In this blog, Dr Eric Hardter, Associate Director of Regulatory Affairs, discusses the critical importance of proper planning and early engagement with FDA for Investigational New Drug (IND) applications.
In this blog, Boyds’ Dr Katherine Bowen, Senior Director of Regulatory Affairs, and Dr Julie Warner, Vice President of Regulatory Affairs, explore the ever-evolving world of oncology drug development and the regulatory landscape in the US and EU.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published the “MHRA Roadmap towards the future regulatory framework for medical devices”. With the of release of this document on the 9th January 2024, the Agency has provided an update on the intended timelines to implement the future core regulations via a series of new Statutory Instruments.
In this article, Dr Harriet Gray-Stephens, Pharmaceutical Physician in the Clinical and Medical Affairs team at Boyds, discusses the importance of diversity in clinical trials and the steps that are being taken to improve the quality of data derived from clinical research.
In this blog, Naomi Clout, Senior Regulatory and Medical Writer at Boyds, discusses the importance of Plain Language Summaries as an effective scientific communication tool that can be easily comprehended by people who aren’t experts in the field and the steps involved in creating a PLS.
To address challenges faced in Europe’s pharmaceutical sector, the European Commission (EC) has proposed a new pharmaceutical strategy for Europe¹. This patient-centred strategy aims at creating a future-proof regulatory framework to ensure that patients have access to high-quality, effective and safe medicines, while boosting the sector’s global competitiveness.
In this blog, Celine Courtay-Cahen, Senior Manager, Regulatory Affairs, explores the challenges and prospects of harmonising paediatric drug development efforts between the European Union and the United States.
In this interview, Dr Karen Mullen discusses what inspired her to pursue a career in STEM, her tips for overcoming adversity, and how to encourage more women to consider careers in the industry.
In our latest blog, Dr Karen O’Hanlon sets out the approach the team follows to help maximise trial success.
In our latest blog, Clinical Project Manager, Chris Moore explores the key challenges faced by US biotech companies planning to initiate their gene therapy study in the UK or Europe.