European Medical Device Investigator Initiated Study Conference

Maximizing Medical Device Investigator Initiated Research through Effective Management of Investigators & Studies, Training on Policies, Procedures & Regulations, all within a Unclear Regulatory Framework in Europe

April 23-24, 2012 | Berlin, Germany

ABOUT THE CONFERENCE

Throughout the medical device industry, manufacturers are struggling with the volume of requests from investigators who are interested in conducting research studies on new and existing products. While these studies were traditionally only led by a select number of key opinion leaders, many doctors and physicians in Europe are now considering these types of studies as a way to advance not only medical technology, but also their own profiles as industry experts. Executives in Medical and Clinical Affairs need to be prepared with strategies and policies which will govern how to best handle these types of research; especially given the rapidly evolving regulatory environment.

Throughout the program, interactive sessions will enable professionals to engage in a lively debate and discussion on the challenges and opportunities that investigator initiated research presents to today's global medical device corporation. As with all Q1 programs, the strictly controlled attendance will minimize participation of outside consultants, providing attendees with an atmosphere focused on knowledge share, learning and networking; ideal for those consultants and solution providing companies looking to enter this exciting market.

| Read More |

TOPICS TO INCLUDE:

Establishing a Common Terminology Framework: Defining "Sponsors," and Other Challenges
Aligning External Studies with Corporate Medical Strategy
Determining the Best Approach for Each Investigator Initiated Study
Identifying Which IIS to Support for Maximized Return on Investment
Developing a Cohesive Investigator Initiated Study Contract
Obtaining & Securing IP Protection When Conducting External Research Studies in the EU, Focus On Germany
Establishing Clear Study Protocols with External Investigators
Strategies for Engaging With Physicians in Investigator Initiated Research
Best Practices: Achieving Better Collaboration by Training External Investigators
ISO 14155 Revision: Clarifying New Requirements with Investigators
Opportunities in the Internal Management of Device Investigator Initiated Studies
Overcoming Hurdles in Funding Of an IIS & Fair Market Value
Ensuring Financial Disclosure in Investigator Initiated Studies
Overcoming Challenges in Turning Away Studies While Maintaining Physician Relationships
Learning Opportunities from the Pharmaceutical Industry's Experience in IIS
Successful Insurance Planning In Investigator Initiated Studies