ISI is dedicated to keeping industry up-to-date on current regulations and interpreting agency guidances and providing practical roadmaps and best practice strategies on how to plan for and transition to electronic submission processes and systems. ISI's Sentinel Program is a regulatory thought leadership program that includes quarterly webinars, reports and analyses, an educational workshop series, and an audio interview program with industry’s leading luminaries.
Recent Recorded Webinars
eCTD and NeeS Take Center Stage
April 7, 2010
Presenters:
Karin Gröndahl, Medical Products Agency (MPA)
Kate Wilber, ISI
Sentinel Magazine
April 2010 Issue
Have you heard about the company that took the eCTD by storm? AstraZeneca has proven itself to be an innovator not just in the lab, but also at the regulatory level. ISI invites you to register to read Sentinel Magazine, an exciting new forum for regulatory professionals, to find out how AstraZeneca:
- Ensures seamless movement of documents from its document management system into regulatory submission solutions for eCTD, NeeS, and paper
- Developed true user ownership and responsibility of regulatory documents through its progressive “frontloading” model
- Embraced collaboration to get up to speed on tools and establish best practices for business processes
White Paper Reports
Sentinel Report #2: An International Flavor Emerging Markets
February 4, 2009 (File Size: 1.1 MB, PDF File Format)
A changing global climate and slowing growth in the major pharmaceutical markets has led many forward-thinking life sciences companies to turn their attention to emerging markets, in particular in Asia, Eastern Europe, and Latin America. But regulatory practices in these markets are less well developed than in industrialized nations and can be difficult to maneuver. This paper explores the intricacies of several of these key markets, offering insights on how to make the most of the opportunity to expand into new countries while avoiding the regulatory pitfalls that prevail.
Educational Workshops
As an additional effort in supporting its commitment to keep clients informed on industry guidance and regulatory compliance, ISI also offers a wide variety of workshops throughout the year. Workshops filter through years of experience in submitting hundreds of submissions and implementing systems at major Life Science organizations around the world into focused, intensive sessions. These dynamic sessions are designed to impart industry-relevant insight, tips, workarounds and valuable field-tested methods and techniques. And because curriculum is developed by industry experts, participants will come away with a unique experience that can be garnered nowhere else.
Throughout the course of the workshop, discussions will be held on topics such as, the advantages and disadvantages of the eCTD, how to overcome the disadvantages, process and procedure changes you may need to implement, and common issues encountered by the FDA with submissions that have been received.
Audio Interview Program
The shift to eCTD requires a fresh way of looking at how documents and data fit into the submission dossier, and companies are eager to make the kind of process transition that takes full advantage of the new structural efficiencies. This latest in a series of informational interviews, produced by ISI for its innovative Sentinel Program, features Tara Washlack of Abraxis BioScience, Inc. Using the company’s first eCTD regulatory submission as a backdrop, Tara talks about the challenges and rewards of building a cradle-to-grave electronic workflow that also gives Abraxis the flexibility to make a seamless transition back to paper for those regions still requiring paper. Tara Washlack is the Supervisor of Publishing & Documentation in Regulatory Affairs at Abraxis. Prior to heading up that group, Tara served as a Regulatory Scientist with Abraxis. She is a graduate of Carnegie Mellon University in Pittsburgh, PA.