All Regulatory Rapporteur articles in CPD Supplements – Page 2
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JournalRegulatory complexities and challenges of biosimilars
This continuing professional development (CPD) supplement focuses on the regulatory complexities and challenges associated with biosimilar products and their development. Although biosimilar products have been registered and approved for use in the EU for more than a decade, there is increasing speculation and excitement on the potential for biosimilars with increasingly complex structures, eg, multi-subunit, extensively post-translationally modified, and lipid-containing products.
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JournalFDA meetings: How to hold a successful meeting across the drug development lifecycle
This continuing professional development supplement discusses the available meeting options for products regulated by CDER and CBER, which should help the reader select the appropriate avenue to receive the Agency’s advice and develop a viable regulatory interactions strategy.
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JournalWhat is regulatory affairs, how does it fit into the bigger healthcare picture and the role of industry in the regulatory process
An overview of a session at Regulatory Careers Live 2025 for students, graduates and those hoping to enter the profession on the role of regulatory affairs in the healthcare industry
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CommentaryRegulatory affairs as a career
An overview of a session at Regulatory Careers Live 2025 for students, graduates and those hoping to enter the profession on regulatory affairs as a career
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CommentaryThe job search
An overview of a session at Regulatory Careers Live 2025 for students, graduates and those hoping to enter the profession on how to successfully find and secure your first regulatory affairs job
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