MIND covers the entire drug development process from discovery to registration and consists of the following compulsory courses:
Discovery and Development of Medicines (overview course)
A comprehensive overview of drug development and an understanding of the dynamics of drug development and intercommunication across research disciplines.
Drug Discovery
To provide the student with an understanding of the elements involved in modern drug discovery covering target identification & validation and lead identification & optimization.
Pharmacology
Pharmacology concepts applied in the drug development process. Basic concepts and drug classes are introduced. Emphasis is put on pharmacokinetics and experimental in vitro and in vivo tools.
Non-clinical Safety and Toxicology
The requirements and conclusions to be drawn from the results of non-clinical safety assessment conducted in vivo as well as in vitro.
Drug Formulation and Delivery
How optimal performance of drug formulation can be achieved by considering the physicochemical properties of the active pharmaceutical incredient (API) and excipients.
Chemical Process Development and Production of Active Pharmaceutical Ingredients (API)
In depth knowledge of the different aspects of chemical process development from discovery through pilot plant size to optimized production scale synthesis and preparation of a Drug Master File.
Drug Regulatory Affairs in Drug Development
How regulatory affairs professionals interact with the specialists involved in the process of drug development, the EU legislative framework, application procedures and strategic regulatory issues.
QA, QC, GXP for Pharmaceutical Production
Quality assurance and quality control of drug development and manufacture for worldwide distribution.
Clinical Pharmacology and Biostatistics
A thorough understanding of clinical pharmacological considerations during drug development.
Biopharmaceuticals - Pharmaceutical Development and Safety Assessment
An interdisciplinary introduction to the new advances in the development of macromolecules into effective biopharmaceuticals.
University of Copenhagen
Faculty of Pharmaceutical Sciences
Universitetsparken 2
2100 Copenhagen
Denmark
Phone +45 35 33 60 00
Fax +45 35 33 60 01
Mail farma@farma.ku.dk
Web www.farma.ku.dk