Duration of course: Two days training course

Number of participants: Max 25 Participants

Registration: Kindly click to register for the event.

Who Should Attend?

Employees who work for pharmaceutical firms, contract research organizations, medical device companies and academic institutions involved in the supervision or oversight of clinical trial practices and policies will find this course of interest.

When delivered as an in-house program, this course is fully customizable to meet the specific needs of an organization, department or employees' functional responsibility.

Learning Objectives

Upon completion, attendees will be able to:

• Identify and define the principles and requirements for GCPs.
• Define the basic roles and responsibilities of sponsor, monitor, investigators and FDA.
• Understand how GCPs can impact clinical research progress and ensure their implementation.
• Clearly put into practice the regulatory, source documentation and record-keeping requirements for clinical trials.
• Ensure that their data and supporting documentation are accurate and presentable for inspection.
• Comply with 'Informed Consent' and 'Human Subject Protection' requirements.
• Detect and prevent fraud and misconduct in clinical trials.
• Manage a FDA GCP inspection.

Training Focus

This training course provides a solid understanding of GCP requirements and clinical quality assurance overviews for clinical trials. Attendees will gain experience in proven techniques for detecting, correcting and preventing clinical study deficiencies at domestic and international clinical sites. This course teaches participants how to ensure that their data and supporting documentation are completely accurate, factual and in the appropriate format for regulatory authorities.

Included in the course work are practical examples and a roadmap for evaluating SOPs, consent forms, investigator brochures and source documents through presentations and interactive case studies.

About Your Expert Trainer and Certificate

Our expert trainers are joining us from the USA and/or Europe who are all highly qualified professionals referenced internationally. Upon the completion of the training, certificate of attendance and accreditation will be issued in the name of participant.