Sarah, what is the Generic Drug Cluster, and what is the significance of the Cluster? · We know the importance of generic drugs to the public. Ninety percent of patients’ prescriptions in our country are now filled with generics – many of these are critically needed, life-saving drugs – that may provide enormous cost savings. Generic drugs play an important role in helping to address rising health care costs and in promoting access to medicines across the world. To enhance our knowledge and view of the global generic drug landscape, we i ...
배울 내용 ; How to create a registration dossier ; How to provide a qualified assessment of clinical documents ; How to develop an understanding of language fundamentals and style-guide conventions ; How to increase your salary
Basic understanding and terminologies related to Dug Regulatory Affairs (DRA). ; Why Regulatory Affairs (RA) professional is required in Pharma Industry and essential qualities of RA professionals. ; Understand the role of a Regulatory Affairs Professional in Pharmaceutical industry, Types of companies hiring RA professionals, and DRA objectives. ; Navigation through historical background of US Drug Law and Regulations, and The USFDA regulations for Research and Development (R&D) of Pharmaceuticals.
accelerates drug development, and closes critical gaps in care—ultimately making science... offices in Singapore and India. The Senior Regulatory Affairs Specialist will support and carry...
Our Regulatory Affairs Consulting team offers standalone services and integrated support from product development to commercial and lifecycle maintenance.
Introduction to Drug Regulatory Affairs Overview of Regulatory Authorities and their Functions
MD, PhD or equivalent preferred • Minimum 3 years in Regulatory Affairs • Established regulatory experience • Effective collaboration • Familiarity and understanding of the drug...
Increase program success ; Regulatory approval procedures are becoming increasingly stringent and time-consuming. Not having the right regulatory strategy in place will cost time and money, and may result in the failure or delay of your drug development program. Increase your program’s chance of expedited success with global program development guidance from seasoned experts from industry and regulatory agencies. Certara’s integrated team of regulatory strategists provides regulatory strategy, consulting, and regulatory submissions support ...
Empowering Professionals in the Pharmaceutical Industry: A Comprehensive Online Course in Drug Regulatory Affairs
Overview ; Complete this On-Demand Training Course to learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy. This comprehensive course employs a blend of recorded lectures, real-world examples, scenario-based activities, and self-paced online modules. This basic to intermediate level training course focuses on prescription drugs and well-characterized biological products. This on-demand training course takes an average of 19 hours to complete. Learners have ac ...