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The key learning objective of this webinar is to introduce participants to recommended practices used by investigational new drug application (IND) sponsors and FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effective drugs. Effective communication with FDA is critical in successfully bringing any therapeutic product to market. However, communication includes much more than the written regulatory submission. Effective communication in all its forms must be concise, carefully considered, and reviewed to achieve the desired outcome.


  • Gain insight into communicating with FDA during IND drug development :
  • What topics might be discussed with FDA and why
  • Understand the basic elements of communication
  • Learn about “Sponsors” and FDA Responsibilities
  • Understand the roles of the various participants
  • Determine the elements of the documentation and why it is Important
  • How to manage an FDA Inspection


During the IND phase of drug development it is often critical for the sponsor to discuss with FDA issues that can impact things such as patient safety, quality, efficiency, and more. It is vital that the sponsor provide the best information to FDA to help make the best decisions. What is the best way to conduct this communication?Should it simply be an oral conversation or would it require a meeting? What documentation is best to prepare for the meeting and after the meeting? We will include some suggestions for communicating during and after an FDA inspection.


  • Introduction to issues of Science, Compliance, and Quality
  • Background History of some of the reasons for the practices
  • Different types of communications -Oral, Face-to-face, Documentation
  • The scope of the issues -Justification for Approvals, Plans, Compliance
  • Different FDA personnel -Project Manager, CBER, CDER, Others
  • Timing, depth of detail, format
  • Questions and Answers


  • Quality Assurance personnel
  • Quality Control personnel
  • Research & Development
  • Regulatory Affairs Professionals
  • Project Managers
  • Auditing Professionals
  • Scientists
  • Product development managers


Richard Chamberlain Consulting with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of computerized project scheduling, strategic planning, Quality Management and Computer Systems Validation, Managed large-scale clinical projects including development of Remote Data Entry systems, Adverse Event reporting, Drug Supplies, project planning and supervision of staffs. Taught numerous public and in-house courses on various aspects of Computer Systems Validation and Auditing Computer Systems. Assisted in the development and validation of numerous computerized systems in all GxP environments. Assisted with the development of all varieties of Standard Operating Procedures and other required documentation for Quality Management and compliance to regulations. Familiar with the various aspects of Computerized Systems and CFR 21, Part 11,FDA Guidelines for Computers, ICH-GCP, and GxPs.

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