securPharm Infotagung
zur Fälschungsschutzrichtlinie3.
16. März 2016
Der Deutsche Schutzschild gegen Arzneimittelfälschung
Was pharmazeutische Unternehmen
jetzt wissen müssen.
Kennzeichnung von
15.09.2016
Datei
PD
21 January 2015
1
An agency of the European Union
EU-Risk Management Plans:
Important Risks and Missing
Information and RMP Life Cycle
Management
Follow-up
Joint AESGP and EFPIA Presentation;
15.09.2016
Datei
PD
16 January 2015
1
An agency of the European Union
Q&A on Off-Label Use
Proposal in response to EFPIA paper of 3rd October 2014
EMA Industry Stakeholder Platform - Operation of EU Pharmacovigilanc
15.09.2016
Datei
PD
16 January 2015
1
An agency of the European UnionXavier Kurz, Head of Monitoring and Incident Management Service, Pharmacovigilance Department
Strategy and pilot phase for patient registries
Draft
15.09.2016
Datei
PD
19 January 2015
1
An agency of the European Union
Guidance on Post-Authorisation Efficacy Studies
(NB: under development)
Industry Stakeholder Platform on the implementation of the
Pharmacovigi
15.09.2016
Datei
PD
16 January 2015
1
An agency of the European Union
PSUR Repository
Industry Stakeholder platform - Operation of EU pharmacovigilance legislation
Presented by Irene Rager on 12 January 2014
Head o
15.09.2016
Datei
PD
1
RMPs for nationally
authorised products
Stakeholder meeting 12 January 2015 Slide 1
Industry Stakeholder platform - Operation of
EU pharmacovigilance legislation
12 January 2015
RMPs for nati
15.09.2016
Datei
PD
16 January 2015
1
An agency of the European Union
Post-authorisation safety studies (PASS)
Encouraging joint studies
Industry Stakeholder platform - Operation of EU pharmacovigilance legislation
15.09.2016
Datei
PD
1
An agency of the European Union
The ENCePP network: facilitating the conduct of PAS
Henry Fitt
Head of Best Evidence Development
2nd industry platform meeting on the implementation of Pharmacov
15.09.2016
Datei
PD
16 January 2015
1
An agency of the European Union
Generic RMPs - parallel
submissions and common EU
RMP
John Barber & Klaudija Marijanovic-Barac, EGA
EGA
Generic RMPs - parallel submissions &
15.09.2016
Datei
PD
