Search results for " regulations"

Article Successfully Moving Regulated Data to the Cloud
Changing working practices and regulations One example from FDA’s guidance document describes the use of shared login accounts. Previously, shared accounts have been used to conveniently access a r…

Article Early Communication with Regulators is Essential for SMEs
With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process. …

Article A Look Ahead at BioPharma Manufacturing and Regulation
These rules are set to take place in July 2014 after further regulations are developed. How will the new standards differ from current import and foreign registration requirements? FDA: FDASIA …

Article Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
As the European Union takes a closer look at its biosimilars guidelines, some key issues are proving difficult to resolve. The European Union is strengthening its pioneering role in the regulati…

Article Bioterminology: A Guide to the Biopharmaceutical Lexicon
CFR Code of Federal Regulations; the U.S. regulations that directly apply to biopharmaceutical development are in Title 21 parts 58, 210, 211, and 600. Parts 50, 56, and 312 apply to clinical trials. …

Article Good Manufacturing Practices: Challenges with Compliance
Obstacles to compliance BioPharm: What challenges do you see in complying with FDA’s CGMP regulations for biopharmaceutical manufacturing? Smith (Catalent): In general, it is not difficult t…

Article A Look into the Future of Biopharmaceutical Quality
Quality regulations, and industry, may have to continually adapt to address these challenges. To gain perspective on what the future holds for biopharmaceuticals and how the industry and regula…

Article Roadmap Leads to Innovative Biomanufacturing Strategies
It is no wonder that companies seek to comply with the same regulations in very different ways. Success stories BioPharm: The first edition of BPOG’s Biomanufacturing Technology Roadmap was jus…

Article FDA Framework Spurs Advanced Therapies
In addition, because Lonza takes a science-based approach to the development of advanced therapy medicinal products (ATMPs) while at the same time evaluating risk, the new regulations lay the groundwo…

Article 25 Years of Biopharmaceutical Innovation: An Expert Roundtable
They've considered the technologies and developed regulations or guidelines to cover them quite rapidly. It's interesting, for example, that the European Pharmacopoeia now contains general chapters fo…

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