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New York Professional Events List
4th European Clinical Trials Inspection Readiness Summit (exl)
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4th European Clinical Trials Inspection Readiness
During clinical trials, inspections provide a framework to ensure quality and integrity of care, data and drug performance. As sponsors of clinical trials, it is important for pharmaceutical companies to ensure GCP guidelines are upheld by implementing inspection readiness. These inspections, often conducted by the FDA, EMA, MHRA and other regulatory authorities, all have unique regulations and caveats. These nuances mean that becoming — and remaining — inspection-ready can be a difficult, time-consuming battle. Because inspections can occur without notice, sites must be prepared for visits from many different stakeholders over the course of a clinical trial.
Join the 4th European Clinical Trials Inspection Readiness Summit and inspire an organisational culture that prioritises inspection readiness as integral to the success of your organisation. Unfavourable inspection findings can delay trials, result in costly corrective measures and shut down drug development. Concentrating on more areas of inspection readiness — such as metrics, data integrity and technology — can guarantee findings are never a surprise.
Organisational culture is often thought to be an unchangeable and steadfast belief system, but is more accurately represented as a state that must evolve to stay relevant. At the 4th European Clinical Trials Inspection Readiness Summit, our esteemed faculty will address the importance of fostering a culture of inspection readiness within your organisation, as well as ways to do so. With interactive sessions, case studies and panel discussions about effective communication pathways, integrated technology application and standardised operating procedures, you will return to work prepared to change your organisation to embrace a culture that continually places quality first.
Top Five Reasons to Attend
- Understand the different perspectives of inspection readiness and how they can be used to improve clinical operations
- Explore systems and methodologies that promote and guarantee compliance with all inspecting agencies and their respective regulations
- Improve oversight and communication to ensure trials are organised and conducted to protect study participants’ rights, safety and welfare
- Utilise metrics from past inspections to foster the intelligent design of procedures and to assist in identifying trends that improve and encourage inspection readiness
- 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:
- Inspection Readiness Software Providers
- Data/Records/Archive Management Vendors
- TMF Vendors
- Quality Management Service Providers
- Electronic Signature Companies
- Regulations/Documentation/Inspection Readiness Consultants
Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
NO REFUNDS ALLOWED ON REGISTRATIONS
This Event Listing is Promoted by
New York Media Technologies LLC in association
with EXL Events Inc
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