Clinical Testing Plan and Submissions – a TWO Part Course
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Who Should Attend
Participants MUST Attend Both Parts
This 2-part course is designed for professionals within the pharmaceutical and biologics industries who are
interested in the planning and submissions of INDs. The training will be especially valuable to:
• Regulatory Personnel
• QA Managers
• Directors and VPs
• Representatives of the Contract Research Organizations
(CROs)
Description
The FDA procedures for the clinical testing of drugs, potentially leading to the filing of an NDA or ANDA, are
evolving rapidly. This two-part, accredited program examines the steps involved in designing and filing for
permission to conduct the clinical tests (the IND); the FDA issues and concerns in reviewing IND applications; the
details of the pre-IND FDA meeting; and the procedures for electronic IND filing. Registration for both sessions is
required. The course is divided into two 90-minute sessions, each in turn divided into three modules.
Participants MUST Attend Both Parts
SESSION 1: Planning the Clinical Study and IND Filing
Module 1: Overview: Clinical Testing Concerns
• QbD
• Post marketing clinical testing
• Phases of Clinical Testing
Module 2: Steps
• Planning the Clinical Testing Process
• Pre-clinical
• IND filing
• Pre-meeting
• Design
• Research
• Investigator's Brochure
• IRB approval
• Format
Module 3: FDA Criteria and Concerns
• Foreign studies
• Design issues
• Safety and IRB review
• Study Size
• Blood/brain barrier
Question and Answer Session
SESSION 2: Dealing with the FDA Pre-IND Meeting and Details of Electronic Filings
Module 1: Quality Issues in Clinical
• Clinical Team pre-IND meeting with FDA
• Focusing on the important issues and meta-issues
• Evaluating research facilities and strategies
• Ethical issues
• Protection of the safety, rights of persons participating
Module 2: Prep for the Pre-IND Meeting
• Early interactions with FDA staff to help to prevent clinical
issues from arising
• Selection of appropriate CROs and Investigators
• The Mock-Meeting: managing expectations
• Efficient use of FDA resources
Module 3: Electronic INDs
• Evolving process
• Industry guidance and FDA guidelines
• e-Forms
• Alternatives: paper, paper with electronic index, paper with
hyperlinks
Question and Answer Session