Regulatory Chemistry, Manufacturing and Control (CMC) requirements determine the strategy parameters for new pharmaceutical process development and changes post approval. Knowledge of CMC requirements and relevant agencies is a key success factor in pharmaceutical approval and compliance. In particular, globalization has caused a significantly more complex regulatory environment for the manufacture and distribution of pharmaceuticals (and medical devices). Most product supply chains are now multinational with increasing trends towards investment in rapidly developing but poorly regulated nations. The development of regulatory strategies for product development and post approval changes requires the understanding of many national regulatory agencies and international harmonization efforts. The advent of Biosimilars will place increased emphasis on CMC product characterization and process comparability and/or interchangeability as the key criteria for introduction of “generic” biologics.
Often the introduction of product production and distribution improvements is limited by the effectiveness of the Chemistry, Manufacturing, and Control (CMC) regulatory strategy employed by the firm. Understanding of post approval reporting requirements for product deviation and needed field actions is an important responsibility of Regulatory CMC organizations. Requirements vary globally and are subject to strict filing timelines. In addition, management of inspectional schedules and resolution of inspectional findings or other enforcement actions is the responsibility of Regulatory CMC. Effective CMC organizations coordinate with global regulatory agencies to develop risk based approaches to inspection frequency and focus. Similar risk-based approaches are developed with global regulatory agencies to detect and prevent counterfeiting and product diversion. These are increasingly difficult problems in the global environment.
Persons knowledgeable in the principles and practice of regulatory CMC requirements of are in high demand and hold positions of significant responsibility within the private and public sectors of the healthcare industry. The primary goal of this course is to provide students with an advanced background in the principles and requirements of regulatory CMC including Post Approval reporting requirements, deviation reporting, Inspection coordination and resolution, and Good Distribution Practices (GDP) practices. Through a series of lectures and case studies this course will teach the critical thinking and judgment skills that are needed for the development of CMC regulatory strategies and influence.
MEng program students only
- Introduction to the Registration and Commercialization of New biotechnology products + Post Approval Changes
- Stability Considerations for Biotechnological Products
- Biosimilars – Scientific and Quality Considerations
- GMP and Inspection Management
- Understand the Data requirements for CTD (Module 3)
- Post Marketing Surveillance – Pharmacovigilance
- Escalation of FDA Enforcement Actions