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Introduction to Regulatory Affairs Professionals' Roles
| Content Provider | Scilit |
|---|---|
| Author | Su, Dacia |
| Copyright Year | 2021 |
| Description | Regulatory affairs professionals can be found in all sorts of companies, for example, biotech, pharmaceuticals, medical devices, diagnostics, and even nutritional products. They play critical roles in the health product lifecycle, from development through post-market approval. The usual responsibilities would be in the following general areas: To keep track of the ever-changing regulations in the countries in which the company wishes to distribute its products. To advise companies on the regulatory changes that would affect proposed activities where this is often one of the important factors for a commercial product launch. It often enables the commercial team to be able to launch the product effectively, by being prepared once product approval is given. 64To ensure that their companies comply with all of the regulations and laws. To identify risk and develop contingency plans. For medical products, risk associated in the medical device would often translate to harm to people. To present registration documents to regulatory agencies and carry out all subsequent negotiations necessary to obtain and maintain the right to market the products. It is not a simple process as it often involves collating and evaluating scientific data. Book Name: Medical Affairs |
| Related Links | https://api.taylorfrancis.com/content/chapters/edit/download?identifierName=doi&identifierValue=10.1201/9781003207696-8&type=chapterpdf |
| Ending Page | 65 |
| Page Count | 3 |
| Starting Page | 63 |
| DOI | 10.1201/9781003207696-8 |
| Language | English |
| Publisher | Informa UK Limited |
| Publisher Date | 2021-11-25 |
| Access Restriction | Open |
| Subject Keyword | Book Name: Medical Affairs Market Medical Devices Commercial Often Product Launch Regulatory Affairs |
| Content Type | Text |
| Resource Type | Chapter |
