Q12 Aims to Align CMC with Accelerated Development & Approval

Dr. Moheb M. Nasr, who serves as Vice President, CMC Regulatory Strategy for GlaxoSmithKline, is a member and rapporteur of the Expert Working Group for the ICH Q12 Guideline, Technical and Regulatory Considerations for the Pharmaceutical Product Lifecycle. “We realized that the ICH 8 through ICH 11 Guidelines were mostly on the development stage of the life cycle, and there is a gap that needs to address the commercial phase of the life cycle,” he explains in this exclusive Global Forum podcast. “Hence, there was an agreement to develop an ICH Q12 to address this gap and in particular to develop a roadmap to facilitate the management, from the technical, commercial, and regulatory perspectives, of the life cycle.” Dr. Nasr also serves on the program committee for DIA’s 2017 CMC Workshop, where he will co-chair the session that further explains the Benefits and Challenges of ICH Q12 Life Cycle Management. Register to attend the DIA 2017 CMC Workshop!