Regulatory toxicology: more experts needed
31 May 2023
No Comments
INTRODUCTION Many years ago, around the mid-1990s, I was discussing with a manager of
Archives: Articles
How to transition to e-labelling – practical first steps
3 May 2023
No Comments
E-labelling provides patients and healthcare professionals with up-to-date product and safety information. Schlafender Hase’s Dr. Jutta M. Hohenhörst discusses the benefits of e-labelling for the medical device sector and provides some practical tips for getting ahead with processes, procedures and solutions that deliver efficiencies across today’s labelling landscape, and add value for patients.
Next-generation approaches to statistical significance
3 May 2023
No Comments
Biopharma Excellence recently hosted a panel discussion featuring experts in biotech and the evolving regulatory environment to discuss the challenge of achieving statistical significance with novel and highly targeted therapies.
Daniel O’Connor of the UK’s MHRA, with a remit of Innovation Acceleration within a regulatory context, noted that the challenge of achieving statistical significance when target populations are tiny is nothing new, but conceded that randomised trials aren’t always viable – especially with very rare conditions. He urged drug developers to seek scientific advice before finding workarounds.
Applications of artificial intelligence in healthcare
3 May 2023
No Comments
INTRODUCTION Artificial intelligence (AI) is intelligence demonstrated by machines, as opposed to the natural
Sustainability – What Does it Mean for Excipient Makers and Users
3 May 2023
No Comments
IPEC, an industry association of manufacturers, distributors and users of excipients is about to publish an updated draft version of its Excipient Information Package – User Guide and Templates. This new version will include a new part to facilitate and standardise the exchange of Sustainability information covering the very broad range of aspects dealing with Corporate Social Responsibility and Environment, Social and Governance.
This article provides a heads-up and a call out for your feedback when a draft version is ready for review.
Sustainable microbial oils for a greener future
3 May 2023
No Comments
OVERVIEW COLIPI is a Hamburg-based start-up that produces vegetable and plant oil alternatives through
Bexagliflozin
3 May 2023
No Comments
Bexagliflozin (EGT1442), sold under the brand name Brenzavvy by TheracosBio, is an antidiabetic medication used to improve
Life Sciences Regulatory experts share predictions for 2023
3 May 2023
No Comments
Amplexor’s closest industry partners and BE THE EXPERT event speakers review the major milestones in the Life Sciences Regulatory sphere in 2022 and predict developments for 2023.
Maximising supplier controls to ensure optimal quality and safety
28 April 2023
No Comments
As the global Life Sciences market experiences ongoing disruption to international supply chains, this has created turbulence and consolidation for brands and manufacturers as they grapple with the complexity of ensuring safety and quality. As companies strive to build confidence in their end-to-end safety profile, Arriello’s Helen Lowe examines how they can ensure quality without boundaries.
Quality matters: Challenges in 2023 across the life sciences supply chain
28 April 2023
No Comments
New waves of innovation in Life Sciences, and a redoubled effort by regulators to maintain patient safety, are placing increased pressure on drug and device manufacturers to assure the consistent standards across manufacturing processes, systems and supply-chain partnerships. After practical supply chain issues in 2022, added to the impact of continued medicinal/device innovation, 2023 will bring new regulatory changes linked to process digitalisation and automation. REPHINE’s Dr. Eduard Cayón discusses the implications.