Navigating the complexities of rare disease drug development
In this article, Dr Eric Hardter, Associate Director of Regulatory Affairs at Boyds, discusses the investigational phase of the rare disease drug development process with a focus on US regulatory requirements.
The FDA Pre-IND Meeting – A Best Practice for Mitigating Early Regulatory Risk
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.
Navigating the regulatory landscape in oncology drug development
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.
MHRA announces new pathway for device regulations
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.
The importance of diversity in clinical trials
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.
A guide to plain language summaries (PLS)
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.
EU Pharmaceutical Legislation Reform – Impact on clinical trials for innovative GMO medicines
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.
Paediatric Development Harmonisation in Europe and the US: Myth or Reality?
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.
Ada Lovelace Day 2023: turning curiosity into a career
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.
Clinical study management: the key to trial success
In our latest blog, Dr Karen O’Hanlon sets out the approach the team follows to help maximise trial success.
