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Submitted URL: http://link.info.fdachannel.com/ss/c/tUJlBFZv62131_x3hZqR8Gl6ChXPKH6es3SHwHY-ttGa1o1ke4v1ZxNEobkR8nQtLuoR8kyUrre7pV1B9v2v3z4OdPw...
Effective URL: https://www.compliance.world/en-US/Clinical-Trial/Standard-Operating-Procedures-for-Good-Clinical-Practice-by-Sponsors-of-Cli...
Submission: On September 16 via manual from US — Scanned from DE
Effective URL: https://www.compliance.world/en-US/Clinical-Trial/Standard-Operating-Procedures-for-Good-Clinical-Practice-by-Sponsors-of-Cli...
Submission: On September 16 via manual from US — Scanned from DE
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1. Home
2. Life Sciences
3. Clinical Trial
4. Standard Operating Procedures for Good Clinical Practice by Sponsors of
Clinical Trials: Drugs and Biologics
STANDARD OPERATING PROCEDURES FOR GOOD CLINICAL PRACTICE BY SPONSORS OF CLINICAL
TRIALS: DRUGS AND BIOLOGICS
Sep 24, 2021 - 01:00 PM
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Starting at
$299
PREMIER PRO PRICE: $269 (SAVE 10%)
Single registration
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About Price / Register Speaker
If you’re challenged by changing clinical trial rules and procedures, Standard
Operating Procedures for Good Clinical Practice by Sponsors of Clinical Trials:
Drugs and Biologics is exactly what you need.
* New requirements established in the 2016 revision of ICH E6
* New FDA guidances, including new data integrity expectations
* The impact of risk-based monitoring
* Processes addressing the use of new technology in conducting clinical trials
* The impact of the revised Common Rule
* The increased use of centralized institutional review boards (IRBs)
This webinar will cover extremely valuable sections on:
* General administration, with SOPs on fulfilling regulatory obligations,
document development and change control, and sponsor research team training
* Regulatory affairs, with SOPs on FDA contacts and meetings, and FDA
submissions
* Protocol development, which addresses elements of trial design including case
report forms, protocol amendments and investigator documents
* Study start-up, which focuses on investigator selection and qualification and
initiation visit and site training
* Clinical operations and project management, with SOPs on communications with
IRBs, managing investigational product management, records retention,
close-out visits and termination of research
* Subject management, with SOPs on human subject protection, recruitment,
protected information and adverse event recognition
* Data management, which focuses on data collection and transcription and
electronic data collection and management
* Quality assurance, with SOPs on audits and regulatory inspections
* Interim analysis, which includes SOPs on assessing the need for and
establishing a data monitoring committee
Who Will Benefit
* Pharmaceutical company professionals involved with clinical trials
* Biotech company professionals involved with clinical trials
* Clinical operations professionals
* Clinical affairs professionals
* Quality assurance professionals
* Regulatory professionals
* Compliance professionals using FDA, ICH and GCP guidelines
WEBINAR EVENTS
ATTEND LIVE WEBINAR
SEP 24, 2021 - 01:00 PM
Duration: 3 Hours
Single attendee
$299
PREMIER PRO PRICE: $269 (SAVE 10%)
--------------------------------------------------------------------------------
Group of 3 to 5 +1 Thumb Drive or 5 online Recorded version
$429
PREMIER PRO PRICE: $386 (SAVE 10%)
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Group of 6 to 10 +1 Thumb Drive or 10 online Recorded version
$699
PREMIER PRO PRICE: $629 (SAVE 10%)
--------------------------------------------------------------------------------
TRAINING CD-DVD
Physical CD-DVD of recorded session will be despatched after 72 hrs on
completion of payment
$799
PREMIER PRO PRICE: $719 (SAVE 10%)
--------------------------------------------------------------------------------
RECORDED VIDEO
Recorded video session
$599
PREMIER PRO PRICE: $539 (SAVE 10%)
--------------------------------------------------------------------------------
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