Efficient and Transparent Approval Processes for Pharmaceuticals
Purpose: This course is designed around the long history of medicine approval that involves many national and international stakeholders. There is a need for the process to be of high quality, efficient, as well as transparent. Participants learn how to balance these requirements in the assessment/approval processes and apply them to their own contexts.
Content: The course covers: pharmaceutical policy and ethics, regulatory science, risk theory, building quality into assessment processes, inspection preparations, as well as how to handle new trends in drug development such as the need for transparency and patient involvement. Guest lecturers, excursions, and hands-on practice provide the theoretical and practical knowledge needed for participants to understand and critically use some of the new trends in approval of medicines to their own Action Plans and proposed solutions.
Target group: The course targets professionals working with drug evaluation or similar, staff responsible for product and company approvals, specialists in clinical trials, and those developing framework/standards for assessing/approving drugs. No particular employment category is required, and there is also relevance for both experts and decision makers.