Drug development and clinical trials, 3 credits (hp)
Course given autumn 2022
Week 39-41 (29 September – 14 October)
Fredrik Ek (firstname.lastname@example.org)
Ana Carneiro (email@example.com)
Marcus Järås (firstname.lastname@example.org)
Ph.D. students at a Faculty of Medicine
The course equals two week (3 hp/credits). 10 days are scheduled, as well as self-studies.
Number of participants
The course covers the general process for development of a new drug from preclinical discovery via pre-clinical development and clinical trials. The course will address scientific, strategic and regulatory challenges from discovery to approval of a new drug and also includes key methods and terminology. It also covers the importance of the professional groups that are involved in the different phases of the development of a new drug. This course will prepare you for future work in the pharmaceutical industry as well as work in academia regarding innovations, early drug development and entrepreneurship.
- give an account of drug development from discovery to registration of a new
drug and describe commonly occurring methods associated with drug development.
- give an account of important breakpoints in the drug development process
- give an account of different types of patents that occur in drug development
- describe the laws and rules that control the development of a new drug in the
pre-clinical and clinical phase
- describe the different phases of the clinical development
- give an account of different possibilities for funding drug development in the preclinical
and clinical phase
- participate in teamwork to provide theoretical and practical solutions for
assignments related to drug development and clinical trials
- behave with a professional approach, respect others' opinions in discussions of
drug development and clinical trials and meet set deadlines
- reflect on ethical considerations during the drug development process
- reflect on different strategies to achieve scientific, market-related and regulatory
goals during drug development
The fundament in the course is seminars by experts mainly from the Life science industry, but also from Region Skåne and Lund University. In addition to seminars, the students will carry out team-based activities. The working methods in the course mostly involve active learning, requiring the students to prepare before each teaching component. The students are expected to behave professionally and, just as in a future work situation, participate constructively in team-based activities.
Multiple-choice questions to test learning outcomes for knowledge and understanding. If there are special reasons, other forms of assessment may apply. The examiner, in consultation with Disability Support Services, may deviate from the regular form of examination in order to provide a permanently disabled student with a form of examination equivalent to that of a student without a disability.
Marking scale: Fail or Pass.
To achieve the grade of Pass as a final grade, the grade of Pass is required on the multiple-choice question test.
PhD students at a Medical faculty.
Relevant articles will be distributed to the students during the course. The students will also search for relevant information themselves.