Recordati’s Post

I was just appointed Chairman of the DIA Regional Advisory Board for the Americas. I am so excited to be working with such a smart, experienced and active group of people who are already making waves in our industry. The DIA has been around for 60 years. It is most well known for being the largest and most cross functional community that is a neutral convener of all the major corners of Drug Development. This is the only place you will find 50-100 regulators from around the world who are responsible for reviewing and approving new medicines for all of us. While regulatory has always been DIA’s core strength, there is much more here. Data Management, Clinical Operations, Safety and PV, Patient Recruitment, Medical Writing, etc. Some areas have grown, but others have suffered from a lack of engagement. I am trying to help bring new ideas. As we look to create and educate the next generation of drug developers - We need to hear from the industry at large. What do you get out of DIA today? What do you wish DIA would do more of? Let me know in the comments or DM me on the side. #ClassPicture #DIA2024 #ClinicalTrials

LIFE SCIENCE | MARKET ACCESS | DANISH MEDICINES COUNCIL Following long-term criticism of the evaluation procedures and timeframes of the Danish Medicines Council (Medicinrådet) (the "Council"), the Council has implemented certain measures to meet the new timeframes, which as of 1 April 2024 will be 14 (the fast track process), 16 or 18 weeks. The Council has launched two initiatives to meet the evaluation timeframes: An agreed application deadline and a new application validation process. Have a read below: Medicinrådet, Lif - Lægemiddelindustriforeningen, DANISH BIO - DANSK BIOTEK, Dansk Erhverv - Sundhed og Life Science, Danish Industry,Danske Regioner - Danish Regions #sundpol

If you are interested in the future of the Therapeutic Products Act, check out this article...

New Zealand's Therapeutic Products Act 2023 received Royal Assent in July last year, but following the election of a new coalition government, its future already looks doubtful. In the event that the Act is repealed, Sean Brogan and Blake Carey opine that it would seem unlikely that New Zealand's therapeutic products regulatory landscape will be subject to any further significant reforms for at least the next three years. Businesses would do well to use this relatively settled time to pursue areas of growth and expansion. https://lnkd.in/gYywfPAd #insights #legislation #therapeuticgoods #intellectualproperty #newzealand  

𝐊𝐞𝐞𝐧 𝐭𝐨 𝐬𝐭𝐚𝐲 𝐮𝐩 𝐭𝐨 𝐝𝐚𝐭𝐞 𝐰𝐢𝐭𝐡 𝐭𝐡𝐞 𝐄𝐔 𝐩𝐨𝐥𝐢𝐜𝐲 𝐚𝐧𝐝 𝐬𝐭𝐚𝐤𝐞𝐡𝐨𝐥𝐝𝐞𝐫 𝐥𝐚𝐧𝐝𝐬𝐜𝐚𝐩𝐞? 💡 Our colleagues at MAP Patient Access Limited recently put together an EU policy report that summarises and analyses policy updates related to Advanced Therapy Medicinal Products (ATMPs) across the EU. You can see the Executive Summary in the document below ⬇ We know how challenging it can be to keep track of the policy and stakeholder landscape affecting your product. Yet, staying informed about critical government, public body, and stakeholder announcements is essential for making informed decisions and shaping your broader strategy. Get in touch if you'd like to request the full report, or if you would like to find out more about our tailored policy tracker service 📩

Celebrating 25 years of generic drugs in Brazil (Law 9787/99): Let's remember some details: 💊 Generic drugs are usually cheaper, accessible and sets a competitive market in which customers benefit from it. WHO states that equitable access to safe and affordable medicines as vital to the attainment of the highest possible standard of health by all. I'll recommend this article to celebrate this date: https://lnkd.in/g7_3EvJ6

With the #NoPatientLeftBehind mantra initiated in America to make medicine affordable for everyone in the country, it's time for New Zealand to lead a pathway forward with the same goal. It is time for our new government health ministers to sit at the table with pharmaceutical agencies involved in targeted treatment medicine AND patient advocacy groups to learn each other's challenges, strengths and gaps. Then, we formulate a way forward to provide treatment and support to the patients who need medicine in NZ. It's 2024, for goodness sakes. Let's stop the rhetoric of “high cost of medicine” and “price gouging by pharma” and discuss like advanced and cultured contemporaries. Let us all ensure #NoPatientLeftBehind

Hearing about the latest on EU Regulation of medicines and the changes coming up in future from today’s panel led by my colleague Judith Krens. An interesting discussion to start to Day 2 at the Kisaco Research Life Sciences Congress. #lifesciences #regulatorylaw #medicines #pinsentmasons

When it comes to #pharmaceutical and #biotech companies and their #reputation with doctors, fighting for #patientaccess to new medicines will improve their reputation, according to a survey of 540 physicians. The study, published by WE Communications titled 'Reputation Rules: Unlocking Physician Prescribing Power', shows almost two in three Australian physicians believe fighting for patient access can improve the reputation of a company. "The research emphasises the importance of ensuring the extensive work the industry does in supporting and advocating for access is communicated to the prescribing community," WE Communications Australia Head of Health Emma Hussey told MedNews Aust/NZ. "HCPs want #transparency from industry and, in return, are willing to partner to support efforts towards better access for patients.” Full analysis in today's MedNews Aust/NZ (paywall). #corporatereputation #pharmareputation #fightforpatients #medicinesaccess #patientaccessgap

🌟 Dive into enlightening discussions with Jacqueline van Druten (MICR.CIM.RD) of CLIN-r+ on navigating clinical markets and regulatory landscapes. Don't miss out on similar insights at #MedTechMalta 2024. Book your tickets now: https://lnkd.in/dZzM7xE9 #MedTechExpertise #RegulatoryNavigation