Each year on World Patient Safety Day, the global health community comes together to highlight a critical area where lives and wellbeing can be protected. This year’s theme, “Patient safety from the start: safe care for every newborn and child”, moves the spotlight to the youngest and most vulnerable among us. 

Every child deserves the best chance at a healthy life. However, risks during pregnancy, childbirth, and early childhood remain high worldwide. Protecting the health of newborns and children means paying close attention at every stage – from safe delivery practices and accurate medication dosing to early diagnosis and well-designed paediatric clinical trials. Pharmora supports patient safety throughout clinical development, through regulatory review and in the post-marketing setting.Preventable harm in these early years can have lifelong consequences, making all patient safety not just a medical responsibility, but a societal one. 

Pharmora’s Role in Neonatal and Paediatric Safety
Pharmora brings established expertise to this year’s World Patient Safety Day theme. We are led by a Chief Medical Officer who trained in paediatrics before retraining as a GP and pharmaceutical physician. This passion for improving the health and safety of neonates and children, as well as adults, continues to drive the work we do. 

Children process medicines differently, and their vulnerabilities need tailored safety approaches. At Pharmora, we understand these unique challenges and work to ensure paediatric safety is a priority at every stage. Our reviews of clinical data and protocols always include a focus on age-appropriate dosing, monitoring requirements, and early identification of risks.  

Over the years, Pharmora has contributed in many ways to protecting the youngest and most vulnerable patients. For example, when working in clinical trials, we participate in protocol review, ensuring that any pregnancy prevention measures or special points to consider are captured. Our scientists work to verify inclusion and exclusion criteria, ensuring pregnancy and contraception requirements are clear and are applied consistently across study protocols. We also help establish and improve pregnancy follow-up processes, so that pregnancies occurring during clinical trials or in the post-marketing setting are tracked safely. This work involves mapping existing communication pathways, drafting or reviewing operating procedures and templates, and creating follow-up forms that capture all the relevant information.  

Protecting patients during on-going clinical trials is especially critical when pregnancy is involved. At Pharmora, We closely monitor any exposures during pregnancy, with rapid escalation of adverse events and serious adverse events, alongside ongoing signal detection to identify emerging risks. 

Another important part of our work is reviewing the data supporting marketing authorisation applications. We have worked on applications that include indications for paediatric and neonate populations. This requires not only literature review, but also careful assessment of clinical trial evidence, pharmacokinetic data, and risk management plans. Through diligent review of the submissions, asking the right questions, and using both our scientific and regulatory insight, we help ensure that applications for paediatric use are underpinned by strong, reliable safety evidence with robust risk management plans. Post marketing, it is vitally important that the accurate and clear information is provided to the physicians, the patients – and for paediatric use, the patients’  parents. This information will include warnings and precautions, a list of the possible adverse reactions that could occur, potential interactions and any specific guidance for use in different age groups.Although adverse reactions are thought to occur in only 2 to 5% of children for whom drugs are prescribed, early recognition and prompt withholding of a drug is essential, and review of the proposed post marketing information is a key part of this process. 

Pharmora and Patient Safety
At Pharmora, patient safety is at the heart of everything we do. Our team of experienced scientists and physicians work across the full lifecycle of clinical development, helping sponsors and regulators ensure that data is accurate, reliable, and aligned with the highest safety standards. From cleaning and validating safety datasets, to monitoring for adverse events and checking pregnancy precautions, we bring the expertise needed to identify risks early and protect patients throughout their care journey. 

Examples of our safety activities include: 

• Patient profiles – Developing accurate profiles ensures that trial participants are properly characterised, so safety risks can be identified and managed from the very start. 

• Serious Adverse Event (SAE) alerts – Monitoring and processing adverse event reports quickly allows sponsors and regulators to respond to potential risks in real time. 

• Safety data cleaning – Meticulous review of trial datasets helps identify inconsistencies, errors, or missing information that could otherwise compromise patient safety or study integrity. 

• Pregnancy and paediatric precautions – Careful checks around pregnancy-related risk and paediatric safety ensure that vulnerable groups receive the right protection throughout clinical development. 

• Regulatory support – Our team reviews data for regulatory submissions and product extensions, helping ensure that new medicines meet stringent safety requirements before reaching patients. 

 World Patient Safety Day is a reminder that protecting patients, especially the youngest and most vulnerable, requires constant vigilance. At Pharmora, we are proud to play our part by applying scientific rigour, regulatory insight, and medical expertise to every project we support. From paediatric data reviews to pregnancy precautions and ongoing safety monitoring, our commitment is clear: patient safety isn’t just part of our work, it’s at the very heart of it.