Regulatory professional

Regulatory professionals too often assume that any analytical method can undergo the steps necessary to validate its use in marketing a pharmaceutical product. In many cases the need for validation of a particular analytical method is often revealed late in the drug development process by corporate regulatory and quality assurance (QA) professionals who are responsible for compliance with the regulatory requirements associated with product registration. Commonly these individuals view the requirements and parameters of the validation processes as independent of the actual analytical chemistry and technical objective of the method itself. 

From this point the analytical department assumes leadership and begins by selecting the analytical technique. The selection process is dependent upon several related factors, including the analyte itself and the level of measurement precision required. Once the technique has been chosen, a suitable method is identified either from modification of an existing method or the development of a new method. Upon successful demonstration of method feasibility, the technical team members, in collaboration with the regulatory professionals, draft a test procedure and a validation protocol. 

Undoubtedly the major responsibility for generating a validated analytical method falls on the shoulders of the analytical chemist. The chemist must select an analytical technique that will fulfill the regulatory and technical requirements set forth by the regulatory professionals. This includes not only the analyte to identify or quantitate, but also the purity specifications for assay methods and the impurity specifications and the limit of detection and quantitation for related compound methods. The analytical technique chosen will depend upon the degree of precision, linearity, range, and accuracy necessary to meet the regulatory requirements. Once a new method is developed or the feasibility of an existing method is established,... 

Ultimately the technical objective of an analytical procedure, which is included as part of a registration application for pharmaceuticals, is the responsibility of the analytical department. This objective is directly related to the regulatory objective as defined by the regulatory professionals. For example, the regulatory professionals require a means to quantitate an API in a finished pharmaceutical for release between 95-105% of label claim. This translates into a technical objective for the analytical chemist that involves the selection of an analytical technique and the development of a method that has the required accuracy and precision to meet the requirements for release. 

This FDA Orphan-Drug Review checklist has been designed in consultation with FDA reviewers, industry consultants, and regulatory professionals to serve as a summary tool indicating the evaluative criteria used by the Office of Orphan-Drug Development to critique and assess applications received. It can be used internally as a part of the Quality Assurance process, as a guideline for regulatory development of an application, and/or as a self-assessment tool to predict likely FDA response to an application. 

A regulatory professional must be aware of the guidance documents that FDA has made available to assist industry to understand expectations regarding drug development and the approval process. The website providing the complete list of FDA guidances is updated almost daily. It may be accessed at http //www. fda.gov/cder/guidance/index.htm. 

This division has the greatest interest for the regulatory professional since the submission of new drugs is the most important and most difficult part of the working environment. As a consequence, this division will be dealt with in great detail. 

The MSDS provides comprehensive information about a chemical substance or mixture, including potential health, safety, and environmental hazards, and guidance on safe handling, use, and storage. Employers, workers, regulatory professionals, emergency personnel, and others use MSDSs as a source of information about hazards, advice on safety precautions, and regulatory information. The... 

How so Let us be more specific. Broadly, the regulatory professional is charged with ensuring compliance with established regulations and current standards for approval, and that the development and approval programs for medically necessary products are well-designed and well-executed. This function promotes bringing safe and medically important products to market as quickly as possible and with an appropriate product label. 

Of all of these, the ability to clearly communicate, negotiate, and build consensus using complex data is most pivotal to the successful regulatory professional. 

From a compliance standpoint, the regulatory professional oversees many aspects of the clinical study, including assurance that the application to permit... 

The established label must also be kept crurent as to the latest safety information, any changes associated with the drug class, or any changes to the product or its approved clinical uses. This is overseen by the regulatory professional, who coordinates submission and review of post-approval label revisions with regulatory bodies worldwide. 

Notwithstanding all the requirements for a complete, comprehensive and approv-able application, the regulatory professional is now called upon to assist in the design of the approval application and its subparts. The ultimate intent of this exercise is to render an application that is reviewer friendly. In the past, this ended at good copies, complete tables of contents, tabs, and reviewer guides. Now, with the advent of electronic applications, the sponsor may creatively use electronic commentary, hyperlinks, and application schematics to ease review. All of this translates into an efficient and potentially more rapid review, which is one of the cardinal aims. 

For the regulatory professional, discussions with regulators span the continuum of complexity. One moment, these discussions may be gaining concurrence on the most intricate issues - product quality issues, the design of clinical development... 

The regulatory professional must be seen as competent, trustworthy, and as a true partner to the regulator. This relationship must be built, nurtured, and maintained to assure good communication and review practice. It is built upon an a priori assumption that the regulatory professional is technically astute, sensitive to the reviewer s concerns, and established as (ever and always) a guardian of patient safety. 

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