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Good Clinical Practice Introduction, Refresher and Hot Topics

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Remote Course

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. This interactive course uses quizzes and workshops throughout. 

What will I learn?

  • Refresh your knowledge in the principles of GCP as required by the guidelines
  • A comprehensive understanding of the roles of the sponsor, principal investigator, contract research organisation, 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:

Ensure that you perform all clinical trials activities so that you comply with the necessary regulations and guidelines.

Tutors

Tutors will be comprised of (click the photos for biographies):

Susana Tavares

Susana Tavares

Director of Research Quality Assurance, Stavares Consulting Unipessoal Lda

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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.

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Caroline Dracass Meader

Caroline Dracass Meader

Director/QA Consultant, Forward Q Ltd

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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.

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Programme

Please note timings may be subject to alteration.

Day 1

09:00

Introductions

09:15

ICH E6 R2 (Part 1)

A general refresher of the guideline

10:15

Break

10:30

ICH E6 R2 (Part 2)

A general refresher of the guideline

11:45

Break

12:00

Risk Assessment and management in clinical research

Including a risk assessment workshop

13:00

Lunch

14:00

Feedback on the workshop about risk assessment

14:30

ICH E8 R1

General considerations for clinical studies

15:30

Break

15:45

Why GCP really matters

Practical exercises

16:45

Questions and Answers

Get answers to any questions you've had throughout the course from our expert tutors

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

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Book now

Click below for Course dates/fees:

Remote Course
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