OnDemand Available: 10 Killer Applications for Digital Signatures in the Life Sciences Enterprise

Originally Recorded:
Wednesday – October 1, 2014 / 01:00 pm EST/10am PT – Free Attendance

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Includes live polls and a Q & A session.

Overview:

Life sciences enterprises of all sizes are using digital signatures in a variety of ways across their business operation. They’re using this technology with their core quality management systems (QMS) and electronic document management systems (EDMS), as well as within various departments such as FDA-regulated clinical operations, manufacturing, field sales and service, research and discovery, and in non-FDA regulated back office applications.

Join us as we take a closer look at each of the 10 killer applications for digital signatures within a life sciences enterprise and uncover the tangible benefits that thousands of these enterprises are already enjoying. We’ll explore a number of real-world use cases involving these applications. Whether you’ve already deployed digital signatures within some of your departments or you’re still at the consideration stage, this webinar will be worth your while.

Topics include:

• Defining standard digital signatures and their global acceptance in regulated applications
• Considerations in using digital signatures for closed system applications throughout an enterprise for corporate governance
• Strategies for deploying digital signatures in open systems for the front and middle office: collaboration and secure document exchange

Key Takeaways Include:

• Discover new ways digital signatures can be used in the life sciences enterprise
• Discover the value of digital signature automation for specific business processes
• Learn the unique considerations for digital signatures in both closed and open systems from end-user case studies

Who Should View:

• QA & Compliance
• IT
• COO
• CIO
• Department heads within: clinical operations, manufacturing, product management and project management

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Webinar: Expedited Programs for Drug Development

Leveraging Expedited Programs for the Development of Drugs and Biologics for Serious Conditions and Rare Diseases

October 8, 2014 @ 1PM EDT
Reserve your spot now

in partnership with Cardinal Health

FDA is committed to advancing the development of therapies for the treatment of serious conditions and rare (orphan) diseases.  As part of this commitment, FDA provides expedited pathways to decrease the development and review time for new drugs and biologics that address unmet medical needs.  In addition to these expedited pathways, which are fast track, priority review, and accelerated approval, FDA recently introduced the new breakthrough therapy designation.

This new designation will allow for more intensive guidance from FDA throughout the development process. This presentation will examine each of FDA’s four expedited programs and their impact on recently approved products indicated for serious conditions and rare diseases.

Includes a live Q&A session, and post-webinar OnDemand access for all who register.

Key Takeaways:

• FDA regulations, legal acts, and guidances governing expedited programs for serious conditions and rare diseases 
• The concepts of serious condition, available therapy, unmet medical need, and rare disease
• Understand and distinguish the differences between FDA’s four expedited development programs - fast track, breakthrough therapy, priority review designations, and accelerated approval pathway
• The qualifying criteria and features of each expedited program, as well as what is required for requesting a specified designation
• The impact of expedited programs on recent New Drug Application (NDA) and Biologic License Application (BLA) approvals
• How to leverage expedited programs to support the development of pharmaceuticals indicated for serious conditions and rare diseases

Who Should Attend:

• Professionals who wish to broaden their understanding of drug development in the pharmaceutical or biotechnology industry, including:
• Regulatory Affairs Directors/Managers
• Research and Development Directors/Managers
• Clinical Research Associates
• Medical Writers
• Quality and Manufacturing Director/Managers
• Quality Assurance Directors/Managers
• Project Managers

Reserve your spot now

PharmaVOICE is partnering with Cardinal Health Regulatory Sciences

Move Aside, Paper: Capturing Clinical Trial Outcomes in the Digital Age

The FDA wants to hear from patients directly during clinical trials. Their “Voice of the Patient” initiative gives the FDA a broader perspective on outcomes across many treatment areas. Technology is more important than ever for collecting valuable, accurate, timely information from patients.

In this article, you’ll learn about:

• The scientific realities of patient reporting
• Misconceptions about paper-based survey tools
• 8 keys to implementing electronic tools successfully
• The eCOA landscape
• How to choose the best solution

 Read this article now at http://bit.ly/almac-showcase