Clinical Data Management - Benefits of Standardization in Establishing CDM Processes

  • Check with publisher
  • Published date: April 2, 2018
  • Modified date: April 2, 2018
    • Philadelphia, pennsylvania, United States

Course "Clinical Data Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
When new drugs or devices are tested in humans, the data generated by, and related to, these trials is known as clinical data. This data represents a huge investment by the biopharmaceutical or device company and is one of its greatest assets. It is this data that will eventually make a new product both useful as a treatment or therapy and marketable. The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s to the highly computerized specialty it is today.
This seminar is based on the current state of regulations and will cover the essential parts of the data management plan, study startup, study conduct, study closeout and study monitoring.
Angela Bazigos
CEO, Touchstone Technologies Silicon Valley
Seasoned Executive with 40 years of experience in the Life Sciences & Healthcare Industries. Positions include Chief Compliance Officer . Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA Patent on speeding up software compliance . Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents.
Location: Philadelphia, PA Date: May 17th & 18th, 2018 and Time: 9:00 AM to 6:00 PM
Price: $1,295.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*
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Until April 20, Early Bird Price: $1,295.00 From April 20 to May 15, Regular Price: $1,495.00
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