Online Training 2015 - Drug Dossier Submission Implementation to Match eCTD Standards - By Compliance Global Inc

Overview:
For the last 10 years or more virtually all data, documents, records are composed on a computer. The Electronic Common Technical Document (eCTD) is the standard, accepted electronic format for NDA, ANDA, IND, BLA, DMF and BMF submissions to the FDA. The introduction of legacy paper records into and eCTD is accomplished via scanning onto a text readable format. However, there are vast stores of pre-clinical studies, clinical trials and drug information paper records that are archived in 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 the Session:
Records policy and procedures
Records data map
History of eCTD
Incorporating paper records into a eCTD
Converting paper documents into a useful electronic format
Indexing and organizing scanned records and integrating them
Long term record storage and retrieval
Learning Objectives:
Implement an effective records management system
Develop strategies for eCTD submission
Gain an understanding of converting paper records to electronic versions
Who Will Benefit:
Research & Development
Regulatory
Clinical
Legal
Information Technology
Validation
Level
Beginner
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https://www.complianceglobal.us/product/700024
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