Course code: FMIMA1101U (previously A-8110)

Course objectives

There is a need for an effective pharmaceutical quality system to enhance the quality and availability of medicines around the world in the interest of public health. We aim to give an overview of existing legislation related to quality systems, and further, on the efficient implementation of such systems.

Target group

The course is intended for MIND students, MPRA students and other drug development professionals who are working within drug development and manufacturing related activities, and who need basic knowledge about legislation within drug 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

Expected learning outcomes

The main objective of the course is to obtain a broad insight into the legislation and guidelines governing quality assurance (QA) and quality control (QC) and their implementation in the manufacture of medicinal products.

Upon completion of the course, participants are expected to be able to:

Knowledge

• Summarise the processes related to QA/QC activities in GXP (e.g. GLP, GCP, GMP and GDP) environment
• Demonstrate a basic knowledge about the relevant national and international legislation related to quality systems
• Demonstrate a basic knowledge about quality demands during development of medicinal products from research until distribution.

Skills

• Apply legislation related to quality systems and to other quality areas into practical cases
• Work in a regulated environment
• Identify relevant quality regulations and guidelines

Competencies

•  Extract relevant and practically useful information from legislation related to quality systems
• Exchange knowledge with other drug development professionals when implementing basic quality principles in practice
• Integrate quality thinking throughout the drug development process from the earliest research studies to marketing of a medicinal product.

Contents

The course contains a proper review of the relevant national and international legislation followed by lectures on how the pharmaceutical industry implements the quality system for practical use. The structure and content of a quality manual is described. Also the QA and QC activities for companies with marketed products are presented in details to all GXP areas, with the main focus on GMP.

Topics read: 

• International legislation GXP (meaning GLP, GCP, GMP and GDP): EU, FDA, PIC/S, ICH, OECD
• National legislation GXP: Medicinal Products Act, Executive orders on marketing authorisation, quality, labeling, manufacture, distribution and handling, Euphoriant Act
• Manufacturers authorization, authorization to handle euphoriant substances Company quality manual: Policies, guidelines, SOP's, work instruction
• QA/QC activities (GMP): Audit of suppliers; audits within the group; self-inspection; deviation and change control systems; site master file; third party audits; authority inspections; handling of complaints and recall including pharmacovigilance matters; validation activities including document approval and authorization; SOP's approval and authorization; GXP training and documentation; harmonization of GXP activities within a company (laboratories/production); specifications; release of packaging materials; release of starting materials; release of API (Active Pharmaceutical Ingredients); release of finished products; certificates of analysis (COA); Certificate of Compliance  (COC).
• QA/QC activities (GCP and GLP): Monitoring and audits
• QA/QC activities (GDP)
• Participation in industries association working groups discussing new legislation and harmonization of QA/QC activities, national and international.

Course materials/syllabus

The course material is a collection of legislation, presentations (hand-outs) and cases, approximately 250 pages. Reference to the legislation will be sent to the student on forehand, and the handouts of presentations will be given to the student during the course. The syllabus will be comprised of all 250 pages. 

Teaching methods

Lectures, cases and group discussions.

Examination and assessment

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

Examination design: The purpose of the examination is to test that the examinee has achieved the learning objectives. The exam is a combination of multiple-choice questions and case studies. 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, as implied in the general course objectives and abstracts of the topics.

Assessment: According to the 7-point grading scale

Examiner(s): Course director and an external examiner

Exam aids: All written exam aids are allowed. Certain electronic pocket calculators are allowed.

Grading

Grade 12 is given when the participant:

•  combines convincingly the learned elements of the quality system
• demonstrates with few unimportant deficits mastering of relevant terms and principles in the quality system.

Grade 7 is given when the participant:

•  documents a certain overview of the learned elements of the quality system
• demonstrates with minor deficits a firm knowledge of relevant terms and principles in the quality system

Grade 02 is given when the participant:  

• demonstrates a limited overview of the quality system and ability to combine learned elements is limited
• demonstrates only to a limited extent and with a number of deficits capability to handle relevant terms and principles of the quality system.

Student workload

Preparation: 30 hours (app. 10 hours during the course)
Confrontation: 38 hours
Examination: 2 hours
A total of 70 hours

Course directors

Professor Jukka Rantanen, PhD, Department of Pharmaceutics and Analytical Chemistry, Faculty of Pharmaceutical Sciences, University of Copenhagen

Quality Consultant Pia Selgan Rasmussen, M.Sc. (pharm.), Selgan Quality Support

Lecturers

Pia Selgan Rasmussen ( SQS), Torben Elhauge (Qsol), Birthe Emilie Nielsen (LEO Pharma), Björg Sandberg (Lundbeck), Line Michan (Danish Health and Medicines Authority) and Annette Byrholt Hansen (Danish Health and Medicines Authority)

List of lecturers may be subject to change.

Practical information

Status: Master's level (second-cycle). Compulsory for MIND students, elective for other part-time master's students at the Faculty of Pharmaceutical Sciences (subject to study board approval) and open for freelance students who meet the admission criteria.

Date: 11-15 March 2013. Examination on the last day of the course.

Application deadline: 4 January 2013.

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 7,460, freelance students DKK 8,920. freelance students from non-EU/EEA countries DKK 11,290. An additional fee of DKK 1,400 is charged for course materials and lunch. Prices may be subject to change.

Course capacity: 25 participants

Language of instruction: English

Preliminary course description