Safety & vigilance at Winicker Norimed
Experience combined with continuous training
The regulatory requirements for the systematic safety surveillance of your pharmaceutical or medical device are extensive and require profound know-how and considerable personnel resources. Our interdisciplinary team of experts combines experience with continuous training in the current regulatory requirements.
We support you with the monitoring of your preparation or product in compliance with all safety requirements – in individual studies or throughout the entire product lifecycle.
Our range of services
in safety & vigilance
- Screening and triage of literature and data from studies and other data sources for safety-relevant aspects
- Preparation and creation of Individual Case Safety Reports (ICSR) including follow-up
- Medical reviews
- Entry of safety data into the sponsors´ databases
- Electronic submission of ICSR to the relevant authorities
- Submission of SAEs and medical device incidents to the relevant authorities
- Translation of case-specific documents English-German or German-English (e.g. hospital reports, doctor´s letters)
- Reconciliations
- Creation / update of reports to the authorities
Your contact
for safety & vigilance
Dr.
Petra Hofmann
Head of Pharmacovigilance / Medical Device Vigilance
petra.hofmann@winicker-norimed.com
+49 (0) 911 / 92680 – 8765
Winicker Norimed GmbH
Deutschherrnstraße 15-19, 90429 Nuremberg
Phone: +49 (0) 911 / 9 26 80 – 0
Fax: +49 (0) 911 / 9 26 80 – 8839
E-Mail: wn@winicker-norimed.com