Arik Gorban | iGATE
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. Continue reading "IT Compliance Spotlight on Pharma, Medical Device and Biotech Merger and Acquistions"
In The Headlines
Kevin L. Jones | Faegre Baker Daniels
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?
Continue reading "Pharma in China – Compliance Challenges and Options"
Topic of Discussion
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.
Continue reading "Data Integrity: Make Sure This Hot Topic Doesn’t Burn You or Your Suppliers, Contract Manufacturers or Contract Laboratories"