Accelerated review, approval, and access procedures that more efficiently address unmet patient needs have challenging consequences for the regulatory, technical, and quality requirements of drug development. This complexity increases the need for clearly communicating harmonized regulatory, technical, and quality standards. DIA provides a thorough understanding of requirements and strategies needed to support problem-solving as well as continuous improvements and innovation in biopharmaceutical manufacturing.
Common Deficiencies Found in the Active Pharmaceutical Ingredient (API) Section of Non-sterile Generic Products Submitted for Registration by SAHPRA
This research study aims to determine the qualitative and quantitative common deficiencies included in the API section of dossiers submitted to SAHPRA. The study was conducted retrospectively over a 7-year period (2011–2017) for non-sterile generic products that were finalised by the Pharmaceutical and Analytical pre-registration Unit.
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Implementing Internal Quality Review: A Potentially Important Step towards a Self-Reliant Clinical Trial Site
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Defining Gene Therapy Medicinal Products in the EU: Scientific and Regulatory Perspectives
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New FDA Guidance Addresses Challenges with Cell and Gene Manufacturing Comparability and Complexity
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Navigating Chemistry, Manufacturing, and Controls Through the Drug Development Process Online Course
Register for this On-demand Training Course which will demonstrate CMC sections of regulatory submissions, the FDA inspection process, and how to avoid or minimize 483s (noncompliance) using real-life scenarios.
Pharmacovigilance Quality Management System Online Course
This beginner to intermediate level hands-on virtual live training course describes contemporary principles, practical approaches, and regulatory expectations for the Pharmacovigilance Quality Management System.