An Introductory overview of the FDA and EMA Requirements

[Joseph Wilcox]

The aim of this webinar is to provide an introductory overview of the requirements demanded by the FDA and EMA (arguably the two most important regulatory authorities for drug developers) for EIM (the IND and IMPD) and to provide an brief review of where the agencies differ as well the commonalities of approach for their EIM dossiers.

Although each regulatory authority publishes guidelines and instructions regarding the requirements for the Entry Into Man (EIM) of a new medication, such information is often located in different pages of the authority's website and it can be time consuming to acquire and review all the relevant information.

The FDA's website, for example, has 27 sections [topics] with a total of 183 subsections, each of which can be multiple pages with links. The EMA website is equally extensive and complex.

A brief overview of EIM requirement dossiers from other important regulatory authorities will also be provided

• The most important regulatory authorities for drug developers
• What is an IND, what is an IMPD
• What are the required components for the IND the IMPD dossiers
• What are the common features to both the IND and the IMPD dossiers
• Notable differences between the IND and IMPD
• EIM Requirements for other important regulatory authorities

• Clinical Scientists
• Clinical Operations Staff
• Clinicians and other Medical/Scientific Professionals who support their department of Regulatory Affairs in preparing IND and IMPD dossiers