1087 Courses delivered Online

The heaviest legal penalties imposed on drug companies concern interactions with healthcare professionals in the context of prescription drug marketing, notably for violations of the Anti-Kickback Statute and the False Claims Act. Monetary penalties have amounted to billions of dollars in some cases.

In this course we explain how to advertise and promote prescription drugs in various media, whether to healthcare professionals or consumers, in compliance with legal requirements and guidance from the FDA.

This module provides an introduction to the basics of medical device regulation, especially the requirements that manufacturers must meet in order to market devices in Europe and the USA.

21CFR11 applies to records that are required to be submitted to the FDA, or that are subject to FDA inspection, and that are in electronic form – that is, as computer files. It applies to all computer systems used to create, modify, maintain, archive, retrieve, or transmit such records – from a humble spreadsheet program to a complex information management system.

Embark on a flavorful journey through "American Cuisine: Exploring the Flavors of the USA" course. From the soulful Southern dishes to the bold Tex-Mex fusion, discover the rich tapestry of regional flavors and cultural influences. Immerse yourself in New England's maritime cuisine, savor the heartland's hearty fare, and explore the Pacific Northwest's culinary landscape. From Native American traditions to delectable desserts, join us for a culinary adventure celebrating the diverse tastes and traditions that define American gastronomy. Perfect for aspiring chefs and food enthusiasts alike.

The NCSP® Foundation accredited (APMG International), certified (NCSC/GCHQ-UK) and recognized (DHS-CISA-USA) certification course introduces business, technology, auditing, and management professionals to the fundamentals of digital business, its risks, and the NIST Cybersecurity Framework's role in helping organizations manage and mitigate digital risk. This course also introduces candidates to an Affordable, Pragmatic, and Scalable Digital Value Management System (DVMS) Create, Protect, and Deliver (CPD) model designed to enable any size organization to quickly adopt and adapt the frameworks and models (NIST-CSF, NIST Privacy Framework, CMMC, etc.) that may be required to address internal, external (regulatory) and cyber threat landscape changes. The DVMS enables enterprises to become adaptive, cyber-resilient organizations capable of creating, protecting, and delivering trusted digital business value to their stakeholders.

The NCSP® 800-53 Practitioner accredited (APMG International), certified (NCSC/GCHQ-UK), and recognized (DHS-CISA-USA) certification course teaches Digital Business, Operational Stakeholders, Auditors, and Risk Practitioners a Fast-Track approach to adopting and adapting the NIST Cybersecurity Framework and its 800-53 controls across an enterprise and its supply chain.The course also teaches candidates how to build a Digital Value Management System (DVMS) CPD overlay model capable of enabling the quick adoption and adaption of new frameworks and models (NIST-CSF, NIST Privacy Framework, CMMC, etc.) that may be required to address internal, external (regulatory), and cyber threat landscape changes. Finally, the course teaches candidates how to ensure the organization's DVMS is designed for use within the organization and auditable by government regulators looking to verify regulatory outcomes. The NCSP Practitioner 800-53 course is designed for both the Implementer and Auditor topics and participants select the exam they want to take (or an additional exam can be ordered to be certified as both an implementer and auditor).

This foundation-level module is the ideal introduction for new entrants to the field of pharmaceutical regulatory affairs and compliance. It describes the principal requirements that must be satisfied to gain and maintain approval to market medicinal products in the USA and Europe. The legal framework and the roles of major players in regulation are presented. The life-cycle of a drug is outlined. The various procedures available for assessment and approval of products are described and their requirements outlined. Obligations to be fulfilled after marketing approval are discussed.

The CTD is the internationally recognised standard format for submissions to medicines regulatory authorities. In the European Economic Area, the USA and Canada, the CTD, in its electronic format (eCTD), is mandatory for all applications for marketing approval and all subsequent related submissions. The CTD is accepted in many other countries, being mandatory for new prescription medicines in some. This module explains the rationale for the CTD and provides guidance on its structure and format and the ways in which it is used.

Drug safety monitoring and risk management are vitally important for medicinal product developers, licence holders and clinical investigators. In addition to their duty to protect public health, increasingly tight regulation and potentially massive payments to litigants provide strong incentives for pharmaceutical and biotechnology companies to ensure that they maintain efficient systems for drug safety / pharmacovigilance and that all staff are aware of the basic requirements. This course will provide them with an overview of the most important aspects of this discipline, both before and after marketing of products, especially as they apply in Europe and the USA.