2nd European Clinical Trials Inspection Readiness Summit

2nd European Clinical Trials Inspection Readiness Summit
You know better than anyone how crucial it is to be prepared for regulatory inspections at your clinical trial sites. Maintaining inspection readiness at all times means managing a constantly evolving set of processes that must be in place in order to ensure an inspection is given immediate and complete access to clinical trial records. Sponsor companies need to be at the helm of the effort to remain compliant — which is a huge burden to bear.

Sponsor companies must evaluate potential clinical trial partners, define clear responsibilities for each stakeholder and attain top-notch document quality, at the same time ensuring that all relevant information is accessible to speakers whenever they may arrive. Anything less than complete GCP compliance can result in heavy fines and a loss of reputation in the market.

The 2nd European Clinical Trials Inspection Readiness Summit provides life science industry professionals with lessons learned by industry speakers who have firsthand experience. Delegates will leave the event armed with best practices in partner oversight and metrics, data quality, legacy system interoperability, and risk assessment tools; a better understanding of what health authorities command; and the confidence needed to bring SOPs to the table for company-wide implementation.

Top Five Reasons to Attend

1. Review crucial information and analyze regulations from around the world, with a focus on FDA, EMA, PMDA and MHRA regulations
2. Benchmark the success of your clinical trial with metrics for measuring the performance of CROs and trial sites
3. Learn strategies for ensuring there is a comprehensive clinical trial storyboard so inspectors can recreate the trial
4. Leverage process maps that can be applied to streamline TMF management and the key team members who need to be involved
5. Innovate your inspection readiness SOPs armed with information on risk-based modeling for inspection readiness