fme US, LLC’s Post

We are proud to see Irfan Hassan's experience of the #TOPRA #Awards for #RegulatoryExcellence being promoted. Nominations are now open for 2024 and will close on 3rd June. For regulatory advice from our award winning team, contact us at info@psephos.com #RegAwards24 #PayitForward #medtech #medicaldevices #regulatorycompliance

And that’s a wrap!! It’s been a busy 2 days at the 4th International We! Are Clinical Research conference at Kozminski University Warsaw. Thank you to Łukasz Więch, MD, MBA for inviting me to be a panellist and talk about implementation of ICH E6 (R3) with my fellow panellists Dr Hanna Preus MBA, FRQA, MICR, Edward Czerwinski and Tomasz Kosieradzki. It was a really informative session giving perspectives from auditors, sites, sponsors and CROs and brilliantly facilitated by Łukasz Więch, MD, MBA. Great questions from the audience too. Key takeaways: 🤵🏼♀️Oversight responsibilities for sponsors and investigators are more defined in terms of service provider qualification, contracts and computerised system. Small outsourcers will need help to implement these processes 🧑🏽⚕️A whole section of the guidelines has been dedicated to data governance with more defined procedures for drafting plans, data analysis, data QC 🧐 Quality by design should be implemented for each clinical trial so that studies are designed well and systems are in place to get it right first time. This will mean studies take longer to set up but will be generate better data. Start ups will need to find different ways to share milestones to show investors the advantages of the new system. 🧬Trial design needs to be operationally feasible, include critical to quality factors and be risk proportionate. The process needs to be collaborative and involve more stakeholders including participants. #clinicalresearch #gcp_guidelines

We're a bit late to the party for this application having only just launched last week, but if you've got a moment, please nominate Mindamigo for the Medilink Midlands most promising start-up award! Deadline today 🙏 Our aim - complimenting the current CBT narrative, but becoming more holistic, with ACT the foundation of future treatment models. ACT - a highly effective, easily initiated, therapeutic model encompassing eastern wisdom, applicable to individuals and organisations alike. https://lnkd.in/e3nsBgFA

🎯 We grow when we get out of our comfort zone and that's what happened over the last four months when I decided to take on the challenge of doing the Access, Value & HEOR Management Specialization at PharAcademy. It's been months of learning and sharing in the most diverse areas, allowing me to deepen my knowledge of access to medicines.   A journey where I could count on the company of Joana Baptista Roque, Tiago Rodrigues, Bianca Silva and Duarte Pinto, the best 🌟 As well as the mentoring of excellent trainers, Miguel Papança, Miguel Lopes, Raquel Chantre, Nuno Miguel Piedade Silverio, Vasco Conde, Sónia Caldeira, Susana Duarte, Alexandre Morais Nunes, Nadine Ribeiro, Ana Charrua Rodrigues and António Paulino, where their sharing was undoubtedly valuable and enriching for all of us 🤗   For this and much more, thank you all so much!! #MarketAccess #Value #Pricing #HealthTechnologyAssessment #AddedTherapeuticValue #CostEffectiveness #HealthEconomics #OutcomesResearch #HEOR #GovernmentAffairs #ValueBasedHealthcare #ValueBasedPricing #Negotiation #Contracting #Financing #Reimbursement #RealWorldData #RealWorldEvidence #NationalHealthSystem

We hope you’ve had a wonderful summer. ⛱ As we write it appears to be well and truly over here in the UK, with thunderstorms, rain and decidedly chilly weather in abundance! 🌧️🌩️ Although we did enjoy the summer (what there was of it here), we were also busier than ever, with 12 proposals submitted, 8 new enquiries leading to potential new business either later this year or early next year and 7 new studies commenced through the summer period. 📈 So, as our name suggests, we are indeed gaining momentum and looking forward to a packed Q3 and Q4! 🚀 Undoubtedly this ever-increasing activity is due to the industry’s growing awareness of the effectiveness of our “new era” methodology. It is clear that our model of collaborating with a worldwide elite team of local clinical trial experts, whilst providing a single point of project management, is resonating with a growing number of sponsors. 🌍 The outcomes of cost effectiveness, shortened timeframes and reduced risk, due to delivery by the highest level experts on an on-demand basis, is helping us gain traction in a very competitive industry. 💡 We are eternally grateful to our sponsors, partners, global consultants and of course to our in-house team for their support in ensuring we can continue to deliver outstanding trials across the world and thus improving patient outcomes. 🙏🏼 If you would like to find out more about either potentially working with us or asking us to work for you, then please don’t hesitate to get in touch via LinkedIn or our website! 🌐 momentum-pharma.com Subscribe to our newsletter for more updates 👉🏼 https://lnkd.in/e_hNEUD8 #NewEraCRO #MomentumPharma #ClinicalTrials #BusinessGrowth

Different activities are required depending on the country-level response to Joint Clinical Assessment (JCA) evaluation. Discover the key questions, considerations and processes for each outcome. Our Access Consulting team is always available for a conversation to help you navigate your preparation for JCA: AccessCustomerStrategy@parexel.com

Different activities are required depending on the country-level response to Joint Clinical Assessment (JCA) evaluation. Discover the key questions, considerations and processes for each outcome. Our Access Consulting team is always available for a conversation to help you navigate your preparation for JCA: AccessCustomerStrategy@parexel.com

With thanks to Ibec for hosting the annual meeting between industry and South East Oireachtas members to discuss National competitiveness in context of #Budget2025. The importance of investing in Higher Education South East Technological University came across from industry leaders. The industry base of the South East region spans agrifood, medical devices, technology, pharma, sustainable products, hospitality - both indigenous and FDI - all hugely important for the Region and Ireland Inc.

Congratulations!! You finally landed your first Managing Director's role. Now, among the million things you need to invest in there is also this strange animal called the Pharma Association. Your Regional President wants you to take an active role in the association but you wonder how active and how much should you invest in your trade association. When I managed Public Policy in the Asia Pacific, I had the great privilege to be part of the Regional A-team of managing directors and support leads. And since we had a charismatic, policy-oriented, President who had to rebuilt a trade association from scratch, I wanted to support the team by providing guidance on the factors that determine investment in local trade associations. We have tracked MDs roles in their respective pharma associations - a couple were Chairpersons of the Board, most were on the Board of Directors, some were leading working groups in areas of priority to our company, but none played no role at all. Here is the list of questions I asked them to consider when making an informed decision about their involvement in their pharma associations: 1. How critical are the public policy issues to your business? If critical, move to question #2. If not, go back to attend those other million issues. 2. How effective is your trade association today? if it's ineffective, does it make sense to invest in it at all. 3. Is there enough Policy capacity and competency in your organization, and does it makes sense to pursue an issue only with your company resources (people, financial)? Usually going it alone will require more resources and will lack the collective power benefits. 4. Are there global implications to the issues that the trade association promotes - this one is binary and if the answer is yes, there's not much choice. 5. How aligned are the association's priorities to your company priorities - misalignment will require A LOT more investment. From here, one can assign weights to each category and points in each and decide the level of investment. What question did I miss? Jan Van Acker, KG ANANTHAKRISHNAN, Michael Azrak, Kevin Peters, Ashish D. Pal, Beaver Tamesis, Christopher G Tan, Joe Romanelli, Koen C. Kruijtbosch, Avi BenShoshan, Rehan A. Khan, George Zaki, Caron Li #PhRMA #EFPIA #IFPMA #ABPI   

It says a lot about life sciences and innovation in Ireland when two conferences are running on the same day in different parts of the country, both exploring innovation, challenges, and the ever-changing digital landscape. Whether you are in Dublin and attending the PDA Ireland Chapter Event on the 26th September https://lnkd.in/e4ryfjQw or Cork attending the ISPE Ireland Affiliate event https://lnkd.in/eMbCpF9s there will be significant gains and discussion points to be had. Proud to be part of the Life Sciences community where patient outcomes are at the forefront of all that we do and that technology and digitalization continue to drive even better outcomes. 🔬💡 #LifeSciences #Innovation #Ireland #DigitalTransformation #NeutralStance