Safety of Medicines – University of Copenhagen

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Master of Medicines Regulatory Affairs > Courses > Safety of Medicines

Why should you enroll?

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 anunderstanding 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.

What do you gain?


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 andbiopharmaceuticals.

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

Course dates:

  • 23-25 April + 2-3 May 2018

Course fee:

  • DKK 19,975 for EU/EEA citizens
  • DKK 21,335 for non-EU/EEA citizens

Application deadline:

  • 26 February 2018