ALS 419: Chemistry, Manufacturing, and Controls Regulation of Pharmaceuticals
Course Number: ALS 419
Course Name: Chemistry, Manufacturing, and Controls Regulation of Pharmaceuticals
No. Units: 1.5
Faculty/Instructor(s): Michelle Wells
400-level Technical/Business Designations: Technical
Clinical and Regulatory Affairs: Required
Pharmaceutical Discovery and Development: Elective
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.
Prerequisite of ALS 362 or Permission of Instructor (PPM; PPC); Recommended: ALS 418
The objective of ALS 419 is to provide students with a board understanding of the scientific and regulatory principles needed for CMC compliance and innovation in the pharmaceutical and medical device industries. Specifically:
Provide students with an understanding of the structure and responsibilities of CMC regulatory professionals and organizations.
Provide students with an understanding of national regulatory agencies, international harmonization efforts, and other organizations that set regulations and standards for the pharmaceutical and medical device industry.
Instruct students in the requirements and principles of the International Conference on Harmonization (ICH) and World Health Organization (WHO), and specifically where these guidelines are in force.
Help students to develop the logic and critical thinking skills to develop regulatory strategies for new product development and post-approval changes for innovative pharmaceuticals and generics or Biosimilars.
Provide students with an understanding of best practices in counterfeit management.
Teach students the expectations and responsibilities of regulatory leadership in the Pharmaceutical and Medical Device Industry through a case study approach of successful strategies and enforcement actions.
By the end of this course the student will understand the scientific and regulatory basis for CMC regulatory compliance and innovation in the pharmaceutical and medical device industries.
Students will be prepared for entry professional roles in CMC regulatory affairs organizations through understanding of global regulatory agencies and inspectorates and instruction in post approval reporting requirements for existing products and the newly introduced comparability/interchangeability requirements for generics and Biosimilars.
Students will also understand the reporting requirements for deviations and the conduct of recalls or counterfeits management.
Students will learn the authority of, and how to interact with, national inspectorates and regulatory compliance offices. There will be with particular emphasis on inspection coordination and resolution of compliance or product quality issues.
Last, the student will be prepared for management positions in pharmaceutical and medical devices industries through instruction in regulatory expectations for management, industry best practices, and case studies of management failures in regulatory compliance.