The Electronic Common Technical Document (eCTD) has been the standard, accepted electronic format for NDA, ANDA, IND, BLA, DMF and BMF submissions to the FDA since 2008. The introduction of legacy paper records into an eCTD is accomplished via scanning onto a text readable format. However, there are vast stores of pre-clinical, clinical and drug safety paper records that are archived by many companies for drugs that failed to reach the marketing stage for a variety of reasons. This archived data could support submissions for other new or emerging indications for the drug or support efficacy or safety for related drugs.
Why Should You Attend:
The tendency, after a drug fails in clinical trials is to retain all related information permanently. There are strategies to optimize the storage and organization of legacy information, paper as well as electronic, about a specific drug, rather than maintain this information in diverse repositories and locations. Information in a jumbled state is very expense to manage and maintain and vital information is often lost or very difficult to locate. Converting all legacy paper records to an electronic format and organizing them can be daunting.
Areas Covered in this Webinar:
Records policy and procedures
Records data map
Incorporating paper records into an eCTD
Converting paper documents into a useful electronic submissions 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
FDA philosophy on drug regulation
What is the eCTD?
Selecting solutions for submitting an eCTD
Learning records and information management
Dealing with legacy records
Who Will Benefit:
Research & Development
Charlie Sodano began his career as a discovery research chemist at Pfizer. And since1985 has specialized in the management of electronic information as well as paper based records. He managed Information Services departments at RJR Nabisco, Berlex Biosciences and Bayer HealthCare Pharmaceuticals, and holds BS and MS and Ph.D. degrees in Chemistry. Charlie has more than 25 years' experience in the design, improvement and roll-out of Electronic Laboratory Notebooks and electronic records management and archiving systems. He has made numerous presentations at US and international meetings of the American Chemical Society, ARMA International, AIIM, Institute of Food Technologists, EMC Documentum User Meetings and conferences sponsored by leading training and education organizations. Member of the American Chemical Society and ARMA International and Regional Advisor for ARMA International, Pacific Region.
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