A structured approach for pharmaceutical pre-marketing safety surveillance (Record no. 75659)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 02096ngm a2200445 a 4500 |
| 001 - CONTROL NUMBER | |
| control field | HST5570 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | UkLoHST |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS | |
| fixed length control field | m c |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr|cna|||a|||| |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | vz|czazum |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 211104s2021 enk|||||||||||s|||v|eng d |
| 028 50 - PUBLISHER NUMBER | |
| Publisher number | 5570 |
| Source | Henry Stewart Talks |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (UkLoHST)4771 |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | UkLoHST |
| Language of cataloging | eng |
| Transcribing agency | UkLoHST |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Tremmel, Lothar, |
| Affiliation | (CSL Behring, USA) |
| Relator code | spk |
| 245 12 - TITLE STATEMENT | |
| Title | A structured approach for pharmaceutical pre-marketing safety surveillance |
| Medium | [electronic resource] / |
| Statement of responsibility, etc. | Lothar Tremmel. |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) | |
| Place of publication, distribution, etc. | London : |
| Name of publisher, distributor, etc. | Henry Stewart Talks, |
| Date of publication, distribution, etc. | 2021. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 1 online resource (1 streaming video file (41 min.) : |
| Other physical details | color, sound). |
| 490 1# - SERIES STATEMENT | |
| Series statement | The biomedical & life sciences collection, |
| International Standard Serial Number | 2056-452X |
| 500 ## - GENERAL NOTE | |
| General note | Animated audio-visual presentation with synchronized narration. |
| 500 ## - GENERAL NOTE | |
| General note | Title from title frames. |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | Contents: Key-concepts in safety surveillance -- Pre-marketing and post-marketing surveillance -- Assessing drug-event relatedness via increased frequency analysis -- The FDA's final rule on IND safety reporting -- Surveilling for unknown unknowns -- Providing context and perspective to emerging suspected safety issues -- The importance of interdisciplinary collaboration -- The Aggregate Safety Assessment Plan (ASAP). |
| 506 ## - RESTRICTIONS ON ACCESS NOTE | |
| Terms governing access | Access restricted to subscribers. |
| 538 ## - SYSTEM DETAILS NOTE | |
| System details note | Mode of access: World Wide Web. |
| 610 10 - SUBJECT ADDED ENTRY--CORPORATE NAME | |
| Corporate name or jurisdiction name as entry element | United States. |
| Subordinate unit | Food and Drug Administration. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Drug approval. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Drugs |
| General subdivision | Safety regulations. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Drugs |
| General subdivision | Testing. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Adverse Drug Reaction Reporting Systems |
| General subdivision | standards. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Drug Approval |
| General subdivision | methods. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Drug Development |
| General subdivision | standards. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Drug Evaluation, Preclinical. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Evaluation Studies as Topic. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Medical Informatics |
| General subdivision | trends. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmacovigilance. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Product Surveillance, Postmarketing. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Risk Assessment. |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE | |
| Uniform title | Henry Stewart talks. |
| Name of part/section of a work | Biomedical & life sciences collection. |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://hstalks.com/bs/4771/">https://hstalks.com/bs/4771/</a> |
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