It is vitally important that pharmaceutical and biotech companies marketing their products in Europe familiarize themselves with what the European Medicines Agency (EMEA) has to say on the subject of risk management. Do you need a risk management plan if you are using centralized procedure? How about decentralized procedure or mutual recognition? Where does risk management go in the dossier? And what sort of risk minimization will be expected?
In this audio conference, EU regulatory expert Dr. Stefan Blesse answers these and more questions about EMEA's Guideline on Risk Management Systems for Medicinal Products for Human Use, offering insight and examples as to why it should be considered a strategic opportunity, and not a threat to industry.
EMEA & Risk Management: What You Need to Know is being presented by Dr. Stefan Blesse, Principal Consultant, with Granzer Regulatory Consulting & Services and airs on Thursday, June 4, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com
