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About us
Good Clinical Practice Introduction, Refresher and Hot Topics
Course Information
This course is tailored for project managers, QA, monitors, study coordinators, principal investigators, laboratory technicians and all the professionals involved in clinical trial activities seeking to refresh their knowledge and responsibilities within the GCP framework.
What will I learn?
- Refresh their knowledge in the principles of GCP as required by the guidelines
- A comprehensive understanding of the roles of the sponsor, principal investigator, contract research organization, quality assurance, and other applicable roles within the framework of Good Clinical Practices principles
- Increased efficacy in inspections and audits
- Discuss real examples of the application of GCP
This course is structured to encourage delegates to:
Delegates will ensure that they will perform all clinical trials activities complying with the regulations and guidelines in order to comply with regulations and guidelines.
Tutors
Tutors will be comprised of (click the photos for biographies):
Susana Tavares
Experienced Director of Research Quality Assurance with a demonstrated history of working in the pharmaceuticals industry. Strong skills as a manager and in Auditing CROs, partners, sites, systems, documental audits along several regions in preclinical, clinical and pharmacovigilance field. Also high experienced as a trainer and in quality systems among Good Clinical Practice (GCP), Good Preclinical Practices (GLP), Pharmacovigilance, Medical Affairs and corporate quality systems. Hosted a high number of FDA, EMA, Infarmed inspection for GCP, GLP and pharmacovigilance.
Caroline has 18 years experience as a QA professional and over 30 years’ total experience in the field of clinical research working at study sites, pharmaceutical companies and CROs. She has been an Independent QA Consultant for the last 14 years, involved in planning, conduct and delivery of clinical audit programmes, conducting GCP and GVP audits, development of SOPs and provision of compliance, GCP and inspection preparation training.
Programme
Please note timings may be subject to alteration.
Day 1
09:00
Introductions
09:15
ICH E6 R2 - general refresher of the guideline (will include quizzes) - Part 1
10:15
Break
10:30
ICH E6 R2 - general refresher of the guideline (will include quizzes) - Part 2
11:45
Break
12:00
Risk Assessment and management in clinical research (will include a workshop)
13:00
Lunch
14:00
Feedback on the workshop about risk assessment
14:30
ICH E8 R1 on general considerations for clinical studies (will include quizzes)
15:30
Break
15:45
Why GCP really matters - Practical Exercises
16:45
Questions and Answers
17:00
Close of Course
Extra Information
Course Material
This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event.
Please note this course will run in UK timezone.
The advantages of this include:
- Ability for delegates to keep material on a mobile device
- Ability to review material at any time pre and post course
- Environmental benefits – less paper being used per course Access to an online course group to enhance networking.
You will need a stable internet connection, a microphone and a webcam.
Development Level
Learn
Recommended Events
Good Clinical Practice Auditing - Principles and Practice
Good Clinical Practice Inspection Preparation - Navigating a Rapidly Changing Environment
Implementing Good Clinical Laboratory Practice
Risk Management in Clinical Trials
Recommended Products
A Monitors Guide to Investigator Site Audits eBooklet
Good Clinical Laboratory Practice (GCLP) eBooklet
Good Clinical Practice Regulatory Authority Inspections eBooklet
Introduction to Good Clinical Laboratory Practice (GCLP) elearning
Introduction to Good Clinical Practice (GCP) elearning
Investigators' Guide to Investigator Site Audits eBooklet
The Implementation of VICH for Good Clinical Practice (GCP) elearning
Webcast - Are we there yet? The E-archiving journey
Webcast - Case Study: GCP Audit Strategy for Trust-sponsored
Webcast - Clinical Investigator EU CT Regulation
Webcast - Clinical Trials Directive: CT3
Webcast - EU Clinical Trial Regulation
Webcast - Quality Systems