• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » EMA revises policy on conflicts of interest

EMA revises policy on conflicts of interest

November 21, 2014
CenterWatch Staff

The EMA has published its revised policy on handling declarations of interests for scientific committee members and experts. The revisions reflect a more balanced approach to handling conflicts of interests that aims to effectively restrict the involvement of experts with possible conflicts of interests in the agency’s work, while maintaining EMA’s ability to access the best available expertise.

The revised policy, endorsed by the EMA management board in March, takes into account input from stakeholders at the agency’s September 2013 public workshop “Best expertise v. conflicts of interests: striking the right balance.”

“The priority of EMA is to ensure that the integrity of our scientific assessments of medicines is not compromised by private interests in the pharmaceutical industry,” said Noël Wathion, EMA’s chief policy adviser. “But over recent years, we also have recognized that an overly-rigid approach may limit the availability of expertise needed to ensure the robust scientific assessment of medicines. The updated policy should now allow a level of involvement better tailored to the interest profile of each expert.”

The revised policy includes a number of measures that better take into account the nature of the declared interest before determining the length of time any restrictions may apply:

  • An executive role or a lead role in the development of a medicine during previous employment with a pharmaceutical company now results in a lifetime non-involvement with the concerned company or product
  • For the majority of declared interests, a three-year cooling-off period. Restrictions to involvement decrease over time and make a distinction between current interests and interests within the last three years
  • For some interests, such as financial interests, there continues to be no cooling-off period required when the interest is no longer present.

Overall, requirements for experts who are members of scientific committees remain stricter than for those participating in EMA advisory bodies and ad-hoc expert groups. Similarly, requirements for chairs and members in a lead role (e.g. rapporteurs) are stricter than requirements for the other committee members.

All EMA scientific committee members and experts are required to submit their updated declarations of interests by the end of January. The agency will screen each expert’s declaration and assign an interest level. The interest level assigned and the nature of his or her involvement in EMA activities will determine the restrictions applied.

To ensure that this process is transparent, the updated declaration of interests and the assigned interest level of each expert will be published on the EMA web site.

The new policy takes effect Jan. 30, 2015.

Upcoming Events

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Revamp-360x240.png

    Califf Calls for Major Evidence Generation Revamp, Experts’ Opinions Differ

  • AskTheExpertsGreen-360x240.png

    Ask the Experts: Managing Investigational Products

  • SurveywBlueBackground-360x240.png

    Survey Outlines Site Challenges, Successes on Diversity

  • PatientCentricity-360x240.png

    Site Spotlight: DM Clinical Shows Patient Centricity Doesn’t Have to Break the Bank

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing