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.
This session is designed for clinical research professionals either at a pharmaceutical company or at a study site who are considering conducting ISSs and would like more information on the process to be able to abide by international regulations as well as understanding the process of how a company and sponsor collaborate.
The goal of this training is to help the clinical research professionals avoid liability, identify opportunities for improving the processes for conducting ISSs and to describe ways companies and study sites can best interact.
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 write the informed consent?
What are the regulatory reporting requirements?
Who provides the study information on Clinicaltrials.gov (US) or European Clinical Trials Database (EudraCT Version 8.0, operational since 10 March 2011?
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.This session is designed for clinical research professionals either at a pharmaceutical company or at a study site who are considering conducting ISSs and would like more information on the process to be able to abide by international regulations as well as understanding the process of how a company and sponsor collaborate.
The goal of this training is to help the clinical research professionals avoid liability, identify opportunities for improving the processes for conducting ISSs and to describe ways companies and study sites can best interact.
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 write the informed consent?
What are the regulatory reporting requirements?
Who provides the study information on Clinicaltrials.gov (US) or European Clinical Trials Database (EudraCT Version 8.0, operational since 10 March 2011?
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
- Coordinators at study sites who must manage the process
- Farm bureaus and members
- Legal Affairs
Course Provider
Charles Laudadio,
