION
Leverage Limited Resources to Effectively Select and Qualify Clinical Trial Vendors to Mitigate Risk
Christiane Helmrich, Ph.D., Head of Quality Assurance Product Development, MEDAC GMBH
Anja Klein, Ph.D., Head of Clinical Project Management, MEDAC GMBH
SMALL COMPANY PERSPECTIVE: TRIAL MASTER FILE (TMF)
Design, Develop and Maintain an Inspection-Ready Trial Master File
Karen Hue, Director, Quality Assurance Europe, AIMMUNE THERAPEUTICS
For more information and to register, visit our conference website at https://goo.gl/zGE4p9 and use Discount Code 798719PR to save 15% off the standard rate.
ABOUT EXL EVENTS
ExL Events, a division of Questex, LLC, is the industry leader in developing innovative, educational conferences that serve the pharmaceutical and allied healthcare communities in the United States,Europe, Latin America and additional markets. Its experienced team conducts extensive market research and targeted outreach. The results translate into innovative, high-quality events designed to exceed the dynamic informational and networking needs of audiences. ExL Events conference platforms facilitate the exchange of critical information between industry executives and suppliers to support their scientific and commercial goals. Visit www.exlevents.com for more information.
CONTACT
For business development and sponsorship opportunities, please contact Arthur Butler,Business Development Manager, at +1 917-932-0429 or abutler@exlevents.com.
Do you have a question or comment that you would like addressed at this event? Would you like to get involved as a speaker or discussion leader?
Please contact Conference Production Director Kristen Hunter at +1-212-400-6241 or khunter@exlevents.com.