Archives: Articles

Solving the last (or first!) mile of global RIM transformation: improving local Affiliate engagement

Building on his recent talk at Amplexor (ArisGlobal)’s annual global BE THE EXPERT conference, Steve Gens of Gens & Associates reports the top-level findings of a far-reaching new regulatory study into the evolving role and challenges at a regional and country level. Improving local Affiliate effectiveness is critical for a true end-to-end global regulatory information management capability.

Read More »

Preparing for eCTD 4.0 compliance

It would be easy to conclude that the implementation of IDMP standards for future regulatory exchanges is the be-all and end-all of pharma regulatory process modernisation and the only driver of current IT and data-based projects. Yet the significantly updated eCTD 4.0 standard, whose details have now been published, is at least just as important, affecting the way Life Sciences companies submit dossiers internationally. Amplexor’s Agnes Cwienczek summarises the key requirements and the preparations now needed.

Read More »

The biocidal product regulation10 years on

Biocides are important tools for society to maintain its standards of health and to achieve its targets for a sustainable future. The benefits that biocides offer to meet these goals are balanced by the need to ensure they can be used safely. The Biocidal Product Regulation (BPR) controls the use of biocides and it has been in force now for 10 years. The BPR is arguably the most complex piece of legislation regulating the use of chemicals in Europe. Its complexity is compounded by delays in delivering its core purpose. This article looks at some of the changes to the BPR over the last 10 years, it considers progress made in delivering key regulatory objectives and offers some thoughts on how the BPR might evolve in the future.

Read More »

New processing concepts and cluster technologies: catalysts for a faster and more efficient transition to using biobased carbon materials in a circular bioeconomy

Addressing some of the challenges in a transition to the circular bioeconomy, this paper first explores the use of next generation processing approaches to help move pharmaceutical, chemical, and biomaterial products from fossil carbon to its biobased alternative. It posits the use of system-oriented cluster technologies through the application of cluster governance to increase both collaboration and knowledge exchange and to help facilitate the transition to a circular bioeconomy in a fast and effective manner.

Read More »

Multicatalysis – Pushing the boundaries beyond multi-disciplinarities

The concept of multi-catalysis is an emerging field targeting the development of new efficient catalytic systems combining multi-step synthesis in new ‘one-pot’ transformations or in multi-catalytic sequences. In this article, we will review the main classification of multi-catalysis strategies and illustrating some case-studies which combine different catalysis fields leading to some remarkable opportunities to outcompete classical approaches. Despite major challenges that need to be addressed with respect to compatibility issues and catalyst reactivity ordering, the implementation of such processes enables to strengthen the collaboration across many disciplines enhancing interdisciplinary competences.

Read More »

Login