Drug Regulatory Affairs in Drug Development

Course content

All aspects within the pharmaceutical development process of medicinal products are subject to various degree of regulation. The pharmaceutical law frame, guidelines covering Quality, Safety and Efficacy as well as Health Authorities' attitudes and requirements etc. have a great influence on the drug development process and the success of it. Regulatory affairs professionals deal with these aspects. Knowing this discipline and how to focus the development process and co-operate with the regulatory affairs professionals can be vital for the success of a medicinal product development and so the survival of a pharmaceutical company.
 

The contents will cover the role and responsibility for the drug regulatory affairs professionals – how they are involved in the development process, how to co-operate with this function, the pharmaceutical law frame in EU, US and outside EU/US, the application and approval procedures, regulatory strategic issue, how to build up an application for a marketing authorization, variations, incentives, pharmacovigilance, and how to approach the issues of Quality, Safety and Efficacy from a regulatory point of view.

Education

This course is a compulsory course at the Master's Programme in Industrial Drug Development.


The course serves as continuing professional development (CPD) for drug development professionals interested in or working under drug regulation, e.g. employees in QA/QC, CMC, analytical development and pharmaceutical development.

Master’s level (second cycle higher education). Open for freelance students who meet the admission criteria. Compulsory for MIND students, elective for other part-time master's students. (subject to study board approval).

Learning outcome

Upon completion, participants are expected to be able to:

Knowledge:

  • Give an overview of how, when and with whom regulatory affairs interact with the drug development process, particularly with quality, safety and efficacy
  • Recognize the different types of applications and application procedures available in the EU, US and outside EU/US
  • Understand the law frame and guidelines within regulatory affairs

Skills:

  • Explain the scientific advice procedure
  • Discuss the law frame and guidelines within regulatory affairs

Competencies:

  • Understand, interpret and follow regulatory guidelines
  • Apply knowledge of regulatory affairs area in the participant’s working environment

The course will consist of 15-20 lectures over a 5-day period. Each lecture will leave time for extensive discussions facilitating active participation by the participant. Group discussions and case stories will be an important part of the course.

The syllabus comprises selected EMA guidelines and EC directives, and corresponds to approximately 300 pages required readings.

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English

ECTS
2,5 ECTS
Type of assessment
Written examination, 2 under invigilation
The test is composed of essay questions. The purpose of the examination is to test that the examinee has achieved the expected learning outcomes. The percentage of items on the test devoted to a particular topic will roughly correspond to the emphasis given the topic in teaching of the course, and as implied in the general course objectives and content.
Aid
Written aids allowed

Calculators are not allowed.
Apart from the standard programs and IT tools listed under The Faculty of Health and Medical Sciences at http://pc-eksamen.ku.dk/pc_exam students will at this exam also have access to use a USB stick (for notes etc.)

Marking scale
7-point grading scale
Censorship form
External censorship
Criteria for exam assessment

Knowledge:

  • Give an overview of how, when and with whom regulatory affairs interact with the drug development process, particularly with quality, safety and efficacy
  • Recognize the different types of applications and application procedures available in the EU, US and outside EU/US
  • Understand the law frame and guidelines within regulatory affairs

 

Skills:

  • Explain the scientific advice procedure
  • Discuss the law frame and guidelines within regulatory affairs

 

Competencies:

  • Understand, interpret and follow regulatory guidelines

Part time Master and Diploma courses

  • Category
  • Hours
  • Preparation
  • 28,75
  • Class Instruction
  • 38
  • Exam
  • 2
  • English
  • 68,75