Good Clinical Practice (ICH GCP) for Clinical Research
What you'll learn
- This training course will help professionals, whether currently active in clinical research or planning to be involved, to understand their GCP roles and to manage a GCP compliance clinical trial
- Comprehend the key ICH-GCP requirements and regulatory expectations regarding conduct of clinical trials
- Understand the responsibilities of an investigator/ investigator team within clinical trials
- Know what, why and how clinical trial activities are to be performed and documented
- Learn about the quality issues affecting clinical research
Requirements
- It doesn’t matter if you are completely new to GCP and no prior GCP knowledge is necessary to participate in this course
Description
CONDUCT A SUCCESSFUL CLINICAL TRIAL JUST GOT EASIER…You’re Just Seconds Away From The Essential Good Clinical Practice (GCP) Training & Advice!
“ICH Good Clinical Practice (GCP) E6 (R2) for Investigators and Clinical Research staff”
INTRODUCING THE GOOD CLINICAL PRACTICE GCP COURSE
A course designed not only for investigators and site staff but also its content is key for CRAs, Clinical Operations staff, Clinical QA, and Regulatory Affairs departments.
This training course will help professionals, whether currently active in clinical research or planning to be involved, to understand their GCP roles and to manage a GCP compliance clinical trial.
The learners will receive information regarding key elements such as informed consent, investigational products handling, safety reporting and trial specific documentation, including data integrity key principles.
THIS INTRODUCTORY GCP COURSE WILL HELP YOU TO:
Comprehend the key ICH-GCP requirements and regulatory expectations regarding conduct of clinical trials
Understand the responsibilities of an investigator/ investigator team within clinical trials
Know what, why and how clinical trial activities are to be performed and documented
Enroll today (30 day money back guarantee) to be inspection ready...
Who this course is for:
- Anyone who wants to elevate their GCP knowledge, including but not limited to the following roles or departments: Investigators, Study-Coordinators, Study-Nurses, Clinical Trials Pharmacists, Clinical Research Associates, Clinical Operations staff overseeing clinical sites , Clinical Quality Assurance, GCP Regulatory Affairs
Instructor
Dr Leire Zúñiga is the Founding Director and Principal GCP Consultant of Pharmity. Pharmity is a consultancy firm with headquarters in Spain that delivers quality consultancy, auditing and online training services globally to the pharmaceutical and biotechnology industry.
Leire has worked in the Pharmaceutical, Biotech and CRO industries since 2003 within Quality Assurance.
Just before moving to the consulting area and setting up Pharmity, Leire worked as a Senior Quality Assurance Manager in one of the largest CROs working as part of a global compliance team for internal and external clients worldwide.
During her professional career Leire has developed an in-depth knowledge in Quality Assurance, having conducted GxP and CSV audits across the globe.