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Tuesday, June 26, 2012
10:00 AM to 11:30 AM
Peter M. Lassoff, PharmD (SPKNON), Vice President and Head of Global Regulatory Affairs, Quintiles, Inc., United Kingdom
Dr. Peter Lassoff, Pharm.D., is Vice President and Head, Global Regulatory Affairs for Quintiles. Peter is responsible for a large group of regulatory professionals for the only fully integrated bio and pharmaceutical services provider, offering regulatory execution and strategic services.
| Sunita Ahir
, D-Target, a Premier Research Company, Switzerland
Dr Sunita Ahir is a Regulatory Affairs Manager at D-Target. Her role is to advise clients on all aspects of the CE marking process. She has extensive experience of medical devices having worked for BSi Healthcare as a technical expert reviewing Class IIb and III submissions.
This symposium will discuss the shifting borderlines between medicines and other product both a continuing concern and an opportunity for all companies, and the role of clinical trials in establishing the best treatment of care using both drugs and devices. We will also identify regulatory issues related to safety, performance and effectiveness.
Discuss the differences in global regulatory practices dealing with drug device combination
Identify the borderlines advantage in obtaining market access for their products
Explain the role of a clinical trial in establishing the best treatment of care using both drugs and devices.
Audio Synchronized to PowerPoint