Master's Course "Drug Regulatory Affairs"

Study plan (WS 2017 - SS 2018)

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Written examination Thursday 22 March 2018, 1.00 p.m. (module 2, 3 and 5)
Location: University main building, lecture room X

Oral examination (module 8, 9 and 10), time period September - November 2018

Modul 01

Definition and description of the functions of Drug Regulatory Affairs, Good Regulatory Practices

Part 1:    
Friday   15 September 2017 from 8.30 a.m - 6.30 p.m
Saturday   16 September 2017 from 8.00 a.m. – 4.00 p.m.
Location:   Uni-Club
Part 2:    
Friday   22 September 2017 from 8.30 a.m. – 6.30 p.m.
Saturday   23 September 2017 from 8.00 a.m. – 4.00 p.m.
Location:   Uni-Club
     
    Deadline seminar paper: 23 October 2017

Modul 02

Pharmaceutical Law

Part 1:    
Friday   13 October 2017 from 8.30 a.m. – 6.30 p.m.
Saturday   14 October 2017 from 8.00 a.m. – 4.00 p.m.

Location: 

 

Alanus Hochschule, Campus II, Villestr. 3, 53347 Alfter

Part 2:    
Friday   20 October 2017 from 8.30 a.m. – 6.30 p.m.
Saturday   21 October 2017 from 8.00 a.m. – 4.00 p.m.
Location:    Uni-Club
     
    Deadline seminar paper: 20 November 2017

Modul 03

International Marketing Authorisation Procedures

Part 1:    
Friday   27 October 2017 from 8.30 a.m. - 6.30 p.m.
Saturday   28 October 2017 from 8.00 a.m. - 4.00 p.m.
Location:    Haus der evang. Kirche, Adenauerallee 37, Bonn
Part 2:    
Friday   24 November 2017 from 8.30 a.m. - 6.30 p.m.
Saturday   25 November 2017 from 8.00 a.m. - 4.00 p.m.
Location:    Uni-Club
Part 3:    
Friday   08 December 2017 from 8.30 a.m. - 6.30 p.m.
Saturday   09 December 2017 from 8.00 a.m. - 4.00 p.m.
Location:    BfArM, Kurt-Georg-Kiesinger Allee 3, Bonn
     
    Deadline seminar paper: 08 January 2018

Modul 04

General aspects of Module 1 (CTD) and authorisation of specific medicines

Part 1:    
Friday   19 January 2018 from 8.30 a.m. - 6.30 p.m.
Saturday   20 January 2018 from 8.00 a.m. - 4.00 p.m.
Location:    Haus der evang. Kirche, Adenauerallee 37, Bonn
Part 2:    
Friday   26 January 2018 from 8.30 a.m. - 6.30 p.m.
Saturday   27 January 2018 from 8.00 a.m. - 4.00 p.m.
Location:
  Uni-Club
     
    Deadline seminar paper: 26 February 2018

Modul 05

Pharmacovigilance / Maintenance of marketing authorisations

Part 1 Pharmacovigilance:
Friday   02 February 2018 from 8.30 a.m. – 6.30 p.m.
Saturday   03 February 2018 from 8.00 a.m. – 4.00 p.m.
Location:    Uni-Club
Part 2 Maintaining of marketing authorization:
Friday   16 February 2018 from 8.30 a.m. – 6.30 p.m.
Saturday   17 February 2018 from 8.00 a.m. – 4.00 p.m.
Location   Uni-Club
     
    Deadline seminar paper: 03 April 2018

Modul 06

Information management, eCTD

Thursday   01 March 2018 from 8.30 a.m. - 6.30 p.m.
Friday   02 March 2018 from 8.30 a.m. - 6.30 p.m.
Saturday   03 March 2018 from 8.30 a.m. - 6.30 p.m.
Sunday   04 March 2018 from 8.30 a.m. - 2.00 p.m. (practical task)
Location:   Pharmaceutical Institute Bonn-Endenich

Modul 07

Quality management / medical devices

Part 1:
Friday   16 March 2018 from 8.30 a.m. – 6.30 p.m.
Saturday   17 March 2018 from 8.00 a.m. – 4.00 p.m.
Location:   Uni-Club
Part 2:
Friday   23 March 2018 from 8.30 a.m. – 6.30 p.m.
Saturday   24 March 2018 from 8.00 a.m. – 4.00 p.m.
Location:   Haus der evang. Kirche, Adenauerallee 37, Bonn
     
    Deadline seminar paper: 23 April 2018

Modul 08

Chemical-pharmaceutical documentation

Part 1:    
Friday   13 April 2018 from 8.30 a.m. – 6.30 p.m.
Saturday   14 April 2018 from 8.00 a.m. – 4.00 p.m.
Location:   Uni-Club
Part 2:    
Friday   27 April 2018 from 8.30 a.m. – 6.30 p.m.
Saturday   28 April 2018 from 8.00 a.m. – 4.00 p.m.
Location:   Uni-Club
     
    Deadline seminar paper: 28 May 2018

Modul 09

Pharmacological-toxicological documentation

Part 1:    
Friday   11 May 2018 from 8.30 a.m. – 6.30 p.m.
Saturday   12 May 2018 from 8.00 a.m. – 4.00 p.m.
Location:   Uni-Club
Part 2:    
Friday   25 May 2018 from 8.30 a.m. – 6.30 p.m.
Saturday   26 May 2018 from 8.00 a.m. – 4.00 p.m.
Location:   Uni-Club
     
    Deadline seminar paper: 25 June 2018

Modul 10

Clinical documentation

Part 1:    
Friday   01 June 2018 from 8.30 a.m. – 6.30 p.m.
Saturday   02 June 2018 from 8.00 a.m. – 4.00 p.m.
Location:   Wissenschaftszentrum, Ahrstr. 45, 53175 Bonn
Part 2:    
Friday   22 June 2018 from 8.30 a.m. – 6.30 p.m.
Saturday   23 June 2018 from 8.00 a.m. – 4.00 p.m.
Location:   Uni-Club
     
    Deadline seminar paper: 23 July 2018

Modul 11

Pharmacoeconomics / Health policy

Thursday   05 July 2018 from 2.00 p.m. – 6.45 p.m.
Friday   06 July 2018 from 8.30 a.m. – 6.30 p.m.
Saturday   07 July 2018 from 8.00 a.m. – 4.00 p.m.
Location:   Uni-Club
     
    Deadline seminar paper: 06 August 2018

Modul 12

Decision analytics

Friday   20 July 2018 from 8.30 a.m. – 6.30 p.m.
Saturday   21 July 2018 from 8.00 a.m. – 4.00 p.m.
Location:   Haus der evang. Kirche, Adenauerallee 37, Bonn
     
    Deadline seminar paper: 20 August 2018