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Just the Right Tool: ICH E6 (R2) Compliance Tools for Small to Mid-Size Companies
Session Chair(s)
Maryrose Petrizzo, MS
President and Consultant
Clinical Quality Assured,LLC, United States
The new ICH E6 (R2) guidance with it’s emphasis on risk assessment and Sponsor Oversight, has proven to be challenging for small to mid-size companies to comply .This workshop will present tools for compliance developed by the DIA GCP/QA Community.
Learning Objective : Identify the new requirements of ICH E6 (R2); Discuss challenges to comply for small to mid-size companies; Demonstrate a simplified risk assessment tool; Demonstrate a tool for vendor oversight.
Speaker(s)
Facilitator
Sandy Mohan, PHD
Immune Design, United States
Vice President, Quality and Compliance