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Two-Way Communications

Two-Way Communications. Exchange of information during the Review process between Regulatory Authority and Sponsor. Communication. The process by which meanings are exchanged Elements Sender – Initiator of Information Receiver - Receiver of Information

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Two-Way Communications

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  1. Two-Way Communications Exchange of information during the Review process between Regulatory Authority and Sponsor

  2. Communication • The process by which meanings are exchanged • Elements • Sender – Initiator of Information • Receiver - Receiver of Information • Message - Has many forms, focus will be on electronic information only. • The best form to use depends on many variables including importance, urgency, and goal of the communication

  3. Objectives • How to communicate or Form of communication • Define sender and receiver • Storage – Where, how and who

  4. How to Communicate • Transmission is out of scope • Must be secure Internet • Gateway • E-mail • Web • Other

  5. Define Sender/Receiver • Both applicant and regulatory authority will be both sender and receiver • Is there is a need to maintain communication thread?

  6. Discussions • Will we let agency make changes to submission content? • Suggestion: We can have another (message.xml) that is specific to regulatory authority but resides within the submission • Tightly linked to submission backbone • Elements and Metadata to be defined

  7. Possible communication • Ability to allow the regulatory authority to associate a file to an submission group (reviewable unit) and zero to many submissions. This document should be one of many types (e.g., an approval letter). • Ability to allow the regulatory authority to comments/questions to specific files or logical documents. • Ability to allow the regulatory authority to update status of submission (on hold, approved, clock status). • Ability to allow the regulatory authority to update the submission type and submission group identifier. • There is a need to keep a communication thread. At minimum, a correspondence needs to be linked either to the original submission or a supplement. It should be possible for an applicant to respond and link to one or more communications. • Acknowledgments of receipt

  8. Review Cycle • Applicant • Creates message • Assigns ACTION • Sends message • Regulatory Authority • Receives message • Attaches an ACTION • Sends message • How?

  9. Current Should Accommodate Initial Message 0000 Change Requested <none> Response 0001

  10. Future Should Accommodate Initial 0000 Message 0000-R Message is placed within the submission under appropriate document/entity Message 0001

  11. Example 1

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