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Discover 𝘼𝙈𝙎 𝗔𝗱𝘃𝗮𝗻𝗰𝗲𝗱 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗦𝗲𝗿𝘃𝗶𝗰𝗲𝘀 as your comprehensive partner in the 𝗹𝗶𝗳𝗲 𝗰𝘆𝗰𝗹𝗲 of your medicinal product! Our services span the full drug development cycle from 𝗣𝗵𝗮𝘀𝗲 𝗜 𝘁𝗿𝗶𝗮𝗹𝘀 𝘁𝗵𝗿𝗼𝘂𝗴𝗵 𝘁𝗼 𝗺𝗮𝗿𝗸𝗲𝘁𝗶𝗻𝗴 with over 𝟴𝟬𝟬 𝗰𝗼𝗺𝗽𝗹𝗲𝘁𝗲𝗱 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀, 𝟮𝟱𝟬 𝗡𝗜𝗦 and successful participation in more than 𝟯𝟬𝟬 𝗔𝗠𝗡𝗢𝗚 𝗽𝗿𝗼𝗷𝗲𝗰𝘁𝘀. Benefit from short communication channels and efficient professional exchange between our employees in your projects. As one of the 𝗽𝗶𝗼𝗻𝗲𝗲𝗿𝘀 𝗼𝗳 𝗘𝗨 𝗛𝗧𝗔 and a trendsetter in new statistical methods, we continuously set and meet high standards. 𝗣𝘂𝘁 𝘆𝗼𝘂𝗿 𝘁𝗿𝘂𝘀𝘁 𝗶𝗻 𝗔𝗠𝗦 - 𝘁𝗼𝗴𝗲𝘁𝗵𝗲𝗿 𝘄𝗲 𝘄𝗶𝗹𝗹 𝘀𝗵𝗮𝗽𝗲 𝘁𝗵𝗲 𝗳𝘂𝘁𝘂𝗿𝗲 𝗼𝗳 𝗺𝗲𝗱𝗶𝗰𝗶𝗻𝗮𝗹 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝘀 𝗮𝗻𝗱 𝗱𝗲𝘃𝗶𝗰𝗲𝘀! #pharmaceuticalresearch #lifecyclemanagement #clinicalstudies #innovation #EUHTA #AMNOG

We know it can be challenging to quantify the impact and value of Medical Affairs. But with the right tools, methods, and metrics you can be better equipped to demonstrate impact and value to your teams. Learn more and get in touch: https://lnkd.in/e6JDywJK #medicalaffairs #medaffairs #science #strategy #pharma #clinicaldevelopment

Last week, we hosted Paula van Hennik, Group Head for Clinical Regulatory Sciences at ProPharma, at the myTomorrows office for an educational #myTalks presentation. As part of her presentation, Paula unpacked the #MarketingAuthorisation process, touching upon the EU registration process, key similarities and differences between the EU and US, and the importance of benefit-risk decision-making. Some key insights: ✅ Pharma companies should start their drug development journey with the end goal in mind, considering reimbursement and pricing strategies early-on will increase the chances of success. ✅ A global drug development plan that combines EU and US regulatory strategy is vital for avoiding regional product specific requirement differences and reducing procedural timelines. ✅ Early interaction with statisticians, methodologists, regulators, and health technology assessment (HTA) bodies can further strengthen the scientific and executional feasibility of a development plan. We are grateful for Paula’s unique and relevant insights!

The FDA Public Workshop "Streamlining Drug Development and Improving Public Health through Quantitative Medicine" held on April 25, 2024 is now available to view on YouTube! This workshop was hosted by the newly established FDA Center for Drug Evaluation and Research (CDER) Quantitative Medicine Center of Excellence (QM CoE). It provided an overview of the scope, goals, and current state of this new CoE, while gaining feedback from the public on needs and opportunities in education, outreach, and policy. Visit FDA's YouTube Channel to view this public event: https://lnkd.in/drCXdG7T #FDA #publichealth #quantitativemedicine #clinicalpharmacology #modeling #modelingandsimulation #drugdevelopment #translationalsciences #drugs #generics #engagement #stakeholders #regulatoryscience #policy

I am happy to inform that I have completed the Certification in Drug Commercialization, from UC San Diego. This course focused on pharmacoeconomics, marketing strategies, intellectual property strategies, and strategic alliances. In addition, this course covered postmarketing clinical trials. #drugcommercialization #drugdevelopment #coursera #pharmacoeconomics #marketing #ucsandiego #pharmacy

The considerations of developing a new medicinal product can be a minefield. Implementing new manufacturing technologies, innovative mechanisms of action, and more stringent safety regulations can significantly impact the choices and the cost of developing the product. Luckily, the medical industry has always provided solutions for developing and guiding medicinal products. Herein lies the Scientific Advice Meeting. This resource is a well-known avenue for drug developers to seek counsel from healthcare authorities. These authorities have an arsenal of seasoned industry professionals who can provide expert feedback on the forward processes of your drug development. In a strange twist of fate and for those unfamiliar with the process, you may need some guidance to help you access this guidance. ProductLife Group steps up to the plate to offer a free webinar on the scientific advice process. We will cover the WHY, WHO, WHAT, WHEN, and HOWs of the Scientific Advice Meeting and provide you with the basics of this unique resource. We will focus on the EU and the US authorities, providing details in these key regulated markets. Click the registration link and join our webinar to learn the “ins and outs” of Scientific Advice and of course, if you have any additional questions, you can freely contact us at marketing@productlife-group.com” Registration link: https://lnkd.in/eaUK3ZHV #SAM #RegulatoryAuthorities #ProductDevelopment #Zwiers Regulatory Consultancy BV, a #ProductLife Group's Company

🔬🧬 Join us for an in-depth exploration of Lyophilization in Pharma & Biotech! 🌿 🌟 Benefits of attending:🌟 🔸 Gain a basic understanding of the freeze-drying process and the factors influencing product and process outcomes. 🔸 Learn about characterization to determine a product's critical temperature before freeze-drying. 🔸 Review formulation development to understand typical excipients and their roles in formulations. 🔸 Discover typical Critical Quality Attributes (CQAs) in freeze-dried products, factors influencing these attributes, and methods for monitoring and controlling them. 🔸Learn how to develop a freeze-drying process using the traditional iterative approach and compare it to using SMART software. 🔸 Explore the requirements for manufacturing Sterile Medicinal Products (GMP) in Annex 1. 🔸 Gain insight into Process Analytical Technology (PAT) for monitoring the freeze-drying process and determining when primary drying is complete. 👨🏫 Our expert trainers Kevin Ward, Mervyn Middleton, and Dr. Mattia Cassanelli will lead the sessions in Flemings Hotel Wien-Stadthalle, Austria. Don't miss this opportunity to enhance your knowledge in the pharmaceutical and biotech industries! 🌐 Register now! 👉https://lnkd.in/e9esFNJk #Lyophilization #Pharma #Biotech #Training #ViennaAustria 🇦🇹🔍

The evolution of new technologies has transformed how journal performance is evaluated 📈🎯 🔗 https://ow.ly/PFyc50ThcLb This transformation provides a great opportunity for publication teams within medical affairs and pharma to shift away from conventional citation-based metrics. Instead, they can delve into alternative impact metrics that better reflect the various facets of contemporary research dissemination and engagement. 🔎 Explore the effective utilization of the newest impact metrics for journal selection by checking out our recently launched whitepaper 🔗 https://ow.ly/PFyc50ThcLb #MedAffairs #Pharma #PharmaResearch #PharmaJournals #ImpactMetrics #JournalSelection

It was a great experience partnering to write this whitepaper on a topic so many clients have asked about. With approximately 90% of candidates entering clinical trials failing to achieve regulatory approval, understanding the reasons behind these failures is crucial for companies aiming to future-proof their product candidates. Read our latest whitepaper, “Learning the Lessons of Failure: How to improve the economics of Life Sciences R&D” and dive deep into eight real-world case studies that reveal the challenges and invaluable lessons learned from drug development programs. View here: https://ow.ly/mIL530sBS4g #clinicaltrial #drugdevelopment #regulatory

Missed the live FDA Workshop on "Streamlining Drug Development and Improving Public Health through Quantitative Medicine"? Don’t worry! You can now watch the full session on YouTube. 👉 Check it out here and join the conversation: https://lnkd.in/drCXdG7T #FDA #publichealth #quantitativemedicine #clinicalpharmacology #modeling #modelingandsimulation #drugdevelopment #translationalsciences #drugs #generics #engagement #stakeholders #regulatoryscience #policy #MIDD