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Drug development and clinical trials

Drug development and clinical trials, 3 credits (hp)

Course given autumn 2022

Week 39-41 (29 September – 14 October)

Course leader

Fredrik Ek (fredrik.ek@med.lu.se)

Ana Carneiro (ana.carneiro@med.lu.se)

Examiner

Marcus Järås (marcus.jaras@med.lu.se

Target group

Ph.D. students at a Faculty of Medicine

Language

English

Scope

The course equals two week (3 hp/credits). 10 days are scheduled, as well as self-studies.

Place

See schedule

 Number of participants

15

Course content

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.

 

Learning outcomes

  • 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

 

Course design

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.

 

Assessment

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.

 

Grades

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.

 

Entry requirements

PhD students at a Medical faculty.

 

Literature

Relevant articles will be distributed to the students during the course. The students will also search for relevant information themselves.

Apply here

The course is still open for application for autumn 2022.