Addressing Industry Pain Points
A proactive agenda focused on policy outcomes to advance specific operational interests of ACRO members.
ACRO directly engages regulators, customers and other stakeholders to facilitate our collective input on issues and initiatives such as the 21st Century Cures Act and the EU Clinical Trial Regulation. In 2017, ACRO’s Board of Directors established a committee to develop a proactive agenda focused on specific policy outcomes that would advance the collective interests of ACRO members.
Objective
ACRO’s Industry Pain Points Committee is tasked with identifying and prioritizing issues that affect members and could be addressed via the Association’s primary audiences of regulators, customers and policymakers.
Process
- Representatives from each member company work through their respective organizations to identify industry issues and corresponding subject matter experts.
- Committee consolidates input, proposes priority issues and desired outcomes to the ACRO Board of Directors.
- ACRO’s Board of Directors selects projects to focus on and charges the Committee and ACRO staff with developing and advancing initiatives for those priorities.
Current Projects
ACRO’s Industry Pain Points Committee is currently focused on:
- FDA BIMO Inspection Efficiency
- EMA/MHRA Trial Master File Expectations
- MHRA GxP Data Integrity Guidance
- ICH E6-R2, Sec. 5.2.1 Sponsor Oversight Ambiguity