๐ฅ๐ฒ๐ด๐๐น๐ฎ๐๐ผ๐ฟ๐ ๐๐ฎ๐ฐ๐ธ ๐ ๐ผ๐ฟ๐ฒ ๐ฅ๐ฒ๐น๐ถ๐ฎ๐ป๐ฐ๐ฒ ๐ข๐ป ๐๐ ๐ฃ - ๐ฃ๐๐/๐ฆ ๐๐ฎ๐๐ฒ๐๐ ๐ฆ๐๐ฟ๐ฎ๐๐ฒ๐ด๐ถ๐ฐ ๐ฃ๐น๐ฎ๐ป In case you missed it, theย Pharmaceutical Inspection Co-operation Scheme (PIC/S) published its 2023-2027 strategic plan. PIC/S is a cooperative arrangement between regulatory authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. PIC/S is comprised of more than 50 participating authorities. ๐๐๐ฎ ๐๐ฉ ๐๐๐ฉ๐ฉ๐๐ง๐จ: This strategic plan highlights the focus of PIC/S over the next five years. The priorities outlined in the document are ๐น Inspection reliance ๐น Preferred forum for GxP harmonization ๐น Centre of excellence for training ๐น Preparing regulatory inspectorates for the future ๐น Partnership and stakeholder cooperation, and ๐น PIC/S operational capacity #drugdevelopment, #regulatoryreliance, #inspections, #GMP
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๐๐๐ฟ๐ผ๐ฝ๐ฒ๐ฎ๐ป ๐ฅ๐ฒ๐ด๐๐น๐ฎ๐๐ผ๐ฟ๐ ๐ฃ๐ฎ๐๐ต๐๐ฎ๐ ๐ฆ๐ถ๐บ๐ถ๐น๐ฎ๐ฟ ๐๐ผ ๐๐ต๐ฒ ๐จ๐ฆ ๐๐๐โ๐ ๐ฑ๐ฌ๐ฑ(๐ฏ)๐ฎ Have you wondered ๐ฅ๐ฐ๐ฆ๐ด ๐๐ถ๐ณ๐ฐ๐ฑ๐ฆ ๐ฉ๐ข๐ท๐ฆ ๐ข ๐ณ๐ฆ๐จ๐ถ๐ญ๐ข๐ต๐ฐ๐ณ๐บ ๐ฑ๐ข๐ต๐ฉ๐ธ๐ข๐บ ๐ด๐ช๐ฎ๐ช๐ญ๐ข๐ณ ๐ต๐ฐ ๐ต๐ฉ๐ฆ ๐๐ ๐๐๐โ๐ด 505(๐ฃ)2? In this short video, I answer this question. #drugdevelopment #pharmaceuticals #biopharma #regulatoryaffairs ____________________________________ ๐๐ฆ๐ญ๐ช๐ฆ๐ท๐ฆ ๐บ๐ฐ๐ถ๐ณ ๐ฏ๐ฆ๐ต๐ธ๐ฐ๐ณ๐ฌ ๐ฎ๐ช๐จ๐ฉ๐ต ๐ง๐ช๐ฏ๐ฅ ๐ต๐ฉ๐ช๐ด ๐ท๐ข๐ญ๐ถ๐ข๐ฃ๐ญ๐ฆ? ๐๐ช๐ต ๐ณ๐ฆ๐ฑ๐ฐ๐ด๐ต ๐๐ข๐ฏ๐ต ๐ต๐ฐ ๐ธ๐ฐ๐ณ๐ฌ ๐ต๐ฐ๐จ๐ฆ๐ต๐ฉ๐ฆ๐ณ? ๐๐ฆ๐ณ๐ฆ ๐ช๐ด ๐ข ๐ญ๐ช๐ฏ๐ฌ ๐ต๐ฐ ๐ด๐ค๐ฉ๐ฆ๐ฅ๐ถ๐ญ๐ฆ ๐ข ๐ค๐ข๐ญ๐ญ:ย https://rb.gy/dizmuu
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The #FDA issued a new draft guidance on Real-World Evidence: Considerations Regarding Non-Interventional Studies. The document includes approaches to attributes of study design, data sources, and analyses. #drugdevelopment #regulatoryaffairs #biopharma
Thanks to Tala Fakhouri, Stefanie Kraus, and many others at FDA who contributed to guidance on the design and analysis of non-interventional (observational) studies; see https://lnkd.in/gWQuPXVk. This guidance provides recommendations to sponsors and investigators who are considering submitting such studies for regulatory decision-making involving drugs and biological products. The document is part of our continued commitment to support a robust Real-World Evidence Program in accordance with the 21st Century Cures Act; please also see related guidance on specific real-world data sources and other topics at https://lnkd.in/e8Ycfmqs. #RWD #RWE #FDA #noninterventional #observational
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๐ง๐ต๐ฒ ๐ฃ๐ฎ๐๐, ๐ฃ๐ฟ๐ฒ๐๐ฒ๐ป๐, ๐ฎ๐ป๐ฑ ๐๐๐๐๐ฟ๐ฒ ๐ผ๐ณ ๐ข๐ป๐ฐ๐ผ๐น๐ผ๐ด๐ ๐๐ฑ๐๐ถ๐๐ผ๐ฟ๐ ๐๐ผ๐บ๐บ๐ถ๐๐๐ฒ๐ฒ๐ There is still time to register! At 9:30 am ET on March 19, 2024, the US #FDA will host a ๐๐ฐ๐ฏ๐ท๐ฆ๐ณ๐ด๐ข๐ต๐ช๐ฐ๐ฏ ๐ฐ๐ฏ ๐๐ข๐ฏ๐ค๐ฆ๐ณ focusing on the role of the Oncologic Drugs Advisory Committee (ODAC) in the regulatory process.ย ย A panel of ODAC members and regulators will provide insights on considerations for member selection and ODAC meetingsโ preparation. Panelists will discuss: ๐น ODAC composition and planningย ๐น Topics that are brought to ODACย ๐น Oncology Center of Excellenceโs efforts to streamline ODACย ๐น Experiences from current and past ODAC members and chairs The virtual meeting is free and open to the public, but registration is required. Here is a link to more information and instructions on how to register: https://lnkd.in/e2s4D-RM #drugdevelopment #regulatoryaffairs #biopharma #oncology
Conversations on Cancer: ODAC Chronicles - the Past, Present, and Future of Oncology Advisory Committees
surveymonkey.com
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๐๐น๐ถ๐ป๐ถ๐ฐ๐ฎ๐น ๐ง๐ฟ๐ถ๐ฎ๐น ๐ฉ๐ฎ๐น๐ถ๐ฑ๐ถ๐๐ Have you wondered ๐ธ๐ฉ๐ข๐ต ๐ช๐ด ๐ต๐ฉ๐ฆ ๐ท๐ข๐ญ๐ช๐ฅ๐ช๐ต๐บ ๐ฐ๐ง ๐ข ๐ค๐ญ๐ช๐ฏ๐ช๐ค๐ข๐ญ ๐ด๐ต๐ถ๐ฅ๐บ? In this short video, I answer this question. #drugdevelopment #pharmaceuticals #biopharma #regulatoryaffairs #clinicaltrials ____________________________________ ๐๐ฆ๐ญ๐ช๐ฆ๐ท๐ฆ ๐บ๐ฐ๐ถ๐ณ ๐ฏ๐ฆ๐ต๐ธ๐ฐ๐ณ๐ฌ ๐ฎ๐ช๐จ๐ฉ๐ต ๐ง๐ช๐ฏ๐ฅ ๐ต๐ฉ๐ช๐ด ๐ท๐ข๐ญ๐ถ๐ข๐ฃ๐ญ๐ฆ? ๐๐ช๐ต ๐ณ๐ฆ๐ฑ๐ฐ๐ด๐ต ๐๐ข๐ฏ๐ต ๐ต๐ฐ ๐ธ๐ฐ๐ณ๐ฌ ๐ต๐ฐ๐จ๐ฆ๐ต๐ฉ๐ฆ๐ณ? ๐๐ฆ๐ณ๐ฆ ๐ช๐ด ๐ข ๐ญ๐ช๐ฏ๐ฌ ๐ต๐ฐ ๐ด๐ค๐ฉ๐ฆ๐ฅ๐ถ๐ญ๐ฆ ๐ข ๐ค๐ข๐ญ๐ญ:ย https://rb.gy/dizmuu
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Ready to dive into the rhythm of the regulatory world with us? The Regulatory Affairs Professionals Society (RAPS) is inviting you, the virtuosos of our industry, to lend your voice to the RAPS Global Compensation and Scope of Practice Survey. This isnโt just any survey; itโs the crescendo where your experience helps shape our professionโs future tune. It's quick, it's insightful, and it harmonizes our understanding of global compensation trends. Please take a moment to hit the right notes with us by participating here: https://lnkd.in/eG7PZV3a Letโs orchestrate a brighter future together - Let's make some noise! P.S. No need for perfect pitch, just your genuine insights!
2024 Global Compensation & Scope of Practice Survey
industryinsights247.com
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๐๐จ ๐๐ฒ๐ฎ๐น๐๐ต ๐ง๐ฒ๐ฐ๐ต๐ป๐ผ๐น๐ผ๐ด๐ ๐๐๐๐ฒ๐๐๐บ๐ฒ๐ป๐ - ๐๐ผ๐ถ๐ป๐ ๐๐น๐ถ๐ป๐ถ๐ฐ๐ฎ๐น ๐๐๐๐ฒ๐๐๐บ๐ฒ๐ป๐๐ ๐ผ๐ณ ๐ ๐ฒ๐ฑ๐ถ๐ฐ๐ถ๐ป๐ฒ๐ Hot off the press -ย Today, the European Commission published the first draft Implementing Act under the Health Technology Assessment (HTA) Regulation. The document is now available for public consultation.ย This initiative aims to support cooperation among EU countries to clinically assess new health technologies. It focuses on conducting joint clinical assessments of medicinal products and ensuring that EU-level assessments of new medicines are carried out promptly and with the involvement or consultation of relevant experts. The goal is to promote the efficient use of health system resources while respecting national competences. Stakeholders have until April 2, 2024 to comment. A link with more information is in a comment below.
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๐ฃ๐ฟ๐ถ๐ผ๐ฟ๐ถ๐๐ ๐ฅ๐ฒ๐๐ถ๐ฒ๐ ๐ฉ๐ผ๐๐ฐ๐ต๐ฒ๐ฟ Have you wondered ๐ธ๐ฉ๐ข๐ต ๐ช๐ด ๐ต๐ฉ๐ฆ ๐๐๐'๐ด ๐๐ณ๐ช๐ฐ๐ณ๐ช๐ต๐บ ๐๐ฆ๐ท๐ช๐ฆ๐ธ ๐๐ฐ๐ถ๐ค๐ฉ๐ฆ๐ณ (๐๐๐) ๐ฑ๐ณ๐ฐ๐จ๐ณ๐ข๐ฎ? In this short video, I answer this question. #healthcare #drugdevelopment #pharmaceuticals #biopharma #regulatoryaffairs ____________________________________ ๐๐ฆ๐ญ๐ช๐ฆ๐ท๐ฆ ๐บ๐ฐ๐ถ๐ณ ๐ฏ๐ฆ๐ต๐ธ๐ฐ๐ณ๐ฌ ๐ฎ๐ช๐จ๐ฉ๐ต ๐ง๐ช๐ฏ๐ฅ ๐ต๐ฉ๐ช๐ด ๐ท๐ข๐ญ๐ถ๐ข๐ฃ๐ญ๐ฆ? ๐๐ช๐ต ๐ณ๐ฆ๐ฑ๐ฐ๐ด๐ต ๐๐ข๐ฏ๐ต ๐ต๐ฐ ๐ธ๐ฐ๐ณ๐ฌ ๐ต๐ฐ๐จ๐ฆ๐ต๐ฉ๐ฆ๐ณ? ๐๐ฆ๐ณ๐ฆ ๐ช๐ด ๐ข ๐ญ๐ช๐ฏ๐ฌ ๐ต๐ฐ ๐ด๐ค๐ฉ๐ฆ๐ฅ๐ถ๐ญ๐ฆ ๐ข ๐ค๐ข๐ญ๐ญ:ย https://rb.gy/dizmuu
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Today is Rare Disease Day. Heartfelt thanks to those dedicated to supporting, treating, and researching rare diseasesโyour work is invaluable. Individuals with rare diseases, remember: you are part of a large, caring community. Over 30 million in the U.S. face similar challenges across approximately 10,000 rare diseases. Patient advocacy groups are actively championing your cause. Awareness is essential. Please, spread the word! #rarediseaseday #orphandrugs
Rare disease patients are often in critical need of new therapies, having few or no treatment options. FDA is working hard to change this. In 2023, 51% of CDERโs novel drug approvals target rare diseases. Check out pages 7-9 of this report to learn about the drug approvals for rare diseases last year:ย https://lnkd.in/gEy4dhBU
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๐จ๐ฆ ๐๐ฒ๐ด๐ถ๐๐น๐ฎ๐๐ถ๐๐ฒ ๐ฃ๐ฟ๐ผ๐ฝ๐ผ๐๐ฎ๐น๐ ๐๐ผ ๐ฆ๐๐ฝ๐ฝ๐ผ๐ฟ๐ ๐ฃ๐ฎ๐๐ถ๐ฒ๐ป๐๐ ๐๐ถ๐๐ต ๐ฅ๐ฎ๐ฟ๐ฒ ๐๐ถ๐๐ฒ๐ฎ๐๐ฒ๐ In case you missed the announcement, the House Energy and Commerce Committee will host a hearing on February 29 to discuss a substantial package of rare disease legislation. The package contains provisions to ๐น Renew the Rare Pediatric Disease Priority Review Voucher, ๐น Establish new pediatric testing criteria for molecularly-targeted cancer medications, ๐น Promote non-animal testing alternatives to accelerate drug development, and ๐น Modify statutory requirements for rare disease exclusivity and drug price discussions for rare disease medications. The hearing will be open to the public and press and will be live streamed online. A ๐ is in a comment below. #drugdevelopment ย #healthcare #rarediseases #pediatrics
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๐๐ฟ๐ฒ ๐๐ป๐ฐ๐ผ๐ป๐๐ถ๐๐๐ฒ๐ป๐ ๐ง๐ฒ๐ฟ๐บ๐ ๐ฆ๐น๐ผ๐๐ถ๐ป๐ด ๐๐น๐ผ๐ฏ๐ฎ๐น ๐๐ฑ๐ผ๐ฝ๐๐ถ๐ผ๐ป ๐ผ๐ณ ๐ฅ๐ฒ๐ฎ๐น-๐ช๐ผ๐ฟ๐น๐ฑ-๐๐ฎ๐๐ฎ? At this week's meeting focused on oncology applications of real-world data (RWD) and real-world evidence (RWE), Mark McClellan, founding director of the Duke-Margolis Institute for Health Policy, highlighted inconsistent terminologies in the use of RWD/RWE as a barrier to their global adoption. McClellan pointed out the efforts being made by regulators globally to address challenges identified by the International Coalition of Medicines Regulatory Authorities (ICMRA), which include the need for harmonized terminologies, best practices, and transparency in RWD. Despite progress, there is still a need for further work in harmonizing terminologies. A recent dashboard published by the Duke-Margolis Center shows the uptake of RWD and RWE across 13 countries, defining key terms and indicating the number of guidance documents issued by various regulatory authorities. The dashboard reveals that the US #FDA leads in publishing documents on RWD and RWE, but there is a lack of consistency in defining key terms like data quality, reliability, and relevance across different regulators. Literature supports that inconsistent use of RWD and RWE in the industry, is also leading to confusion. A ๐ to the Duke-Margolis Centerโs dashboard is in a comment below. Itโs an excellent resource โ check it out! #drugdevelopment #regulatoryaffairs #realworlddata #realworldevidence
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