Medical and Regulatory Affairs

Premier Research to Present at the 24th Annual EuroDIA Meeting

Premier Research will be participating at the 24th Annual EuroDIA Meeting in Copenhagen, Denmark.

Sherri Hubby, Director, US Quality Assurance, will present “A Global Perspective from Ethics, Accreditation Bodies and Industry on Conducting Clinical Trials to Ensure Compliance” on Tuesday, March 27 at 16:00. With the increased challenges that come with conducting clinical trials in global markets and shortened timelines, many groups must work together to achieve balance and build public assurance. This session will review how quality programs are being conducted to assess compliance and to ensure consistency of ethical review and decision-making despite cultural differences. Practical information will be shared including how to identify gaps for managing clinical trial weaknesses and audit readiness tips.

In addition, she will present a poster entitled “A Comparison of Regulatory Evidence Techniques used by Pharma and Regulators regarding Investigator Misconduct in Clinical Trials.” The poster will review the process of collecting legal evidence when scientific misconduct is suspected at a clinical investigator site. A comparison between the investigative techniques utilized by different regulatory agencies will be covered and how pharma can be best prepared.

Gloria Miller, Senior Auditor – Quality Assurance, will present a poster entitled “Pharma Quality Agreements.” The objective of this poster is to provide an understanding of the basic elements of a Pharma Quality Agreement as well as to assist in determining when quality agreements are needed and mitigate risk with properly executed quality agreements.​