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
Industry Collaboration in a Regulatory Hothouse
March 26, 2008
Guest Speaker: Charles A. Maniglia, Ph.D., Executive Director, Regulatory Document Management at Purdue Pharma
ISI Presenters: Jascha Minow, Director of Regulatory Solutions
White Paper Reports
Industry Collaboration in a Regulatory Hothouse
March 26, 2008 (File Size: 3.1MB, PDF File Format)
The once overly guarded pharmaceutical industry is waking up to the need for greater collaboration across the enterprise and with partners, as well as progressive, interoperable technology solutions and processes. But a far greater commitment to openness and partnership is needed if companies are to reap the rewards of seamless data access in order to simplify the submissions process. This white paper uncovers some of the regulatory hurdles that lie ahead for the industry and explores opportunities for companies not only to respond to demands, but to become flexible, next-generation players in a complex global market.
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.