PDA - Parenteral Drug Association’s Post

https://lnkd.in/g3_Gj8kx We’re proud that the advancements we’ve made to Calyx #RIM enabled a global market-leading pharmaceutical company to succeed during the #FDA #eCTD4.0 pilot program. Learn more. https://lnkd.in/gMJyMhUa #Regulatory #ChooseCalyx

�� If you missed our speaker sessions on the conference circuit this year, this article wraps them up concisely📣 'The Key Issues Impacting the Clinical Supply Chain' Have a read.... and if you would like further details or you require commercial products for your clinical trial drop me a message anytime 🙋♀️ Lucy #clinicaltrials #clinicaltrialmanagement #clinicaloperations #clinicaldevelopment #clinicaltrial #clinicalsupply

Currently, there are over one million procedures captured in VQI registries, with 10,000 new procedures added each month. This real world data has become a vital resource for medical device manufacturers and pharmaceutical companies. Real world evidence from the VQI has been used to: - meet regulatory requirements - perform post-approval trials - expand current indications for use Learn more at https://lnkd.in/dk2cTp8R #medicaldevices #healthcareinnovation

THIS IS THE LAST CALL! Don't miss out on the opportunity to unlock the gateway to success with our exclusive Intellectual Property Rights in Pharmaceutical Industry Course. Register before 14th September now to secure your spot in this game-changing program designed to equip participants with comprehensive knowledge and a deep understanding of intellectual property rights in the pharmaceutical industry. Register Now: https://lnkd.in/dWUcmN9s #IntellectualPropertyRights #RegulatoryAffairs #MENA #PRAConsultancy

I could not be more proud to have been even a tiny part of this work. I must thank BCT Partners and Riikka Salonen for bringing ITBOM Training and Consulting on as a sub on this most important work. The truth is that I love learning, and as a consultant, that is what I am constantly doing. I also love getting to utilize all the various elements of my background. In this case, my legal history and interviewing background came into play. The work of I-MAK is critically important as we look at access, availability, and equity in access to life-saving and sustainable pharmaceuticals. Please read more about their BluePrint at the link below, but here is a very short summary of what their work is focused on: "Over the last 30 years, drug prices in the U.S. have outpaced inflation by three-fold,1 and thirty percent of Americans currently report not taking their medication as prescribed due to cost.2 Retail spending on prescription drugs in the U.S. was $378 billion in 2021 ($1,147 per person), and by 2031 it is projected to reach $592 billion.3 The issue of patent thickets and its impact on drug prices is particularly relevant to discussions of equity in medicines and healthcare policy. Patent thickets refer to the practice of amassing numerous patents around a single product or technology, creating a barrier to market entry for potential competitors." https://lnkd.in/gAf4VfMP

Check out this March 25 EMA CTIS WEBINAR! The EU CTR comes into full effect in nine months, impacting all involved parties including service providers. On the agenda: 📌 implementation of the CTR; 📌 transitional trials and how they are updated in CTIS; 📌 update on the current status of the CTIS.

CTIS Webinar on Monday next. If you haven't transitioned your trials yet, this will be a 'must attend event'. Topics to be covered: 1. reflection on the implementation of the Clinical Trials Regulation; 2. reflection on transitional trials and how they are updated in CTIS; 3. update on the current status of CTIS.

We asked over 250 medical and commercial pharmaceutical professionals one simple question. What skills and knowledge would MSLs most benefit from developing?   We were stunned by their answers! Discover The Training Your MSLs Need The Most: Here's Our Insights https://lnkd.in/enXX-9TK

We asked over 250 medical and commercial pharmaceutical professionals one simple question. What skills and knowledge would MSLs most benefit from developing?   We were stunned by their answers! Discover The Training Your MSLs Need The Most: Here's Our Insights https://lnkd.in/eYc54vrE

NEW: We are proud to release our new blueprint for reform! “Addressing Patent Thickets To Improve Competition and Lower Prescription Drug Prices” In the blueprint, we present policymakers with four approaches and six steps they can take right now to address patent thickets, improve competition in the pharmaceutical industry, and lower drug prices. Read the blueprint: https://lnkd.in/eRuz2x32