1 Hour and 10 Minute Video | Julie Yeni, Baker & McKenzie SCP & Sara Koski, Baker & MCKenzie SCP

 

After almost two years of drafts and debate, the so-called French Sunshine Act, was finally implemented by the French Ministry of Health by the Decree of May 21, 2013. Heavily motivated by both the US Sunshine Act, as well as local controversies such as the PIP breast implants and the case involving the drug Mediator, the French government has enacted the broad reporting requirements that entail disclosure from both pharmaceutical and medical device companies. However, the final Decree left many questions unanswered. Although interpretative guidelines have been published both by the health sector representative associations and French Ministry for Health and the process for disclosures on a single public website is taking form, compliance with the French Sunshine Act still remains a great challenge for many companies, since numerous issues remain to be clarified.

TOPICS COVERED

  • Detailed review of final Decree definitions and concepts
  • Pragmatic approach and a view to borderline cases and grey zones
  • Step by step guidance for disclosure process and obligations
  • Understanding the consequences for non-compliance
  • Methods for reporting system selection and implementation

Participants that will find this webinar most beneficial will be those involved in pharmaceutical, medical device, biotechnology and diagnostic companies.  Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs
  • Legal Affairs
  • General/Corporate Counsel
  • Compliance & Ethics

Julie Yeni

 

 

 

Julie Yeni
Partner
Baker & McKenzie SCP

Sara-Koski

 

 

 

Sara Koski
Associate
Baker & McKenzie SCP

Julie Yeni, Partner, Baker & McKenzie SCP

Julie Yeni joined the Paris Office of Baker & McKenzie in 2013 and practices in the Pharmaceutical and Healthcare Industries Practice Group of Baker & McKenzie. Her practice focuses in health matters and assists healthcare industries with both counsel and litigation in all the life cycle of healthcare products. She has specific expertise in clinical trials, market access and product regulation, commercial relations between the healthcare industries, and relations between Physicians and the healthcare industry.

Sara Koski, Associate, Baker & McKenzie SCP

Sara Koski joined the Corporate and Mergers & Acquisitions Group at Baker & McKenzie SCP in 2012 and is also a member of the Compliance and Compliance & Risk Management Group

Purchase Video Recording

$395
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