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Background: Putting the patient at the centre of the drug development process has gained prominence in recent years among pharmaceutical companies. The traditional product-oriented research and development approach is increasingly being abandoned. A shift is noticeable in which the focus is truly on the needs of the end user, namely the patient, who must be involved from an early stage in the drug development process. Objective: To gain insights within three therapeutic areas, namely respiratory diseases, rare diseases, and neonatology, into the position of healthcare providers and patients in Belgium with regard to involving the patient throughout the drug development process by pharmaceutical companies. Methods: Online questionnaires were used to assess the needs, expectations, experiences and perceptions of Belgian healthcare providers and patients. Healthcare providers (n = 33) and patients (n = 75) were recruited via their professional association and their patient association or a social media call, respectively. A total of 108 questionnaires were completed. Results: The importance of involving patients throughout the drug development process was recognised by the vast majority of respondents. The median scores for current patient engagement were significantly lower. Despite the fact that 92% of patients want to be involved in a patient-centric initiative and 85% of healthcare providers are willing to support their patient in this, only 40% of patients have ever participated. The main reason why patients found this patient involvement important was the need for clear information and co-determination. They yearn for their voices to be heard. Getting clear information about the disease and treatment was seen by healthcare providers as the most impactful initiative. The biggest risks associated with patient involvement, in their view, were the lack of medical knowledge of patients and individual interest overriding the collective interest. Conclusion: This study shows that the majority of patients want to be involved in various patient-centric initiatives. Even though the importance of this was confirmed by the healthcare providers, it currently only happens in a select number of cases.

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Each pharmaceutical product imported into a market must adhere to the most recent approved registration dossier pertinent to that market. Any changes impacting this dossier have to be submitted to the regulatory authorities. The products supplied to the market must always be in compliance with the approved dossier, hence, the implementation of the change on site-level and the approval of regulatory authorities have to be aligned. Ensuring alignment of the implementation and validation strategy of these changes between different departments poses a significant challenge, particularly alignment between Global Chemistry, Manufacturing and Control (GCMC) and site-level strategies, which is essential yet complex. To address this issue, this thesis introduces a new approach divided into two phases: project initiation and an initial strategy establishment in phase one and further strategy development and implementation follow-up in phase two. This approach was designed through benchmark and brainstorm meetings, gathering input from experienced colleagues to develop and refine a procedure which ensures compliance with regulatory authorities and effective management of the approval of changes. A Regulatory Project Plan (RPP) template, a job aid named "Checklist for implementation of changes with registration Impact”, a timeline and a decision tree were formulated to direct this process. The RPP ensures a clear initial strategy in phase one. Alignment during phase two is streamlined through recurring meetings with GCMC, supported by a standardised agenda described in the job aid and the decision tree. A comprehensive timeline offers clarity and efficiency throughout the process.