Navigating the IND - Guide to Assemble an Acceptable IND Dossier.
Duration : 60 Minutes
Barry Rosenblatt, PhD,
Dr. Rosenblatt is a subject matter expert in the chemistry and manufacturing controls (CMC) of bio-therapeutics, with a proven 36-plus year track record in biotechnology and the pharmaceutical industry. He developed, transfer Read more
A key to success in any development program is getting the drug into humans. In the US, this requires filing an IND that successfully conveys all of the information necessary to provide a package that is comprehensive enough for the FDA to feel that the new pharmaceutical drug has been manufactured and tested to assure a level of safety to the intended patient population. This presentation is designed to supply the attendee with a primer on the required structure, information, and planning required to assemble an acceptable IND dossier.
Course Objectives:
• The attendee will learn about the rationale and structure of an IND
o Required information for small molecules vs Biologics
o The importance of the Target product profile
o The contents required for the CMC section
o The investigator’s brochure
o Post phase 1 considerations
Why Should You Attend:
Understanding the relationships between the different groups involved in the IND process is one of the keys towards a successful filing. This includes all facets of the elements required, covering process scientists, manufacturing personnel, analytical and QC, QA and regulatory, and project managers.
Course Outline:
• What is an IND?
• The IND checklist
• Key information Small molecules vs Biologics
• The Target Product Profile
• What is it
• Effects on the IND
i. Example of a TPP
ii. Case study
• The CMC section
o Contents
• Biomarkers as tools for development
• The investigators brochure
• Pharmacology and Tox
• Beyond Phase I
• Post Phase 2 considerations
• Questions for registration Registration
• BLA vs NDA
• Process Validation (Verification)
• Gap analysis
• Preparing for the Pre-approval inspection
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Process Scientists
• Manufacturing Personnel
• Analytical Scientists
• Quality Control analysts
• Quality Assurance
• Regulatory
• Project managers
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
