Because our staff and consultants are considered thought
leaders in the CRO industry, we are often tapped for our
knowledge by both industry/trade publications and conferences.
Below are a few examples:
Orange Country Regulatory Affairs Discussion Group,
August 10, 2004
Clinical
Trial Management & Part 11 Compliance
Facilitating
the FDA Bioresearch Monitoring Inspection for Sponsor/Monitors:Touch
Briefings 1995
Orange Country Regulatory Affairs Discussion Group,
November 16, 2004
Emerging
Data File Initiatives & Standards: Potential Impact
on Global Clinical Studies
Regulatory Affairs Certification Discussion Group,
September 17, 2005
Good
Clinical Practice
Good
Laboratory Practice CFR 21 Part 58
Investigational
Device Exemptions 21 CFR Part 812
Investigational
New Drug Application 21 CFR Part 312
Ethics Presentation, September 15, 2006
University
Southern California School of Pharmacy Regulatory Science
Program
RAPS and ACRP Atlanta Chapters: "Regulatory Reality
in a GCP World" Ethics Presentation, January 20, 2007
Managing
Clinical Study Processes & Procedures to Facilitate
a Successful BIMO Inspection
