$1,499 – $1,699

US Good Clinical Practice (GCP) Regulations and ICH GCP Guidelines

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San Francisco

San Francisco, CA

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Description

Compliance with GCP is essential to obtain approval of an NDA or BLA from the Food and Drug Administration (FDA). Parallel rules that are very similar exist for most world wide regulatory venues also. Persons responsible for clinical trial management at the site or sponsor level must have a foundational understanding of GCP, even if many activities are outsourced to a Contract Research Organization (CRO), since regulators expect sponsors to maintain oversight over CRO operations. Site level personnel who manage clinical trials must be familiar with the portion of the regulations that apply to their operations, and it is helpful for these personnel to understand the broader picture, including the sponsor responsibilities.

This program will emphasize FDA's GCP requirements for human use pharmaceutical and biologic drug products. A brief overview of the requirements for medical devices will be included, as well as an overview of related requirements for Institutional Review Boards and for disclosure of potential financial conflicts of interest by clinical investigators.

The key ICH Guideline (E6) relied upon by most ex-US regulatory agencies will also be discussed, but the emphasis will be on US requirements.

Learning Objectives:

Upon completing this course participants should:

  • Understand the legal basis and basic provisions of GCP
  • Know the difference between requirements for sponsors and CROs vs sites
  • Understand the FDA inspection and enforcement process and become familiar with key resources to aid in inspection preparation
  • Understand enforcement options available to FDA to deal with violations

Who will Benefit:

This course is designed for people tasked with developing, maintaining and/or improving company policies and procedures for maintaining a state of compliance with US GCP regulations, including, but not limited to:

  • Clinical Quality Assurance professionals
  • Clinical Operations professionals
  • Clinical Research Associates
  • Regulatory Affairs personnel
  • GMP professionals who have GCP quality management responsibilities but less formal training in GCP principles, who wish to expand their knowledge base
  • Others at the sponsor, CRO and site level who want to enhance their knowledge of GCP

For Registration - http://www.complianceonline.com/fda-good-clinical-practice-gcp-regulations-seminar-training-80505SEM-prdsm?channel=eventbrite

Note: Use coupon code REFERRAL10 and get 10% off on registration.

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San Francisco

San Francisco, CA

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Refund Policy

Refunds up to 30 days before event

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