The working group discussed a number of business scenarios including:
Some of these scenarios were removed from requirements iteration #1 or merged with other scenarios.
Showing posts with label RPS. Show all posts
Showing posts with label RPS. Show all posts
Saturday, October 4, 2008
RPS 2 Vancouver Working Group Meeting
An RPS2 Working Group meeting was held in Vancouver the week of September 15.
The working group discussed a number of business scenarios including:
Two Way Communication – Pre-Submission Correspondence
Submission Activities – Request Submission Number
Submission Activities – Meeting Request and Responses
Notification of Decision or Action
Request/Response for Additional information during a review cycle
Follow-up/Postmarket Correspondence
Referencing – Permit Use of Master file, Master Access File or Third Party Documentation
Referencing – Comparison Information
Referencing – Reference Information sent to an external party
Referencing - Paper Submission
Labeling Negotiations
Interim Actions (i.e., complete response letter, tentative approval, non-final actions, hold decisions, etc.)
Administrative Actions – Technical/Validation Reports/Errors
Some of these scenarios were removed from requirements iteration #1 or merged with other scenarios.
The working group discussed a number of business scenarios including:
Some of these scenarios were removed from requirements iteration #1 or merged with other scenarios.
Tuesday, September 2, 2008
RPS has a wiki!
Regulated Product Submissions (RPS) now has a Wiki (or more accurately, it's part of the overall HL7 Wiki).
To get there, go to Main Page HL7 Wiki. You will have to log in, but you can use the following credentials for read only access:
user name: wiki
password: wikiwiki
(You must create a user name and password if you want to contribute.)
Once you get there, click on the Regulated Product Submissions link in the Projects category.
There is not much in the main area, but following the RPS R2 Project link at that point will give you access to write-ups on Scope and Domain Analysis, as well as a link to business scenarios. Look for information and updates to be posted fairly often.
To get there, go to Main Page HL7 Wiki. You will have to log in, but you can use the following credentials for read only access:
user name: wiki
password: wikiwiki
(You must create a user name and password if you want to contribute.)
Once you get there, click on the Regulated Product Submissions link in the Projects category.
There is not much in the main area, but following the RPS R2 Project link at that point will give you access to write-ups on Scope and Domain Analysis, as well as a link to business scenarios. Look for information and updates to be posted fairly often.
Monday, September 1, 2008
Cross Application Links in eCTD
A little while ago, a client asked me about referencing documents submitted in one application from another application. Her question was in the context of an IND and an NDA, both submitted in eCTD format - did she have to re-submit documents in her NDA that had already been submitted in her IND?
The ICH guidance is basically silent on this subject, although the structure does not specifically prohibit any valid relative link. EMEA has stated that it is not allowed - in "EU Region Question and Answer and Specification Change Request Document", see question 13:
"In the EU it is possible to refer to a file located in the same sequence or any previous sequence of the same eCTD. It is not possible to refer to other eCTDs."
If you think about it a little, it requires each agency to maintain a specific set of folders in order for the links to work, and for the sponsor to understand what that structure is.
For example, if the agency stores eCTDs in a known folder path like this:
then I could provide a relative file path from my "NDA" 222222 back to files in my "IND" 111111. But if the agency does not maintain that exact folder structure, my links will break.
Gary Gensinger of FDA has said in several presentations that FDA will accept references to documents in other applications.
In order to do this, your publishing tool must be able to handle this scenario. A leaf must exist in your new application (you cannot reference leafs from other applications, only content files). You will need to know:
Name of the file
Location in Original Submission
Access in through the hlink:xref element, and the operation attribute is NEW.
Gary provided the following example:
With the following commentary:
You want to reference a leaf submitted in 0000 of your IND 012345 for NDA282166, sequence 0000 - Your file is named study-report.pdf in 5.3.5.2. Using the following relative path will allow you to reference the study report:
../../IND012345/0000/m5/5352/study-report.pdf
../ gets you out of the 0000 submission in NDA 282166
Adding ../ gets you out of the NDA 282166
Adding IND012345/0000/m5/5352 gets you to your files location
What I haven't heard is how many people are taking FDA up on this offer.
By the way, the RPS specification will be designed to allow cross application referencing from the start, and will not reply on a relative folder path.
The ICH guidance is basically silent on this subject, although the structure does not specifically prohibit any valid relative link. EMEA has stated that it is not allowed - in "EU Region Question and Answer and Specification Change Request Document", see question 13:
"In the EU it is possible to refer to a file located in the same sequence or any previous sequence of the same eCTD. It is not possible to refer to other eCTDs."
If you think about it a little, it requires each agency to maintain a specific set of folders in order for the links to work, and for the sponsor to understand what that structure is.
For example, if the agency stores eCTDs in a known folder path like this:
then I could provide a relative file path from my "NDA" 222222 back to files in my "IND" 111111. But if the agency does not maintain that exact folder structure, my links will break.
Gary Gensinger of FDA has said in several presentations that FDA will accept references to documents in other applications.
In order to do this, your publishing tool must be able to handle this scenario. A leaf must exist in your new application (you cannot reference leafs from other applications, only content files). You will need to know:
Access in through the hlink:xref element, and the operation attribute is NEW.
Gary provided the following example:
With the following commentary:
You want to reference a leaf submitted in 0000 of your IND 012345 for NDA282166, sequence 0000 - Your file is named study-report.pdf in 5.3.5.2. Using the following relative path will allow you to reference the study report:
../../IND012345/0000/m5/5352/study-report.pdf
../ gets you out of the 0000 submission in NDA 282166
Adding ../ gets you out of the NDA 282166
Adding IND012345/0000/m5/5352 gets you to your files location
What I haven't heard is how many people are taking FDA up on this offer.
By the way, the RPS specification will be designed to allow cross application referencing from the start, and will not reply on a relative folder path.
Tuesday, August 12, 2008
RPS 2 News
On July 24th, 2008, a kickoff meeting was held at FDA's Whiteoak facility for Regulated Product Submission (RPS) Version 2. For those of you who have not been following RPS, it is a Health Level Seven (HL7) standard to facilitate the processing and review of regulated product information. The goal of RPS is to create a regulated product submission message that:
Is general enough to handle all regulated products such as drugs, biologics, medical devices, vet meds, combination products and food products
Allows sponsors to send regulatory information using predefined parameters to identify and catalog their content
Provides enough information to allow regulators to support structured review by providing the ability to consistently locate specific information
July's kickoff meeting was attended by over 50 representatives from the FDA, EMEA, Health Canada, MEB, PMDA, and a number of vendors and pharma companies, despite significant weather issues that caused flight delays and cancellations. The focus of the kickoff meeting was on requirements gathering and further refinements to scope (there is already a project scope statement, but it could benefit from more input from outside the US).
The group broke up into around eight teams to refine and add to specific requirements topics. Topics included Two-Way/Communicate Regulatory Action, Referencing/Within Docs/to External Warehouse, Forms Data, and several others.
Next steps for the initiative include:
Determining how to organize sub groups. Formation of a leadership team and organization of a development team, a testing team, etc. are being discussed. Issues around leadership (such as determining how decisions are made and who is responsible for what aspects) are especially important.
Continuing to push forward with requirements. FDA has PDUFA imposed deadline of September 2012 for implemenation of RPS 2, so consistent progress is essential.
Progress is being made through ongoing meetings. A biweekly meeting is held (on a rotating schedule to accomodate participants from time zones all over the world) to advance requirements. A weekly leadership currently has a focus on infrastructure and subgroups - progress on organizing the testing group being especially important right now.
If you would like to stay informed on RPS,you can receive updates via a list service by registering at Health Level 7 - Subscribe to List Services. Upcoming meetings and other events will be announced via the list service, and you can still participate in these meetings and events - membership and participation are not limited to a closed group.
July's kickoff meeting was attended by over 50 representatives from the FDA, EMEA, Health Canada, MEB, PMDA, and a number of vendors and pharma companies, despite significant weather issues that caused flight delays and cancellations. The focus of the kickoff meeting was on requirements gathering and further refinements to scope (there is already a project scope statement, but it could benefit from more input from outside the US).
The group broke up into around eight teams to refine and add to specific requirements topics. Topics included Two-Way/Communicate Regulatory Action, Referencing/Within Docs/to External Warehouse, Forms Data, and several others.
Next steps for the initiative include:
Progress is being made through ongoing meetings. A biweekly meeting is held (on a rotating schedule to accomodate participants from time zones all over the world) to advance requirements. A weekly leadership currently has a focus on infrastructure and subgroups - progress on organizing the testing group being especially important right now.
If you would like to stay informed on RPS,you can receive updates via a list service by registering at Health Level 7 - Subscribe to List Services. Upcoming meetings and other events will be announced via the list service, and you can still participate in these meetings and events - membership and participation are not limited to a closed group.
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