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

Volume 2017/2018
Education

Master of Medicines Regulatory Affairs (MRA)

Content

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

The main purposes of the course is for the participant to acquire

1) An understanding of why non-clinical safety studies are conducted  including an understanding of methods for assessing safety in vitro and in vivo (animals),

2) To develop an understanding of and be able to analyze and apply the principles of safety monitoring in clinical phase I, II and III studies. These include in vivo pharmacology studies (e.g. temp, BP, ECG), PK/PD effects, and observations of ADR.

3) Awareness of the necessary pre-authorisation tasks concerning preparation of clinical study protocols pharmavigilance studies (phase IV), execution of clinical studies, preparation of periodic safety reports (PSUR/DSUR), along with other risk management activities after marketing.

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

Learning Outcome

Knowledge

  • Define what non-clinical safety and clinical development and documentation is needed in order to fulfill regulatory requirements.
  • Explain the principles and management of pharmacovigilance and post-marketing risk assessment.
  • Identify the timing and requirement of non-clinical safety studies for both small molecules and biopharmaceuticals.

 

Skill

  • Discuss and evaluate non-clinical safety requirement for specific types of medicines for both small molecules and biopharmaceuticals.
  • Discuss and evaluate requirements for 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.

 

Competencies

  • Plan and make decisions with regard to non-clinical development and documentation.
  • Review and assess global safety data at all levels of the drug development
  • Integrate all safety aspects when assessing drug candidates for selection and for selection of Marked Authorisation approval.
  • Take responsibility for continuous risk-benefit and pharmacovigilance

The syllabus comprises relevant EMA guidelines, EC directives, and a selection of books, book chapters, scientific papers and review papers, For example:

Text book (e.g. Talbot and Aronson, Stephens' Detection and Evaluation of Adverse Drug Reaction, Princples and Practice, Wiley & Sons 2012) 

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 of relevant job experience
• Proficiency in English

It would be an advantage to have passed the course ‘Clinical Development – Efficacy of medicines’ or equivalent course.
Preparation (75 hours)
Lectures (35 hours)
Practical exercises (25 hours)
Credit
5 ECTS
Type of assessment
Written examination, 3 hours
Define an action plan on the basis of a case study (40%)
Short descriptive questions (60%)
Marking scale
7-point grading scale
Censorship form
External censorship
Exam period

Exam schedul is published on the http://mra.ku.dk/calender/exams/

Re-exam

Exam schedul is published on the http://mra.ku.dk/calender/exams/

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:

  • Explane Regulatory requirements for non-clinical safety and clinical development
  • Understand the principles and management of pharmacovigilance and post-marketing risk assessment.
  • Describe the requirement of non-clinical safety studies for both small drug molecules and biopharmaceuticals.

 

Skills:

  • Discuss and evaluate non-clinical safety requirement for specific types of medicines for both small molecules and biopharmaceuticals.
  • Discuss and evaluate requirements for 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.

 

Competencies:

  • Plan and make decisions with regard to non-clinical development and documentation.
  • Review and assess global safety data at all levels of the drug development
  • Integrate all safety aspects when assessing drug candidates for selection and for selection of Marked Authorisation approval.
  • Take responsibility for continuous risk-benefit and pharmacovigilance

 

 

  • Category
  • Hours
  • Preparation
  • 75
  • Lectures
  • 35
  • Theory exercises
  • 25
  • Exam
  • 3
  • Total
  • 138