⭐ ⭐ ⭐ NEW INDUSTRY INSIGHT!! With increasingly stringent product sterility requirements and guidance being included in global regulatory documents issued by regulatory bodies such as the European Medicines Agency (EMA) and the Food and Drug Administration (FDA). Ophthalmic products 👁, where the drug product requires application directly into the eye are one of the leading therapeutic areas subject to heightened regulatory scrutiny. This new Industry Insight from the thought leaders Sterigenics summaries study findings of the key benefits of terminal sterilization and/or aseptic processing when applied to Active Pharmaceutical Products (APIs). Read more today ➡️https://lnkd.in/eiSdj5UZ
Sterigenics’ Post
More Relevant Posts
-
Increasingly stringent product sterility requirements and guidance are being included in global regulatory documents issued by regulatory bodies such as the European Medicines Agency (EMA) and the Food and Drug Administration (FDA). Ophthalmic products 👁, where the drug product requires application directly into the eye are one of the leading therapeutic areas subject to heightened regulatory scrutiny. This Industry Insight summaries study findings of the key benefits of terminal sterilization and/or aseptic processing when applied to Active Pharmaceutical Products (APIs). Read more today ➡️https://lnkd.in/eiSdj5UZ
-
-
Sr. Director New Sterilization Technologies/Research & Development/Corporate Qualified Person
If you are interested in assessing Active Pharmaceutical Ingredients for reduction of bioburden or sterilization, please enjoy reading the full article! #ActivePharmaceuticalIngredients #Sterilization
Increasingly stringent product sterility requirements and guidance are being included in global regulatory documents issued by regulatory bodies such as the European Medicines Agency (EMA) and the Food and Drug Administration (FDA). Ophthalmic products 👁, where the drug product requires application directly into the eye are one of the leading therapeutic areas subject to heightened regulatory scrutiny. This Industry Insight summaries study findings of the key benefits of terminal sterilization and/or aseptic processing when applied to Active Pharmaceutical Products (APIs). Read more today ➡️https://lnkd.in/eiSdj5UZ
-
-
Discover the EMA's newly revised guidelines for therapeutic equivalence and pharmaceutical quality of inhalation and nasal products, and share your feedback by October 2024. #medicalaffairs #medicinesdevelopment #GMDPacademy #EMA
-
Happy World Pharmacists Day! Une merveilleuse Journée Mondiale des Pharmaciens et Pharmaciennes à tous et à toutes! Did you know: -There are 42,500 licensed pharmacists in Canada? -On top of providing pharmaceutical care in community settings, around 15% work in hospitals and 15% in various settings such as governments, associations, academia and industry? -That pharmacists are considered the most accessible health-care professionals -That pharmacists are providing care to patients for 750 million prescriptions per year? https://lnkd.in/gJYABWfF -Pharmacists around the world are meeting global health needs with sustainable development goals? https://lnkd.in/gTrPyUjf
🎉 Happy #WPD2024! Join us in celebrating pharmacists whose expertise helps to deliver safe, effective care for all. International Pharmaceutical Federation (FIP)
-
-
Regulatory Update Biosimilars: The Malaysian National Pharmaceutical Regulatory Authority (NPRA) updated its "Guidance Document and Guidelines for Registration of Biosimilars, Second Edition" on December 15, 2023, superseding the first release in 2008. This revision is primarily intended to align with the current edition of the WHO biosimilar guideline, published in 2022. The key changes include providing more clarity and details in terms of quality, non-clinical, and clinical data requirements, including updates on pharmacovigilance, interchangeability, and labelling. #NPRA #regulatoryupdates
-
📢 The European Commission is proposing amendments to the EMA Variations Guidelines. This will affect human medicines, Commission Regulation (EC) No 1234/2008, Regulation (EC) No 726/2004, and Directive 2001/83/EC. In collaboration with EMA and HMA, the Commission invites feedback from pharmaceutical industry representatives and other interested parties. These proposed changes focus on guidelines for the various categories of variations and their procedures. #EMAGuidelines.
📢 EMA Variations Guidelines \| Proposed Amendments ↪ The European Commission is reviewing the #procedures for ...
blgs.co
-
🚨 Alert: to all my compliance connections working in the life sciences industry! 📝 Did you know... ...that The Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) have just released an updated Code of Practice for the pharmaceutical industry. This 2024 update sets even higher standards for ethical conduct, transparency, and professionalism, ensuring the industry continues to operate with the utmost integrity. Do you want to stay abreast of the constant evolving landscape of compliance in the life sciences industry? Than contact the compliance specialists at GCO Global today for our (permanent or on-demand) compliance solutions. Contact Marlize Eckert, Yana Budel or Andreea Crăcuț to learn more about their expertise and industry knowledge and how you can gain the leverage! #lifesciences #compliance #stakeholderengagement #biotech
📢 Exciting News: The 2024 The Association of the British Pharmaceutical Industry (ABPI) Code of Practice is Here! 📢 The The Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) have just released an updated Code of Practice for the pharmaceutical industry. This 2024 update sets even higher standards for ethical conduct, transparency, and professionalism, ensuring the industry continues to operate with the utmost integrity. 𝗞𝗲𝘆 𝗰𝗵𝗮𝗻𝗴𝗲𝘀 𝗶𝗻𝗰𝗹𝘂𝗱𝗲: ✅ Simplified prescribing information via QR codes ✅ A new abridged complaints procedure for faster resolutions ✅ Several previously optional guidelines are now mandatory These updates aim to improve compliance, streamline processes, and ensure patient safety remains the top priority. Curious to learn more? The new Code takes effect from 1 October 2024, with full implementation by 1 January 2025. Stay tuned and follow GCO Global for new healthcare compliance updates! #ABPI #PharmaCompliance #PatientSafety #PharmaIndustry #Compliance #ABPICode #PMCPA
-
Director at FDA, Office of Pharmaceutical Manufacturing Assessment "The views and information presented here are mine"
International Regulators working together, leveraging resources and expertise in assessment and inspection with the overall aim to facilitate faster access to medicines for patients. Read also at https://lnkd.in/eU8vpmTa
CDER’s collaboration with global regulators on pharmaceutical quality and inspections has resulted in the approval of new manufacturing and quality control sites for five different medicines. The efforts also resulted in three hybrid inspections where one regulator was on-site and others participated remotely. A full report on the findings of these efforts will be published by the International Coalition of Medicines Regulatory Authorities (ICMRA) in the coming months. For more information on how our collaboration with global regulators benefits patients and consumers in the U.S. and worldwide read our From Our Perspective: https://lnkd.in/e4wtjkY7
-
-
📢 Exciting News: The 2024 The Association of the British Pharmaceutical Industry (ABPI) Code of Practice is Here! 📢 The The Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) have just released an updated Code of Practice for the pharmaceutical industry. This 2024 update sets even higher standards for ethical conduct, transparency, and professionalism, ensuring the industry continues to operate with the utmost integrity. 𝗞𝗲𝘆 𝗰𝗵𝗮𝗻𝗴𝗲𝘀 𝗶𝗻𝗰𝗹𝘂𝗱𝗲: ✅ Simplified prescribing information via QR codes ✅ A new abridged complaints procedure for faster resolutions ✅ Several previously optional guidelines are now mandatory These updates aim to improve compliance, streamline processes, and ensure patient safety remains the top priority. Curious to learn more? The new Code takes effect from 1 October 2024, with full implementation by 1 January 2025. Stay tuned and follow GCO Global for new healthcare compliance updates! #ABPI #PharmaCompliance #PatientSafety #PharmaIndustry #Compliance #ABPICode #PMCPA
-
#PatientEngagement Country Guidelines for #Canada are now available ⛳️ Discover the Guidelines for country codes of conduct that govern interactions between #Pharmaceuticals & #patient community. Explore now: https://lnkd.in/dSFR9vwn
Canada Patient Engagement Guidelines
patientengagement.synapseconnect.org
