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| + | [[Category:RCRIM]] | ||
| + | [[Category:RPS]] | ||
| + | |||
[[Main Page]] | [[Regulated Clinical Research Information Management]] | [[Regulated Product Submissions]] | RPS Glossary | [[Main Page]] | [[Regulated Clinical Research Information Management]] | [[Regulated Product Submissions]] | RPS Glossary | ||
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*[[Approval Unit (RPS)|Approval Unit]] | *[[Approval Unit (RPS)|Approval Unit]] | ||
*[[Board of Health]] ([[BoH]]) | *[[Board of Health]] ([[BoH]]) | ||
| + | *[[RPS Hyperlinking|Broken Links]] ([[RPS Hyperlinking]]) | ||
*[[Chemistry, Manufacturing and Controls]] ([[CMC]]) | *[[Chemistry, Manufacturing and Controls]] ([[CMC]]) | ||
*[[Center for Devices and Radiological Health]] ([[CDRH]]) (FDA) | *[[Center for Devices and Radiological Health]] ([[CDRH]]) (FDA) | ||
*[[Center for Food Safety and Applied Nutrition]] ([[CFSAN]]) (FDA) | *[[Center for Food Safety and Applied Nutrition]] ([[CFSAN]]) (FDA) | ||
| + | *[[Contact Type (RPS)|Contact Type]] | ||
*[[Context of Use (RPS)|Context of Use]] | *[[Context of Use (RPS)|Context of Use]] | ||
| + | *[[Correspondence (RPS)|Correspondence]] | ||
*[[Document (RPS)|Document]] | *[[Document (RPS)|Document]] | ||
*[[Document Reference (RPS)|Document Reference]] | *[[Document Reference (RPS)|Document Reference]] | ||
*[[Document Relationship (RPS)|Document Relationship]] | *[[Document Relationship (RPS)|Document Relationship]] | ||
| + | *[[Dossier]] - Generalized synonym for RPS [[Application (RPS)|Application]] concept | ||
*[[Drug Master File]] ([[DMF]]) | *[[Drug Master File]] ([[DMF]]) | ||
*[[Electrocardiogram]] ([[ECG]]) | *[[Electrocardiogram]] ([[ECG]]) | ||
*[[European Union]] ([[EU]]) | *[[European Union]] ([[EU]]) | ||
*[[External Electronic Source (RPS)|External Electronic Source]] / non-retrievable | *[[External Electronic Source (RPS)|External Electronic Source]] / non-retrievable | ||
| + | *[[File (RPS)|File]] | ||
*[[Food and Drug Administration]] ([[FDA]]) (US) | *[[Food and Drug Administration]] ([[FDA]]) (US) | ||
*[[Holder of Reference Master File]] | *[[Holder of Reference Master File]] | ||
| + | *[[RPS Hyperlinking|Hyperlinking]] | ||
| + | *[[International Conference on Harmonisation]] ([[ICH]]) | ||
*[[Investigational New Drug]] ([[IND]]) | *[[Investigational New Drug]] ([[IND]]) | ||
*[[Investigator Brochure]] ([[IB]]) | *[[Investigator Brochure]] ([[IB]]) | ||
| Line 32: | Line 42: | ||
*[[Master File Holder]] | *[[Master File Holder]] | ||
*[[Member State]] | *[[Member State]] | ||
| + | *[[Message (RPS)|Message]] | ||
*[[New Drug Application]] ([[NDA]]) | *[[New Drug Application]] ([[NDA]]) | ||
| + | *[[Package (RPS)|Package]] - Generalized synonym for RPS [[Submission Unit (RPS)|Submission Unit]] concept | ||
*[[Periodic Safety Update Report]] ([[PSUR]]) | *[[Periodic Safety Update Report]] ([[PSUR]]) | ||
*[[Phase I Meeting]] | *[[Phase I Meeting]] | ||
| Line 39: | Line 51: | ||
*[[Pre-submission]] | *[[Pre-submission]] | ||
*[[Product (RPS)|Product]] | *[[Product (RPS)|Product]] | ||
| + | *[[Regulated Industry]] | ||
*[[Regulated Product (RPS)|Regulated Product]] | *[[Regulated Product (RPS)|Regulated Product]] | ||
| − | *[[Regulated Product | + | *[[Regulated Product Submissions]] (RPS) |
| + | *[[Regulatory Activity]] -- Generalized synonym for RPS [[Submission (RPS)|Submission]] | ||
*[[Regulatory Authority (RPS)|Regulatory Authority]] | *[[Regulatory Authority (RPS)|Regulatory Authority]] | ||
*[[Reviewable Unit (RPS)|Reviewable Unit]] | *[[Reviewable Unit (RPS)|Reviewable Unit]] | ||
| Line 47: | Line 61: | ||
*[[Submission (RPS)|Submission]] | *[[Submission (RPS)|Submission]] | ||
*[[Submission Unit (RPS)|Submission Unit]] | *[[Submission Unit (RPS)|Submission Unit]] | ||
| + | *[[Submission Unit Type (RPS)|Submission Unit Type]] | ||
*[[Supplemental New Drug Application]] ([[sNDA]]) | *[[Supplemental New Drug Application]] ([[sNDA]]) | ||
*[[Table of Contents]] ([[TOC]]) | *[[Table of Contents]] ([[TOC]]) | ||
| − | *[[Threaded | + | *[[RPS Threaded Discussions|Threaded Discussions]] |
Latest revision as of 14:51, 25 August 2010
Main Page | Regulated Clinical Research Information Management | Regulated Product Submissions | RPS Glossary
This article is under construction
Please see the RPS Glossary Documentation page for instructions for creating and editing entries.
Glossary of Abbreviations and Terms
- Abbreviated New Drug Application (ANDA)
- Annotated ECG (aECG)
- Application
- Application Number
- Approval
- Approval Unit
- Board of Health (BoH)
- Broken Links (RPS Hyperlinking)
- Chemistry, Manufacturing and Controls (CMC)
- Center for Devices and Radiological Health (CDRH) (FDA)
- Center for Food Safety and Applied Nutrition (CFSAN) (FDA)
- Contact Type
- Context of Use
- Correspondence
- Document
- Document Reference
- Document Relationship
- Dossier - Generalized synonym for RPS Application concept
- Drug Master File (DMF)
- Electrocardiogram (ECG)
- European Union (EU)
- External Electronic Source / non-retrievable
- File
- Food and Drug Administration (FDA) (US)
- Holder of Reference Master File
- Hyperlinking
- International Conference on Harmonisation (ICH)
- Investigational New Drug (IND)
- Investigator Brochure (IB)
- Keyword
- Master Access File
- Master File Holder
- Member State
- Message
- New Drug Application (NDA)
- Package - Generalized synonym for RPS Submission Unit concept
- Periodic Safety Update Report (PSUR)
- Phase I Meeting
- Phase II Meeting
- Post-market
- Pre-submission
- Product
- Regulated Industry
- Regulated Product
- Regulated Product Submissions (RPS)
- Regulatory Activity -- Generalized synonym for RPS Submission
- Regulatory Authority
- Reviewable Unit
- Right of Reference Request
- Sponsor
- Submission
- Submission Unit
- Submission Unit Type
- Supplemental New Drug Application (sNDA)
- Table of Contents (TOC)
- Threaded Discussions
