Transitioning From Paper Records in a Regulatory Environment for Pharmaceutical Companies

Event Information
Product Format
Prerecorded Event
Conference Date
Thu, Apr 27, 2017
Length
60 minutes
Product Description

Implementing Better Controls for the Storage, Retrieval and Conversion of Clinical Trial Information.

After a drug fails in clinical trials, there is a tendency to retail every related detail permanently. There are strategies to optimize the storage and organization of legacy information, paper as well as electronic, about a specific drug, rather than maintaining this information in diverse repositories and locations.

Information in a jumbled state is very expensive way to manage and maintain vital information and is often lost or very difficult to locate. Converting all legacy paper records to an electronic format and organizing them can be daunting.

The total costs associated with submissions to regulatory agencies are astronomical. Some of these expenses are not easily eliminated. Labor costs are almost always the major expense in any organization. Project man-hours can be significantly reduced by better controls for the storage, retrieval and conversion of essential information.  Of course another financial return is gained by the acceleration of the submission process.

This session by expert speaker Dr. Charlie Sodano will analyze the implications of big data and the storage, retail and conversion of information on drug manufacturers.

Session Highlights:

  • Records policy and procedures
  • Records data map
  • Incorporating paper records into a eCTD
  • Converting paper documents into a useful electronic format
  • Scanning costs and resources
  • Indexing and organizing scanned records and integrating them
  • Long term record storage and retrieval
  • Big data – implications to the drug business

Who should attend?

  • Research & Development
  • Regulatory
  • Clinical
  • Legal
  • Information Technology
  • Validation

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Dr. Charlie  Sodano

Charlie Sodano began his career as a discovery research chemist at Pfizer, and since1985 has specialized in the management of electronic and paper information and records.


He holds BS and MS and Ph.D. degrees in Chemistry and has more than 30 years’ experience in the design, improvement and roll-out of electronic records and information management and archiving systems. He managed Information Services departments at...   More Info
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