is being presented by Jonathan Andrus & Jennifer Price, Vice President, Data Management and Quality & Director, Clinical Solutions, of BioClinica and airs on Tuesday, March 8th, 2011. For more details or to register, please visit our site at www.fxconferences.com
In 2010 the FDA released its draft standards plan ‘CDER Data Standards Plan Version 1.0’ which outlines key objectives for a data standards program at CDER. The use of standards in clinical research is evolving and gaining widespread acceptance. This presentation reviews the standards listed in the FDA’s draft plan, along with others relevant to clinical research.
Standards can be used from the beginning of the clinical research process starting with protocol design, moving to data collection, data analysis, and data submission. Standards are also used by disparate systems for the exchange of data. By using standards, your company can design standard data collection and reporting structures and libraries. When using standard libraries, functions such as training and programming can be streamlined to increase efficiencies and reduce rework.
This presentation provides attendees with a general understanding of the current and emerging standards being used today in our industry – including PRM, CDASH, SDTM, ODM, AdAM, LAB, CDISC Terminology, eCTD, HL7, RFD and BRIDG – and how each standard relates to specific job functions.
Showing posts with label CDER. Show all posts
Showing posts with label CDER. Show all posts
Friday, February 4, 2011
Wednesday, October 13, 2010
Part 11 Compliance and CDER Tag-Along Inspections - Are You Ready?
is being presented by John English, Principal, John T. English Regulatory Consulting and airs on Thursday, Novemeber 11th, 2010. For more details or to register, please visit our site at www.fxconferences.com
When 21 CFR Part 11 was published over 15 years ago, it was supposed to be a positive development. The FDA was giving companies a way to save on paper – and time and money – by opening a pathway to using “Electronic Records and Electronic Signatures.” It was supposed to recognize technical developments that were having an impact on the regulated industries.
It has been over five years since an update to Part 11 was promised. At this point, what is definitely coming are “tag-along inspections” to measure the state of industry compliance and to benchmark where companies stand in terms of compliance. CDER, the center driving this, has indicated that the results may lead to an updated approach to Part 11 compliance, a re-work of the regulation and/or regulatory citations for the companies involved.
When 21 CFR Part 11 was published over 15 years ago, it was supposed to be a positive development. The FDA was giving companies a way to save on paper – and time and money – by opening a pathway to using “Electronic Records and Electronic Signatures.” It was supposed to recognize technical developments that were having an impact on the regulated industries.
It has been over five years since an update to Part 11 was promised. At this point, what is definitely coming are “tag-along inspections” to measure the state of industry compliance and to benchmark where companies stand in terms of compliance. CDER, the center driving this, has indicated that the results may lead to an updated approach to Part 11 compliance, a re-work of the regulation and/or regulatory citations for the companies involved.
Subscribe to:
Posts (Atom)