SFKKA9091U Drug Regulatory Affairs - from Drug Discovery to Approval and Marketing

Volume 2013/2014
Education
MSc in Pharmaceutical Sciences - elective, MSc in Medicinal Chemistry - elective, Cand.Scient.Pharm. - elective, Cand.Pharm. - elective
Content

Lectures will cover the following subjects:

  • An overview of the drug development process from drug discovery to development and pharmacovigilance
  • Patenting
  • Career options for a regulatory affairs professional
  • Overview of regulatory agencies and procedures in Europe
  • Special regulatory pathways
  • Requirements for a regulatory application
  • Analytical, pharmaceutical, toxicological and clinical documentation
  • Bioavailability and bioequivalence
  • Biotechnology products/Biologics
  • Regulatory affairs in pharmacovigilance
  • Marketing
  • Health technology assessment

 

Synopsis and presentation:
The synopses and presentations will be based on drafting a regulatory plan
Learning Outcome

Formål / Objective

The process of discovering, developing, and bringing a new drug to market under the regulatory framework is complex and highly cross-disciplinary. In the first part of the course, the aim is to provide the students with an overview of the different phases and various scientific disciplines involved in drug discovery and development, viewed from the regulatory affairs perspective. The regulatory affairs expert plays an essential role in developing and trialling new medicines, and on placing and monitoring them on the market. The second part of the course will aim to give more detailed insight into the legal framework, the considerations and practicalities, and the scientific background involved in the regulatory process.

Målbeskrivelse / Course outcome

At the end of the course, students will:
  1. Have knowledge concerning drug registration within the EU, including the political and legal framework, EMEA and ICH guidelines, application procedures and documentation with focus on pharmaceutical-chemical documentation.
  2. Have knowledge of the different phases of the drug development process in the pharmaceutical industry, and how drug regulatory affairs plays a role in each phase.
Literature

Handouts and guidelines available at the course homepage and material need to prepare the regulatory plan.

It is an advantage to have knowledge within pharmaceutical sciences or drug registration, or of subjects related to the pharmaceutical drug development process. For example, knowledge regarding clinical trials, toxicology, bioavailability studies, or pharmaceutical formulation or pre-formulation.
• Lectures: 20 hours
• Workshops (with lecture present): 16 hours
• Oral presentation and opponency: 4 hours
  • Category
  • Hours
  • Colloquia
  • 4
  • Guidance
  • 16
  • Lectures
  • 20
  • Preparation
  • 98
  • Project work
  • 66
  • Total
  • 204
Credit
7,5 ECTS
Type of assessment
Course participation
Assessed on the basis of the student’s participation, understood to mean that the student:•has participated satisfactorily in preparing a guideline synopsis
•has participated satisfactorily in the group’s presentation and discussion of the guideline
•has fulfilled the role of opponent to satisfaction.
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment

Assessed on the basis of the student’s participation, understood to mean that the student:
•has participated satisfactorily in preparing a regulatory plan
•has participated satisfactorily in the group’s presentation and discussion of the regulatory plan
•has fulfilled the role of opponent to satisfaction.

On the presentation day there are regulatory expert panel present to discuss with the students. The students ability to discuss regulatory matters with experts will be part of the assessment.