Pharmaceutical

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Australia, Department of Health and Ageing, Therapeutic Goods Administration (TGA) resource Agency Web Sites Member contributionOCEG Reviewed
The Australian community expects that medicines and medical devices in the marketplace are safe and of high quality, and of a standard at least equal to that of comparable countries.
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Bristol-Myers Squibb : Compliance & Ethics resource Examples Member contributionOCEG Reviewed

The Bristol-Myers Squibb Compliance & Ethics web site. The site contains the following:

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BWise Technology Provider
Corporate Integrity LLC Advisory and/or Audit Firm
Critical Examination of the FDA's Efforts to Preempt Failure-to-Warn Claims, A (2008) resource Articles OCEG Reviewed
Georgetown Law Journal, Vol. 96, 2008     Abstract: This article explores the legality and wisdom of the FDA's effort to persuade courts to find most failure-to-warn claims preempted. The article first analyzes the FDA's justifications for reversing its long-held views to the contrary and explains why the FDA's position cannot be reconciled with its governing statute.
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Deloitte Advisory and/or Audit Firm
Drugs for Human Use (21 C.F.R. Part 300 et seq.) resource National Regulations OCEG Reviewed
Subchapter D - Federal Regulations on Drugs for Human Use
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Drugs; General (21 C.F.R. Part 200 et. seq.) resource National Regulations OCEG Reviewed
Subchapter C - General Federal Regulations - Drugs
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easy2comply Technology Provider
easy2comply Risk Management software

easy2comply Risk Management software solution enables efficient operational/ enterprise risk management in order to improve business processes and performance and simplify regulatory compliance. easy2comply allows you to identify, measure, control and manage operational/ enterprise risk by documenting your processes, risks and controls, accumulating and quantifying loss events, and providing management insight via reports, dashboards, heat-maps, what-if simulations and remediation plans. The software provides a full set of functionality, best practices, built-in work flow and a decision support system for ORM optimization. easy2comply’s unique architecture enables building a common framework and repository for multiple GRC processes, while allowing each individual project to be managed separately according to its own time frame, functionality, methodology and work flow. easy2comply’s singular software architecture provides the technological basis for enabling GRC convergence and a truly integrated GRC framework.

  • IT.12 - Finance/Treasury Risk Management
  • IT.26 - Risk Management
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