Drug Regulatory Affairs in Drug Development

This course is designed to give you the necessary basic background to understand and incorporate drug regulatory affairs in the drug development process. Knowing how to focus the development process in regards to regulatory affairs and co-operate with the regulatory affairs professionals can be vital for the success of a medicinal product and the survival of a pharmaceutical company.

All aspects within the pharmaceutical development process of medicinal products are subject to various degree of regulation. The pharmaceutical law frame, guidelines, Health Authorities' attitudes and requirements have a significant influence on the drug development process and its success rate.

WHAT YOU WILL LEARN

Upon completion of the course you will have an extensive overview and understanding of the drug regulatory affairs in drug development and be able to:

• Understand the role of regulatory affairs in the drug development process, particularly in respect of requirements to quality, safety and efficacy
• Understand the law frame and guidelines within regulatory affairs
• Discuss the law frame and guidelines within regulatory affairs
• Understand, interpret and follow regulatory guidelines
• Apply knowledge of regulatory affairs in your daily work
• Recognize the different types of applications and application procedures available in the EU, US and outside EU/US

COURSE CONTENT

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.

The faculty of the course includes a series of experts both from regulatory affairs departments in industry and from the regulatory authorities. In this way the students will receive detailed information from people with hands-on experience in regulatory affairs in their daily work.

The course participants include people from different companies and institutions and with a variety of professional roles. This facilitates the lively discussions during the lectures and even during the breaks.

PARTICIPANTS

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

COURSE DETAILS

Course details

5 days. Expected to be offered next time in autumn 2020

Course fee

• DKK 10,750 for EU/EEA citizens
• DKK 12,488 for non-EU/EEA citizens

Application date

Closed

EXAMINATION

2 hours written examination 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.

Credit

2,5 ECTS