ABSTRACT
Post-approval changes (PACs) to the registered information of authorised medicinal products are introduced routinely worldwide to enhance the robustness and efficiency of the manufacturing process, ensure timely supply in case of increased demand, improve quality control techniques, respond to changes in regulatory requirements and upgrade to state-of-the-art facilities. These are critical to prevent supply disruption and continuously improve existing medicines and vaccines. Due to the complexity of current PAC systems across markets, a change can take 3 to 5 years to approval globally (Hoath et al in BioProcess Int, 2016) thus hindering innovation and increasing the risk of shortages. The key messages are as follows: 1. Industry believes that global regulatory convergence of post-approval changes to Marketing Authorisations (MAs) using science- and risk-based approaches will enable a more efficient management of quality and supply improvements and will facilitate patients' access to innovative medicines and vaccines of the highest quality. 2. National Regulatory Authorities (NRAs) should establish national or regional guidelines in line with international standards (regarding a risk-based classification of changes and standardisation of requirements) (Guidelines on procedures and data requirements for changes to approved biotherapeutic products, in WHO Technical Report Series, 2018, Guidelines on procedures and data requirements for changes to approved vaccines, in WHO Technical Report Series, 2015), have clear procedural guidance including timelines and implement reliance pathways to accelerate the approval of changes. This paper briefly outlines the challenges for PACs and provides solutions for a more flexible and aligned global system.
Subject(s)
Change Management , Vaccines , Humans , Europe , Marketing , Quality ControlABSTRACT
Increased life expectancy rates in people with a stoma prompt the need to gain a better understanding of what are the concerns and the strategies of adaptation in this population in the long term to provide appropriate guidance and ongoing care. Therefore, the aim of this study is to explore the experiences and perceptions of people living with a colostomy for at least 20 years with regard to body changes and how these influence stoma care. This is phenomenological study. Five main themes were identified following data analyses: 1) accepting the stoma and living one's life almost fully; 2) changes; 3) practices to which I owe the recovery of my autonomy; 4) we are in need: before, during and after; 5) most people don't know. After many years, interviewees did not report significant changes in the way they had to manage their stoma and activities of daily living. Participants underlined how their healthcare needs continue throughout their lives, thus outlining the key role they attribute to nurses, stoma therapy services and associations of people with a stoma.
