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.

This audio conference covers:

• Overview and background of EMEA's risk management guideline
• The major goals of risk management
• When do you need a risk management plan?
• Best practices for compiling your risk management plan
• Important tools for risk minimization and communication

About the speaker:

Dr. Stefan Blesse is a principal consultant with Granzer Regulatory Consulting & Services, based in Germany. He has spent more than 15 years working in Regulatory Affairs, and has held various positions of global responsibility with both large and small pharmaceutical companies like Hoechst and Bayer. He has extensive experience with CTD submissions, and has been involved in submissions around the world, including the US, Europe and Asia-Pacific.

Who should attend?

• VPs, Directors and Managers of Regulatory Affairs
• Directors and Managers of Risk Management
• Safety Directors and Managers
• Epidemiologists
• Outcomes Researchers

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.