July 17 to 18, 2023
Facilitating Patient Access through Digital Modernization
and Content Harmonization (Convergence) of the CMC Submission
As the pharmaceutical industry edges into the digital age of PHARMA 4.0, significant changes are coming for CMC principles and practices, knowledge management, and data sharing, to simplify and streamline global regulatory agency review of submissions. Simultaneously, stakeholders are learning ‘the hard way’ that speed to market with sustainable supply is an imperative to the public health globally. Patients cannot wait indefinitely for the industry to modernize regulatory processes and harmonize product quality standards.
This 2-day CMC forum will review the many initiatives that make up the next frontier in CMC.
On Day 1, key leaders will review content and data harmonization initiatives such as Structured Content Data Management (SCDM), revision of ICH M4Q, ISO IDMP and SPOR (Substances Products Organizations and Referentials), Pharmaceutical Quality/CMC (PQ/CMC), and Structured Product Quality Submissions (SPQS). Efforts toward multi-regulator collaboration will be presented, including reliance pathways, “The Pharmaceutical Quality Knowledge Management Strategy (PQ-KMS) initiated by the ICMRA, and the efforts of Accumulus. Digital initiatives such as Knowledge-aided Assessment & Structured Application (KASA), rolling dynamic review and Project Orbis will be reviewed, providing the purpose and status of each initiative.
Day 2 will focus on faster access to medicines through greater harmonization of the CMC principles and practices. Manufacturers produce the same product (quality, safety and efficacy) for worldwide use; yet global agencies continue to have different perspectives on what CMC content is acceptable to patients. Therefore, this workshop includes patient-centric, science-driven, risk-based approaches and will discuss the impact of divergence caused by a lack of globally harmonized quality standards and information requirements as part of regulatory review and approval.