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Clinical Trials & Human Research
Clinical Trials & Human Research: A Practical Guide to Regulatory Compliance
Available
Offers strategies for complying with regulatory requirements while reducing liability.

List Price: $129.95
Member Price: $119.95
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HIPAA and Human Subjects Research
HIPAA and Human Subjects Research: A Question & Answer Ref Guide
Available
Invaluable information on the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

List Price: $27.95
Member Price: $22.95
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Promotion of Biomedical Products
Promotion of Biomedical Products: Regulatory Considerations
Available
Examines advertising, labeling and promotion regulations.

List Price: $109.95
Member Price: $99.95
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Validation Standard Operating Procedures
Validation Standard Operating Procedures: 2nd Edition
Available
Researches achieving compliance with FDA’s GMPs, GLPs and validation requirements.

List Price: $239.95
Member Price: $224.95
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Nanofabrication Towards Biomed. App.
Nanofabrication Towards Biomedical Applications
Available
Discusses techniques, tools, application and the impact of nanofabrication.

List Price: $149.95
Member Price: $99.95
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Guidebook to Better Medical Writing
Guidebook to Better Medical Writing
Available
Filled with examples, checklists, step-by-step directions, tips, techniques and authoritative advice on medical writing.

List Price: $35.95
Member Price: $32.95
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Good Laboratory Practice (GLP)
Good Laboratory Practice (GLP)
Available

This course outlines the regulatory systems involved in creating and improving GLPs, how GLPs fit into a quality system, what types of studies are covered and how GLPs for the US Food and Drug Administration (FDA), US Environmental Protection Agency (EPA) and the Organization for Economic Cooperation and Development (OECD) fit together.



List Price: $330.00
Member Price: $240.00
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Good Manufacturing Practice (GMP)
Good Manufacturing Practice (GMP)
Available

This course provides a basic understanding of current Good Manufacturing Practices (CGMP) and their impact on product quality and patient safety. It covers a wide range of issues including US and EU regulations.



List Price: $390.00
Member Price: $300.00
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Regulation of Combination Products
Regulation of Combination Products
Available
This course examines the current regulations and policies covering the identification, jurisdiction and review of combination products in the US. It covers premarket activities, applicability of Good Manufacturing Practice (GMP) and postmarket requirements, such as adverse event reporting, inspection and enforcement.


List Price: $270.00
Member Price: $180.00
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Key Regulatory Topics: CTD
Key Regulatory Topics: CTD
Available
Offers a useful compilation of guidelines on the Common Technical Document submission process.

List Price: $34.95
Member Price: $29.95
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Displaying results 1-10 (of 60)
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