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.
A four-hour workshop for HR Professionals in the area of Attraction, Selection and Recruitment of Neurodiverse people.
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
Level 4 QLS Endorsed Course with FREE Certificate | CPD & CiQ Accredited | 120 CPD Points | Lifetime Access
Level 5 QLS Endorsed Course with FREE Certificate | CPD & CiQ Accredited | 150 CPD Points | Lifetime Access
Free Level 5 QLS Endorsed Certificate | CPD Accredited | 150 CPD Points | Advanced Learning Materials | Lifetime Access