PSURs + RMPs in a changing global environment - Tips for your strategy in international markets
- Think global, act local: strategies for optimising resources and ensuring alignment
- Global planning of PSUR schedules: solutions and strategies
- How to ensure alignment of local RMPs with global RMPs
- How to manage different local requests
Periodic safety update reports (PSURs) and
risk management plans (RMPs) have been
well-established documents in the EU since
2012. However, periodic reports and RMPs
are also required in many countries outside
the EU.
Managing different requirements
(e.g., different reporting intervals, data lock
points (DLPs), safety concerns, risk manage-
ment activities, etc.) on a global scale is
becoming increasingly challenging for
pharmacovigilance experts.
In this workshop, participants will learn how
to effectively manage periodic reports and
RMPs globally. Class discussions, exercises
and valuable practical tips will help
participants better understand and address
the challenges of the global regulatory
environment. The workshop schedule may
be adapted to the participants' needs and
experience.
Termin
Datum: | 14.06.2016 |
Ort: | Hotel Mondial am Dom Kurt-Hackenberg-Platz 1 -50667 Köln |
Preis: | 990,00 EUR zzgl. MwSt. |
Zielgruppe
This seminar will be of benefit to all those
working in the pharmaceutical industry,
involved in managing PSURs or RMPs
globally.
Kontaktinformationen
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