Calendar

*For full course students there is always an extra day, the Saturday, which is in brackets after the dates. There is no exam after Seminar 4.1.

Seminar 1: European pharmaceutical regulatory environment

Course 2014/2015:
09-12 (13) September 2014*

Course 2015/2017:
15-18 (19) September 2015*

European pharmaceutical regulatory environment

Seminar 2: Regulatory Procedures for clinical trial applications, marketing authorizations, variations in the EU, USA, Japan and China

Course 2014/2015:
28-31 October (01 Nov) 2014*

Course 2015/2017:
08-11 (12) December 2015*

Seminar 3: Particulars of specific product classes: monoclonal antibodies, vaccines, ATMPs and blood products

Course 2015/2017:
30 March-01 (02) April 2016*

 Particulars of specific product classes: monoclonal antibodies, vaccines, ATMPs and blood products

Seminar 4.1: The Module 3 (CMC Dossier) of biopharmaceuticals

Course 2015/2017:
May 31st  - June 3rd 2016

The Module 3 (CMC Dossier) of biopharmaceuticals

Seminar 4.2: Non-clinical and clinical development of biopharmaceuticals including biosimilars and the Module 4 and 5 requirements

Course 2014/2015:
03-06 March 2015*

Course 2015/2017:
07. – 09.09.2016

Non-clinical and clinical development of biopharmaceuticals including biosimilars and the Module 4 and 5 requirements

Seminar 5: Specific considerations for the development and authorization of medicinal products for children

Course 2014/2015:
29-30 April (01 May) 2015*

Course 2015/2017:
End of November 2016*

Specific considerations for the development and authorization of medicinal products for children

Seminar 6: Pharmacovigilance – Post-authorisation surveillance standards to meet regulatory requirements for product safety

Course 2014/2015:
03-05 June 2015*

Course 2015/2017:
February 2017*

Pharmacovigilance – Post-authorisation surveillance standards to meet regulatory requirements for product safety

Seminar 7: The roles of the supervising authorities and the essential characteristics of quality systems

Course 2014/2015:
22-24 July 2015*

Course 2015/2017:
May 2017*

The roles of the supervising authorities and the essential characteristics of quality systems

Seminar 8: Scientific advice, regulatory strategy and health technology assessment

Course 2014/2015:
02-04 (05) September 2015*

Course 2015/2017:
July 2017*

Scientific advice, regulatory strategy and health technology assessment

Seminar 9: Good Regulatory Affairs practice: communication skills, project management and tools for the daily practise

Course 2014/2015:
08-09 (10) October 2015*

Course 2015/2017:
October 2017*

Good Regulatory Affairs practice: communication skills, project management and tools for the daily practise