IT Compliance Spotlight on Pharma, Medical Device and Biotech Merger and Acquistions

Mergers and acquisitions are not a new trend in Life Sciences. We have seen pharmaceutical, medical device, and biotech companies growing through mergers and acquisitions for the last two decades. Today, many of these companies are operating with IT-related compliance issues and significant inefficiencies resulting from lack of planning and management fear of political nightmares when trying to consolidate and harmonize methodologies and compliance activities after a merger or an acquisition. Often, management is only concerned with validation activities that are related to hardware and software changes and are not aware of the impact of the integration of new business areas and process changes. We hear executives stating that they’ll consider validation activities once they determine the required changes to computer system architecture and applications. [Read more...]

Pharma in China – Compliance Challenges and Options

China poses unique compliance challenges for pharmaceutical companies, with several well-known foreign companies getting caught up in corruption investigations in the past year. President Xi Jingping has publicly made fighting corruption one of his cornerstone policies. Additionally, the DOJ and SEC have been quite vocal in recent years about their ongoing Foreign Corrupt Practices Act (FCPA) enforcement focus on the pharmaceutical industry, with a particular focus on China. In recent years, 10 investigations under the FCPA involving alleged violations in China by pharmaceutical and medical device makers. Finally, it’s been long known that the structure of the healthcare system and environment in China creates a high-risk industry. So why, despite knowing these things, did certain pharmaceutical companies recently find themselves embroiled in corruption scandals?
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Data Integrity: Make Sure This Hot Topic Doesn’t Burn You or Your Suppliers, Contract Manufacturers or Contract Laboratories

How confident are you that there are no data integrity issues within your firm, or within the many suppliers, contract laboratories or contract manufacturers you use in the development, manufacture and supply of your products or services?

There has been a noticeable increase in the past year or so in the number of significant enforcement actions taken by regulators, particularly the US FDA and the UK MHRA, related to data integrity. These have included the refusal to accept new product filings and the refusal to allow products to be marketed if manufactured at a site with known data integrity issues.
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Strengthening Compliance Through Effective Process Management

The pharmaceutical industry is facing a number of key challenges, including complying with rigorous regulatory requirements, improving productivity, reducing costs, and finding new sources of revenue. Pharmaceutical companies need to be more comprehensive and integrated in how they address these challenges. In the past, companies would often address these challenges with narrow improvement efforts managed within functions. This is no longer sufficient. It is now necessary to take a more holistic enterprise-wide view when transforming your business. In particular, it is essential to manage compliance not only through centralized functions but also by building accountability into your end-to-end global process design so it becomes the way you run and manage your business.
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The Economic Reality of Drug Shortages

Ten years ago or so, little if any attention was paid to drug shortages. Occasionally, a drug would come in short supply due to a manufacturing or raw material problem, but it was an abnormality. For the past several years, drug shortages have become a way of life. The U.S Government Accountability Office (GAO) recently issued a report1 stating that although the number of new drugs in short supply declined in 2012, the total number of active shortages has increased since 2007. The GAO reports that a majority of the drugs in short supply are generics, and a majority of those are sterile injectables, such as generic preparations of chemotherapy. [Read more...]

Controlling Compliance Risk in Global Clinical Research Activities

To say that globalization matters to pharmaceutical and medical device companies is an understatement. Labor, research, and payer coverage and reimbursement obstacles in North America and Europe, as well as increasing patent challenges, are forcing an intense focus on maximizing development activities and commercial opportunities around the world, including in jurisdictions that were barely on the radar screen in decades past. At the same time, speed to approval in developed markets remains critical, and a significant portion of the value proposition of research conducted in developing markets is often focused on support of approval applications in the US and EU, where the scrutiny of research and publication practices has steadily grown. Taken together, these trends require legal, regulatory, and compliance professionals to pay close attention to how clinical research activities are planned and executed.
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