5th Clinical Trials Inspection Readiness Summit

An inspection from the FDA can pop up at any time throughout a clinical trial pipeline, and being prepared is key. The industry must move toward innovative methods and utilize new technologies to ensure compliance in a global environment. Change your inspection readiness strategy into one that is proactive and preventative, instead of one that is mainly concerned with putting out fires. Developing effective strategies for risk management through effective vendor selection and oversight, expert knowledge of FDA guidances, budget management, and TMF and pharmacovigilance audits will put your organization ahead of the pack.

The 5th Clinical Trials Inspection Readiness Summit is designed to explore best practices for developing and maintaining compliance at clinical trial inspection sites. Delegates will leave the event armed with strategies regarding partner oversight, metrics, data quality, TMFs, legacy system interoperability and risk assessment tools. Additionally, this event will provide opportunities for sharing best practices and networking across all contributors and stakeholders, including sponsors, regulators, CROs and project teams.

Top Five Reasons to Attend

• Leverage strategies for obtaining additional resources and funds through increased corporate buy-in
• Manage TMF data, documents and processes via eTMF during the study, and use a paper format for the final TMF filing and archive
• Prepare to reveal your internal inspection process itself as a potential object of audit
• Identify critical areas to ensure TMF completeness and accuracy, and how to facilitate the smooth transfer of documents between sites and sponsor companies
• Explore the difference in regulatory guidelines in order to tailor SOPs for each site

Who Should Attend

Professionals in the life sciences industry with responsibilities in the following areas:

This program is also of interest to clinical QA/compliance professionals involved with: