2.1 Good Clinical Practice
| 2.1 Good Clinical Practice |
| Pharmaceutical physicians are required by the nature of their job to keep themselves abreast of scientific advances that will have a major impact on the development of the new medicines of the future. A registered medical practitioner with appropriate special training should be in overall control of any research involving human subjects. This must include training in medical ethics and up to date best practices. Specific areas of ethical concern for Pharmaceutical Physicians: - Ensuring that they remain well informed about current scientific and medical knowledge in the areas of therapeutics in which they work. - Maintaining the high standards required by national and international regulations. - Assimilating constructive feedback from management, internal review committees, ethics committees and the regulatory authorities. - Designing clinical research programmes and protocols in areas of medical need according to regulatory requirements, national and international codes of practice, and the declaration of Helsinki. - Ensuring that they fulfil their obligations in clarifying, evaluating and reporting adverse events, whether they come from research protocols, spontaneous reports or as part of a formal surveillance programme. - Ensuring that documents submitted to the regulatory authorities accurately reflect the data that have been gathered in the development process. - Ensuring that relevant data are made available for publication and that articles submitted to journals accurately reflect the data on which they are based. - Passing of accurate and verifiable information to the company’s sales department. - Teaching, training, appraising and assessing of other members of the medical department. |
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