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By William P. Stoltman and Ruth Stevens

When a pharmaceutical scientist first enters the drug development environment, they may feel overwhelmed by the plethora of laws, regulations, and associated guides and guidances that exert control over what, how, and when they participate in the tasks involved in bringing a product from an idea to a commercial reality. Prior to their entry into the pharmaceutical industry, such scientists were likely mostly focused on the peer-review process involved in successfully publishing research articles. Once working in the industry, the scientist is confronted with specific requirements regarding all aspects of their work, especially documentation.

In order to survive and succeed as part of the drug development process, it’s critical to know how to navigate the requirements of regulatory compliance. Whether or not compliance requirements are met can mean the difference between work that contributes to a successful product development program or work that ends up costly but futile.

An adequate familiarization with the components of regulatory compliance should include:

  1. knowing where the rules come from and how they are created;
  2. knowing what the critical rules are for a given individuals’ responsibilities;
  3. knowing how to navigate and understand the rules; and
  4. knowing how to stay current with the rules.

For drug development, there are three primary regulatory compliance “pillars,” i.e., three main areas of regulatory requirements as presented in the Code of Federal Regulations (CFR):

  • Good Laboratory Practices (GLPs): Control the conduct of preclinical animal studies on proposed drug products, which must be largely completed before the proposed product can be tested in humans.
  • Good Clinical Practices (GCPs): Regulate the conduct of clinical studies of proposed new drug products in humans.
  • Good Manufacturing Practices (GMPs): Specify the requirements for producing and testing the proposed drug product, including demonstrating the product’s shelf life.

In order to obtain approval of a product application—­­­a new drug application, abbreviated new drug application, or biologics license application—the requirements specified in these regulations must be met. All of these requirements feed directly into the contents of an application to market a new drug product, which now must be provided to the Food and Drug Administration (FDA) in the electronic common technical document (eCTD) format.

The live training course Overview of Regulatory Compliance: Connectivity and Impact on June 2 presents fundamental components required for regulatory compliance starting with the statutory authority for drug regulation following the mechanisms for the creation of regulations, and it illustrates the use of the information developed under the regulations in drug product applications. The organizing team is confident that drug development personnel from all areas of expertise and professional levels will benefit from attending this first installment of the Regulatory Affairs 102 live training course. This installment sets the foundation for the next nine live webinars covering of the three compliance pillars: GLP, GCP, and GMP.

William P. Stoltman, J.D., is senior director of Quality Assurance and Regulatory Compliance at Camargo Pharmaceutical Services in Cincinnati, Ohio. He has over thirty years of experience in the pharmaceutical industry, primarily in the area of quality assurance, regulatory affairs, and compliance, including a great deal of contact with FDA.
Ruth Stevens, Ph.D., M.B.A., has had an integral role in all aspects of drug development for more than 25 years, and brings former FDA team leader experience to her role as chief scientific officer and EVP of Camargo Pharmaceutical Services. She is a pharmacokineticist and an expert in regulatory strategy, and has overseen the development of the full range of regulatory submissions as well as applications for compassionate use.