Course calendar – University of Copenhagen

Course calendar for Master of Medicines Regulatory Affairs

 

Compulsory Courses

Spring

2018              

Autumn

2018

Spring 2019

Clinical Development and Documentation 10-13 April 23-26 April            
Drug Regulatory Science 3 days in week 47 (19-23 November)

Discovery and Development of Medicines

 

7-11 + 22-25 + 28 January 2019

Global Pharmaceutical Policy - Rationales and Stakeholders

3-6 April

The EU Regulatory Environment - Procedures and Applications

3-5 September
The US Regulatory Environment 6-8 June 12-14 June

Transparency and Trustworthiness in Drug Development

20-24 August

Safety of Medicines - From Non-clinical Development to Pharmacovigilance 14-18 May x
Labelling as a Driver for Regulatory Strategy
Fixed Electives Spring 2018 Autumn 2018
Quality - Drug Substance and Drug Products 8-10 October
Biopharmaceuticals - Quality Development and Documentation 3-5 April
Electives Spring 2018 Autumn 2018
Quality by Design (QbD) in Pharmaceutical Development 20-24 August
Market Access for Pharmaceutical Products 20-24 August
Biopharmaceuticals Medicines Development 13-17 August

(x) course is expected to be offered, but days of lectures not yet scheduled.