The development and maintenance of products for the life sciences sector requires virtually permanent (and increasing) ongoing interactions with healthcare professionals. This includes post-market clinical follow-up studies, pharmacovigilance, health technology assessments, reimbursement discussions and the development of new products. As these needs grow in future, companies need to reconcile such demands with the draconian nature of the new Bribery Act- described as the FCPA on steroids.
As reiterated by the recent multimillion dollar fines imposed on J&J, bribery allegations must be considered throughout the product lifecycle, and even in M&A transactions. This masterclass will summarise the law and the interaction with the ABPI Code of Practice. In addition, implications of the historic Memorandum of Understanding, published by the ABPI and PMCPA in consultation with the SFO, will also be discussed.
Attend the masterclass and receive:
• A clear understanding of the new law and its impact on crucial areas of practice in the life sciences sector
• A consideration of the new law on various agreements with healthcare professionals: research agreements, collaboration agreement, clinical trial agreements, consultancy agreements, PMCFU agreement, pharmacovigilance arrangements, speaker agreements, educational grants and sponsorships
• How to handle Bribery Act considerations in commercial agreements with non-HCPs and M&A transactions.
• A practical guide to structuring and implementing a compliance regime considering the requirements in the UK, Germany and the Netherlands
Official Website: http://www.smi-online.co.uk/briberyact12.asp
Added by Vinh Trinh on February 13, 2012