Nine renowned speakers will cover the following topics:
- Medication Error: Impact on the Pharmacovigilance-System (Dr Uwe Schulz, Recordati Pharma GmbH)
- MLM-Compliance: How to use MLM from EMA? (Dr Leonardo Ebeling, Ebeling & Assoc.)
- 8 ways to say I don´t know – The impact of null Flavors in E2B (R3) (Dr Marc Zittartz, pharmaSOL)
- Pharmacovigilance-Inspections in the EU: Transparency, Short-Comings, Harmonisation (Dr Axel Thiele, Senior Expert Pharmacovigilance, Bonn)
- Risk Management Strategy – Differences and Similarities between EU RMP and US REMS (Dr Heinz Weidenthaler, Bavarian Nordic)
- PV-Interactions with Distributors, Licensors or external MAHs - How to deal with Senior/Junior Partners, Implications for SDEAs, Regulatory Interdependencies (Martin Dornseiff, InfectoPharm)
- Some similarities and differences of the PV-Activities regarding NCEs and Biologics (Dr Ute Höffner, Biogen Idec)
- Pharmacovigilance from a legal perspective: Liabilities of MAH, QPPV and Stufenplanbeauftragter (Dr Matthias Runge, Sander & Krüger Rechtsanwälte)
- Vigilance for Medical Devices (Dr Nadine Epp, Dr. Ebeling & Assoc.)
In his own talk, chairman Dr Leonardo Ebeling will explain the new Medical Literature Monitoring (MLM) service launched by the European Medicines Agency EMA in 2015. He will also shed light on practical aspects important for using MLM-derived ICSR data. The MLM service currently monitors 400 active substances, including 100 herbals.
The seminar is suited for employees concerned with the maintenance and implementation of pharmacovigilance/vigilance systems, with critical processes and quality systems.
Further information: http://germanpharmacovigilanceday2016.eventify.it