ANI Pharmaceuticals, Inc.’s Post

I've said it before and I'll say it again...if you are involved in the world of pharmaceutical GDP then joining the GDP-UCI will absolutely be of benefit to your business. Want to know more? Then take a look at GDP-UCI or contact Alan Kennedy for more details. #GDPUCI #GDP #Letsgettalking

🔍💊 In a heated Senate hearing on February 8th, the CEOs of Bristol Myers Squibb, Johnson & Johnson, and Merck faced rigorous questioning from various United States senators regarding the exorbitant prices of prescription drugs in the US. The testimony unfolded as a clash between the imperative of funding innovation and the growing outcry over affordability and accessibility. #SenateHearing #PharmaCEOs #DrugPricing #HealthcareAccess #Pharmaceuticals #HealthcareIndustry #PolicyDebate #MedicalCosts #AffordableMedicine #PatientAdvocacy #PrescriptionDrugs #HealthPolicy #Senate #PublicHealth #MedicalCosts #PrescriptionCosts

“𝘐𝘵 𝘪𝘴 𝘨𝘳𝘦𝘢𝘵 𝘵𝘰 𝘴𝘦𝘦 𝘺𝘰𝘶 𝘵𝘢𝘭𝘬 𝘢𝘣𝘰𝘶𝘵 𝘰𝘶𝘳 𝘤𝘶𝘳𝘳𝘦𝘯𝘵 𝘤𝘩𝘢𝘭𝘭𝘦𝘯𝘨𝘦𝘴, 𝘢𝘯𝘥 𝘩𝘰𝘸 𝘸𝘦 𝘤𝘢𝘯 𝘪𝘮𝘱𝘳𝘰𝘷𝘦 𝘸𝘩𝘢𝘵 𝘸𝘦 𝘥𝘰 𝘵𝘰𝘥𝘢𝘺. 𝘞𝘩𝘪𝘭𝘦 𝘢𝘭𝘭 𝘵𝘩𝘦 𝘵𝘢𝘭𝘬 𝘢𝘣𝘰𝘶𝘵 𝘥𝘢𝘵𝘢 𝘪𝘴 𝘨𝘳𝘦𝘢𝘵, 𝘸𝘦 𝘴𝘵𝘪𝘭𝘭 𝘩𝘢𝘷𝘦 𝘵𝘰 𝘶𝘴𝘦 𝘥𝘰𝘤𝘶𝘮𝘦𝘯𝘵𝘴 𝘧𝘰𝘳 𝘢𝘭𝘮𝘰𝘴𝘵 𝘦𝘷𝘦𝘳𝘺𝘵𝘩𝘪𝘯𝘨 𝘸𝘦 𝘥𝘰 𝘵𝘰𝘥𝘢𝘺.“ That's the feedback my colleague Geert Van Peteghem received after his presentation at the GPRAS conference last month in Brussels. Our upcoming webinar is going to focus on solving the challenges you face today: 𝐇𝐨𝐰 𝐝𝐨 𝐲𝐨𝐮 𝐦𝐚𝐤𝐞 𝐬𝐮𝐫𝐞 𝐲𝐨𝐮 𝐬𝐩𝐞𝐧𝐝 𝐚𝐬 𝐥𝐢𝐭𝐭𝐥𝐞 𝐭𝐢𝐦𝐞 𝐚𝐬 𝐩𝐨𝐬𝐬𝐢𝐛𝐥𝐞 𝐰𝐡𝐞𝐧 𝐩𝐫𝐞𝐩𝐚𝐫𝐢𝐧𝐠 𝐜𝐨𝐫𝐫𝐞𝐜𝐭𝐥𝐲-𝐟𝐨𝐫𝐦𝐚𝐭𝐭𝐞𝐝, 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐭 𝐏𝐃𝐅𝐬 𝐟𝐨𝐫 𝐠𝐥𝐨𝐛𝐚𝐥 𝐬𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧𝐬? You will find the answer in one of our sessions on December 14. The link to both sessions is in the comments. See you there! #regulatoryoperations #pharmaceuticals #regulatorysubmissions #PDF #automation

Stay ahead of the game in the fast-paced world of #pharmaceuticals with #TheMicro Newsletter. We bring you thoughtfully curated and actionable information to fuel your success. Whether you're looking to stay updated on the latest trends or seeking strategies to enhance your operations, The Micro Newsletter has got you covered. https://okt.to/iePO20

🗞 Less than a year since the European Commission proposal, the European Parliament adopted the reports on the revision of the #pharmaceutical legislation yesterday (10 April). In line with the #ENVI proposals, the European Parliament recognised the need to strengthen the #incentive framework for #innovation.   📍 A forward-looking #regulatory system, a holistic approach to #access, and more predictable incentives are some of the elements addressed by the Parliament. However, uncertainties remain about additional obligations and requirements that may be particularly burdensome for #SMEs.   ✒ Our Secretary General, Alexander Natz, urged caution in the implementation of these policies, balancing innovation with rapid and safe access to new #therapies for #patients.   👉 Read EUCOPE's press release: https://lnkd.in/dRXknvvE

🌟 Virtually attending the Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development - May 29 - 30 🌟 This event is a great opportunity to learn directly from the FDA’s experts in drugs, devices, and biologics. I'm looking forward to strengthening my foundational knowledge of the FDA’s regulatory requirements and gaining insights into the latest industry activities. This conference is a great chance to stay ahead in our ever-evolving industry and ensure that we continue to innovate safely and effectively. https://lnkd.in/g3pe_FCB Who else is attending? #REdI2024 #MedicalInnovation #FDA #RegulatoryAffairs #ClinoptimaSolutions

TGIF! Ready to leave the document chaos behind? With Freyr rDMS by your side, enjoy a relaxed weekend! Have a stress-free Friday knowing your files are organized, compliance is handled, and your desk is clutter-free. Let’s toast to efficiency and peace of mind. Discover the magic in the comments section. #Pharmaceuticals #RegulatoryAffairs #FreyrDigital

Less than a week until RAPS 2023! Join us from October 3-5 at booth 415 for a dynamic lineup of speakers and insightful discussions. Ritu Dhami discusses the high demand for regulatory professionals in biopharmaceutical and medical device industries, especially for entry-level positions. Learn how we can bridge the experience gap and build a talent pipeline. Melissa Stefko, Lisa Hawkins, & Philippos Papadopoulos dive into the groundbreaking Modernization of Cosmetics Regulation Act (MoCRA), exploring its impact on the cosmetics industry. Discover the opportunities and challenges that await in this ever-evolving regulatory landscape. Don't miss out on these engaging sessions! Register now and be part of the conversation. #RAPS2023 #RegulatoryAffairs #CosmeticsRegulation https://lnkd.in/eMszciKS

Yesterday, 10 April, the European Parliament adopted their reports on the revision of the #GeneralPharmaceuticalLegislation (#GPL). The European Parliament supported all the compromise amendments (Directive and Regulation) proposed by the ENVI Committee (Environment, Public Health and Food Safety). On many topics, including #RegulatoryDataProtection, #OrphanMarketExclusivity and the #access proposal, Parliament reports are an improvement compared to the Commission’s proposal. However, there are still questions on the incentive framework, #MedicineShortages and the #EnvironmentalRiskAssessment (ERA).   Discussions are still taking place in the Council and then trilogue negotiations can begin. It is not anticipated that the legislation will go into effect until 2028. Thanks EUCOPE - European Confederation of Pharmaceutical Entrepreneurs to always keep us informed and also inform others about the requirements and practical implications on smaller #raredisease companies like AOP Health. #EUPharamaPackage #importantvote #needs #changeahead

"It's You Vs You": A Call to Action Success in our field is about facing challenges head-on, including the ones we set for ourselves. This principle reminds us that our biggest growth comes from conquering personal obstacles. Share your strategies for overcoming self-doubt and pushing beyond your limits. #professionalgrowth #pharmaceuticals #regulatory #pharma