Kinesys Consulting Ltd

Apply now for the MedTech Accelerator: Rapid Regulatory Support Fund!    Calling all SMEs in the MedTech industry. On behalf of the UK Government’s Office for Life Sciences, CPI has created a fantastic opportunity to access funding for external regulatory support for both new and existing MedTech products.    With a total investment of £4.2m from Innovate UK, SMEs can receive up to £30,000 per UK SME to navigate the intricate MedTech regulatory landscape. If your business relies on external expertise to bring new products to market or re-register existing ones to meet updated regulatory requirements, this program is tailored for you.   Don't miss out! Applications open on Wednesday, 9th October 2024, at 9 am and close on Thursday, 31st October 2024, at midday.    Secure your spot and apply for reimbursement of activities conducted with an independent regulatory affairs consultant.    For regulatory support please contact Dr Edward Staunton, Director, Regulatory and Quality, Medical Devices at Edward.Staunton@clinigengroup.com    For more information about the application please visit https://lnkd.in/eKed3NHK   #MedTech #RegulatorySupport #FundingOpportunity #SMEs#InnovateUK #CPI #UKGovernment #AcceleratorProgram

Sanofi has announced the launch of its high-dose egg-based quadrivalent influenza vaccine (QIV-HD) in the UK. This vaccine is designed for people aged 65 and older, as well as clinically at-risk individuals aged 60 to 64.   A meta-analysis of 21 studies involving over 45 million people aged 65 and over found that high-dose influenza vaccines reduce serious complications. These include a 27.8% reduction in pneumonia hospitalisations and a 16.7% reduction in cardiorespiratory hospitalisations compared to standard-dose vaccines.   https://lnkd.in/gGmYg5sa newdrug #influenzavaccine #hospitalisations

Our Regulatory Affairs Services   SCIENTIFIC ADVICE PAEDIATRIC INVESTIGATION PLANS   EMA / FDA ORPHAN DRUG DESIGNATION   EU PRIME AND UK EAMS SCHEMES   CLINICAL TRIAL APPLICATIONS   MARKETING AUTHORISATION APPLICATION & ORAL EXPLANATION   Get in touch today to see how we can help you with your projects https://lnkd.in/eRU9XSYh

What will life sciences roles look like over the ensuing years?   Often referred to as a ‘science-superpower’ or ‘jewel in the crown,’ the UK life sciences sector provides highly skilled, stimulating careers using the latest technology, right across the country. Cutting-edge research and breakthrough science requires the harnessing of talent and capabilities from across the UK’s skills system.   You can read the full article here    https://lnkd.in/eifNTgQc

Our recent publication in Nature Communications reports the function of the enzyme PNPLA3 in balancing lipid levels in the liver and bloodstream. By understanding how loss of function of this enzyme could drive progression of steatotic liver disease, including metabolic dysfunction-associated steatohepatitis (MASH), our scientists are aiming to identify new therapeutic approaches for patients living with this disease. Learn more here: https://learn.az/6049U8RXF

Interesting session on the new EU Regulation requiring a joint EMA regulatory - HTA assessment. It covers the assessment of relative effectiveness and safety, not reimbursement or pricing which is done at the national level after the joint assessment. This will be effective for ATMPs and Oncology products from January 2025, Orphan Drugs from 2028, and all Centralised products from 2030. Ultimately, it will probably force drug developers to consider relative effectiveness and safety, as well as value to patients of their products, at an earlier stage of clinical development than has typically been done until now. #TOPRASYM2024

It has been lovely to meet you all at the #TOPRA #Symposium today. #TOPRASYM24

Getting ready for day 2 at the #TOPRA #Symposium in Rotterdam. Don’t forget our experts will be available for meetings today. Come and say hello at booth 2! #TOPRA #Symposium #Rotterdam #expertspeakers

Come and meet our experts Gerry McGettigan Elaine Murphy Graeme Deuchar and Yan Yu at the TOPRA Symposium in Rotterdam. We are at Booth 2!

Meet the Kinesys-Clinigen team at the TOPRA Symposium in Rotterdam at Booth 2! We'll be there from September 30th to October 2nd. If you're attending, we'd love to connect with you during the event. Additionally, our experts will be available for meetings on September 30th and October 1st after the conference. Looking forward to engaging with you at the symposium! Please email rjoshi@kinesysconsulting.com if you'd like to arrange a meeting with one of our regulatory experts.  Do come and say hello to the Kinesys-Clinigen team at booth 2.  We look forward to seeing you at the Symposium!