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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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.

Tips for a Successful NDA Submission

Webinar | June 16 | 1pm ET / 10am PT | Presented by Rho

Marketing application submissions are the final hurdle before a product makes it to market. This webinar will share tips on regulatory strategy, data integration and readiness, and electronic publishing to help you avoid common pitfalls in the submissions process. Register Now!

Parallel Screening Approach for the Non-Invasive Delivery of Macromolecules

Webinar | June 14 | 11am ET / 8am PT | Presented by: Catalent

Don't miss this informative and complimentary webinar on the dynamic research field of non-invasive delivery of macromolecules. You'll hear from the Non-Invasive Macromolecule Delivery Consortium (NMDC) experts on overcoming biological barriers for non-invasive delivery of macromolecules. Reserve your spot today!

Exploring Digital Health Technologies: The Devices and Data Being Used in Trials Today

Webinar | Now Available On-Demand | Presented by Validic

In this webinar, we'll explore the 4 categories of digital health technologies — wearable fitness devices, clinical devices, sensors and apps — and discuss what each category includes, endpoints they collect and how they’re being used in trials today. Register to Watch Now!

UDI After Submission: Managing the Lifecycle of a UDI Record

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

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? Register to Watch Now!

Optimizing Sponsor/CRO Relationships

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

Developing and maintaining strong relationships can make or break a clinical study. In this webinar, two experts with experience managing clinical programs from both a CRO and a Sponsor perspective provide tips and strategies for optimizing these relationships. Register to Watch Now!

Leveraging Forecasting Models to Optimize Clinical Trial Supply Management

Webinar | Now Available On-Demand | 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 to watch now!

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!

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!