Sebastian König’s Post

Flawless submissions are more than just paperwork; they empower a strong strategy. Ready to build a winning strategy? Learn the pillars of submission excellence. https://lnkd.in/gjtPYEAB #submissionexcellence #submissionstrategy #regulatorysubmissions #pharmaceuticals

Pharmaceutical businesses still face drug and medical supply shortages throughout the industry. This article identifies three main trends impacting the industry in 2024: ongoing drug shortages, federal oversight and the Drug Supply Chain Security Act. #pharmaceuticals #supplychain

Pharmaceutical businesses still face drug and medical supply shortages throughout the industry. This article identifies three main trends impacting the industry in 2024: ongoing drug shortages, federal oversight and the Drug Supply Chain Security Act. #pharmaceuticals #supplychain

DATA MONITORING COMMITTEES; FDA RECENT GUIDANCE DOCUMENT, FEBRUARY 2024 AT CLINREG PARTNERS, WE WILL PARTNER WITH YOU FOR YOUR SUCCESS AND TO MAKE SURE YOU STAY INFORMED OF ALL THE NEW AND REVISED GUIDANCE DOCUMENTS #regulatoryaffairs #regulatory #regulatorycompliance #pharma #pharmaceutical #pharmaceuticalindustry #pharmaceuticalmanufacturing #clinregpartners

Pharmaceutical businesses still face drug and medical supply shortages throughout the industry. This article identifies three main trends impacting the industry in 2024: ongoing drug shortages, federal oversight and the Drug Supply Chain Security Act. #pharmaceuticals #supplychain

Decision-making by drug regulators and HTA institutions takes place under uncertainty caused by data gaps. Uncertainty has a major impact on value perception and pricing. This newsletter deals with uncertainties of the authorities and how drug manufacturers should deal with it for optimal pricing. #pharmaceuticals #cellandgenetherapies #decisionmaking #marketaccess #uncertainty #marketingapproval #HTA #value #pricingstrategy #managedentryagreements

Whether you're navigating the complexities of supply chain management or seeking seamless solutions for drug development and manufacturing, Gyma has got you covered, globally! #pharmaceuticals #drugdevelopment #supplychainmanagement #insights

Pharmaceutical businesses still face drug and medical supply shortages throughout the industry. This article identifies three main trends impacting the industry in 2024: ongoing drug shortages, federal oversight and the Drug Supply Chain Security Act. #pharmaceuticals #supplychain

Learn how to speed and simplify the creation, review, and approval of compliant commercial content. #pharmaceuticals #contentstrategy #VaultPromoMats

Congratulations Ann Kane and well done on this. Ann covered the following areas on this programme: - Introduction – to pharmaceutical, (bio)pharmaceutical manufacturing in a GMP (Good Manufacturing Practice) regulated environment, quality systems, regulation and validation - Industry regulations and guidelines for GMPs – including, FDA GMPs for the United States, EMA GMPs for European Union, ICH, and PICs GMP regulation - FDA medical device rules – medical device regulations & and guidelines - GMPs vs ISO 9001:2015 – what’s the difference and why we use both - Process validation and documentation – design and verification of manufacturing systems - Key manufacturing technologies – such as organic chemical synthesis, biopharmaceutical manufacturing, tablet manufacturing and aseptic and sterile manufacturing - Supporting technologies  – such as purified water generation, storage and distribution, clean steam, water for injection, storage and distribution - Introduction to Quality Risk Management (QRM) – and the importance of risk management and the basic steps involved in its application - Working in a cleanroom environment – layout, classification, gowning and monitoring - Professional Writing Skills Program – This will guide you through the assignment writing process and equip you with the written communication skills you need for working in the industry For an end-of-module assignment, Ann completed a report on the cGMPs that are required to consistently manufacture safe medicines, vaccines and medical devices for patients. It included: - The key requirements of a quality management system - The cleaning validation sequence and how to determine cleanliness levels - The documentation of a complete risk management process in terms of identifying risk, analyzing risk, evaluating risk and controlling risk. - The typical equipment and process stages used in the manufacture of active pharmaceutical ingredients - The generation, storage and distribution of pharmacopoeia grade Purified Water (PUW). - The common cleanroom configuration and airflow direction that governs personnel and material flows in a biopharmaceutical manufacturing environment Well done again on your hard work.