THE SUNSHINE ACT: WHERE APPLICABLE AND HOW TO ENSURE COMPLIANCE

Description
Regulatory

Many stakeholders expressed concerns about the influence the pharmaceutical or device industry has over healthcare actors including healthcare professionals and organizations, families, patients, service providers and the public. Up until a few years ago, there was little regulation governing these relationships and Pharma/Device companies did not need to disclose whether they, for example, sponsored events or made transfers of value (i.e. donations, gifts etc.) to healthcare professionals and organizations.

Following the introduction by the US of the ground-breaking Physicians Payments Sunshine Act in 2010, the transparency landscape has rapidly shifted in Europe.

This TRIUM training provides a map as created by the Mental Health Europe (MHE) organization © 2017, which aims to give a glimpse into the situation in Europe where many countries have introduced Sunshine Laws, Regulations and Rules which require transparency around ‘transfers of value’ between Pharma and healthcare professionals. The legislation and rules adopted vary from regulations to attempts at better self-regulation from Pharma and the healthcare profession through the adoption of voluntary Disclosure Codes (which are not mandatory to follow).  A brief introduction of what country has a Sunshine Act regulation or not, and if not, what Codes are followed and their requirements will be the core of this session, enabling you to ensure compliance when conducting trials in Europe.

Learning objectives

By the end of this TRIUM Training you should be able to:

  • Explain the difference between a Sunshine law and Disclosure Codes
  • List the requirements for the European country of your interest
Intended audience

Skilled Level
Can perform task or skill independently, consistently, accurately, and has a moderate level of expertise. Efficient and high quality work. Able to independently navigate resources and uses tools well.

Trainer
Esther Daemen
Esther Daemen is currently ‘Quality &Training Director – Data Protection manager’ at TRIUM Clinical Consulting and has over 27 years of working experience in the healthcare/pharma & device field. She served many organizations in different research roles and as professional development director at ACRP global. She gained a bachelor’s in nursing and earned project management, training and DPO certificates as well as and a master´s degree in Business. Esther is also a highly sought-after presenter at professional conferences/universities and a writer of peer-reviewed articles for professional magazines like ‘The Clinical Researcher’. Her work was rewarded by the KP Morgan 'OECT Summit 10Years Speaker Achievement Award' in 2020, the ‘Best trainer to watch’ 2010 Training Magazine award and by having her organization ‘Kendle’ being listed as one of the top 125 training providers in the world in 2008. "TRIUM is an expert Contract Research Organization that offers a unique combination of global CRO services, staffing solutions, quality services, GDPR consultancy and risk-based approaches as well as training services. It’s our mission to be a passionate, dedicated business partner with a focus on excellence to provide start‐to‐finish clinical trial activities tailored to the timing, budget and specific needs of the Sponsor.”