If you have any further questions or you are just eager to learn more about our upcoming events, do not hesitate to contact us. We would also appreciate your comments and suggestions that could help us improve our future conferences.
“Thank you very much for inviting me to the meeting, it was very usefull and well organized.”
Pharmacovigilance & Medical Information Associate, Abbott, Spain
“Thank you for organizing such an intersting and useful event, all the presentations lived up to my expectations!”
Head of Pharmacovigilance, Tha Dutch Medicines Evaluation Board, Netherlands
“It was a great pleasure being with you and attend the meeting. I think you succeeded in putting together an interesting program, and your work was appreciated by the audience.”
Sabine Straus, Head of Pharmacovigilance, the Dutch Medicines Evaluation Board, Netherlands
“I apprecitated highly qualified and experienced speakers from broad backgrounds.”
Teresa Martinez, Drug Safety Specialist, Roche
“Well organised event. I was happy to participate also from a professional point of view as the speakers and topics covered were high-level and comprehensive. Excellent event.”
Sanne Lassen, Senior Pharmacovigilance Specialist, Amgros
With the promise to be the biggest change to the regulation of human medicines since mid-1990’s, the European Union has redefined the practice of Pharmacovigilance by new legislation taking effect from July 2012. By managing risk proactively, avoiding administrative burdens, and providing for a greater connection between safety assessments and regulatory action, the new set of rules aims for improved public health in general and greater patient safety in particular.
- Recent developments and insights into new features and key changes introduced by the new PV legislation and its implementation (RMPs, safety reporting, PASS/PAES, etc.)
- Overview and implications of the ICH E2C (R2) guideline
- PV developments outside the ICH region
- Creation of a successful and cost-effective PV system in the frame of the new legislation
- Creation of safety data exchange agreements
- Effectiveness of risk minimisation and establish monitoring system
- PV in special products & populations (vaccines & elderly)
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