The EU Unitary Patent – Overview and Practical Considerations

Nov 4, 2014

The preparations have spanned almost 40 years, and there have been many significant obstacles to overcome. However, the “Unitary Patent” and the dedicated “Unitary Patent Court (UPC)”are now an inevitability. Jon Gowshall and Charlotte Fox of Forresters give an overview of the new system and look at some of the practical implications of the Unitary Patent and UPC for patent owners. The UPC agreement was signed on 19 February 2013, and will come into force as soon as it has been ratified by enough countries (thirteen including the UK, Germany, and France), probably in 2015. ...

Read More

Keeping Data Secure and Validated in the Cloud – Addressing the Misconceptions Surrounding Cloud Computing in Pharma

Jul 1, 2014

The requirement to demonstrate compliance, while still maintaining process efficiency and ease of use for marketing teams and time-to-market for life science companies, has led to a surge in interest in cloud computing systems for the management of commercial compliance. David Bennett of Zinc Ahead discusses the use of cloud computing within life sciences, focusing on the misconceptions that surround cloud computing systems in the three areas of data security, validation, and compliance. The article reviews different cloud environments and the benefits for life sciences – emphasising the importance of data validation and compliance in conjunction with privacy and security ...

Read More

Achieving Operational Excellence in Drug Safety with an Effective Quality Management System

Jul 1, 2014

The International Conference on Harmonisation (ICH), European Medicines Agency (EMA) and US Food and Drug Administration (US FDA) have laid out their expectations with respect to Quality Management Systems (QMS) for PV. Chitra Lele, PhD – Chief Scientific Officer, Sciformix Corporation – reviews the QMS-related requirements and specifications, and compares and contrasts the requirements of various organisations, primarily to elaborate on how these requirements can be implemented, what constitutes a robust QMS and how it can be built into PV operations. ...

Read More

Merging and Acquisition Perspective in Pharmaceutical Industry

Jul 1, 2014

It is very difficult to estimate how many mergers and acquisitions in the pharmaceutical industry have succeeded. It is even more difficult to define what success means. K. Sreekanth Reddy, V. Balamuralidhara, Shilpi Khattri and T. M. Pramod Kumar of JSS College of Pharmacy, JSS University, Mysore look into the challenges of corporate takeovers, showing us why 80% of mergers do not meet their pre-merger financial goals and 50% become failures. ...

Read More