MAP Patient Access Limited’s Post

#Didyouknow A set of new resources have been released by the ACT EU! Available here: https://lnkd.in/dX8mrJWd 📌An interactive map of the support initiatives available in each EU Member State to support non-commercial sponsors at national, EU or global level. https://lnkd.in/dMRHRSZ2 📌 An updated mapping & governance page, clarifying the roles and responsibilities of the various expert groups working within the European medicines regulatory network #EMRN https://lnkd.in/dU4Qkp_5 #clinicaltrials #clinicalresearch #pharma #pharmaindustry #ACTEU

It is happening! I am sure we have all heard about the seismic changes that are occurring globally not only for everyone in HEOR and market access, but for the pharmaceutical industry as a whole: the Inflation Reduction Act (IRA) in the USA and the European Regulation on Health Technology Assessment (EU HTAR) in Europe. Please join me along with my Lumanity colleagues Ron Akehurst and Jonathan Kowalski for a webinar on April 18th as we explore the practical realities and our latest insights for successfully preparing for Medicare Drug Price Negotiations (as authorized under the IRA) and the new EU Joint Clinical Assessment (JCA, as part of the EU HTAR) in Europe. I am looking forward to seeing you at the webinar! Please see the registration link in the comments. #Lumanityperspectives #EUHTA #IRA #inflationreductionact #jca

I am looking forward to speaking at DIA 2024 next week and interacting with the government and regulatory affairs community who will join me in California. I will be chairing two crucial sessions on significant topics: high-risk excipients and drug shortages. The workshop titled Quality in Focus: Diethylene and Ethylene Glycol Challenges on Tuesday, June 18 at 11:00 AM will delve into the critical aspects of FDA's guidance on DEG testing, including quality tools available from Pharmacopeias, including USP, for ensuring the quality of excipients. You can learn more about this topic in a recent piece I contributed to @The Medicine Maker: US Pharmacopeia Mission to Address DEG/EG Contamination https://lnkd.in/eWPk-Zkj  The Roundtable Discussion: Securing the Chain - US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation will be on Wednesday, June 19 at 11:00 AM. We will discuss how the medicine supply chains are becoming increasingly complex, requiring innovative solutions to ensure the continuous supply of quality medicines. As a standard-setting organization, US Pharmacopeia supports this work by facilitating global information exchange and enabling manufacturers to focus on production while ensuring product quality, safety, and supply chain resiliency. If you want to learn more about the drug shortages issues, please check out USP's call to action and the USP Annual Drug Shortages Report at https://lnkd.in/ecu5rYM3 If you are attending DIA and have time to catch these sessions, I look forward to interacting with you. #DIA2024 #Pharma #DrugQuality #RegulatoryAffairs

#Savethedate The European Medicines Agency will hold a registration-free webinar to present the 2 new HMA-EMA catalogues of real-world data sources and studies   📅 4 March 🔗 Follow live: https://lnkd.in/dis54bNa 📺 Watch the recording after the event #Background EMA and the Heads of Medicines Agencies (HMA) have launched two public electronic catalogues: one for #realworlddata #RWD sources and one for RWD studies aiming 👉 to help medicines regulators, researchers and #pharmaceuticalcompanies to identify the most suitable data sources to address specific research questions and support the assessment of study protocols and results. 👉 to promote transparency, encourage the use of good practices, and build trust in research based on RWD. #clinicalresearch #clinicaltrialdesign #clinicalpractice #goodclinicalpractice #pharma

EMA Policy 0070 states the agency will share anonymized clinical drug trial documents for anyone to read and learn about the research. Senior Transparency Specialist Honz Slipka breaks down this regulation in this Clinical Research News article. Read it to learn how to ensure successful Policy 0070 submissions for your drug program. https://ow.ly/Yx9M50QXCa5 #EMA #Transparency #Policy0070 #HealthCanada #DrugApproval #Disclosure #RegulatoryAffairs #Compliance

It's been a few months since the European Medicines Agency relaunched Policy 0070. Since then, our Transparency & Disclosure team at Certara has worked on quite a number of submissions for various pharmaceuticals, and we've observed a few things: 1. Although the policy is still in its first few months, the EMA is quite organized and very responsive. 📩 - From preparing structured Lists of Expected Documents, to replying to inquiries about out-of-scope documents, everything moves quickly and dynamically. 2. Publicly disclosed Anonymization Reports available through the EMA portal indicate various approaches to clinical data anonymization. ⚖ - Some sponsors use a qualitative assessment, some use quantitative risk measurement, some use both. Which one do you think is best? 3. Commercially confidential information (CCI) remains a vague and subjectively grey area. 💰 - While we've developed a process that work very well, the strategy for protection of sensitive company data is still one of the most common and first questions that we get asked by clients.

𝗗𝗶𝗱 𝘆𝗼𝘂 𝗸𝗻𝗼𝘄⁉️ The new EMA guideline on Quality and Equivalence of Locally Applied, Locally Acting Cutaneous Products will come into effect on April, 2025. 🔬 This guideline introduces comprehensive approaches to ensure the quality, safety and therapeutic equivalence of cutaneous medicinal products, emphasizing in vitro testing and innovative methodologies. Get a detailed summary of the guideline here ⬇️ Contact us to discuss how LEF - Laboratório Estudos Farmacêuticos can help you navigate these changes. 🔗 www.lef.pt | lef@anf.pt 🔔𝗙𝗼𝗹𝗹𝗼𝘄 𝘂𝘀! LEF - Laboratório Estudos Farmacêuticos #EMA #PharmaceuticalInnovation #TherapeuticEquivalence #InVitroTesting #PharmaceuticalCompliance #RegulatoryUpdates

📖Discover the latest insights on the use of External Control Arms (ECAs) in FDA novel drug approvals from 2017 to 2023. This targeted review by Axtria, presented at ISPOR 2024, delves into the methodological aspects and challenges of ECAs, highlighting their role as a complement to Randomized Clinical Trials (RCTs) in clinical research. Download full report: https://lnkd.in/gjabeA3r #ClinicalResearch #FDA #DrugApproval #RWE #Lifesciences

The MPP 2024 panel's Q&A part is in full swing. Moderated by Mike Wallenstein from Novartis, Chair of the MPP 2024 Program Committee, the panel offers insights into national and regional regulatory strategies, current challenges, and recent developments related to the regulation of combination products. It will also cover ongoing global harmonization efforts. Following opening remarks, Virginia Rojo Guerra from European Medicines Agency, Karoline Mathys from Swissmedic, James Bertram from FDA, Francoise Schlemmer from Team-NB, Theresa Jeary from BSI, and Ruth Foster from MSD are now sharing perspectives about ongoing and potential future plans on both national and international regulatory strategies. #MPP2024 #Pharma #Medtech #CombinedProducts

Exciting news: First NASH drug was approved by FDA. 👏 https://lnkd.in/egBDf6ya #NASH new drug R&D is not easy. Let's collaborate and work together to transform new and meaningful solutions to benefit more people living with NASH. Find how BioDuro-Sundia can help: https://lnkd.in/gDwxUM4U