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
29.01.2015
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 &
29.01.2015
Datei
PD
16 January 2015
1
An agency of the European Union
Management of EU RMP versions
during parallel regulatory
submissions
Presented by: Mark Caldwell/EBE
Deputy QPPV, Janssen (Johnson & Johnson)
29.01.2015
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;
29.01.2015
Datei
PD
16 January 2015
1
An agency of the European Union
Post-Authorisation Safety Studies
Current issues from the generics sector
Presented by:
Key messages
1.Generic MAHs are not routinely committi
29.01.2015
Datei
PD
16 January 2015
1
An agency of the European Union
EUCOPE –
European Confederation of
Pharmaceutical Entrepreneurs
Presented by: Dr. Jörg Plessl
Challenges of Post Authorization Studies
(PAS):
29.01.2015
Datei
PD
16 January 2015
1
An agency of the European Union
Post-Authorisation Safety Studies
Key challenges and solutions
Presented by: Gro Laier/EFPIA/NovoNordisk
Presentation by:
AESGP
EBE
EFPIA
E
29.01.2015
Datei
PD
16 January 2015
1
An agency of the European Union
Post-Authorisation Efficacy
Studies (PAES)
Development of Scientific Guidance
Presented by: Emma Du Four
Role, Organisation: EFPIA/AbbVie
Pres
29.01.2015
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
29.01.2015
Datei
PD
BAH UM VIER – Ausgabe 19 – 29. Januar 2015 • 1
1. Bundesregierung unterstützt die globale Impfallianz GAVI mit 600
Millionen Euro
Die deutsche Bundesregierung will bis zum Jahre 2020 insgesam
29.01.2015
Datei
PD
