Pharmacological and Clinical Aspects of Drug Safety

Course content

The course covers the pharmacology of adverse reactions, molecular mechanisms of toxicity, drug metabolism, drug-drug interactions and pharmacogenomics, pharmacokinetic and pharmacodynamic (PK/PD) aspects and allergic reactions. Examples of the most frequent and/or important adverse reactions with their clinical manifestations in different organ systems are described (nervous system, skin, gastrointestinal, liver, kidneys, cardiovascular, pulmonary, endocrine and metabolism). Characteristics of special populations and patients with specific risk factors for adverse effects are also presented, including the safety of drugs in pregnancy and lactation, paediatric patients and older adults. The course also comprises classification of adverse events (diagnostic terminology), evaluation (causality assessment, severity and seriousness), and reporting. Furthermore, the requirements for information recorded in individual case safety reports (ICSRs), guidelines and timelines for submission to regulatory authorities. The role of the marketing authorisation holder and periodic drug safety update Reports (PSURs) are also covered. Additionally, the possibility of preventing adverse effects, including individualised treatment (personalised medicine).

 

Topics are:

  • Pharmacological aspects of adverse reactions
    • Types of adverse reactions
    • Molecular mechanisms (drug-receptor interactions, specific organ toxicity)
    • PK/PD aspects, drug metabolism and excretion
    • Drug-drug interactions leading to adverse effects
    • Pharmacogenetics and risk of adverse effects
    • Dose-time-response – acute and chronic drug effects
    • Immunological aspects: allergic reactions, immunosuppression and -stimulation
  • Patient-related and clinical aspects
    • Clinical manifestation of adverse drug reactions in different body systems
    • Special populations and risk factors
    • Pregnancy and breastfeeding
    • Pregnancy outcomes and congenital malformations
    • The paediatric and the elderly population
    • Chronic diseases, hepatic or renal impairment
    • Drug addiction and abuse
    • Medication errors
    • Individualised treatment (personal medicine).
  • Individual case safety reports (ICSRs)
    • Definitions: Adverse events, adverse reactions, seriousness and severity
    • Overdose, abuse, misuse, medication error or occupational exposure, lack of effect
    • When to suspect, how to diagnose and when to report an adverse event
    • Requirements for the content of ICSRs
    • Causality assessment principles
    • Coding terminology (MEDDRA)
    • Sources of reports (healthcare professionals, patients)
    • Regulatory requirements and processes related to the submission of ICSRs 
    • International guidelines (GVP, ICH, FDA).
    • Reporting to regulatory authorities and the content of PSURs
Education

Master of Industrial Drug Development (MIND) - elective

The course is preapproved as an elective in the  Master Medicines Regulatory Affairs (MRA) programme. It is also open to single course students who meet the admission criteria.

See course calendar for course dates

 

Learning outcome

The aim of the course is to 

After completing the course the student is expected to be able to:


Knowledge

  • Understand pharmacological aspects of adverse drug reactions
  • Describe different types of adverse reactions and molecular mechanisms
  • Explain PK/PD aspects‚ drug metabolism and excretion, interactions and pharmacogenomics
  • Describe clinical features of adverse reactions in different body systems
  • Explain the risk of adverse reactions in special populations
  • Describe terminology, evaluation and reporting requirements of adverse reactions

 

Skills

  • Apply pharmacological knowledge to specific adverse effects
  • Describe treatment choice related to specific risk factors and populations
  • Evaluate clinical information in ICSRs and perform causality assessment
  • Compile, summarise and evaluate information on adverse effects
  • Present and discuss safety-related problems based on information in a PSUR

 

Competencies

  • Interpret data on suspected adverse drug reactions in ICSRs and PSURs
  • Discuss and explain specific drug-event combinations based on pharmacological principles
  • Argue for drug choice in relation to specific risk factors for adverse reactions
  • Collaborate and communicate effectively with other professionals with pharmacological, clinical and regulatory expertise

Online part:
Webinar and e-lessons that will introduce you to the background and pharmacological aspects of adverse reactions, equivalent to one full course day but can be taken over a period of 1 week.

On campus part:
Lectures, theory exercises including group work with real and simulated safety scenarios.
Self-study of course literature.

The syllabus comprises relevant legislation (including EMA directives and guidelines), good pharmacoepidemiology practice guidelines, ICH and FDA guidance documents, book chapters, scientific papers and review papers. Selected chapers from textbook (Mann’s Pharmacovigilance, current edition).

A list of reading material will be distributed electronically before the course with recommendations for reading. During the course further material for exercises, group work and case studies will be distributed.

Applicants must meet the following criteria:
• A bachelor's degree, a professional bachelor’s degree, a diploma degree, a master’s degree or equivalent within chemistry, biochemistry, pharmacy, medicine, biomedicine, human biology, molecular biology, veterinary sciences, health sciences, nursing, engineering or equivalent.
• At least two years of relevant work experience related to development of medicines
• Proficiency in English

Oral
Continuous feedback during the course of the semester
Peer feedback (Students give each other feedback)
ECTS
5 ECTS
Type of assessment
Written assignment, 3 hours
Type of assessment details
The assignment has two parts:
1. A case study that is presented with a short description and/or a scientific publication. The student is expected to identify key information, analyse the case study, critically assess data, methods and results, by answering a series of questions.
2. Short questions covering different topics of the course.
Aid
All aids allowed
Marking scale
7-point grading scale
Censorship form
No external censorship
Exam period

Announced in the exam plan on the MIND homepage mind.ku.dk

Re-exam

Announced in the exam plan on the MIND homepage mind.ku.dk

Criteria for exam assessment

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

Knowledge

  • Understand pharmacological aspects of adverse drug reactions
  • Describe different types of adverse reactions and molecular mechanisms
  • Explain PK/PD aspects‚ drug metabolism and excretion, interactions and pharmacogenomics
  • Describe clinical features of adverse reactions in different body systems
  • Explain the risk of adverse reactions in special populations
  • Describe terminology, evaluation and reporting requirements of adverse reactions

 

Skills

  • Apply pharmacological knowledge to specific adverse effects
  • Describe treatment choice related to specific risk factors and populations
  • Evaluate clinical information in ICSRs and perform causality assessment
  • Compile, summarise and evaluate information on adverse effects
  • Present and discuss safety-related problems based on information in a PSUR


Competencies

  • Interpret data on suspected adverse drug reactions in ICSRs and PSURs
  • Discuss and explain specific drug-event combinations based on pharmacological principles
  • Argue for drug choice in relation to specific risk factors for adverse reactions
  • Collaborate and communicate effectively with other professionals with pharmacological, clinical and regulatory expertise

Part time Master and Diploma courses

  • Category
  • Hours
  • Lectures
  • 20
  • Preparation
  • 88
  • Theory exercises
  • 15
  • Exam
  • 15
  • English
  • 138

Kursusinformation

Language
English
Course number
SMIM24001U
ECTS
5 ECTS
Programme level
Part Time Master
Duration
This is a blended learning course.
Online Part - 1 week duration but the workload is equivalent to one course day
On Campus Part - one week with workload equivalent to 5 course days
-----
Combining one week of online learning, which is equivalent to one full course day and one week of on-campus/​classroom-based learning.

See course calendar
Placement
Autumn And Spring
Price

Fees are published on the programme's homepage at  https://mind.ku.dk/tuition/ Fee includes course materials and lunch/coffee. Prices may be subject to change.

Schedulegroup
See course calendar
Capacity
25 participants
Studyboard
Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
  • Department of Drug Design and Pharmacology
Contracting faculty
  • Faculty of Health and Medical Sciences
Course Coordinators
  • Morten Andersen   (15-7072757768713164716768757668714376787167316e7831676e)
  • Maurizio Sessa   (14-4f6377746b7c6b713075677575634275777066306d7730666d)
Teacher

Morten Andersen
Maurizio Sessa

Saved on the 04-04-2024

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