Regulatory requirements for IND and IDE application process
Contents of IND and IDE
Establishing communications with FDA
Submissions to IND or IDE to the FDA
Amendments to IND and IDE applications
Type of FDA meetings
Progress reports for IND and IDE
Who should Attend
Clinical Research Associates
Project Managers
Project Team Leaders with limited direct regulatory experience
Data Managers
Regulatory Associates
Grant Administrators
Manufacturing, Clinical, and Pre-Clinical Personnel which will be contributing to the IND/IDE or want to learn more about IND/IDE applications process
Quality Assurance specialists
Past Events
Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings 2020 - 2020, Philadelphia, Pennsylvania, United States (83994)
Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings 2019 - 03-04 Oct 2019, Philadelphia, Pennsylvania, United States (82332)
Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings 2019 - 28-29 Mar 2019, Philadelphia, Pennsylvania, United States (80290)
Important
Please, check "Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings" official website for possible changes, before making any traveling arrangements
