home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
  HUM-MOLGEN -> Events -> Meetings and Conferences  

Investigator Initiated (Sponsored) Trials – ISSs

  August 08, 2012  
ComplianceOnline, Online Event

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.

 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?
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.

Organized by: ComplianceOnline
Invited Speakers: Dr. Laudadio, is a Pharmaceutical Executive with more than 32 years of experience in large, small, and mid cap global pharmaceutical companies and CROs. He is an accomplished MD with a multi-faceted background in clinical research and medical affairs coupled with a history of leadership and clinical expertise which has significantly contributed to approval of multiple drugs in small molecules and biologics. Global experience leading drug development programs including multiple INDs, NDAs and BLAs Regulatory interactions with both FDA and European agencies by helping to develop the clinical and regulatory strategy development and clinical trial execution globally.
Deadline for Abstracts: 2012-09-13
Registration: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702420?channel=hummolgen
E-mail: referral@complianceonline.com
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.