Investigator Initiated (Sponsored) Trials – ISSs

This webinar will cover definitions, responsibilities, regulatory requirements and strategies to conduct Investigator Initiated (Sponsored) Trials - ISSs. It outlines the processes a company or investigator must undertake to be able to conduct such a clinical research study in humans.

Why Should You Attend:

The legal and regulatory hurdles are a major pitfall for ISSs. Recent legislation and newly revised guidance documents for the pharmaceutical industry are being introduced regularly in light of the latest anti-kickback statutes. Pharmaceutical companies must carefully navigate the guidelines to ensure a successful outcome in these investigator-initiated studies without violating regulations.

Areas Covered in the Seminar:

• Who is the Sponsor?
• Who is the Investigator?
• Who is the Applicant and how do you submit?
• FDA and European nomenclature and regulations.
  • CFR Sec. 312.3 Definitions and interpretations (FDA).
  • Directive 2001/20/EC.
• Who holds the IND?
• Who has the intellectual property rights?
• Who has publication rights?
• Who has liability for drug adverse events?
• Who provides financial support?
• Who provides drug supplies?

Who Will Benefit:

• Pharmaceutical Medical Directors in Clinical Research and Medical Affairs
• Pharmaceutical medical support personnel who work in clinical research or medical affairs who may initiate or oversee IISs by their company
• CRAs, CDAs, MSLs, Managers, etc.
• Investigators at study sites interested in conducting ISSs

Event Details:

Date:              September 13, 2012

Time:             10:00 AM - 11:00 AM PDT

Cost:              $199 per attendee per computer terminal

Registration:  SIgn-Up on-line now.  Add to your shopping cart.