Understanding The New NIH/HHS Final Rule On Clinical Trial Reporting – Tips For Compliance Success

Date: April 6, 2017
Time: 1:00pm-2:30pm, EDT US
Duration: 90-Minutes
Price: $299 - Includes Bonus Handouts!

The recent changes in National Institutes of Health/Health and Human Services (NIH HHS) requirements (Final Rule) for registration of clinical trials and submission of results information will apply to all clinical trials of medicinal products (including Biologics) and device products.  This Final Rule clarifies and expands the requirements for registration and submission of data from clinical trials.  The Final Rule also outlines the potential civil or criminal actions which may be taken by the regulatory agency for non-compliance.

This final rule is a mandatory piece of your clinical studies that, if ignored, will irreparably harm or even destroy your trials.  Fortunately, we have broken down the final rule into a digestible, convenient format that will put you and your studies on the road to compliance.    

By attending this 90-minute presentation you will learn…

  • The requirements set forth in the new Final Rule to enable you to prepare yourself for compliance
  • Who the “responsible party” is
  • The new required format for protocol submission
  • The new formats for reporting clinical trial results and adverse events
  • The current timeframes for registering and updating ClinicalTrials.gov

This course will benefit individuals working within a Sponsor’s clinical operations and regulatory affairs groups, as well as investigators conducting Investigator Initiated Trials.

For over 10 years, Michael Pierro has provided consulting services to the Biotechnology, CRO and Pharmaceutical Industry in the areas of clinical operations (Standard Operating Procedures, Project Management and Clinical QA GCP auditing) and GCP/SOP training (live & Internet delivery). In this work, he draws on over 30 years of experience in clinical operations and training in the pharmaceutical & biotechnology industry.

Previously employed by Barnett International, Michael served as Director, Business Development: Consulting & Clinical Training responsible for development and implementation of GCP related standard operating procedures, specialized compliance related training programs and related consulting services. Clients include Pharmaceutical, Biotechnology, CROs, University Medical Centers and US Federal Government.   

Immediately prior to joining Barnett, Michael was Director of Global Training for Hoechst Marion Roussel’s (Aventis) Global Clinical Quality Assurance Department. In this role, he directed all GCP Auditing, SOP and technical training programs and activities within the company’s Global Drug Development Center and other development sites throughout the world.   In previous roles with Hoechst Marion Roussel and other major pharmaceutical companies, Michael served as a Senior CRA, Manager of Phase IV Clinical Operations and Chairperson of the SOP Steering Committee and GCPAuditor.  He was involved in several NDA and SNDA preparations and filings as well as other reports to the regulatory agencies.

Michael Pierro Clinical GCP/SOP Training Instructor