An Investigational New Drug Application (IND) is a submission to the US Food and Drug Administration (FDA) for permission to conduct a clinical trial of a medicinal product. This module describes regulatory requirements that sponsors or sponsor-investigators must meet for successful compilation, filing and maintenance of INDs. The IND and its role are defined, and the contexts in which it is required are specified.
To conduct a clinical trial in the European Economic Area under the Clinical Trials Directive the sponsor must apply for authorisation from the national competent authority (i.e. medicines regulator), and favourable opinion must be obtained from a research ethics committee, in each member state in which the trial is to take place. This module sets out the requirements for successful compilation, submission and maintenance of the applications.
The First Jeep Project - Key Lessons Learned The First Jeep Project - Key Lessons Learned Presentation would focus on the key elements that led to the success of the first Jeep project as follows: Introduction Superb Requirements Ingenuity and Flexibility Rigorous Testing Courageous Leadership Conclusions 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 First Jeep Project - Key Lessons Learned The First Jeep Project - Key Lessons Learned Presentation would focus on the key elements that led to the success of the first Jeep project as follows: Introduction Superb Requirements Ingenuity and Flexibility Rigorous Testing Courageous Leadership Conclusions 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.
Level 7 QLS Endorsed Course with FREE Certificate | CPD & CiQ Accredited | 180 CPD Points | Lifetime Access
Level 7 QLS Endorsed Course with FREE Certificate | CPD & CiQ Accredited | 180 CPD Points | Lifetime Access
Level 4 QLS Endorsed Course with FREE Certificate | CPD & CiQ Accredited | 120 CPD Points | Lifetime Access
Free Level 7 QLS Endorsed Certificate | CPD Accredited | 180 CPD Points | Advanced Learning Materials | Lifetime Access