by Saad Shakir (First published as a BMJ Rapid Response on 12th May 2020) A key component of efforts to control COVID-19 will be an effective vaccine. There are many potential COVID-19 vaccines in preclinical development and clinical trials around the world. History has shown that the benefits far outweigh risks for vaccines of infectious diseases. The normal vaccine development process including clinical trials may take 10 - 15 years. To address urgent public health need, such as the COVID-19 pandemic, the vaccine development process can be dramatically shortened to as little as 12-18 months, including testing and release. To protect [...]
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How pharmacovigilance needs to adapt in order to handle the challenges of advanced therapies and the COVID-19 pandemicdsru2020-05-06T13:42:43+00:00
Saad Shakir writes: Pharmacovigilance has expanded in the last 10 to 15 years, shifting from low-level regulatory compliance to a more proactive approach. This is largely due to the 2012 EU legislation expanding the scope of pharmacovigilance to include risk management, risk minimisation and the introduction of reporting systems such as EudraVigilance in Europe and Sentinel in the US. These changes are of benefit to public health, ensuring that potential health risks or adverse events are identified quickly in conventional medicines, allowing swift action to be taken when needed. However development of pharmacovigilance needs to keep up with introduction of novel [...]
The DSRU team is heavily engaged in conducting studies related to the COVID-19 pandemic. Dozens of clinical trials are underway around the world, many on repurposed drugs, but it is important to look at the benefit-risk balance of the proposed new treatments. Inevitably clinical trials on these products will be shortened, so it will be essential to monitor the effectiveness of these new treatments at the post-marketing stage. Our preparations to provide near real-time intensive monitoring of new COVID-19 vaccines are well underway and we are in touch with stakeholders in order to form a consortium. This builds on our experience [...]
The DSRU team is used to working remotely while maintaining high standards and completing studies on time. We have the connectivity to enable us to remain open for business, conducting our current work and accepting new business as usual. We welcome enquiries about potential new studies and projects and will continue to handle them in the usual way, including discussing your requirements with you online, by email or phone. Please do not hesitate to contact us.
Professor Saad Shakir writes: What are Cytokines? Cytokines are a group of proteins that are secreted by cells in the immune system. They act as chemical messengers to regulate other immune cells. Cytokines are released from one immune cell to affect the actions of another cell in the immune system by binding to receptors on its surface. Cytokines include interferons, interleukins, lymphokines and tumour necrosis factors. Cells which release cytokines include macrophages, lymphocytes (both B and T lymphocytes) and other immune cells. Cytokines exert their effects in tissues locally or circulate in the blood and lymph. The difference between cytokines [...]
Pharmafocus published an interview with our Director, Saad Shakir, in its March issue, focusing on the need for pharmacovigilance to evolve in order to handle the challenges posed by scientific innovation and political upheaval. While we have seen a shift to more proactive pharmacovigilance, we will need further modification of existing methods, especially for biologic therapies where patients tend to be sicker, taking many medicines and suffering concurrent illnesses. Read the article in full here: https://en.calameo.com/read/0061133857c3d689fd31b?page=16
Benefit-risk assessment is used to weigh up the benefits of a specific treatment with the risks of that treatment. The DSRU team has just published a report on a systematic benefit-risk assessment conducted to compare the benefits and risks of a new mode of delivery of an existing drug with that of the well-established tablet/ film formulation. This key publication explains how a semi-quantitative benefit-risk method is used to support risk management. The paper, “Systematic benefit-risk assessment for buprenorphine implant: a semi-quantitative method to support risk management”, reports on a benefit-risk assessment conducted by the DSRU to determine whether a new [...]
Improving your presence and impact in your organisation We are delighted to be working in collaboration with The Gravitas Programme to bring you a new one day training course designed to enable you to communicate with confidence, increase your personal visibility and handle challenging situations more effectively. People with gravitas network better, communicate better, present better and lead better. In a competitive environment, people who know how to access their personal gravitas build stronger relationships and get better results from stakeholders and teams. As part of the course, you’ll explore the six key ingredients to gravitas and apply simple techniques to develop [...]
DSRU Education & Training is celebrating two decades of training health and pharmaceutical professionals, many of whom have gone on to senior UK pharmacovigilance roles. More than 4,000 delegates from the pharmaceutical industry and regulatory agencies including pharmacists, GPs and other health professionals have attended academic and industry courses and training events run by DSRU since it began a training programme in 2000. DSRU Director Saad Shakir said: “Our courses are all designed to impart the latest research and best practice examples to help health and pharmaceutical professionals do their jobs better. This is good for patients and ensures the best [...]
Addressing the uncertainty around implementation of the Medical Devices Regulation (MDR) The new European regulations on medical devices entered into force in 2017 and must be fully implemented by 26th May 2020. As the deadline approaches, there is still a lot of confusion amongst device manufacturers about interpretation of the regulations and the practical implications. We have developed this training course in consultation with experts in devices vigilance in order to address the uncertainty and to provide clear practical guidance on handling the changes to vigilance requirements. The course would be of interest to staff working in Quality Assurance, Regulatory Affairs, [...]