lexisnexis whitepaper

Download whitepaper – Pharmaceutical & Life sciences: Third Party Due Diligence

Whitepaper by LexisNexis Few industries are as exposed to risk as the pharmaceuticals and life sciences. It is no longer enough to carry out basic checks alone on third-parties. Companies must engage in enhanced due diligence if they are to avoid the large fines and regulatory penalties. Effective third-party due diligence is increasingly recognized as a strategic driver for sustainable …

Out with the old for cancer treatment?

Today is #WorldCancerDay and it strikes me that it is great to see all of the developments in cancer treatments within the scientific community. The way in which we develop medicines is changing, and now everywhere you look you see information about ‘personalised’ or ‘precision’ medicine. One of the areas which is being hailed as a key disease group which …

BioPharma Mexico is where experts like Landsteiner Scientific go to network, learn from each other, and discuss the latest biopharma industry developments.

Landsteiner’s Francisco Kuri Breña on the Regulation of Biocomparable INN’s

The pathway that goes from fabrication to marketing of biosimilars is designed with safeguards to guarantee their comparability to reference drugs in terms of biochemical properties and clinical effects. In Mexico as in other countries, the law establishes a strict set of requirements in order to obtain marketing approval, which involve head to head comparison with the reference drug, sophisticated …

Download: Delivering effective training on compliance

Dr. Britta Luescher, Compliance Director, Novartis International AG, Switzerland gave a presentation at Pharma Compliance Europe 2013 on “Delivering effective training on compliance-Implementing a comprehensive training and monitoring system”. Download the presentation to learn: Delivering effective compliance training Training as part of a comprehensive compliance system What are the considerations for delivering effective compliance training? Consistency: Consider training as promoting a …

Download: Effective development and implementation of a compliance programme

Kristine Aachmann Bethe, Corporate Counsel, Business Ethics Compliance Office, Novo Nordisk A/S gave a presentation at Pharma Compliance 2013 on the effective development and implementation of a compliance programme. Her presentation began by highlighting why compliance is so important to Novo Nordisk, explaining that now, as part of big pharma, there are increased demands and expectations to meet and exceed.  As well, …

Download Ebook: Top 15 solution providers to the pharma compliance industry

  In this report, we’ve highlighted the Top 15 solution providers to the pharma compliance industry including: Top 5 software technology companies Top 5 law firms Top 5 consultancies that have shown innovation and leadership in the field. Feedback is welcome, so please let us know what you think. Download ebook Following on from the success of our inaugural Pharma …

Download: The Perils of Pharma: The Pharmaceutical Industry and the FCPA

In recent years, the pharmaceutical industry has been subjected to increased scrutiny and enforcement by U.S. authorities in the context of the Foreign Corrupt Practices Act (FCPA). In an effort to gain an understanding of the situation, this paper reviews some of the relevant case studies and concludes with steps that companies can take to mitigate risk. Download and learn: Enforcement: Pharmaceutical Case …

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Download ebook: Compliance Challenges & Conclusions

Predictions and tips to benchmark and drive your compliance programme CEE is regarded as a strong growth market for pharma, but operating in the region comes with its own challenges. In an era of changing social environment and a growing demand for increasing transparency, compliance faces a raft of challenges in this region including working with distributors, managing risk, understanding local …

Download whitepaper: Concepts behind consumer segmentation for improvement in population medication adherence

  The single most important factor that can be improved in chronic disease therapy is medication adherence. Efficacy and ultimately clinical outcomes can be incrementally improved. A virtual treasure exists in making sure that patients take the medicines that are prescribed to them. Behavioral principles identified for successful adherence have been found in many therapeutic areas. The difficulty is that …

Guest post: Rising generics use triggers increased worldwide regulation

  This article was originally posted on GaBI Online. The increasing use of lower cost generics is prompting regulators across the globe to introduce stricter regulations focusing on the quality of these products. Just a few of the countries that have updated regulations governing generics include emerging markets such as Brazil, Mexico, Russia and South Africa. This leads to delays …