Drug Regulatory Affairs - from Drug Discovery to Approval and Marketing

Course 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 synopsis and presentations will be based on drafting a regulatory plan

Education

MSc in Pharmaceutical Sciences - elective

MSc in Medicinal Chemistry - elective

Cand.Scient.Pharm. - elective

Cand.Pharm. - elective

Learning outcome

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.

At the end of the course, students will be able to:

Knowledge

  • understand drug registration within the EU, including the political and legal framework, EMA and ICH guidelines, application procedures and documentation with focus on pharmaceutical-chemical documentation.
  • describe the different phases of the drug development process in the pharmaceutical industry, and how drug regulatory affairs plays a role in each phase.

• Lectures: 30 hours
• Workshops (with lecture present): 16 hours
• Oral presentation and opponent: 6 hours

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.

ECTS
7,5 ECTS
Type of assessment
Course participation
The continuous assessment is done on the basis of the course participation, including that the student:

• has participated in 80% of the lectures
• has written a synopsis which is then approved by the lecturer
• has participated satisfactorily in preparing a regulatory plan
• has participated satisfactorily in a group's presentation and in a discussion of the regulatory plan
• has fulfilled the role of opponent to another group's presentation to satisfaction.

A Course certificate is obtained on the basis of the student’s course participation and performance on presentation day.
On presentation day the student will perform a presentation based on the regulatory plan described in the synopsis.
On the presentation day there will be a regulatory expert panel present. The panel will participate in the discussion of the presented regulatory plan with the students. The students ability to discuss regulatory matters with the experts will be part of the assessment.
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assessment

To obtain a course ceritficate, students should be able to:

Knowledge

  • understand drug registration within the EU, including the political and legal framework, EMA and ICH guidelines, application procedures and documentation with focus on pharmaceutical-chemical documentation.
  • describe the different phases of the drug development process in the pharmaceutical industry, and how drug regulatory affairs plays a role in each phase.
  • Category
  • Hours
  • Lectures
  • 30
  • Preparation
  • 90
  • Colloquia
  • 4
  • Project work
  • 66
  • Guidance
  • 16
  • English
  • 206