6th Clinical Trials Inspection Readiness Summit (EXL)


6th Clinical Trials Inspection Readiness Summit (EXL)
Event on 2017-08-07 08:00:00
DESCRIPTION

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 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

Sponsors
inSeption

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
Readiness Summit
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.

Partners
MEDtube

MEDtube is an innovative video education platform for health professionals. It allows sharing videos and other materials with a community of more than 110,000 users worldwide, as well as building e-learning courses. The videoteque is updated daily and now contains almost 15,000 videos.
PharmaLeaders

PharmaLeaders.com is an online environment dedicated to enriching the careers of more than 200,000 life sciences professionals. With breaking news and informative content grouped into one of nine segmented channels, in-depth special reports, job and events postings, and so much more, industry executives, manufacturers, marketers and educators can count on PharmaLeaders for the tools they need to succeed in today’s competitive market environment.
pharmaphorum.com

pharmaphorum drives innovation within the pharmaceutical industry, by bringing together healthcare through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.

PharmaVOICE

PharmaVOICE magazine, reaches more than 41,000 qualified subscribers and 100,000 users with its digital edition. PharmaVOICE is the forum that allows business leaders to engage in a candid dialogue on the challenges and trends impacting the industry. PharmaVOICE provides readers with insightful and thought-provoking commentary in a multiple-perspective format through forums, topics, and articles covering a range of issues from molecule through market. PharmaVOICE subscribers are also kept abreast of the latest trends and information through additional media resources, including Social Media, WebLinx Interactive WebSeminars, Podcasts, Videocasts, White Papers, E-Surveys and e-Alerts.

PM360

PM360 is the premier, must-read magazine for marketing decision makers in the pharmaceutical, biotech, and medical device industries. Published monthly, PM360 is the only journal that focuses on delivering the full spectrum of practical information necessary for product managers and pharma marketing professionals to succeed in the complex and highly regulated healthcare environment. The journal’s targeted and insightful editorial focuses on issues that directly impact critical decision making, including: planning and implementation of cutting edge strategies, trends, the latest technological advances, branding/marketing, advertising/promotion, patient/professional education, sales, market research, PR, and leadership. Additionally, the ‘360’ in our title signifies the combination of this critical, how-to info with personal and career insights for an enjoyable and thought-provoking read. By providing the full circle of enriching content, PM360 is truly an indispensable tool for busy and productive marketing professionals to stay at the top of their game.

Technology Networks

Technology Networks is an internationally recognised publisher that provides access to the latest scientific news, products, research, videos and posters. Our global community is made up of over 300,000 researchers and scientific professionals from the life science, drug discover and analytical arenas.

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.

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at The Rittenhouse Hotel
210 West Rittenhouse Square
Philadelphia, United States

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