Schlafender Hase’s Post

Looking forward to today‘s discussion on better access to medicines online and what we can learn for the EU’s upcoming #PharmaLegislation revision!

An excellent forum with abundant information to share! The world of Medical Devices is in a constant state of development and change

GVP is continuously changing and interpreted differently. Let’s talk about it.

Please stop by the booth if you are there and hear about what we can do to assist you in: 1) accelerating your regulatory filings, 2) relieving SMEs of the burden of technical writing (we write INDs, BLAs and NDAs from source documents) and 3) global regulatory strategy. Because we see so many INDs/BLAs/NDAs over the course of a year, we have a unique insight into what the regulatory authorities are focusing on and asking about today. We also do RTF and CRL remediation too but hopefully you will use us first so that remediation isn't needed!

We are pleased to announce a Customer Service event on March 5, 2024 at Humboldt-Universität zu Berlin in Berlin, Germany, where attendees will have the opportunity to engage with subject matter experts of USP-Europe on 'Quality: Critical Element for Assuring Access to Safe and Effective Drugs'. The main topics to be covered: 1️⃣ Measurement uncertainty and potential risk of non-compliance 2️⃣ Impurities – Perspectives of pharma Industry and how USP supports 3️⃣ Nitrosamines- Risk assessments, Procedures development and validation, Analytical challenges, Limits, USP resources and Tools 4️⃣ Complex generics-Technical and Regulatory challenges in developing Complex Injectables 5️⃣ New Reference Material category- ARM (Analytical Reference Material) – mAbs analytical characterization and How can they complement the biopharma manufacturing life cycle! For more information and registration to this free event, please visit this link ➡️: https://ow.ly/Uvrv50Qyq0O

Join me at the DIA Southeastern Europe (SEE) Conference to connect and collaborate with regional, EU, and international regulatory experts. Let's discuss the harmonisation with EU regulatory systems, a key step towards EU accession. The conference will discuss the impact of new EU Pharmaceutical Legislation on regional regulatory systems, emphasizing quicker access and alignment with the EU framework. Hear from SEE regulators and other major stakeholders about their challenges, future priorities, and opportunities for regional cooperation and collaboration with EU and international authorities. Don't miss this opportunity to learn from best practices and network with regulators and leaders from across Europe and beyond. https://lnkd.in/dNQcNPBH

@Matt Wetzel @Julie Tibbets An excellent overview of where we're at and where we could be heading as the complex legal, regulatory and compliance requirements are ever changing for the life sciences, medtech, and diagnostic industries.

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

RDD2024, held in Tucson one month ago, released its contents. For those of you who could not attend, ask your colleagues to share the materials since it was an excellent RDD. Many interesting updates, showing how intense the Inhalation Drug Delivery transition is between sustainability for pMDI gases and other issues and systemic delivery of drugs. Some takeaways (with a bias on pMDIs, of course): 1) Focus on pMDI Gas Transition: The conference saw a continued surge of interest in pMDI (pressurized metered dose inhalers) transitioning to propellants with low global warming potential (LGWP). Kindeva Drug Delivery, with Nicholas Smalley and Ann Purrington, managed a best-ever regulatory session on how the regulatory challenges, with FDA's Bryan Newman and Markham Luke, MD PhD, and Richard Lostritto, Ph.D. You should download the materials of those. Regulatory presence is significant given the hurdles of this transition, which is easier than the CFC, but not that easy due to the gas characteristics, challenging valves, and formulations. All the major players, including us - RxPack -and Università degli Studi di Parma, had posters about valves, formulations and measurement systems, and gas behaviors (Koura and Honeywell). Kindeva Drug Delivery, Honeywell, and Bespak managed intriguing workshops. 2) Beyond Asthma and COPD: The focus has broadened from traditional uses like asthma and COPD to other indications. Sessions covered inhaled delivery of large molecules for diseases like cystic fibrosis and pulmonary infections. Talks explored using nanoparticles to deliver mRNA to the lungs for potential cancer treatments. 3) Nasal drug development sessions and posters addressed spray-drying nasal vaccines and methods for nasal-to-brain delivery. Boehringer Ingelheim and the future of soft mist inhalers for delivery of systemic drugs APIs was an interesting angle, with Boehringer's cooperation with Kenox Pharmaceuticals, Inc. It is also clear that Boehringer Ingelheim's impetus on inhalation for COPD and Asthma is not what it used to be. See you in Parma and Edinburgh in the next months. #pmdi #inhalation #transition

✴ This month, MAIN5 exhibited at the TOPRA Symposium 2024. Our experts Katharina Mayer, Melita Luša, Piotr Wierzchowski, Marjeta Panjan Žalec, and Managing Partner Tore Bergsteiner attended this cornerstone event for regulatory professionals in the healthcare industry, exploring the latest trends and innovations in regulatory affairs. The Symposium provided us with invaluable insights into the evolving regulatory landscape and numerous opportunities to network with peers and engage with industry leaders. Our participation was truly rewarding, allowing us to forge valuable connections and gain new perspectives. 🌟 At MAIN5, we believe in the importance of celebrating exceptional work within the industry, which is why we are very proud to sponsor the upcoming #TOPRA #Awards for #RegulatoryExcellence 2024. This event honors outstanding achievements in the regulatory field and offers a platform to celebrate the very best in our industry. The ceremony will take place on November 28, 2024, and MAIN5 will present the award in the “#Contribution category, which honors regulatory affairs professionals who have made significant contributions to a team or regulatory project(s) over the past three years. We are eagerly looking forward to attending and recognizing the winners, enjoying an evening of celebrating regulatory excellence. #TOPRASymposium2024 #RegulatoryExcellence #MAIN5 #LifeSciences #Innovation #Regulatory #TOPRA #Award