5th European Clinical Trials Inspection Readiness – 5th European Clinical Trials Inspection Readiness

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.

Feedback From the 4th Inspection Readiness Summit:

“Good range of linked topics, good discussions from a good sized and engaging audience.” —Director, CQA, EISAI LTD

“Very knowledgeable and informative. Thought-provoking.” —Associate Director CQA, AIMMUNE THERAPEUTICS

“The closing Day One session with ex-MHRA inspector’s Q&A was a highlight of the day. Really helpful answers. Well done!” —QH Auditor, PSI CRO

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
Startdate: 2019-05-20
End Date 2019-05-21

Description: The 5th European Clinical Trials Inspection Readiness will be taking place on 20–21 May 2019. Click here to receive more information!
Performer: ExL Events
Address : 5th European Clinical Trials Inspection Readiness