SMRMIF005U Safety of Medicines - from Non-clinical Development to Pharmacovigilance

Volume 2023/2024
Education

This course is a compulsory course at the Master of Medicines Regulatory Affairs (MRA)

 

See course calendar for course dates

 

The course is compulsory at 2016-curriculum.

Course is open for master students and single course students.

Content

The content of this course covers the regulatory issues concerning medicines safety from non-clinical and clinical development up to post marketing pharmacovigilance, with emphasis on regulatory issues in the post-authorisation phase.

The course content includes:

1) non-clinical safety studies including methods for assessing safety in vitro and in vivo (animals).

2) principles of safety monitoring in clinical phase I, II and III studies. This includes in vivo pharmacology, PK/PD aspects, the observation of adverse events and their assessment (causality and seriousness).

3) pre-authorisation tasks concerning safety documentation, preparation of clinical study protocols and execution of clinical studies with focus on the collection and reporting of safety data (development safety update reports, DSUR).

4) pharmacovigilance and risk management activities after marketing (phase IV), including spontaneous reporting, signal detection, periodic safety update reports (PSUR), benefit-risk assessment, planning and conduct of post-authorisation safety and effectiveness studies, and the implementation of risk minimisation measures.

5) regulatory requirements and processes concerning medicines safety both before and after marketing authorisation, including the roles of regulatory bodies (EMA, PRAC and CHMP, FDA), EU and international guidelines (GVP, ICH).

After completion the student will be able to account for, scientifically discuss, advise on and evaluate the role of non-clinical, clinical and epidemiological scientific safety assessments and related regulatory requirements as the basis for the continuing safety assessment of medicines.

Learning Outcome

Knowledge

  • Explain regulatory safety requirements covering non-clinical and clinical development as well as the post-authorisation phase.
  • Explain the principles and management of pharmacovigilance before and after authorisation including risk-benefit assessment and risk management.
  • Identify the timing and requirement of non-clinical, clinical and post-authorisation safety studies for both small molecules and biopharmaceuticals.

 

Skill

  • Discuss and evaluate safety requirements for specific types of medicines, including both small molecules and biopharmaceuticals.
  • Discuss and evaluate requirements for non-clinical, clinical and post-marketing safety assessments.
  • Evaluate efficacy and safety data obtained from non-clinical safety studies, clinical studies and post-marketing risk assessment.
  • Apply and evaluate requirements for post marketing pharmacovigilance and risk management.

 

Competencies

  • Plan and make decisions with regard to non-clinical development and documentation.
  • Review and assess global safety data at all phases of drug development and post-authorisation.
  • Integrate all safety aspects when assessing drug candidates for selection during clinical development and for market authorisation approval.
  • Take responsibility for continuous risk-benefit assessment, pharmacovigilance and risk management.

The syllabus comprises relevant international guidelines and regulations, EC directives, and a selection of books, book chapters, scientific papers and review papers.
A complete list of reading material will be distributed electronically before the course.
 

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years working experience within regulatory affairs
• Proficiency in English
Preparation (75 hours)
Lectures (35 hours)
Practical exercises (25 hours)
  • Category
  • Hours
  • Lectures
  • 35
  • Preparation
  • 60
  • Theory exercises
  • 14
  • Exam Preparation
  • 27
  • Exam
  • 3
  • Total
  • 139
Oral
Continuous feedback during the course of the semester
Peer feedback (Students give each other feedback)
Credit
5 ECTS
Type of assessment
Written assignment, 3 hours
Type of assessment details
Written assignment, 3 hours

Define an action plan on the basis of a case study (40%)
Short descriptive questions (60%)

The examination will be held on Digital Exam - The online platform for examination at the University of Copenhagen approximately one month after completion of the course
Aid
All aids allowed
Marking scale
7-point grading scale
Censorship form
External censorship
Exam period

Exam schedul is published on the mra.ku.dk

Re-exam

Exam schedul is published on the mra.ku.dk

Criteria for exam assesment

The exam is based on the combined evaluations of case study and questions.

To achieve the grade 12 the student should be able to:

Knowledge

  • Explain regulatory safety requirements covering non-clinical and clinical development as well as the post-authorisation phase.
  • Explain the principles and management of pharmacovigilance before and after authorisation including risk-benefit assessment and risk management.
  • Identify the timing and requirement of non-clinical, clinical and post-authorisation safety studies for both small molecules and biopharmaceuticals.

 

Skill

  • Discuss and evaluate safety requirements for specific types of medicines, including both small molecules and biopharmaceuticals.
  • Discuss and evaluate requirements for non-clinical, clinical and post-marketing safety assessments.
  • Evaluate efficacy and safety data obtained from non-clinical safety studies, clinical studies and post-marketing risk assessment.
  • Apply and evaluate requirements for post marketing pharmacovigilance and risk management.

 

Competencies

  • Plan and make decisions with regard to non-clinical development and documentation.
  • Review and assess global safety data at all phases of drug development and post-authorisation.
  • Integrate all safety aspects when assessing drug candidates for selection during clinical development and for market authorisation approval.
  • Take responsibility for continuous risk-benefit assessment, pharmacovigilance and risk management.