Phortas’ Post

Nicoletta Dentico (Society for International Development) speaks about why Europe needs public pharmaceutical infrastructure”. “The pharmaceutical monopoly of the private sector is not sustainable anymore, there is a need for substantial law reform”. Public health is too important to be left in the hands of the private sector. Nothing is carved in marvel: we need to capture the opportunity for a Public Pharmaceutical Infrastructure now. We all need to be engaged and united, acting like the branches of a big strong tree 🌳 #publipharmaeurope

Willkommen to Berlin! Welcome to Berlin! Today I am speaking at one of the pre-conference workshops about the "importance of a regulatory strategy in global drug development" and "how to navigate within the regulatory landscape in global drug development" at the #RAPSEuroConvergence conference. Please do not hesitate to come and discuss with me, as a member of the #CencoraPharmaLex Development Consulting team. Looking forward to exchanging with you in the coming days! #Regulatory #Strategy #Drugdevelopment #CencoraPharmaLex

RAPS San Francisco Chapter and PBSS GROUP San Francisco are excited to collaborate on a full day workshop on Regulatory Global Submission: Strategies and Best Practices for FDA, EMA, and PMDA. Two FDA speakers (Jay Fajiculay, Pharm.D. and Kristina N. Luong, PharmD, BCPS) and one EMA speaker (Efstratia Vatzaki) will join remotely with an exclusive panel discussion. Other topics are Yoshiko Stowell, PhD, RAC, PMP: "Overview of Regulatory Submissions 101, NDA, MAA, and J-NDA" Huong Huynh Reagan: "Harnessing the Power of Patient Data: Impact of Public-Private Partnerships in Regulatory Science and Drug Development" Xiling Song: "Strategies and Best Practices to Accelerate Right First-Time CMC Dossier Readiness for Global Regulatory Submissions" William S. "Streamlining Repurposed Drug Development: 505(b)(2) NDA Strategies" Yoshimasa Shimoto "Changes in Japan Regulatory Environment and Implication for Drug Development" There would be another panel discussion to hear from the afternoon speakers. Don't miss out the networking opportunities and meet with the major Sponsor, BioIVT and visit Meadowhawk Biolabs, Inc.'s vendor show. Register Today at https://lnkd.in/gdcghhhV #regulatory #RAPS #regulatorysubmissions Regulatory Affairs Professionals Society (RAPS)

Introducing "Introduction to EU Regulatory Affairs" by @James Parsley, Head of CMC & Principal Consultant, and Ellen Wilkinson, Senior Consultant from Scandea. In this insightful white paper, they delve into the complex landscape of EU regulatory affairs, offering guidance for drug developers navigating the path to marketing authorization in the EU. Learn about EU product classifications, legal bases for MA, expedited development designations, and more. Stay ahead in the evolving regulatory environment. Read the full white paper here: https://lnkd.in/gXU8VgSS For more information, visit www.Scendea.com or contact [email protected]. #RegulatoryAffairs #Pharma #DrugDevelopment #EURegulations #PharmaFocusAsia #Scendea"

❓ How can we revolutionize drug approvals and speed up innovation? After analyzing 20 years of FDA drug approvals, we've uncovered the hurdles in drug development: 🔍 How can we generate trustworthy efficacy data faster to keep up with accelerated approvals? 🎯 How can drug developers prioritize their portfolios more effectively? 🤝 How can we better collaborate with regulators to provide them with the right tools for decision-making? The EMA’s qualification of #SV95C as a primary #digitalendpoint for #clinicaltrials paves the way for better answers to these less attention-grabbing questions and for a silent (r)evolution in drug development. At Sysnav Healthcare, our mission is to provide meaningful real world data to accelerate medical progress.

Our New York partner Shireen Barday recently discussed the corporate governance dilemma created by the drug ruling in a decision from the Court of Appeal of the State of California in Gilead Sciences Inc. v. Superior Court, involving Gilead's alleged delay-for-pay business practices, which has drawn significant outcry from all sides.   The public is outraged that Gilead may have delayed the commercialization of a safer drug to maximize profits from the drug it already had on the market. However, businesses in the life science space are outraged that a court in California has upended the well-settled common law rule that a manufacturer can only be held liable for customer injuries if its product was defective in the first place.   The decision, affirmed once on appeal — and now in front of the California Supreme Court — seems to hold that, where a pharmaceutical company has a drug in its pipeline that is safer than another drug it presently has on the market, the company has a duty to commercialize the competing drug with all deliberate speed if there is any indication that the competing drug might be safer or better.   Read the Law360 article below, or via: https://lnkd.in/eH3rGezG   #PallasPartners #LifeSciences #Pharamaceuticals

Join Alison Dennis at the Informa Connect Life Sciences EU Pharmaceutical Law Forum 2024 on 22 May. Alison will be joining a panel discussion with George Pickering and Kim Liiv Rose, MBA applying her life sciences expertise to a discussion of a case study which will cover the benefits to sponsors of conducting a study on a decentralised basis and design elements of a DCT. Key considerations include: ◾ Regulation of the trial, clinical staff and IMP delivery and administration ◾ Privacy considerations including data flows and management, privacy and consent, including e-consent. ◾ Addressing the risks of electronic data collection. #LifeSciences #DigitalHealth #PharmaceuticalIndustry #Medicines #DecentralisedClinicalTrials #MedicalDevices #ClinicalTrials #DCT

Thrilled to share the first part of a comprehensive two-part article published by Law360, authored by me, Sabrina R. and Ana Dukic, exploring accelerated regulatory pathways in the dynamic world of psychedelics. This installment dives into the U.S. and Canada, shedding light on crucial strategies for navigating expedited regulatory processes. In the U.S., we uncover four key programs—Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review—alongside the innovative STAR pilot program. Each program serves a distinct purpose in expediting drug development, ensuring timely access for patients in need. Meanwhile, our insights into Canada reveal the Priority Review program and the Notice of Compliance with Conditions (NOC/c) policy, offering a streamlined approval process for drugs targeting serious or life-threatening conditions. Understanding these expedited pathways is more than academic—it's a strategic advantage in the competitive pharmaceutical landscape. For legal professionals, it means empowering clients with the knowledge to navigate regulatory complexities, guide product development, and facilitate international expansion. Stay tuned for part two, where we'll delve into expedited regulatory pathways in the European Union, the U.K., and Australia. Exciting times ahead for the intersection of regulatory affairs and psychedelic research! 🌐🌈 #fda #healthcanada #psychedelics

With just 3 weeks to go - have you booked your pass for EU Pharma Law yet? You'll need to hurry if you want to join over 200 of your colleagues and peers in Brussels this May. 📅 21-23 May 📍 Steigenberger Wiltcher's, Brussels 🤝 Hybrid Event 💲 Book Today 🌐 https://bit.ly/3NWNEYe Here's just a few reasons you should attend:   🔷 Take part in networking excellence at the largest gathering of legal and pharma professionals in Europe - over 200 confirmed in person attending!   🔷 A speaker line up like no other: EU Commission, EMA, EU Parliament Rapporteur, Sanofi, Teva, GSK, Novartis and more.   🔷 Get accredited with 18 IJE points just for attending. You enjoy three full days of content, and we'll handle the rest!   🔷 Opportunity to make the most of 3 networking lunches, 2 drinks receptions, so you can catch up with old acquaintances and make new connections. Passes are being snapped up fast, so secure you spot now at Europe's #1 Pharmaceutical Law hub! https://bit.ly/3NWNEYe #eupharmaceuticallaw #eupharma #eucommission #pharmaceuticals #pharmaceuticalindustry #pharmaceuticallaw #pharma #pharmalaw #informa #informaconnect #pharmaregulations #reguationsandcompliance #competitionlaw #spcs #regulatoryframeworks #conference #event #hybridevent #hybridconference #brussels

The European pharmaceutical market is evolving rapidly, and companies must adapt. The opportunity to reach all European Union patients is significant. But, failing to address it could mean reduced periods of exclusivity. https://ow.ly/lpLe50Q1ve1 #EuropeanPharma #InnovateInEurope #PharmaStrategies