ScribeAmerica’s Post

I hope to see you at #DIA2024! Please join Victoria Dohnal, RAC, Adriane Fisher, MPH, MBA, Christy Cottrell, and me on Tuesday the 18th for an in-person discussion on "Leveraging New Meeting Opportunities in PDUFA VII: Experiences with Type D and INTERACT" (session #209). I know, it's at 8am PDT, but you'll walk away with FDA and industry perspectives on how things are going with these new mechanisms for sponsors to interact with the Agency. And yes, there will be a chance for audience Q&A... #pdufa #regulatoryscience #regulatoryaffairs #regulatorypolicy CSL

November 13th virtual NJNY RAPS chapter event - Revolutionizing Regulatory Collaboration: Discover the Power and Potential of Reliance Free to all RAPS members and nominal fee if not a member. Registration now open. Join us for an insightful live panel discussion, led by Dominique Lagrave, bringing together industry experts (Priti Shah, Cynthia Ban and Francesca Mangia) regulators (Claire Harrison, Chief Digital and Technology Officer at MHRA), representatives from CEPI (Debra Yeskey, Pharm.D.) and the Gates Foundation (David Mukanga), to explore the evolving landscape of regulatory collaboration and reliance. Learn from experts on how to enhance regulatory collaboration, overcome common industry challenges, and adopt reliance strategies to bring therapies to patients faster. Q&A from attendees to follow the panel discussion. #raps #chapter #regulatoryaffairs #reliance #mhra #CEPI #

Today is #rarediseaseday and sees the completion day of our #SUPPLYProject Many #raredisease patients depend on plasma medicines and need a stable and adequate supply. The SUPPLY project provides a set of recommendations and guidance (available here: https://lnkd.in/eMzTYJvy ) for the EU, National Governments, blood establishments, competent authorities, medical societies, and other professional stakeholders to meet this need. 👉 Now is the time for policymakers, healthcare providers, and stakeholders to consider the guidance provided and work collaboratively to achieve optimal availability of plasma medicines for patients. 👉 Now is the time to examine the recommendations provided to increase plasma collection in the EU by the public health sector to ensure a sufficient, adequate, and resilient supply of plasma and to contribute to European self-sufficiency. 👉 Now is the time to review the recommendations and guidance provided and implement the measures required to ensure the plasma and PDMP system is robust and resilient now and in the next times of crisis. 👉 Now is the time to act in the interests of patients, donors, and all EU citizens.

Did you catch Michael Cartwright's session at the PSI 2024 Conference today? Network and ask your questions regarding the pivotal role of Data Monitoring Committees in ensuring the integrity and safety of clinical trials. #ParexelWithHeart #DataScienceInHealthcare #ClinicalTrialsInnovation #PSI2024 #PSIAmsterdam

Great presentation by Laura Pioppo EMA on the challenges and opportunities we face in the transition to EU CTR regulations. The avice is consistent: start the transition early, earlier than you thought. It is feasible, it requires expert knowledge and it will put you ahead of the competition. https://lnkd.in/eMWp2x5f

Part 5:Societal rot is a choice. Does it make sense to allow open air drug markets in our cities across America under the fig leaf of “compassion”?

Are you about to start your clinical trial? There’s a lot to deal with, and you might need support with the submission process, setting up and training the study team, or with ongoing clinical monitoring. Whatever your needs, Siron Clinical can help – our services cover these areas and much more. Find out how we can support your trial: https://buff.ly/2v4KDzt #clinicaltrials #CRO #clinicalresearch #drugdevelopment

This re-post comes with a health warning!! Please note that the no-doubt well intentioned SUPPLY team have a limited Eurocentric brief. They aim to advise European Nation States - and good luck to them. HOWEVER, other nations considering paying attention to their recommendations will be well advised to do so very selectively. SUPPLY's extraordinary claim, for instance, that public sector plasma collection is "proven more resilient" is so far from true that in any other context it would almost certainly be banned as illegal insubstantiated advertising. Their assertion is not based on science, it's the result of genuinely felt but utterly misled personal beliefs that have no place in dispassionate evidence-based discussion. None of this would matter if SUPPLY's deliberations and pronouncements were only available in Europe, for Europe. However, nations in the LMIC category, struggling to improve plasma availability for patient-centred pharmaceutical use in their own lands, will do well to protect themselves from unhelpful pseudo-ethical evangelism, from the EU, from the WHO, or indeed from any other source still steeped in long-since outdated views based on passion not practicality. Countries that currently have little or no local plasma-derived medicines availability and struggle to afford expensive imports will be best to assess their options on a strictly local basis, relevant to their own lived experience. They are unlikely to find it helpful to listen to the in-bred traditional thinking generated in the privileged HIC world - especially not the European one. Europe, with SUPPLY being just one further example among many, preaches an age-old set of values in relation to plasma procurement. However, on the clinical front line, its patients in fact mostly rely on plasma-derived medicines arising from a completely different system. They rely on medicines that mostly come from the commercial system on which the European authorities are pleased to cast so jaundiced an eye. That's fine, for the European nations. Let us wish them well in their long struggle to achieve regional self-sufficiency in plasma-derived medicines. They're a long way short, but they have the luxury of being able to afford expensive plasma imports from the USA, so time is on their side. We wish them well. However, let us NOT allow European thinking to disadvantage patients in the LMIC world. Europe hasn't yet found a way to apply their preaching successfully in their own territory, so let us not be fooled into thinking of it as wise advice to anyone else. LMIC solutions will be successful if created at home, home-baked and home-delivered. Say I ...... what do you think?? 🤔

It's great to be at the 𝗜𝗠𝗗𝗥𝗙 𝟮𝟱𝘁𝗵 𝗠𝗲𝗲𝘁𝗶𝗻𝗴 virtually today & tomorrow and 𝗵𝗲𝗮𝗿 𝘀𝗼 𝗺𝘂𝗰𝗵 𝗮𝗯𝗼𝘂𝘁 𝗿𝗲𝗹𝗶𝗮𝗻𝗰𝗲 so we can come together from around the world 🌎 for the core principles of IMDRF that 𝗼𝘂𝗿 𝘄𝗼𝗿𝗸 💼 𝘀𝗵𝗼𝘂𝗹𝗱 𝗯𝗲 𝗮𝘃𝗮𝗶𝗹𝗮𝗯𝗹𝗲 𝘁𝗼 𝗮𝗹𝗹. In other words, 𝘄𝗲 𝘀𝗵𝗼𝘂𝗹𝗱𝗻'𝘁 𝗵𝗮𝘃𝗲 𝘁𝗼 𝗱𝘂𝗽𝗹𝗶𝗰𝗮𝘁𝗲 𝗼𝘂𝗿 𝘄𝗼𝗿𝗸 𝗶𝗻 𝗱𝗶𝗳𝗳𝗲𝗿𝗲𝗻𝘁 𝗿𝗲𝗴𝗶𝗼𝗻𝘀 𝗼𝗳 𝘁𝗵𝗲 𝘄𝗼𝗿𝗹𝗱 we should submit the same files 🗄️, and use the same standards 📘. Less differences around the world would make everyone's workloads easier for everyone involved and make the important work of vigilance easier to focus on. #IMDRF #FDA #MEDICALDEVICES #IVD #IVDS #COMBINATIONDEVICES #REGULATORYAFFAIRS #QUALITYASSURANCE

🚨 Breaking News! 🎤 Renowned expert Mrs. Sonia Ben Hamida, PhD, Head of Special Cargo, will share significant updates on International Air Transport Association (IATA) Temperature Control Regulations, explaining the new structure and highlighting recent changes and their profound implications for clinical trials logistics. ⏰ October 1, at 8.30 am, on CTS stream 📍 Exclusive content for VIP attendees of the Outsourcing in Clinical Trials and Clinical Trial Supply NORDICS 2024 conference. ✍️ Please register this week. #oct #cts #nordics #clinicaldevelopment #clinicalsupply #regulations #clinicaltrials