Courses

The Master of Medicines Regulatory Affairs programme offers a number of different courses, each is giving a different perspective on medicines regulatory affairs. On the following pages you can read about each individual course and how you can benefit from it.

You can participate in the courses as part of the Master of Medicines Regulatory Affairs or as single courses.

The courses offered are as follows:

• Biopharmaceuticals - Quality Development and Documentation

  This course addresses the quality requirements for the development of biopharmaceuticals i.e. quality related to active substance.

• Clinical Development and Documentation

  This course will enable Students to contribute to clinical study teams, investigate the requirements for getting the studies authorised by authorities, and eventually put together the clinical sections of a marketing authorisation application.

• Drug Regulatory Science

  This course enable the students to use their knowledge about clinical development of medicine to discuss and put into perspective the legal requirement and guidelines and the background for these.

• Discovery and Development of Medicines

  The aim of the course is to give an overview and an introduction to the various steps, requirements and challenges in the process of development of a new medicine.

• Global Pharmaceutical Policy - Rationales and Stakeholders

  The student will obtain knowledge on medicines authorities and global collaboration, on the general law systems, and legal framework for approval and maintenance of medicines.

• Market Access for Pharmaceutical Products

  This course will provide insight into the key principles and a practical understanding of ‘market access’ as it relates to the pharmaceutical industry

• Transparancy and Trustworthiness in Drug Development

  The course addresses the role and responsibility of a regulatory professional both from a company and from a societal perspective with the latest scientific trends

• The EU Regulatory Environment - Procedures and Applications

  The student will obtain knowledge of the EU pharmaceutical legislation and law frame, the content of a marketing authorisation application (MAA), EU approval procedures, Scientific advice from CHMP and national authorities, and orphan Medicinal products.

• The US Regulatory Environment

  The student will obtain an overview of different regulatory submissions and specific knowledge of how to prepare, evaluate and analyse project development plans

• Safety of Medicines

  The content of this course covers the regulatory issues concerning non-clinical development up to post marketing pharmacovigilance, with emphasis on regulatory issues concerning clinical development and pharmacovigilance.

• Quality - Drug Substance and Drug Product

  This course addresses the quality requirement in medicines development i.e. quality related to active substance.

• Quality by Design in Pharmaceutical development

  This course will provide insight into the key principles of QbD covering quality risk management, formal experimental design and process analytical technology (PAT).

• Biopharmaceuticals Drug Development

  The course will teach the specific characteristics and procedures within the development of biopharmaceuticals.

• Labelling as a Driver for Regulatory Strategy

  This course provides you with the necessary competences to prepare and optimize regulatory strategies.