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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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

Group of 3 to 5 +1 Thumb Drive or 5 online Recorded version

Group of 6 to 10 +1 Thumb Drive or 10 online Recorded version

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

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