news
EU proposes new blood, tissues and cells Regulation
The draft Regulation aims to enhance the protection of donors and recipients of substances of human origin (SoHO) therapies, while facilitating supply and innovation.
List view / Grid view
Regulation & Legislation
article
Tackling fake pharmaceuticals: an industry united against counterfeit products
The market for counterfeit pharmaceutical products remains strong, with dishonest actors proving perennially tenacious. Here, Rich Quelch offers guidance on the technologies and practices that are helping to impede fraudsters.
article
How can evidence-based medicine (EBM) methodology support drug withdrawals?
In this article, Samantha Lane of the UK’s Drug Safety Research Unit discusses the development of an evidence-based medicine (EBM) methodology to assess the positive impact of withdrawing or revoking licences for medicines on public health. The approach leverages electronic health records to model the estimated number of adverse reactions…
video
Video: Free 10-minute pharma data integrity training
Ex-MHRA inspector and NSF expert, Rachel Carmichael, takes a high-level look at why Data Integrity matters in this online introduction training.
news
Research calls for regulators to accelerate the approval of antibiotics
Report by One Health Trust says acknowledging antimicrobial resistance in regulatory frameworks for accelerated drug approval could improve access to new antibiotics.
news
Pilot scheme to analyse raw trial data launched by EMA
The pilot will assess whether analysing raw clinical trial data is beneficial to regulatory decision making on marketing authorisation and post-authorisation applications.
whitepaper
Whitepaper: Maintain product integrity in biologic clinical studies
Cold chain shipping challenges & root causes of common reference product sourcing problems.
news
What can we learn from contamination control failures?
Here EPR summarises the key points of Jeanne Moldenhauer’s article on what can be learned from warning letters and regulatory inspection observation reports.
news
How should cleaning validation sampling locations be chosen?
Here EPR summarises the salient points of a case study, presenting a strategy for identifying worst-case sampling locations on equipment for cleaning validation.
whitepaper
ebook: Guidance on implementation of ARMMs
Many quality control professionals recognise that the need to modernise microbial detection methods is at an all-time high.
article
ESG considerations in Europe and Asia: social inclusion – the new diversity frontier in life sciences
With the focus on environmental, social and governance (ESG) issues rising worldwide, in this article, Morgan, Lewis & Bockius LLP Partners, Lesli Ligorner and Louise Skinner discuss the evolving landscape, presenting the emerging regulations for reporting social factors across Asia and Europe.
video
On-demand webinar: Speed your biologic into phase 1-3 clinical trials
How shortening the timeline from development to clinic can be achieved through parallel processing versus using a task/time compression approach.
video
Webinar: Comparator sourcing success
Collaboration between comparator sourcing specialists and clinical supply managers can improve inventory management and supply chain performance.
article
Global Blood Therapeutics: driving innovation in sickle cell disease
Sebastian Stachowiak, Head of Europe & GCC at Global Blood Therapeutics (GBT), explains how, while the company establishes its presence in Europe, it continues its commitment to advance the care of people living with sickle cell disease by collaborating with the sickle cell community to develop breakthrough therapies, raise awareness…
video
Webinar: Responsibilities of specialised clinical supply experts
Learn the differences in areas of expertise and responsibilities between the Clinical Supply Manager, Project Manager and Financial Project Analyst.
