Audio Conference

The EU Perspective on Risk Management Dr. Stefan Blesse Granzer Regulatory Consulting & Services Purchase recording US$199

Purchase a recording of this audio conference 

Does your company market its products in Europe, or are you planning to enter the EU market? Have you taken the requisite steps to address risk management? Risk management must be an integral part of global product development and commericalization. In this audio conference Dr. Blesse will provide a detailed overview of EMEA's Guideline on Risk Management Systems for Medicinal Products for Human Use and its legislative background. He will also provide examples of why this new regulation should not be perceived as another threat to industry, and how it offers strategic options.

This audio conference will address:

• Understanding the EU risk management guideline
• When you need an EU risk management plan
• The major goals of risk management
• Vital steps in compiling your risk management plan
• Important tools for risk minimization and communication
  

About the speaker:

Dr. Stefan Blesse is a veterinarian and principal consultant with Granzer Regulatory Consulting & Services, based in Germany. He has spent 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 submmission, and has been involved in submissions around the world, including The US, Europe and Asia-Pacific.

Who should attend?

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

This audio conference is classified as General Interest.

Purchase Options

• Purchase a recording of this event US$199