Why Should You Attend:
GLP compliance for all regulatory submissions is critical for Nonclinical Study Sponsors. Regulators including FDA and EMA are increasingly focused on assessing the sponsor’s initial evaluation and qualification, oversight and monitoring of the CROs Sponsors utilize to conduct nonclinical safety studies for pharmaceutical submissions. This webinar will review basic principles for pre-study assessments Sponsors should conduct before placing nonclinical GLP studies.
What do regulators expect Study Sponsors to do when conducting GLP studies include the following:
In this webinar, you will learn valuable basic and in-depth information and guidance for conducting Contract Research Organizations (CRO’s) site qualifications for study placement and assessing laboratories capabilities.
Areas Covered in the Webinar:
Who Will Benefit:
From Pharmaceutical, Chemical, Agrichemical, Food Safety industriesInstructor Profile:
An experienced pharmaceutical consultant with over 25 years of experience including 11 years as a Study Director and over 15 years as a Nonclinical Project Leader and Study Monitor with extensive work experience leading nonclinical development teams with a successful track record of planning, designing, contracting, monitoring and reporting toxicology studies. Extensive experience supporting drug discovery research and development to progress drug candidate(s) through all phases of nonclinical development from IND enabling to post approval. Authored or co-authored multiple NDAs, INDs, Investigator Brochures and regulatory responses for submissions. Demonstrated experience planning and implementing nonclinical development strategies for multiple therapeutic areas. A subject Matter Expert for outsourcing and evaluating Contract Research Organizations (CROs) and Developmental and Reproductive Toxicology. Experienced in training and development of core nonclinical toxicology research teams and facilities conducting GLP compliant studies internationally.
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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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