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Webinar: Understanding Risk-Based Monitoring Post-ICH E6 (R2)

Tuesday, September 25, 2018  |  11:00am-12:00pm EDT

 

Key Topics:

  • The different types of monitoring
  • Elements of ICH E6 (R2) that impact site monitoring
  • Where quality fits into risk-based monitoring
  • The impact of ICH E6 (R2) on monitoring and the sites and how to improve overall quality

 

This Webinar is ideally suited for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinical service providers who have responsibilities in the following areas:

  • Quality Management/Clinical Quality Management
    • Clinical Quality Assurance/QA/CQA
    • Clinical Quality Control/QC/CQC
  • Clinical Operations/Management/Research/Development
  • Compliance/Clinical Compliance/Regulatory Compliance
  • Monitoring/Site Management/Study Management
  • Clinical Outsourcing/Vendor Management/Third Party Management
  • Good Clinical Practice/GCP
  • Auditing/Auditor
  • Clinical Risk/Risk Assessment
  • Regulatory Affairs
  • Medical Affairs

 

 

Presented by:

 

 

 

 

 

Cristin (Crissy) MacDonald, PhD

Executive Director, Client Delivery, The Avoca Group

As leader of the Avoca Group’s Integrated Consulting, Dr. Crissy MacDonald provides consulting to top pharmaceutical, biotech, and contract research organizations, and oversees client deliverables, systems, and processes across Avoca. Crissy has 12 years of pharmaceutical industry experience with expertise in clinical research, process development, and strategic management. Her previous professional roles have touched every stage of the clinical trials process, from pre-clinical research through late-stage clinical development.

 

 

 

 

 

 

Jeff Kingsley, DO, MBA, CPI, FACRP

CEO, IACT Health

Dr. Kingsley, CPI, FACRP received his Bachelor of Science degree from the University of Scranton in 1995 and his Master of Science degree in 1997 in biochemistry. His medical degree was received from the Philadelphia College of Osteopathic Medicine in 2001 and his MBA was received from Emory University’s Goizueta Business School in 2011. He has been faculty with the Columbus Regional Health Family Medicine Residency as well as Director of Family Medicine and Urgent Care. He currently holds faculty appointments at the Mercer School of Medicine and Philadelphia College Osteopathic Medicine. Dr. Kingsley currently serves as Chair of the Board of Trustees for the Association for Clinical Research Professionals He is responsible for overseeing the completion of more than 100 clinical trials with over 1,000,000 patients.

 

Visit Our Team page to learn more about Crissy MacDonald and other members of The Avoca Group.