European Clinical Trials Inspection Readiness Conference

Ensure Quality Assurance and Inspection Readiness Through Good Clinical Practice and Strategic Partnerships


London, United Kingdom

The 5th European Clinical Trials Inspection Readiness Summit is intended to deliver best practices when maintaining a culture of preparedness when dealing with data integrity, data privacy, and good clinical practice (GCP). This will be a great opportunity to discuss sponsor oversight strategies when dealing with regulatory agencies and ultimately staying prepared for inspection throughout the clinical trial process.

When ensuring your organisation is fully prepared for an inspection, you must focus on key areas including quality, data integrity, and data maintenance. With the FDA, EMA, and the MHRA each providing their own unique guidelines to follow, it can be difficult and time-consuming when attempting to prepare for these inspections, which can be unannounced.

Top Five Reasons to Attend

  1. Explore approaches on how to move towards an inspection-ready culture at all times
  2. Implement how to be on top of the regulations by setting up an internal regulatory intelligence network
  3. Compare and contrast EMA and FDA inspection readiness and touch on processes from all perspectives
  4. Understand how to prepare for ICH-GCP E6 (R2) implementation and review data systems and regulatory authority expectations
  5. Convert inspection readiness from a singular activity to an organisational culture that assures quality, compliance and successful clinical trials

Who Should Attend

This conference is designed for professionals from academia and pharmaceutical, medical device and biotechnology companies with responsibilities in the following areas:
  • Quality Assurance/Quality Control/Quality Compliance/Quality Management
  • Clinical Operations/Research/Planning
  • Clinical Outsourcing and Development
  • Records/Data Management
  • R&D Operations
  • Trials Management/Research
  • Global Compliance
  • Risk-Based/Centralised Monitoring
  • Safety and Risk Management Operations
  • Site Performance Management
  • Internal/External Auditing
  • Clinical Project Management
  • Trial Master Files
  • Clinical Documentation Management
  • Global Regulatory Affairs
  • CAPA Auditing
  • Adverse Event Management
  • Metrics and Benchmarks
  • Process Optimization
The conference may also be of interest to the following:
  • CROs
  • Inspection Readiness Software Providers
  • Data/Records/Archive Management Vendors
  • TMF Vendors
  • Quality Management Service Providers
  • Electronic Signature Companies
  • Regulations/Documentation/Inspection Readiness Consultants

Speakers

  • Karim Benlachen, Trial Operations Team Manager, SANOFI R&D
  • Dr. Andrew Bentley, Quality Assurance Manager, MINA THERAPEUTICS
  • Shane Comiskey, Director GCP Quality, REGENERON PHARMACEUTICALS, INC
  • Sally Digby, Senior Document Specialist, CHUGAI PHARMACEUTICAL CO LTD
    Keith Dorricott, Ambassador, METRICS CHAMPION CONSORTIUM
  • Martina Duevel, Senior Global Clinical Project Manager, BAYER PHARMACEUTICALS
  • Robin Farmer, Associate Director of Document Control and Training, DYNAVAX TECHNOLOGIES
  • Barbara Hepworth-Jones, Director, Clinical Development Regulations and Advocacy, GLAXOSMITHKLINE
  • Leona Houghton, Director, PV Quality and Compliance, JAZZ PHARMACEUTICALS
  • Karen Hue, Director QA, AIMMUNE THERAPEUTICS INC
  • Bodo Lutz, Clinical Risk Management and Data Integrity, NOVARTIS CORPORATION
  • Angelika Masuch, Head of Inspection Management, MERCK KGAA
  • Birthe Nielsen, Senior Principal QA Auditor, LEO PHARMA
  • Massimiliano Sarra, Preclinical and Clinical Assessor, ITALIAN MEDICINE AGENCY - AIFA
  • Geoff Taylor, Director, Clinical Quality Assurance, EISAI

Venue

Hilton London Olympia
380 Kensington High Street, W14 8NL
London, UK

To make reservations over the phone, please call +44 207-856-1904 and use code ATRIA. To make reservations online CLICK HERE

You must book your room by April 24, 2019, in order to receive the group rate. Please book your room early, as rooms available at this rate are limited.