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.
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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
Pandemic Alters Policies and Practices for Drug Development and Regulation
By Jill Wechsler
The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.
Drug development and regulati…
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…
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Advancing Global Collaboration for Drug Testing, Regulation, and Manufacturing
Regulatory authorities and biopharma companies are engaged in a range of collaborations to harmonize research methods, approval standards, and quality production methods key to expandi…
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
STEVE
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Steven Lynn, Executive Vice-President, Pharmaceuticals, Regulatory Compliance Associates, shares insight into regulatory require…
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…