6th Clinical Trials Inspection Readiness Summit (EXL)
Event on 2017-08-07 08:00:00
6th Clinical Trials Inspection Readiness Summit
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.
In our research, we at ExL have found that, within the pharmaceutical industry, organizational culture should prioritize inspection readiness as a major part of clinical trial success. Unfavorable inspection findings will cause issues that could delay trials or even shut down drug development. Concentrating on more areas of inspection readiness — such as metrics, data integrity and technology — can guarantee these findings are never a surprise.
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. With two days of advanced sessions, roundtables and case studies about effective documentation standards, the culture of preparedness and improved stakeholder engagement, you will shift your organization to a quality-first, quality-always culture.
Top Five Reasons to Attend
Use different perspectives on inspection readiness to improve clinical operations and guarantee success
Promote and ensure compliance with all regulatory agencies and their regulations using new systems and innovative methodologies
Ensure trials are organized with improved oversight and communication to protect study participants’ rights, safety and welfare
Foster the intelligent design of clinical trial inspection readiness procedures by identifying trends that improve and encourage inspection readiness from past inspection metrics
Assure quality and compliance are paramount, and convert inspection readiness from a singular activity to an organizational culture for 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 Trials Management
Safety and Risk Management Operations
Clinical Project Management
Trial Master Files
Clinical Site Management
Global Regulatory Affairs
Adverse Event Management
Metrics and Benchmarks
Site Performance Management
The conference may also be of interest to the following:
Inspection Readiness Software Providers
Data/Records/Archive Management Vendors
Quality Management Service Providers
Electronic Signature Companies
inSeption – sponsors 6th Clinical Trials Inspection Readiness Summit
inSeption’s insistence upon securing the “right” people to integrate into a true partnership alliance with its clients eliminates the vulnerability so often felt by operational leaders faced with evaluating traditional outsourcing options. inSeption’s core competency of identifying and securing the most experienced and proficient professionals builds the crucial foundation of a successful drug development program. Actively collaborating with its clients to custom design, hand select and assemble high-performing project teams empowers inSeption to tailor its services specifically to meet the needs of their programs. The inSeption model provides increased control, full transparency of project deliverables and timelines, and significant operational and cost efficiencies.
Wingspan Technology, Inc.
Wingspan Technology, Inc. – sponsors 6th Clinical Trials Inspection
Wingspan Technology, a QuintilesIMS company, provides an ECM platform for the life sciences industry in a high-performance, scalable, validated cloud environment. Our industry-leading eTMF is used by sponsors and CROs of all sizes to manage trials from planning through archival. Wingspan eTMF provides the transparency needed to understand TMF health and inspection readiness, along with tools to support and measure the productivity of eTMF processes. As a result, eTMF contributed significantly to supporting our clients’ record of successful health authority inspections.
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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.
This Event Listing is Promoted by
New York Media Technologies LLC in association
with EXL Events Inc.
at The Rittenhouse Hotel
210 West Rittenhouse Square
Philadelphia, United States