Description

GCP consists of basic and refresher courses that provide essential good clinical practice training for research teams involved in clinical trials of drugs, biologics, and devices, as well as those involved in behavioral intervention and social science research studies. Good Clinical Practice (GCP) is the international ethical, scientific and practical standard to which all clinical research is conducted. Everyone involved in research must be trained or appropriately experienced to perform the specific tasks they are being asked to undertake.

 This webinar is intended to help you adequately implement Good Clinical Practices (GCP) including documentation requirements during clinical trials for both drugs and medical devices.

 We recommend that team members leading and deliver research complete, as a minimum, the Introduction to Good Clinical Practice (GCP) course (online or face-to-face). This should be followed by additional specialist courses where appropriate (e.g. Informed Consent) and regular GCP Refresher training.

 In this 180 minutes Instructor-led Live webinar, you will have unparalleled opportunities to bring great value and benefits to your organization and to greatly improve your GCPs with increased awareness of the needs - sustainable compliance

Agenda:-

Session 1: Good Clinical Practice (GCP) Refresher Training                       

• 21 CFR 11, Electronic Records / Electronic Signatures
• 21 CFR Part 50: Protection of Human Subjects – Informed Consent (and IRB’s)
• 21 CFR Part 54: Financial Disclosure by Clinical Investigators
• 21 CFR Part 56: Reporting and Recordkeeping requirements
• 21 CFR Part 312: Investigational New Drug Application
• 21 CFR Part 314: Application for Approval to Market a New Drug

Break / Q & A

Session 2: ICH E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1), 

Who Will Benefit:-

• Clinical Affairs
• Regulatory Affairs
• Quality Assurance
• Research & Development
• Consultants
• Contractors/Subcontractors
• Senior Management
• Anyone Interested in the Topic

Guidance for Industry – Brief Overview

• IRB/IEC
• Investigator’s Responsibilities
• Sponsor’s Responsibilities
• Monitor’s Responsibilities
• Audits
• Protocols / Amendments
• Essential Documents

Conclusion: Summarization; Q&A