This presentation reviews the key concepts of GCP and correlates them to the ICH guidelines.
Why Should You Attend:
Well controlled and well conducted clinical trials are important to both sponsors and investigator sites. Compliance with Good Clinical Practice and ICH guidelines will ensure quality data, speeds up the review process for new drugs and decreases the costs to sponsors. Safeguarding trial subjects is a key priority. Compliance will also ensure successful FDA inspections.
This session will include the key principles of GCP as defined by the ICH as well as incorporate FDA regulatory inspection strategy to identify areas of common deficiency. We will discuss how to use the FDA Compliance Program results to identify key issues in managing and conducting clinical trials.
Areas Covered in the Seminar:
- Background of ICH-GCP.
- Importance of Good Clinical Practice .
- Foundation for Medical Practice.
- Principles of GCP.
- Activities that are common to most trials.
- Linking responsibility to these activities.
- Utilizing ICH guidelines for GCP compliance.
- Using the FDA Compliance Program results to identify key issues in managing and conducting clinical trials.
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, Ros and Research Facilities Conducting Clinical Trials including:
- Managers in Clinical Development and Project Leaders
- Quality Assurance Managers and auditors
- Clinical Research Associates
- Clinical Operations Staff
- Regulatory Compliance Associates and Managers
Instructor Profile:
Carol Owen, has been in the Clinical Research Industry for over 20 years. She recently held the position of Director of Quality Assurance for a large Contract Research Organization. She has been involved in training throughout her career particularly in the areas of GCP compliance, FDA regulations and requirements, and audit training. She has specialized in the pharmaceutical clinical trial business having previously worked for an international pharmaceutical company and two international CROs. She has expertise in a vast array of therapeutic areas and in Phase 1-4 clinical trials.
