Identifying And Managing Unplanned Protocol Excursions And Adhering To Gcp

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During the implementation and conduct of study protocols, investigators often fail to adhere to many elements of GCP regulations. Such violations can potentially impact patient safety and data integrity as well as increase risks to the subject population. Despite extensive and costly monitoring by sponsoring companies, study audits continue to identify protocol deviations and violations resulting in numerous FDA 483 citations.

This presentation will help participants identify key risk elements of protocol non-compliance, understand the responsibilities of the clinical research site and use effective strategies to successfully prevent regulatory and IRB actions.

Areas Covered in the Seminar:

- Designing scientifically sound protocols.
- Understanding applicable regulations and guidance.
- Core protocol team responsibilities.
- Ethical research oversight involving human subjects.
- Challenges associated with successful protocol implementation.
- Frequent audit findings.
- Practical strategies to minimize and manage protocol deviations.
- Key communication issues of investigational team with IRBs, FDA auditors and sponsors.

Who Will Benefit:

This webinar will provide valuable information and provide a familiarity with practices to pharmaceutical, biotechnology and study site personnel, including:

- Sponsor and study site professionals involved in trial planning and management
- Administrative study managers, clinical team leaders and CRAs
- Principal investigators, site managers and study coordinators
- Regulatory compliance associates

Instructor Profile:

Dr. Sheldon Brookman, is President of Clinical Decisions LLC, a consulting company providing clinical and regulatory development strategies. Sheldon has over 25 years of clinical and product development experience in the pharmaceutical industry and has held executive level development and regulatory positions with several pharmaceutical companies and CROs. He has designed and conducted more than four dozen Phase I through IV trials and has filed numerous regulatory submissions in the United States, Canada and South America. He was trained in Industrial Pharmacy at the University of Montreal, where he graduated with honors. Dr. Brookman also holds a PhD in Experimental Medicine and Surgery from the University of Montreal.

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Identifying and managing unplanned protocol excursions and adhering to GCP



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