6th Clinical Trials Inspection Readiness Summit – 6th Clinical Trials Inspection Readiness Summit

FEATURED SPEAKERS INCLUDE:

As clinical trials are conducted, inspections ensure quality and integrity of care, data and drug performance. As sponsors for clinical trials, pharmaceutical companies are required to ensure GCP guidelines are upheld by implementing inspection readiness. These inspections are conducted by regulatory authorities, which all have unique regulations and caveats. These nuances make inspection readiness a difficult and resource-consuming battle. Clinical trials must be prepared for visits from countless stakeholders over their course. At the 6th Clinical Trials Inspection Readiness Summit, you will understand the importance of an organizational culture of inspection readiness and how to implement that cultural change.

Special Focus

EXPLORE INSPECTION READINESS ISSUES IN CLINICAL TRIALS

> Outline common findings during inspections

> Interpret the requirements described by ICH GCP E6R2 and stretegize how to moveforward as an organization

> Determine how quality management sytems can improve inspection readiness and promote quality

USE RISK MANAGEMENT AND SELF CHECKS TO UNDERSTAND AREAS OF OPPORTUNITY

> Utilize and leverage risk-based monitoring to improve inspection readiness

> Understand how sites prepare for inspections and what they need from sponsors to succeed

> Analyze metrics of past inspections to identify trends in findings, using them to better prepare

MAINTAIN INSPECTION READINESS

> Guarantee the integrity, safety, and security of data to safeguard the clinical trial and its participants

> Maintain an inspection ready TMF

> Determine how quality management systems can inmprove inspection readiness and promote quality

INSPIRE CULTURE OF INSPECTION READINESS TO IMPROVE CLINICAL QUALITY

> Instill quality by design – a look at trial design and how it affects inspection readiness

> Implement eTMF and training program to ensure exceptional documentation management

> Explore the difference between medical device clinical trial inspections and traditional clinical trial inspections

Top Five Reasons to Attend

  1. Use different perspectives on inspection readiness to improve clinical operations and guarantee success
  2. Promote and ensure compliance with all regulatory agencies and their regulations using new systems and innovative methodologies
  3. Ensure trials are organized with improved oversight and communication to protect study participants’ rights, safety and welfare
  4. Foster the intelligent design of clinical trial inspection readiness procedures by identifying trends that improve and encourage inspection readiness from past inspection metrics
  5. Assure quality and compliance are paramount, and convert inspection readiness from a singular activity to an organizational culture for successful clinical trials

Past Attendees breakdown

Created with Highcharts 5.0.1153% – Pharmaceuticals25% – Biopharma5% – Biotech5% – Medical Devices5% – CRO4% – Solution Providers3% – OthersHighcharts.com53% – PharmaceuticalsPercentage: 53.0%

Created with Highcharts 5.0.1147% – Manager15% – Specialist15% – Director/Lead13% – Associate4% – Auditor4% – Assistant2% – OthersHighcharts.com15% – Director/LeadPercentage: 15.0%

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
  • Outsourcing/Development
  • Records/Data Management
  • R&D Operations
  • Clinical Trials Management
  • Global Compliance
  • Risk-Based/Centralized Monitoring
  • Clinical Research
  • Safety and Risk Management Operations
  • Internal/External Auditing
  • Clinical Project Management
  • Trial Master Files
  • Clinical Documentation
  • Clinical Site Management
  • Global Regulatory Affairs
  • CAPA Auditing
  • Adverse Event Management
  • Metrics and Benchmarks
  • Process Optimization
  • Site Performance Management

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
  • Readiness Consultants
Startdate: 2017-08-07
End Date 2017-08-08

Description: Improve and promote inspection readiness and document management in clinical research at the 6th Clinical Trials Inspection Readiness Summit.
Performer: ExL Events
Address : 210 West Rittenhouse Square 6th Clinical Trials Inspection Readiness Summit
Philadelphia
PA
USA