Tuesday, 25 October 2016 - Copenhagen, Denmark
Official language: English
2016 will be a very challenging year for all people dealing with safety of drugs, biologics and devices.
Further to the EMA-projects, we have to consider that compliance with regulatory guidance becomes much more complicated and pragmatic approaches are key. A taste of the Programme:
• regulatory surveillance outside Europe.
• Signal Detection with a look on the surrounding signal detection in large data sources and handing of big data.
• New ICSR handing with a focus on the electronic transmission in accordance to the ICH E2B (R3) message standard and on the legal requirements introduced by the Article 57(2) of Regulation (EC) 726/2004.
Anne Gramkow, Head of Drug Safety, QPPV at Pharmacosmos
Martin Holm-Petersen, Head of pvtech® and Senior Consultant at Navitas Life Sciences
Betina Østergaard Eriksen, Director Global Safety Compliance & Deputy QPPV at Novo Nordisk
The seminar is ideally suited for employees of small-, middle- and large-sized companies in the pharmaceutical sector especially concerned with the implementation and/or maintenance of Pharmacovigilance/Vigilance Systems, with its critical processes and quality system. Participants may come from various departments involved in fulfilling Pharmacovigilance/Vigilance requirements as legal Medical Affairs and Regulatory Affairs.