Pharmacovigilance
- the key to patient safety and pharma portfolio value.
PharmaProjekthaus provides a full range of pharmacovigilance services
through its Master Services Agreement with spm² - safety projects
& more GmbH, based in Hirschberg, Germany.
spm² was founded by physicians, IT specialists and pharma executives
with a long standing experience in both the international pharma and the CRO
industry, with particular emphasis on pharmacovigilance in Europe and
the US.
In cooperation with PharmaProjekthaus, spm² offers tailor-made drug safety solutions
either by acting as a full-service external pharmacovigilance department
or by modular project-specific services, eg, planning and implementation
of an EU-compliant pharmacovigilance system, development of risk management
plans, provision of Qualified Persons, generation of Periodic Safety Update
Reports (PSURs) and Annual Safety Reports, management of SAEs from clinical trials as well as support for post-marketing spontaneous reporting.
For further information please visit www.spm2-safety.de. |
