Blog
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.
Considerations for US Biotechs looking to set up gene therapy studies in the UK and Europe
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.
European Commission proposes extension of Medical Devices Regulation transition period in bid to prevent medical device shortages
At the Employment, Social Policy, Health and Consumer Affairs (EPSCO) meeting on 09 December 2022, the European Commissioner for Health and Safety, Stella Kyriakides, put forward proposals in her opening speech to extend the transition rules of the Medical Devices Regulation (EU) 2017/745. The Medical Devices Regulation (MDR) was adopted by the European Parliament and the Council in 2017. The Regulation states that medical devices can be placed on the EU market under CE certifications issued in accordance with Directive
What is a Target Product Profile and when is it needed?
When embarking on a journey it is preferable to have a destination or end goal in mind. The same is true when developing biopharmaceutical products; having an end goal or milestone to target helps keep the project team focused on what is required to reach the desired endpoint. A Target Product Profile (TPP), as the name suggests, defines the desired characteristics of the product, and is generally developed by the R&D project team, and in larger biotech and pharmaceutical companies,
Mitigating the risks with scientific due diligence
The need for scientific due diligence When companies enter into a deal, the successful outcome of that deal is subject to both parties working together to share information until an agreement can be reached. For biotech and life sciences companies, this is often achieved through scientific due diligence. Due diligence carries the simple understanding; you get what you expect and there are no surprises. What are clients looking for from the due diligence process? As an initial step in the
