Why Should You Attend:
All CRO's, Sites, and Sponsors of Clinical Research involved in the drug and device development process have an interest in being prepared for the audit process. Attending this Webinar is a good step toward learning what makes the Good Clinical Practices of Research involving human subjects.
From recruiting subjects to assessing safety of the investigational product and Protocol deviation aversion, this training session covers the high points.
Areas Covered in the Seminar:
Session 1: Why the Investigator must know her/his responsibilities and Legal commitment's in drug and device clinical research from the FDA perspective: How to get your PI more involved in the Clinical Research process.
Session 2: Have a good plan for recruiting study subjects to eliminate the risk of failure.
Session 3: Are your Informed Consents in compliance with the new FDA Regulations – an update of the Informed Consent process
Session 4: Why is Accurate Adverse Event Reporting essential for drug safety - How to Assess and report AEs and SAEs
Session 5: How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant?
Who Will Benifit:
This Webinar will provide invaluable assistance to all personnel in the Pharmaceutical, Biotechnology, and CRO industry Conducting Clinical Trials including:
In CRO's and sites, those benefiting the most would be:
Charles H. Pierce , MD, PhD, FCP, CPI Has 20+ years experience in bringing the message (via webinars, lectures and seminars) of Risk Management through knowledge of GCP Regulations and Investigator Responsibility to the entire investigative team. He has been involved in Investigator and staff GCP training, and medical monitoring in both drug and device studies.
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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