Case Study: Facilitating Efficient Lifecycle Management via ICH Q12

Extended Learning
Learning Level: Intermediate
Time: 1100 - 1230 ET
Session Length: 1.5 hours

ICH Q12 introduces regulatory mechanisms, such as established conditions (ECs), to simplify and expedite post approval product variations and enable continual product improvement. As illustrated by this case study for a small molecule product approved by the US FDA in the pilot program, the appropriate application of ECs helps validate the principles and can successfully narrow the technical and regulatory gaps that limited the realization of flexible regulatory approaches promised by the application of Quality by Design (QbD) principles

Learning Objectives

1. ICH Q12 includes both technical and regulatory considerations for pharmaceutical product lifecycle management. In this session, you will learn about the new tools in ICH Q12.
2. Appropriate application of ICH Q12 tools can successfully narrow the technical and regulatory gaps that limited the realization of flexible regulatory approaches in the past. Learn how science- and risk-based established conditions and reporting categories can be used to both standardize and improve efficiency of product lifecycle management.
3. Flexibility in manufacturing scale, equipment and facility changes is key to managing supply based on changing global market demands. Learn how reductions in post approval submissions can alleviate some of the burden for products that underwent accelerated approvals - especially with COVID vaccines and therapies.

Speakers

Timothy J.N. Watson, PhD

Vice President – Head of CMC Regulatory Affairs

Gilead Sciences

Connie Langer

Senior Director, Quality Regulatory Intelligence

Pfizer

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