Medical Device Investigator Initiated Study

Investigator Initiated Studies (IIS) are valuable assets in medical research. Unlike conventional clinical trials, IIS are often conducted at research hospitals and universities. They fill gaps where clinical trials leave unanswered questions. Conducting an IIS is complex due to factors like limited industry support. In summary, IIS involve cross-functional collaboration, strategic impact assessment, and real-life experiences

Module 1 : Introduction to IIS

  • Collaborative IIS (Investigator Initiated Study) The Best of Both Worlds?
  • Risks and Chances of an IIS (Investigator Initiated Study) seen from the Manufactures Perspective
  • Notified Body Perspective on The Challenges of The Regulatory Requirement Throughout the IIS (Investigator Initiated Study) Process
  • Building a Bridge Between Industry and Investigators: Setting Up an IIS (Investigator Initiated Study) Program
  • IIT´s (Investigator Initiated Trial) GRANT APPLICATION: The Value of the Review and Submission Process
  • Finding your Regulatory Jungle

Module 3 : Considerations of IIS

  • IIS (Investigator Initiated Study) Program Budget Discussion
  • What is it all About?
  • Why, When and How to Apply the Pre-Clinical Approach?
  • To be Considered Before you Start
  • How much can we get out of it?
  • Real-Life Experiences and Examples

Module 5 : Challenges and Conclusion of ISS

  • Challenges and Opportunities in Investigator-Initiated Pre-Clinical Studies.
  • Who Choses Whom? Process of Investigator’ Selection and Manufacturer’s Support of Off-Label Use of the Device
  • CA (Competent Authorities) Perspective Regulatory Compliance in the EU (European Union) Classification of Clinical Investigation Approval Pathways
  • Pursuing and Assessing the Success of IIS (Investigator Initiated Study)

Module 2 : Importance of Investigator Initiated Study

  • What is the importance of IIT’s (Investigator Initiated Trials)
  • IIT’s (Investigator Initiated Trials) versus Industry Sponsor Trial.
  • Expectations from all Parties, the Proposer and the Funder
  • Pitfalls of not having a Proper Proposal Channel
  • The Desired Proposal Process
  • Collaborative Research as an Option

Module 4 : Goals of IIS

  • What is Successful IIS (Investigator Initiated Study)?
  • Receiving the Right Proposal from Right Sponsor
  • Assessing the Strategic Impact of IIS (Investigator Initiated Study)
  • Cross-Functional Collaboration and Transparency
  • Learning from Experience
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Certificate In FCPM [ Online ]

Duration : 4hrs / week ( 2 days/week )

Schedule : Session of 2 hours twice a week

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August 2024
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Certificate In FCPM [ Offline ]

Duration : 4hrs / week ( 2 days/week )

Schedule : Session of 2 hours twice a week

Perks Of Offline Course

Role Play

Get to work on live projects

Face-to-face guidance by PM (Project Manager)

Clinical on-site exposure