11410 Professional Development courses delivered Online

This module provides a guide to signal detection and management for approved products. The subject is presented as a process comprising four stages: signal detection, signal validation, signal analysis and prioritisation, and risk assessment and minimisation.

The Centralised Procedure (CP) is one of three routes available to applicants to gain multinational marketing authorisation within the European Economic Area (EEA) on the basis of a single application. In the CP, one successful application leads to a marketing authorisation being issued by the European Commission that applies throughout the EEA. The CP is mandatory for certain types of products.

Medicines for the prevention, diagnosis, or treatment of rare diseases have become known as ‘orphan drugs’ because of their commercial unattractiveness. Development of such products is successfully encouraged through incentives offered by regulatory authorities. To qualify for important incentives, the sponsor of a drug must gain ‘orphan designation’ for its use in an indication. This module describes the requirements for orphan designation and how to apply for it in the USA and the European Economic Area.

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.

The warehouse plays a crucial role in a medicinal products factory. This module explains the requirements of Good Manufacturing Practice (GMP) for the warehouse, and how to comply with them.

This module addresses characteristic issues influencing the registration of medicinal products based on monoclonal antibodies (mAbs), for use in humans. Regulatory requirements for the registration of biological medicinal products such as those based on mAbs differ in certain respects from those for small-molecule products. This is because of the distinct characteristics of biologics, such as complex structure and susceptibility to variation during manufacture.

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.

Design Thinking in Action This presentation will show you how to use Human Centered Design (HCD) to identify--and design for--critical moments in the employee experience that impact your customers' experiences. Learn how tools and approaches such as segmentation, persona development and journey mapping can help project teams improve employee engagement and the behaviors that drive customer satisfaction. This and other IIL Learning in Minutes presentations qualify for PDUs. Some titles, such as Agile-related topics may qualify for other continuing education credits such as SEUs, or CEUs. Each professional development activity yields one PDU for one hour spent engaged in the activity. Some limitations apply and can be found in the Ways to Earn PDUs section that discusses PDU activities and associated policies. Fractions of PDUs may also be reported. The smallest increment of a PDU that can be reported is 0.25. This means that if you spent 15 minutes participating in a qualifying PDU activity, you may report 0.25 PDU. If you spend 30 minutes in a qualifying PDU activity, you may report 0.50 PDU.

High-Performance Teams: Core Protocols for Psychological Safety and EI Want awesome teams that build great products? Great teams don't happen by accident. And they don't have to take a long time to build.In this session, Richard lays out the case for Continuous / Extreme Teaming. Join in a flight of fun learning activity-sets that will give you a taste of team awesomeness and how to start when you go back to work.Richard builds on the work of Jim and Michele McCarthy, Google, Bruce Tuckman, Gamasutra, Standish Group, Peter Drucker, and Melvin Conway. His learning activity-sets activities are short games, using elements from improvisational theater, The Core Protocols, Extreme Programming, and more.Who should attend? Anyone who wants to create a great team and build great products. You'll leave having embodied the essential elements of accelerated continuous team-building and maintenance. This and other IIL Learning in Minutes presentations qualify for PDUs. Some titles, such as Agile-related topics may qualify for other continuing education credits such as SEUs, or CEUs. Each professional development activity yields one PDU for one hour spent engaged in the activity. Some limitations apply and can be found in the Ways to Earn PDUs section that discusses PDU activities and associated policies. Fractions of PDUs may also be reported. The smallest increment of a PDU that can be reported is 0.25. This means that if you spent 15 minutes participating in a qualifying PDU activity, you may report 0.25 PDU. If you spend 30 minutes in a qualifying PDU activity, you may report 0.50 PDU.

The Value Driven Project Manager This presentation addresses how core values are formed at the individual level and at the organizational level. It will also address how these values drive personal performance and influence the effectiveness of the professional project manager. Is project management a profession or simply a methodology? While the debate continues, there is no doubt that a well-trained, experienced, professional project manager will make a meaningful addition to any organization. The career-minded project manager is an authority on achieving success, and continually practices and develops the skills necessary to overcome any challenges encountered during the process. This video offers keen insight into how core values are formed at the individual level and at the organizational level, and how these values drive personal performance and influence the effectiveness of the professional project manager. This and other IIL Learning in Minutes presentations qualify for PDUs. Some titles, such as Agile-related topics may qualify for other continuing education credits such as SEUs, or CEUs. Each professional development activity yields one PDU for one hour spent engaged in the activity. Some limitations apply and can be found in the Ways to Earn PDUs section that discusses PDU activities and associated policies. Fractions of PDUs may also be reported. The smallest increment of a PDU that can be reported is 0.25. This means that if you spent 15 minutes participating in a qualifying PDU activity, you may report 0.25 PDU. If you spend 30 minutes in a qualifying PDU activity, you may report 0.50 PDU.