Panel Discussion: R3 Transition Office Hours: Small-Group SOP Troubleshooting

About this session

Even after multiple ICH E6(R3) presentations, many research organizations still struggle to implement it. How should SOPs change? What happens when institutional policies conflict with ICH E6 (R3) principles? How should sites revise deviation, oversight, documentation, and training procedures?

In this interactive office-hours session, attendees will bring real implementation questions, SOP excerpts, and operational challenges for discussion with experienced quality and regulatory experts. Rather than another lecture on the guideline itself, the focus will be on practical application, peer discussion, and actionable next steps.

Participants will leave with:

Strategies for updating SOPs and work instructions

Approaches for working within AMC and institutional governance structures

Examples of R3-aligned quality language

Practical solutions to common implementation barriers

Greater confidence preparing their organization for the transition to E6(R3)

Speakers

• MP

  Maryleen Lovell- Petronilia

  Manager Quality Assurance & Compliance · EmVenio Clinical Research

  Speaker

• AW

  Angela Wilmer

  VP, Compliance & Quality Assurance · WCG

  Speaker

• 

  Jennifer Peterson

  Director, Quality · EmVenio

  Speaker