Regulators have long supported quality by design and risk-based approaches for clinical trials, but adoption has been slow. This session explores opportunities and barriers to implementing risk-based record filing with the ICH GCP E6(R3) update.
Key Benefits of Attending This Session:- Learn about the regulatory acceptance of quality by design and risk-based approaches
- Discuss the challenges that have hindered the adoption of risk-based filing of records
- Examine the potential benefits and opportunities for adopting these practices in your TMF management
- Receive practical advice on how to develop a sound rationale for your approach to TMF management
