Principles and Practice of Pharmaceutical Medicine
course to register for the examination, provided the candidate has adequate experience in pharmaceu- tical medicine. Physicians ...
Industry’ is listed as a postgraduate competence (‘capacidade’). Sweden There is a 2-year diploma course in pharmaceutical medic ...
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3 Clinical Research Education and Training for Biopharmaceutical Staff Peter Marks 3.1 Introduction The biopharmaceutical indust ...
A competency-based education and training system (CBETS) details the essential knowledge and skills needed by sponsor’s staff to ...
Clinical Trials’ and ‘Multinational Investigational Drug Companies’ by Bert Spilker. Many regula- tory authorities also provide ...
dose-ranging studies; dose-titration studies; marketing and safety surveillance studies; studies supporting over-the-counter ...
identifying primary efficacy and safety para- meters; determiningappropriatesubjectselectioncriteria; identifying correct dos ...
profile of the overall trial design. Good Quality Schedule of Assessments sections also include acceptable time windows around t ...
The section will also detail the requireme- nts for obtaining informed consent from trial sub- jects. For trials conducted in th ...
the procedures for ordering bulk investigational product supplies; models for bulk investigational product quantity estimation; ...
standards. Normally, the monitor or CRA conducts this. Special attention is paid to the quality of the investigator’s staff and ...
the investigator and sub-investigator(s), the study coordinator or research nurse, pharmacist and laboratory personnel or specia ...
amount of data and the number of visits. Generally, most investigators should be monitored every four to six weeks. The monitors ...
approval process of the NDA/BLA/MAA and the marketing of the drug, safety is the primary concern of any clinical program. Manage ...
consistency and unrecognized errors once they are received in-house. The use of computer edit and logic checks supports this eff ...
interpretation of efficacy findings; ability to ensure that the conclusions are sup- ported by the data; ability to ensure th ...
Certain trends and directions can be recognized in the preparation of NDA/BLA/MAAs. The ICH has the long-term goal of harmonizin ...
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SECTION II Drug Discovery and Development Introduction How does a chemical become a medicine? A better question, given the huge ...
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