Contract Research Organizations Monitoring Essentials for Sponsors

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:

1. Selection and qualification of the CRO to ensure that the CRO that has been selected meets the requirements of the sponsor
2. A contractual agreement that makes clear exactly which tasks have been delegated to the CRO
3. Ongoing study monitoring and oversight of the CRO to confirm throughout the study that the CRO continues to meet the sponsor’s requirements
4. Review best practices for Sponsor monitoring and oversight for Sponsors conducting GLP and Non-GLP services being provided by a CRO

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:

• When to conduct initial GLP site audit?
• Who should conduct the qualification?
• Areas to concentrate on during the site visit::
• Study Director
• Compliance
• IACUC
• Facilities
• Equipment
• Standard Operating Procedures
• Animal Care
• Reagents and Solutions, Expired Supplies and Materials
• Test and Control Articles
• Study Protocol and Study Conduct
• Data Collection and Data Management
• Document Control

Who Will Benefit:

• Senior management of small to mid-size biotech and pharmaceutical companies
• Quality Assurance personnel for sponsor organization
• Scientists placing nonclinical GLP regulated studies
• Toxicology Personnel involved in selection and placement of GLP studies at Contract Research Laboratories

From Pharmaceutical, Chemical, Agrichemical, Food Safety industries

Kevin Denny
Pharmaceutical Consultant , KDTox Consulting LLC

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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