Regulatory affairs

For more information on regulatory affairs jobs, consult the Internet wvnv.job-sites.com/ra/rajobs.htm. 

The importance to a pharmaceutical company of developmental efforts surpasses or equals that of discovery projects. Process chemists work exclusively on commercially promising imdertaldngs and often on successful ones leading to product introductions. By contrast, medicinal chemists expend most of their efforts on ventures that may be scientific successes but that ultimately become commercial failures. Development, to plunder Oscar WQde, has a future while discovery has a past. It is a little known subject, however, so this section supplements both the preceding introduction to chemical development and the coitung chapter detailing the topic. 

Synthetic organic chemists at all degree levels find employment in chemical development, and many but not all of their jobs are permanent ones. Fipcos hire inexperienced B.S. chemists for development jobs, and many experienced researchers transfer from discovery to development research early in their careers. 

This chapter presents an overall summary as a snapshot in time for an ever-evolving arena in the pharmaceutical industry, and the information contained herein is meant to supplement, not replace, the many excellent guidance documents published and maintained by regulatory authorities, worldwide, as well as the comprehensive documents published by the International Conference on Harmonization (ICH). 

The primary focus of this chapter will be on conventional, low-molecular-weight APIs manufactured by chemical synthesis. It is recognized that APIs also are derived from fermentation, proteins, peptides, etc. Specific regulations and guidelines exist for these compounds, which will not be covered in this work. This chapter will also focus mainly on the regulations as they apply to innovator companies seeking approval for new chemical entities. Separate but similar requirements exist for the development and maintenance of drug master files (DMFs) submitted by bulk chemical 

The original investigational applications and subsequent updates are formally reviewed by the agencies. For original applications, the clinical studies may typically be initiated 

Research-oriented companies will evaluate a number of investigational compounds for potential therapeutic indications. A majority of the potential candidates do not survive the safety and efficacy studies conducted as part of the clinical 

Following submission of the application, certain agencies will perform a high-level review of its content to assure that all basic elements are contained in the submission. Once the application is considered accepted for filing, the reviewing chemist or authority from each agency will perform a very detailed evaluation of the CMC documentation, and where appropriate will provide specific questions or comments on the content of the documentation. The CMC questions often seek clarification or additional information or data on specific items, or state concerns the reviewer has with the content or conclusions provided for certain aspects of the application. 

This description, by its very nature, is only an overview on the main provisions of a Manager s role in ensuring a safe and healthy environment in the laboratory. There are many websites offering up to date information on HSE legislation [B-24], and innumerable training courses for those people working in companies who do not offer in house training. 

Some regulations affecting R %D laboratories and chemical plants are statutory whilst others are voluntary. 

In this section the regulations covering the operations within the chemical, pharmaceutical and allied industries will be covered in outline before going on to the concept of Total Quality Management. The other very important area of the regulations covering product registration will be described in Section D, 2.2.2.I. 

The worldwide standards adopted since the late 1980s is the International Organization for Standardisation (ISO) ISO 9000 series and the latest version (2000) contains definitions of relevant terms [B-25]. 

Quality The degree to which a set ofinherent characteristics fulfils requirements. Quality Management System The management system to direct and control an organisation with regard to quality. 

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F. T. Ryan, State and Regulatory Affairs, Governmental Relations, The Goodyear Tire and Rubber Co., Washington, D.C. 

Burden and to the Office of Information and Regulatory Affairs. Office of Management and Budget Paperworx Reduction Project (2070H3003). Washingtcn. O.C. 2Q6Q3. ... 

District of Columbia Department of Consumer and Regulatory Affairs... 

FDA Guideline to Inspection of Validation of Cleaning Processes, Office of Regulatory Affairs, July 1993... 

College of Health Professions Medical University of South Carolina Charleston, South Carolina Wesley G. Byerly, PharmD Executive Director for Research Regulatory Affairs Keely L. Cook, MPAS, PA-C Assistant Professor Doisy College of Health Sciences Saint Louis University St. Louis, Missouri... 

Robert E. Roehrs, Ph.D. Vice President, Department of Drug Regulatory Affairs, Alcon Research Ltd., Fort Worth, Texas... 

Richard C. Honeycutt, Ph.D., was born in Newport News, VA, in 1945. He attended Anderson University in Anderson, IN, from 1963 to 1967 and earned an A.B. in Chemistry. He received his Ph.D. in Biochemistry from Purdue University in 1971 and served as a Postdoctoral Fellow from 1971 to 1973 at the Smithsonian Institution s Radiation Biology Laboratory. Dr. Honeycutt worked as a Senior Chemist at Rohm and Haas Company from 1973 to 1976 and as a Senior Metabolism Chemist at Ciba Geigy from 1976 to 1989. Currently, he is President of the Hazard Evaluation and Regulatory Affairs Company, Inc., which he founded in 1990, and is an analytical biochemist and field research specialist/consultant engaged in exposure assessment of pesticides to humans and the environment. 

Residues and Food Safety Specialist European Regulatory Affairs Aventis CropScience GmbH Industriepark Hochst Frankfurt, Germany... 

Post-authorization evaluation of medicines for human use. This regulatory affairs unit is responsible for issues such as post-marketing surveillance of drugs. 

De Jong, M. 1998. FAQs on EU Pharmaceutical Regulatory Affairs. Brookwood Medical Publications. 

Pisano, D. and Mantus, D. 2003. FDA Regulatory Affairs, a Guide for prescription Drugs, Medical Devices and Biologies. CRC Press. 

US FDA, ITG subject bacterial endotoxins/pyrogens. In Office of Regulatory Affairs (Ed.), Inspector s Technical Guide, Washington, DC, 1987. 

SAFETY, HEALTH AND ENVIRONMENTAL REGULATORY AFFAIRS FOR COLOURANTS USED IN THE PLASTICS INDUSTRY... 

Office of Regulatory Affairs, Conditions Under Which Homeopathic Drugs May Be Marketed, CPG 7132.15, Sec. 400.400, FDA, Rockville, MD, Revised March 1995. 

Ronald A. Salerno Worldwide Regulatory Affairs, Wyeth Research, St. Davids, Pennsylvania, U.S. 

Office of Regulatory Affairs. Guide To Inspections Of Quality FDA, RockviUe,... 

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