Safety of Medicines - From Non-clinical Development to Pharmacovigilance – University of Copenhagen

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Safety of Medicines - From Non-clinical Development to Pharmacovigilance

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.

WHAT YOU WILL LEARN

This course introduces regulatory safety requirements covering non-clinical and clinical development as well as the post-authorisation phase. You will be able to explain the principles and management of pharmacovigilance before and after authorization including risk-benefit assessment and risk management, and identify the timing and requirement of non-clinical, clinical and post-authorisation safety studies for both small molecules and biopharmaceuticals.

During the course, you will learn to 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, and take responsibility for continuous risk-benefit assessment, pharmacovigilance, and risk management.

Lastly, you will be able to integrate all safety aspects when assessing drug candidates for selection during clinical development and market authorisation approval.

COURSE CONTENT

The course will introduce you to:

  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 you 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.

PARTICIPANTS

Participants must meet the following criteria: 
• A relevant bachelor degree or equivalent 
• A minimum of 2 years working experience within regulatory affairs 
• Be proficient in English

COURSE DETAILS

Course dates

5 days, 20-24 May 2019

Course fee

EU/EEA citizens

Non EU/EEA citizens

Master student

DKK 13,000

DKK 15,000

Single course student

DKK 15,000

DKK 17,000

Application deadline

25 March 2019

EXAMINATION

3 hours written examination. At the examination you must:

  • 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.

Credit

4 ECTS

Examination date

17 June 2019 2019 from 10:00 to 13:00 on the Digital Exam platform.

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.

Ekstra information / Sidebar

Lecturers

Torbjörn Callréus, University of Copenhagen
Allan Dahl Rasmussen, H. Lundbeck A/S
Lene Grejs Petersen, Danish Medicines Agency
Andrew Bate, Pfizer
Jon Trærup Andersen, University of Copenhagen
Maurizio Sessa, University of Copenhagen