Best Practices for Communication between IND Sponsors and FDA During Drug Development process

Duration: 90 Minutes
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.
Communication Best Practices
Product ID: 501342
Objectives of the Presentation
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
Why Should you Attend
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.

Areas Covered
  • 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
Who can Benefit
  • Quality Assurance personnel
  • Quality Control personnel
  • Research & Development
  • Regulatory Affairs Professionals
  • Project Managers
  • Auditing Professionals
  • Scientists
  • Product development managers
Topic Background
In December 2015 FDA published a draft guidance relating to investigational new drug applications (INDs). This guidance describes:
  • FDA's philosophy regarding timely interactive communication with IND sponsors as a core activity
  • The scope of appropriate interactions between review team and sponsor
  • The types of advice appropriate for sponsors to seek from FDA in pursuing their drug development program
  • General expectations for the timing of FDA response to IND sponsor inquiries
  • Best practices and communication methods to facilitate interactions between the FDA review team and the IND sponsor during drug development
  • Expectations for appropriate methods, including the frequency, of such communications
This guidance emphasizes that during the IND phase of drug each year, sponsors and FDA engage in thousands of formal and informal communications, including meetings and teleconferences. Therefore, it is important that interactions be conducted efficiently and consistently, with clear, concise and timely communication.
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Instructor Profile:
Richard Chamberlain's experience includes 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. He has also managed large-scale clinical projects including development of Remote Data Entry systems, Adverse Event reporting, Drug Supplies, project planning and supervision of staffs.

Apart from these Mr Chamberlain has 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. He is also 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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