Dante Consulting Services, regulatory submission specialists and providers of expert-led clinical research training, announces a comprehensive webinar series that will focus exclusively on quality control and quality assurance within the pharmaceutical industry. The clinical research training webinars will feature some of Dante's top instructors and educators including CEO Dr. Diane Mauriello. Dante anticipates a large turnout for this series; if you are planning to attend, please register as early as possible (see information below regarding registration).
By using a collaborative meeting interface, Dante Consulting Services will be making this clinical research training webinar series truly interactive.
As quality control and quality assurance continue to take on a more critical role in the regulatory submission process, these webinars will be both timely and informative.
At the present time, the clinical research training - webinar series is planned to include a wide range of topics, including:
Why use quality control in clinical research?
Why is quality control important in regulatory submissions?
What data and regulatory submission documents require quality control?
clinical study reports (CSRs)
tables, listings, figures, and graphs [TLGFs]
patient profiles [PPPs]
pre-clinical reports eCTD modules 2.6
controls, manufacturing and consistency [CMC]
integrated summary of safety [ISS] documents
integrated summary of efficacy [ISE] documents
eCTD modules 2.7
eCTD modules 2.5, 2.6
Quality control provides clinical research Return of Investment (ROI): How?
fast track approvals
cost effective
benefits to well-controlled data and documents
confidence in the accuracy of previously submitted materials to FDA and other regulatory agencies
ability to determine ROI endpoints and outcome benefits for your company
Additional information on the clincal research training - webinars and registration procedures will be posted on the Dante Resources web site in March, 2010. The webinars
are scheduled to begin in April, 2010. Please check back soon for updated information.
