ExL’s 7th Clinical Trials Inspection Readiness Summit

August 13-14, 2018  |  The Inn at Penn  |  Philadelphia, PA

As clinical trials are conducted, inspections ensure quality and integrity of care, data and drug performance. As sponsors for clinical trials, pharmaceutical companies are required to ensure GCP guidelines are upheld by implementing inspection readiness. These inspections are conducted by regulatory authorities, which all have unique regulations and caveats. These nuances make inspection readiness a difficult and resource-consuming battle. Clinical trials must be prepared for visits from countless stakeholders over their course. At the 7th Clinical Trials Inspection Readiness Summit, you will learn to improve inspection readiness and trial success through better documentation and operational standards.

Join Avoca for the Following Session:

Monday, August 13  |  1:45pm

Comparing how agencies (FDA, EMA, MHRA, Health Canada, PMDA, and CFDA) conduct inspections. What are the implications of ICH E6 (R2), based on recent inspection experiences?

Pharmaceutical and biotech companies engage in global clinical trials with the intent of ultimately providing access to innovative new products in multiple international markets. To achieve market authorization approvals, these companies must navigate varying approaches by each agency for regulatory review and inspections. This presentation will share insights from a collaborative effort by Avoca Quality Consortium® Member companies relative to inspections by the FDA, EMA, MHRA, Health Canada, PMDA, and CFDA. Commonalities and differences will be evaluated, including how agency inspections are adapting as a result of ICH E6 (R2).

Key Take-aways:

• Comparisons on inspection focus, approaches, and findings across various agencies
• Sharing of observed changes in inspection focus, approaches, and findings based on ICH E6 (R2)
• Experiences and suggestions for more effective inspection preparation and inspection readiness on an ongoing basis

PRESENTED BY:

Steve Whittaker Senior Consultant, The Avoca Group

Need more information? Contact us with your questions or to schedule a consultation.