The Library

Welcome to the Library, where you'll find a selection of industry resources including eBooks, Whitepapers, Webinars, Survey Reports, Research Reports and more.

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WEBINARS

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The Basics of Biotech 101, 201 & 301

Webinar | Price: $299

This 3-part webinar series is specifically geared toward the non-science professional who needs to better understand industry terminology, science, techniques and issues. This series provides an overview of the science and technology used to enable discovery and the processes scientists use to discover new therapeutics. Download now.

Leveraging Forecasting Models to Optimize Clinical Trial Supply Management

Webinar | May 3 | 11am ET / 8am PT | Presented by: Catalent

Explore how to drive excellence within the clinical supply forecasting process and apply forecasting models to identify potential supply-related issues before they negatively impact your study. Register now!

UDI After Submission: Managing the Lifecycle of a UDI Record

Webinar | Presented By: Reed Tech | Tuesday, May 17 | 11am ET / 8am PT

Medical device labelers have been working hard to comply with the FDA's Final Rule for Unique Device Identification (UDI). But what happens to a UDI record after submission? Reserve Your Spot Today!

The Transformative Role of MSLs in Next Generation KOL Management

Webinar | Now Available On-Demand | Presented by: IMS Health

IMS Health Webinar: Transformative Role of MSLs in KOL Management - Please join experts from IMS Health and the Medical Science Liaison Society (MSLS) in discussing issues surrounding the transformative role of MSLs in managing increasingly critical – yet complex – KOL relationships. Register to watch now!

Shifting Power to the Patients: How Life Science Companies Are Rapidly Adapting to Consumerization and Engagement

Webinar | April 27 | 2pm ET / 11am PT | Presented by: Deloitte

Changes in technology and the health care ecosystem are increasing the patient’s role in decision making and reshaping their expectations from health care companies. How are leading life science companies responding to the consumerization of patients and what do they need to think about to expand their capabilities. Register Now!

Unapproved Animal Drugs: Don't Get Caught "Misbranded"

Webinar | April 26 | 2pm ET / 11am PT | Presented by: Cardinal Health

Join this webinar from Cardinal Health to learn how to evaluate the risk of marketing unapproved animal drugs and the regulatory pathways that will help minimize the possibility of FDA enforcement action. Register Now!

UDI So Far: Lessons for Class II Labelers

Webinar | Presented By: Reed Tech | Now Available On-Demand

Class II medical device labelers are working feverishly to meet the FDA's September 24, 2016 UDI compliance date. What should they know about the efforts of other device labelers so far? Register to Watch Now!

Inspection Readiness Considerations with AbbVie

Webinar | April 13 | 2pm ET / 11am PT | Presented by: Veeva

Moving from paper-based to electronic processes not only requires a shift in technology but also a change in mindset. Hear AbbVie’s lessons learned from a mock inspection and other considerations for maintaining an inspection ready TMF. Register now!

Quantitative Systems Pharmacology Modeling (QSPM) Case Study in Immuno-oncology

Webinar | Now Available On-Demand | Presented by: Applied BioMath

Quantitative systems pharmacology modeling (QSPM) approaches help answer complex, critical Go/No-go decisions in drug R&D. Learn how to leverage QSPM to shorten timelines, lower cost, and increase the likelihood of developing best-in-class drugs. Register to watch now!

Going Global with Cloud Communication

Webinar | Now Available On-Demand | Presented By: 8x8

Done right, expanding your organization internationally can be a boon to your business. Done wrong, it becomes a minefield. Learn what to look for in a global-ready communications system that's right for you. Register to Watch Now!

Minimizing Risk to Maximize Coverage for the Global Supply of Vaccines

Webinar | Now Available On-Demand | Presented by: Catalent

Join us for this informative webinar: Minimizing Risk to Maximize Coverage for the Global Supply of Vaccines, featuring Bill Hartzel, Director of Strategic Execution, Advanced Delivery Technologies, Catalent Pharma Solutions. Register to watch now!

End-to-End Evidence Management Can Enable Value-Based, Personalized Healthcare.

Webinar | Now Available On-Demand | Presented by Deloitte

Value-based, personalized healthcare is evolving the product conversation for Life science organizations to focus on evidence to deliver a more compelling value proposition to customers. Hear from Deloitte leaders around the importance of an end-to-end evidence management process. Register to watch now!

Novel Technologies to Deliver Oral Oncology Therapies

Webinar | Now Available On-Demand | Presented by: Catalent

In this webinar, you'll learn about innovative technologies for oral delivery of oncology therapies, enhancing both therapeutic performance and the patient experience. Presented by Dr. Mark Ratain (University of Chicago Medicine), Mr. Julien Meissonnier and Dr. Jeff Browne (Catalent Pharma Solutions). Register to watch now!

UDI Crunch Time: Preparing Your Data for Submission to FDA

Webinar | Now Available On-Demand | Presented By: Reed Tech

The FDA's Sept. 24 UDI compliance date for Class II device labelers is fast approaching. Join this webinar to learn how to locate, gather, check and submit your data to the FDA before the deadline. Reserve Your Spot Today!

Life Sciences and Mobile Apps

Webinar | Now Available On-Demand | Sponsored By: Appian

This webinar will examine app strategies in the life sciences industry and how they're changing in the wake of new regulatory requirements. Register to watch now!

Clinical Research Statistics for Non-statisticians

Webinar | Now Available On-Demand | Presented by Rho

Through real-world examples, webinar participants learn strategies for choosing appropriate outcome measures, methods for analysis and randomization, and sample sizes as well as tips for collecting the right data to answer your scientific questions. Register to watch now!

Physician Prescribing Trends & Opportunities for Health System-Pharma Collaboration

Webinar | Now Available On-Demand | Presented By: athenahealth

athenahealth conducted a study to learn how health systems and new reimbursement models are impacting prescribing behavior. We'll discuss our findings, including opportunities for pharma marketers, with a health system leader during this webinar. Register to Watch Now!

Special Considerations for Managing Immuno-oncology Studies - A New Paradigm

Webinar | Now Available On-Demand | Presented by: Medpace

Immuno-Oncology Webinar: We are in a new era for researching cancer treatments. Join Medpace medical and operations experts as they discuss the unique considerations for managing immuno-oncology studies as well as insights into best practices. Register now!

Fastest Route to Clinic and Market Enabled by Optimizing API Properties and Formulation

Webinar | Now Available On-Demand | Presented by: Catalent

The clinical and commercial success of a new chemical entity (NCE) requires pre-formulation studies of drug candidates and development of suitable formulations based on the physicochemical and biopharmaceutical properties. Through expert content and case study examples, this webinar will highlight the strategies and state-of-art screening, particle size reduction and formulation technologies to optimize the properties and formulation of your drug candidates. Register to watch now!

Rare Disease 20/20: A Look at the Challenges and Opportunities in Rare Disease Clinical R&D

Webinar | Now Available On-Demand | Presented By: BBK Worldwide

Join the National Organization for Rare Disorders (NORD), Xenon Pharmaceuticals and BBK Worldwide as they take a closer look at the challenges and opportunities in rare disease clinical R&D. Registration is free – click here.

Next Generation GxP Systems in the AWS Cloud

Webinar | Now Available On-Demand | Presented by Amazon Web Services

Amazon Web Services (AWS) has developed a compliance resource that provides guidance to organizations who use AWS in their GxP systems. This webinar will illustrate ways the AWS Cloud facilitates GxP compliance and helps improve infrastructure transparency, consistency, and auditability. Register to watch now!

Analytic Methods for Identifying Quality Risks in Clinical Trials

Webinar | Now Available On-Demand | Presented By: Medidata

Join this webinar on analytic methods to help you minimize regulatory review cycles. Learn how automated systems are using advanced statistical algorithms and machine learning techniques to help sponsors shave months off their quality audit processes and avoid deficiencies. Register to Watch Now!

Drug Manufacturing Solutions in a Complex Industry

Webinar | Now Available On-Demand | Presented by: Catalent

Through expert content and case study examples, this webinar will focus on flexible manufacturing solutions to address the unique needs of today’s pharmaceutical pipelines, with an emphasis on successful technology transfer and tailored manufacturing services. Register to watch now!

Capturing the Voice of the Patient - ePRO, Real World Data, and the Future of Clinical Trials

Webinar | Now Available On-Demand | Presented By: Medidata

Regulators are becoming wary of self-assessments captured on paper, so join this session to learn what is currently driving ePRO decisions. Register to Watch Now!

Enhancing the Customer Experience with Engaging Patient Services Applications

Webinar | Now Available On-Demand | Presented By: Salesforce

Patients increasingly have more control over their healthcare and information, and expect support services, access to their data, and anytime engagement. Join Harvey Guindi and Arun Bhaskar from Health Network Laboratories to hear how they transformed their patient relationships with an engaging suite of applications built on the Force.com platform. Register to Watch Now!