Drug Regulatory Affairs in Drug Development

Course code: FMIMA1081U (previously A-8108)

Lægemiddelregistrering

Course objectives

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.

Target group

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.

Prerequisites

Applicants must meet the following criteria:

• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English

A general insight into drug discovery, quality assurance, safety and clinical aspects of drug development is required.

Learning outcomes

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
• Understand the EU law frame and guidelines within regulatory affairs

Skills:

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

Competencies:

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

Contents

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, the application and approval procedures, regulatory strategic issue, how to build up an application for a marketing authorization, variations, and how to approach the issues of Quality, Safety and Efficacy from a regulatory point of view.

Course materials/syllabus

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

Teaching methods

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.

Examination and assessment

Type of examination: 2-hour written examination (anonymous).

Examination design: 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.

Assessment: According to the 7-point grading scale

Examiner(s): Course director and an external examiner

Exam aids: All written exam aids are allowed. Calculators are not allowed.

Grading

Grade 12:

The examinee:

• demonstrates a well structured presentation with a clear outline providing exact and correct answers.
• combines convincingly the learned elements.
• demonstrates with few unimportant deficits aplomb mastering of relevant terms, principles and guidelines used for preparing relevant documentation for passing the various threshold on the way to final market authorisation.

Grade 7:

The examinee:

• demonstrates a coherent presentation providing understandable unambiguous answers, the great majority of which should be correct.
• documents a certain overview over the learned elements.
• demonstrates with minor deficits a firm knowledge of relevant terms, principles and guidelines used for preparing relevant documentation for passing the various thresholds on the way to final market authorisation.

Grade 02:

The examinee:

• demonstrates a less structured presentation with less precise answers.
• demonstrates a limited overview ability to combine the learned elements.
• demonstrates only to a limited extent and with a number of deficits a firm knowledge of relevant terms, principles and guidelines used for preparing relevant documentation for passing the various thresholds on the way to final market authorisation.

Student workload

Preparation: 30 hours
Confrontation: 38 hours
Examination: 2 hours
In total 70 hours

Course directors

Associate professor Eva Horn Møller, PhD (Pharm.) and affiliated professor Per Helboe (to be confirmed), Department of Pharmaceutics and Analytical Chemistry, The Faculty of Pharmaceutical Sciences, University of Copenhagen.

Lecturers

To be announced. 

Practical information

Status: 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 at the Faculty of Pharmaceutical Sciences (subject to study board approval).

Date:  1-5 October 2012. Examination on the last day of the course.

Application deadline: 1 August 2012. Application form.

Course credits: 2.5 ECTS credits = a student workload of approx. 70 hours

Course fee: Part-time master’s students at Faculty of Pharmaceutical Sciences DKK 7,890, freelance students DKK 9,350, freelance students from non-EU/EEA countries DKK 11,290. An additional fee of DKK 1,350 is charged for course materials and lunch. Prices may be subject to change.

Course capacity: 25 participants

Language of instruction: English

Approved by the MIND/MPRA-study board on 25 August 2011.