|
RESTRUCTURING SERVICES FOR U.S. PRESCRIBING INFORMATION
|
|
TASKS OF A TYPICAL RESTRUCTURING PROJECT
|
Phase I - Creation of Draft Annotated FPI and Highlights Text Modules
Phase II - Client Review and Decision Making
Phase III - Project Finalization
|
CREATION OF DRAFT ANNOTATED FPI AND HIGHLIGHTS TEXT MODULES
|
Typical Deliverables:
- Annotations for FDA and
- Temporary comments to help Client in decision-making (removed in final version).
|
CREATION OF HIGHLIGHTS TEXT MODULES
|
Typical Deliverables:
|
OUR TEXT MIGRATION, WRITING AND COMMENTING POLICY
|
While providing extensive support for decision making, it is our policy to not limit a Client in making decisions on the placement of information (e.g. elevating information to the WARNINGS and PRECAUTIONS section, or to HIGHLIGHTS).
As far as feasible, emphasis given to information by prominent placement is retained (e.g. retaining the relative order of subsections of the former WARNINGS section). Whenever there are several placement options, text is moved to its "baseline" section in the new format. Example: Population subset information (e.g. "on patients with renal impairment" from the former PRECAUTIONS section is moved to the USE IN SPECIFIC POPULATIONS section).
In such cases, it is left to the Client to decide whether information deserves to be placed or repeated in a higher-level section, or whether the sequence of subsections needs to be changed.
When drafting text (e.g. to create transitions between paragraphs, or when creating HIGHLIGHTS text modules), we pay attention to stay within the limits of existing labeling content and emphasis, and not to lose nuances of meaning. Example: "Should not" wording in FPI is not converted to "do not" wording in HIGHLIGHTS modules. Our comments are written in a neutral manner, pointing to decision options rather than recommending a specific solution.
|
CLIENT REVIEW AND DECISION MAKING
|
The Client’s decision making on final format and content is supported by providing:
Comments in the Annotated Draft FPI.
* For each check-point, the Decision-Support Checklist contains convenient full-text citations of CFR 201.56 / 201.57 and FDA's (draft) guidance documents for quick lookup of FDA's expectations plus, if necessary, pointers to approved U.S. labeling that illustrates certain requirements and guidelines.
Based on the materials provided by Pharmiceutics and additional information received during the direct discussion of points to consider with one of our experts, the Client makes all decisions necessary for finalization of the reformatted label.
Our decision support helps the Client to focus on relevant issues and is intended to significantly increase efficiency of decision making. Our Decision-Support Checklist puts relevant background information at the Client's fingertips.
After having received the Client's decisions, we finalize the FPI and Highlights section. The previously provided Migration Table, Annotated Draft FPI and Highlights are updated and combined into a single, submission-ready document, providing FDA with a fully annotated "restructuring roadmap". The Client can use this annotated document to incorporate additional labeling changes with further annotations.
Submission-Ready Document (MS Word document) with Migration Table and annotated prescribing information (Highlights and restructured FPI); quality controlled and submission ready.
Annotation-free version of the restructured PI that indicates text considered to represent recent major changes (MS Word document). This document is prepared for the SPL conversion provider and not intended for submission to FDA. Clients should obtain a clean MS Word version of the completed reformatted draft label from their SPL service provider (either internal or external).
We are available for:
|
COMPANY CORE DATA SHEET (CCDS) SERVICES
|
A Company Core Data Sheet (CCDS) is a company-internal global reference labeling document used to direct the content of local (affiliate) labeling. The CCDS may also be used as an attachment to a Periodic Safety Update Report (PSUR); in this context, all the safety information in a CCDS ("Company Core Safety Information" or "CCSI"), or a specifically identified (e.g. by bold print) subset of this safety information, serves as reference information for determining "listedness".
A CCDS may be created for a new product, to be available at the time of a first submission of local labeling in a first market, or at any later point in a product's life cycle. Ideally, a CCDS is already available at the beginning of the first PSUR period for the second market that requires a PSUR.
The type and depth of information in a CCDS depends on how "active" the product is. The content of a CCDS written for a "mature, stable" product (no new indications or uses planned to be added) may be limited to CCSI, accompanied by a brief description of the product's uses as necessary to interpret the CCSI.
A CCDS for a new, active product may contain all information that most local affiliates might need to draft local labeling.
The CIOMS III/V and VI guidelines describe some general criteria for including safety information in a CCDS/CCSI. However, labeling regulations, guidelines and expectations have significantly changed and become more specific since the CIOMS III and III/V reports were published. Taking these developments into account is crucial from a regulatory and legal/litigation point of view. Equally important for the regulatory viability and defensibility of CCDS and CCSI content and for labeling harmonization are carefully drafted and effective rationales and supporting documentation.
Our unique experience in the field of labeling, and Core labeling in particular, makes QeL the ideal resource for companies that create or revise CCDS and CCSI and harmonize local safety labeling.
|
PROCESS OF CREATING A CCDS/CCSI FOR A STABLE, MARKETED PRODUCT
|
The process of creating a CCDS/CCSI for a marketed product typically begins with a comparative analysis of the content of local labels. Based on English language label texts provided by the Client, QeL prepares a labeling comparison table that highlights labeling similarities and differences. Following a telephone conference in which we explain selected findings and decision options, the Client then evaluates information that is present in all labels as well as information that is missing in some labels, to determine which elements deserve to be included in the CCDS/CCSI.
In this context, QeL provides the Client with guidance on the type and depth of supporting rationales and documentation needed for CCDS/CCSI elements that are not yet present in all local labels and require regulatory submission in one or several markets.
Based on Client feedback QeL drafts a document that, after further Client review, evolves into the final draft CCDS for approval by the Client's labeling committee. Upon request, QeL provides its CCDS template to the Client. This template (accompanied by instructions for CCDS authors and affiliate staff) reduces the implementation difficulties and workload that could result from a CCDS structure that, for example, mimics the EU SPC structure and conventions.
QDS offers a suite of editorial services to help publishers of e-books, product manuals, technical documentation, and web content with the following:
Quadrant eLabeling Services (QeL), a division of Quadrant Data Solutions, was established in 2005 specifically to provide SPL services to the Pharmaceutical Industry and SPL Vendors. From May 2006 till March 2007, QeL’s SPL focus was exclusively on providing Highlights Structuring and Coding guidance and assistance to clients, and since March 2007 its focus has been on creating Company Core Data Sheets and providing Company Core Safety Information Services (CCDS/CCSI Services) and Restructuring Services for U.S. Prescribing Information. It also conducts workshops and seminars focusing on SPL aspects of the Physician Labeling Rule (PLR). QeL brings together an outstanding set of resources uniquely qualified to provide these services.
|
QeL's Consulting Subject Matter Experts
|
| |
Dr Leander Fontaine, M.D.
Pharmiceutics LLC |
Over three decades of pharmaceutical industry experience in labeling, terminologies, coding, pharmacovigilance, clinical development, and regulatory affairs. Active participation in the HL7 SPL Implementation Workgroup.
|
|
|
| |
|
The CCDS/CCSI Services and Restructuring Services for U.S. Prescribing Information, are designed and performed by recognized pharmaceutical experts with the support of highly skilled IT and process design engineers.
QDS provides Explanation-of-Benefit (EOB) processing, including:
