U.S. Review Committee and the Review of Promotional and ... · upon PRC comments and disseminates to Project Manager, ... U.S. Review Committee and the Review of Promotional and Other

1. PURPOSETo describe UCB’s internal review process for approval and management of all promotional and other selected materials, including distribution date and retirement.

2. SCOPEAll material that UCB deems promotional or commercial in intent is within the scope of this SOP and subject to thorough review by qualified UCB personnel. The qualified personnel that must review such material before use are described in the UCB Material Review Guide maintained by the Review Committee Staff (RCS), which can include disease-state, corporate, and product materials.

This SOP does not apply to product labeling for use in packaging. And, unless specified in the Material Review Guide, this SOP does not apply to clinical research materials originating from Research & Development, materials developed by or for UCB Medical Affairs for use with health care practitioners and other designated medical associates, or to market research materials.

For questions on review requirements, Project Manager should first consult the UCB Material Review Guide and then Review Committee Staff (RCS) to determine the appropriate course of review.

In addition, the review requirements of materials not within the scope of this SOP may be covered by other SOPs and controls are in place for these materials to ensure management of the release, production, retirement and destruction of the materials.

Any exceptions to the review of materials as defined in this SOP must be approved in advance by the designated person responsible for oversight of the Review Committee process.

3. HEALTH, SAFETY AND ENVIRONMENTAL PROTECTIONThere are no significant hazards or special instructions relating to the arrangements described in the process that need to be detailed in this SOP.

4. RESPONSIBILITIES

Project Manager

Initiates the RC review process by providing required materials to the Review Committee staff using the electronic review platform.

Completes the electronic New Job Page and/or reviews for accuracy the New Job Page created by a designated third party.

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ation purposes only. MedAffairs & Business Compliance sop-009880 7.0 Effective 08-Dec-2014

U.S. Review Committee and the Review of Promotional and Other Selected Materials

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Provides references and linkage within the electronic system to all claims made for the product and ensures appropriate permissions for copyrighted materials are obtained and cited.

Ensures promotional material is consistent with FDA regulations (e.g., fair balance, adequate substantiation, consistency with approved labeling, not false or misleading) and that messaging is communicated in a balanced manner.

Ensures all projects/materials identified as relevant by sop-015682 Development and Management of UCB Patient Support Programs are assessed for Pharmacovigilance impact through coordination with UCB Drug Safety.

Coordinates with Compliance, where needed, to ensure materials and activities adhere to applicable compliance policies and company standards and ensure Compliance review in advance where appropriate.

Ensures materials submitted to the Committee are high quality and ready for review by others and changes to materials are implemented as determined necessary by the Promotional Review Committee (PRC).

Manages any agency partner before, during, and for any follow-up post PRC review.

Accounts for PRC total review time as part of project planning, ensures prioritization of materials on the review calendar, allowing sufficient time between submission and review in accordance with UCB’s processes.

Reviews comments provided in the automated system prior to the RC meeting to prepare to address the comments provided at the PRC meeting.

Attends the PRC meeting to represent their material or program or assigns a knowledgeable designee to attend who is authorized to make decisions on behalf of the Project Manager.

When attending PRC remotely ensures the workplace is free of distraction and allows for full participation and viewing of material under review.

Approves Print Proof and Final Artwork prior to initiation of printing activities and dissemination of digital materials.

Verifies that OPDP submission has been completed prior to dissemination and notifies appropriate third party/agency of the date the material may be disseminated.

For promotional materials that require revisions due to labeling updates, ensures that materials are updated in accordance with the implementation strategy approved by Labeling Review Committee (LRC).

Manages the expiration process of inventoried materials in collaboration with the Review Committee Staff.

Identifies items that may be categorized as educational leave behinds, notifies UCB Compliance and provides commercial cost, inclusive of shipping where applicable.


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Achieves business objectives in a manner which is compliant with legal and regulatory requirements and company standards.

Review Committee Staff

Responsible for the life cycle of materials through the process, including management of versions of submitted pieces and archival evidence of decisions for all materials.

Maintains the UCB Material Review Guide and other RC tools and ensures appropriate approval of the content.

For materials submitted for PRC review, RCS receives and reviews the electronic New Job Page and corresponding material and determines completeness for review. Determines appropriate reviewers and review type based on material type and productas indicated in the Material Review Guide.

Initiates the PRC workflow, including notification to the PRC members to review materials by a specified date.

Schedules, coordinates, and prepares agenda and facilitates PRC meetings for the review of submitted materials.

Prior to re-review coordinates with Project Manager to ensure requested changes and revisions were incorporated into materials.

Captures comments and annotates submitted materials during PRC meeting based upon PRC comments and disseminates to Project Manager, following the review of the piece.

Captures the final approval status of all submissions in automated system and facilitates discussion during the PRC meeting.

Receives from the Project Manager/agency/designee the “Proof Copy” version of the materials to validate all RC required changes were incorporated.

Provides authorization for preparation of Final Artwork.

For printed material reviews and approves the Print Proof along with the Project Manager prior to print production.

Provides authorization for the production of the materials.

Certifies Final artwork.

For materials that require OPDP submission, prepares and provides Final Artwork to Regulatory Affairs for Certification along with the desired date of first use.

Manages the expiration process of materials within the electronic review platform.

Identifies, investigates and reports deviations of this SOP to line management and to relevant stakeholders. Reports deviations and ensures implementation of corrective actions identified during deviation investigations.


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Ensures appropriate process training for new PRC members prior to their independent participation in PRC and manages recertification process.

Notifies UCB Compliance on approval of all leave behind materials, including textbooks, reprints, and other educational materials that may trigger reporting to a government agency.

Regulatory Affairs

Core PRC member

Ensures all materials are consistent with FDA advertising and labeling regulations and guidance (e.g., fair balance, adequate substantiation of evidence, consistency with approved labeling and not false or misleading) and other regulatory enforcement trends, and OPDP guidance, such as OPDP enforcement letters, as well as consistency with any OPDP advisory comments, and advises on enforcement trends.

Provides available documents related to regulatory history and FDA interactions during development and label negotiations.

Submits final promotional materials to OPDP on or before first use (Form 2253 submission).

Manages submissions of pre-clearance materials to OPDP and following receipt of OPDP comments, coordinates response to OPDP. Manages any communications with OPDP concerning promotional materials

Communicates with PRC on relevant ongoing interactions with FDA, including labeling updates that may impact promotional materials.

Conveys the views/opinions of OPDP and regulatory agency reviewers, when available.

Ensures that any competitor information is balanced and consistent with competitor package insert.

Provides certification, following RCS certification, acknowledging material can progress to OPDP submission.

Legal

Core PRC member

Ensures materials are consistent with all applicable Federal and State laws and regulations pertaining to drug labeling, advertising, consumer protection, and business practices (e.g., fair balance, adequate substantiation, consistency with approved labeling).

Assesses whether materials could be considered false or misleading.


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Assesses materials and programs with respect to Federal and State laws and regulations including: product liability, deceptive trade practices, anti-kickback/fraud and abuse, false claims act and unfair competition considerations.

Advises on relevant intellectual property and trademark matters.

Helps to identify matters that should be submitted to Compliance for review where needed.

Medical

Core PRC member

Ensures that promotional material is scientifically and medically accurate, hassufficient rigor within the context of FDA regulations (e.g., fair balanced presentation of safety and efficacy data, adequate substantiation, consistency with approved labeling), is supported by appropriate statistical analysis, is consistent with the current medical opinion according to published medical literature, and is communicated in an objective and balanced manner.

Ensures that there is adequate evidence within legal and regulatory requirements to support product claims applying FDA’s “substantial evidence” standard. Applying FDA’s substantiation standard, ensures that studies and data cited are appropriate, high quality and adequately support claims being made.

Ensures that promotional material is consistent with medical practice, clinically relevant, have the appropriate level of sophistication for the intended audience, and are not misleading or likely to cause confusion.

Verifies accuracy of cited data by checking references.

Ensures that any competitor information is balanced and consistent with competitor package insert.

Compliance Committee

Responsible for oversight of PRC process, including review of process deviations, ensuring appropriate corrective actions are applied.

Reviews escalations as requested and makes a final recommendation on the submitted material.

Ad Hoc RC Attendees

Responsibilities are based on agenda items.

Invitations to ad hoc members will be coordinated by the RCS.


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5. PROCEDURE

5.1 Promotional Review Committee (PRC) Membership

The functional heads of legal, regulatory, medical and other ad hoc members will appoint appropriately qualified PRC members and any delegates to represent their functional areas as Core PRC reviewers. Additional ad hoc members may participate in the review process as required by the Material Review Guide or as needed.

For materials requiring presentation at a PRC meeting:

There must be at least (2) standing PRC members (or their qualified delegates) participating in the PRC meeting.

PRC meetings with all core reviewers will be in person, when possible.

All PRC members, regardless of function, are expected to actively participate in PRC discussions/review processes to identify and inform Project Manager of collective risks associated with materials and activities and to reach a final decision during the PRC process.

5.2 Life Cycle of Reviewed Materials

This procedure will cover the life cycle of materials submitted for review by the PRC. The life cycle consists of a multi-step process from creation to expiration and destruction, if required.

5.3 Origination / Preparation for Review

Project Managers are required to ensure that all materials, whether for external dissemination or internal dissemination align with requirements of this SOP.

New concepts are subject to review and Project Managers may submit a concept for review and guidance by the PRC prior to engaging in production of complete materials for review. Concept reviews should be conducted for new tactics/media, new claims, or other projects that have not previously been presented to the PRC.

All submissions of material for review through the PRC process should be provided by the Project Manager to the RCS using the electronic review platform, and be accompanied by a completed New Job Page, artwork/material, and supporting documentation/references. The New Job Page can be completed by the Project


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Manager and/or third-party designee. Submission must contain accurate information to guide the review of materials submitted.

To enable appropriate review of material, any material submissions that include cited references must also include annotation to those references, as well as the references,uploaded to the electronic review platform.

Resubmitted materials should reflect all requested changes made by PRC and provide rational for any additional changes not requested.

5.4 Review Process

5.4.1 Initiation of the Review Process

Upon receipt of materials and accompanying New Job Page for review, the RCS ensures that they are accurate and appropriate for review and assigns a unique material code for each material. If not acceptable, the RCS may reject the submission and inform the Project Manager or designee to resubmit when changes have been made.

The RCS references the Material Review Guide to determine appropriate reviewers for the materials and initiates workflow within the automated system.

The Review Types include the following:

Standard Reviews: The Standard Review process generally applies to new concepts or new materials submitted for the first time or materials submitted for subsequent review. These materials should be submitted within minimum lead times as follows:

Seven (7) days prior to PRC meeting for initial review

Three (3) days prior to PRC for materials requiring re-review

Timelines for sequential reviews will be set by the RCS, based on input from Project Manager and reviewers.

Upon request by the RCS and any PRC member, the review time can be extended for more complex and/or medically intensive pieces.

Expedited Reviews: The Expedited Review process is intended for review of time-sensitive business critical materials with the potential to impact patient safety, key business objectives, or that are necessary to meet compliance, legal or regulatory requirements. These requests must be approved by the Vice-President of the Functionand Head of RCS. Timelines for expedited reviews will be determined in collaboration between the RCS and Reviewers.


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5.5 Documentation of Review

PRC reviewers must provide comments using the functionality provided within the electronic review platform during the review process and use one of the following outcome stamps to indicate status of material based on their review.

PRC: Approved as Is = No changes to content of material required

PRC: Approved with Changes = Changes required and does not require a re-review by the RC

PRC: Re-Review = Changes required and material is to be resubmitted for review by the PRC.

PRC: Reject = Material not approvable as presented, withdraw from the review cycle

At the conclusion of the review period, the RCS will ensure comments have been received from all reviewers and a consolidated version of the material is prepared for discussion at the PRC meeting. If comments have not been received from all reviewers by the end of the comment period, the item can be removed from the PRC agenda.

For additional comments provided during the PRC meeting, the RCS annotates the material with the requested changes during the meeting. At the conclusion of the PRCdiscussion the status of material will be documented by the RCS with a Meeting Outcome (MO) stamp reflecting the consensus of the RC for the stated review cycle. These options are:

PRC: MO Approved as Is = No changes to content of material required

PRC: MO Approved with Changes = Changes required and does not require a re-review by the RC

PRC: MO Re-Review = Changes required and material is to be resubmitted for review by the RC.

PRC: MO Reject = Material not approvable as presented, withdraw from the review cycle

The annotated version will be available to the Project Manager in the electronic review platform on conclusion of the review for implementation of the requested changes.

5.6 Escalation Process

If the PRC reviewers cannot reach consensus with the Project Manager in a reasonable amount of time the material issue should be escalated to the PRC core team member’s respective line managers for discussion. Escalation should be coordinated through theRCS.


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If line management of the standing PRC reviewers and Project Managers are unable to reach a consensus on the approval status of the material, then the material may be escalated to the Compliance Committee.

The material will then be put on the agenda for the next regularly scheduled Compliance Committee meeting for a decision or an ad hoc Committee meeting may be requested for urgent decisions.

Final determination on the piece will be withheld pending final decision and/or recommendation from the Compliance Committee and the escalation status of the submission is noted in the electronic review platform.

5.7 Finalization of Materials

For materials with an Approved status, a clean file known as the Proof Copy should be uploaded into the electronic system and provided to the RCS by the Project Manager . RCS will review to ensure the Proof Copy reflects PRC approved content. RCS will indicate status of Proof Copy using the following stamps:

o PRC Proof: Approved

o PRC Proof: Rejected

o PRC Proof: Additional Comments

Final Artwork will then be provided to the RCS and staff will progress material to a certification phase followed by OPDP submission, if required, and then archival in the electronic system.

5.8 Production/Dissemination

For printed materials, the required print proof must be approved by the RCS and Project Manager prior to initiating and scheduling the print job.

The Final artwork is filed with OPDP, if applicable, and noted in the electronic review platform to allow for the production or dissemination of material. Final Artwork can be in a printed or non-printed format.

5.9 FDA (OPDP) Submissions

For materials identified by Regulatory Affairs as requiring submission to OPDP, thematerial may not be disseminated externally until the submission has been completed.

When submission to OPDP is necessary, materials must be submitted on or by the date of first use.

For these materials, the RCS compiles and releases the Final Artwork to Regulatory Affairs for certification. Following certification, Regulatory Affairs will proceed with the submission of the material to OPDP.

Final Artwork should be received by the RCS by noon for same day processing. If received after noon, the final files will be processed next business day.


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Regulatory will receive the Final Artwork from the RCS generally no less than (6) business days prior to the target date of first use.

Shortened released timelines may be acceptable for business critical needs and if agreed in advance with Regulatory Affairs.

After the submission has been completed, the Project Manager receives a notificationthat the material has been submitted to OPDP.

Once the FDA/OPDP submission notification is received by the Project Manager, the material can be released for use.

5.10 Expiration Process

The purpose of the expiration process is to provide for a periodic review of existing material to ensure content aligns with present standards for promotional materials. In most cases this is an annual review, but in some cases the expiration date may be longer or shorter based upon the expiration date identified during PRC.

In some cases materials may require review prior to the designated expiration date. These cases include labeling changes that impact the content of labeling materials, the availability of new data which may impact the content of promotional materials or other key market events. In these cases the early review of the materials can be requested by any function and the reviews will be coordinated by the RCS in collaboration with the Project Manager.

Process

RCS will collaborate with the Project Manager to track and review expiration dates of promotional materials. The default expiration date of all approved promotional pieces is date of approval plus 12 months, unless otherwise requested by the Project Manageror the RCS and approved by the PRC at the time the piece is initially approved.

The Project Manager will receive a notification from the electronic system in advance of material expiration and will be required to take action. Project Manager can take the following actions:

Withdraw the material from use

Submit for recertification as is

Create a New Job when material requires any changes

The Project Manager will ensure the appropriate destruction of the materials in coordination with the Distribution Center per sop-012180, U.S. Distribution, Quarantine and Destruction of Promotional Materials.

The Project Manager, or designee, will notify all field sales force of retired materials and require destruction of any outstanding inventory that is on hand.

Copies of the notifications to the field sales force and verification of destruction must be maintained by the Project Manager.


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6. DOCUMENTATION, RECORD MAINTENANCE, RETENTION AND DEVIATIONSDeviations from the standard review committee practices and protocols (including timelines for the submission of materials for review) shall be reported to the Functional Leader of the Review Committee staff for documentation, investigation and appropriate follow-up.

These deviations are to be documented in a tracking log, which will also serve as a source of promotional material deviation information for review by the Compliance Committee.

RCS shall also document and archive evidence of approval and the final approved piece. All records, information and deliverables related to this procedure will be retained for a period of six (6) years or longer if required by applicable law, contract or regulatory requirement. For GxP records retention refer to Corporate SOP Retention Periods for GxP Records.

7. ABBREVIATIONS AND DEFINITIONSAbbreviations and definitions are used in accordance with the UCB GxP Glossary.

To the extent that these definitions differ from those contained in the UCB Glossary, these definitions will take precedence for the purpose of this policy / procedure.

7.1 Abbreviations

OPDP Office of Prescription Drug Promotion

PRC Promotional Review Committee

RCS Review Committee Staff

DOFU Date of First Use

7.2 DefinitionsCore PRC Member Core PRC is composed of representation from UCB Legal,

Medical Affairs, and Regulatory Affairs

Certification Final copy of material is reviewed by RCS validating PRC comments were incorporated, and when OPDP filling is required RCS provides these final files to Regulatory Affairs, who then verifies material can be prepared for OPDP filing.

Deviation A departure from the process and procedures as outlined in this SOP, including but not limited to timelines established for the submission of materials for review, submission of approved materials to FDA’s Office of Prescription Drug


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Promotion (OPDP), use of expired materials, and RC attendance requirements.

Electronic Review Platform

Digital platform used for the review, approval and archiving of promotional and other selected materials and reference documentation.

Final Artwork Reflect all RC required changes and any additional changes required by RCS/Copy Editor. The final artwork document is the document used for certification, OPDP submission, if applicable, and archival.

Health Care Institution (HCI)

Any legal entity that is a healthcare, medical or scientific association or organization (irrespective of the legal or organizational form) through which one or more HCPs provide or receive services.

Health Care Professional (HCP)

Any person that is a member of the medical, dental, pharmacy or nursing professions or any other person who, in the course of his or her professional activities, may directly or indirectly prescribe, purchase, supply, recommend, administer or arrange for the use of a medicinal product.

Material Review Guide A document reflecting various material types and the respective type of internal review required.

New Job Page Detailed information provided by the Project Manager identifying material type, intended use and other detailed information to guide review of the material.

Project Manager Owner of material submitted for review hereunder.

Proof Copy Material provided by Project Manager or designee to RCS/Copy Editor to validate that all PRC required changes are incorporated.

Promotional Review Committee

Cross-functional committee assigned to review materials identified as promotional, composed of individuals from Medical Affairs, Legal, and Regulatory Affairs departments, and other ad hoc members as needed.

Review Committee Staff Review Committee Project Coordinator and Copy Editor, and other ad hoc members as needed.

UCB Product Any product marketed or being investigated and developed by UCB, Inc., manufactured for and labeled “UCB, Inc.” This does not include products that UCB co-promotes that


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by license are the responsibility of other companies but does include products for which UCB has a reviewing responsibility under any such contract.

8. RELATED DOCUMENTS

8.1 Associated Documents

sop-af-007919

U.S. Material Review Guide

8.2 References

sop-009877, US Regulatory Management of Labeling Materials

sop-009342, Retention Periods for GxP Records

sop-008512, Review and Approval of Global Promotional Scientific Communications

sop-015682, Development and Management of UCB Patient Support Programs

sop-012180, U.S. Distribution, Quarantine and Destruction of Promotional Materials

Federal Food, Drug And Cosmetic Act (FD&C Act)

Section 201 (M) – Labeling

Section 301 – Prohibited Acts

Section 401 – Food & Drug Cosmetic Act

Title 21 Code Of Federal Regulations

Part 99 – Dissemination Of Information On Unapproved/New Uses For Marketed Drugs, Biologics And Devices

Part 201 – Labeling

Part 202 – Prescription Drug Advertising

Part 312.7 – Pre-Approval Promotion

Part 314.81 – Post Marketing Reports

AMA Guidelines On Gifts To Physicians From Industry

PhRMA Code On Interactions With Healthcare Professionals


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9. LIST OF APPENDICESN/A

10. SOP HISTORY

Supersedes SOP(s)(SOP number and version)

Changes

GBA-SOP-001 New

GBA-SOP-001.1 Revised

SMS-SOP-100 Migration into MIKADO CD

sop-009880 v1.0 Document revised to broaden scope of procedure to include cross functional processes between review committee members and other groups to include Quality Assurance, Production Services and Distribution.

sop-009880 v2.0 Updated to add additional clarity on process.

sop-009880 v3.0 Updated to include automated system impacts to roles and responsibilities and to procedural steps. Significant updates to the following sections: 1) Review Committee Staff responsibilities, 2) Entire Procedure, 3) FDA/OPDP Submissions, 4) Expiration ProcessUpdate the name of DDMAC to OPDP (Office of Prescription Drug Promotion). Added Appendix 1 and 2.Section 2, last sentence, added: ‘VP, Corporate Affairs & Operations’.Section 5, 1st bullet, removed: ‘by RC members or Originators if line managers are unable to reach a consensus and shall’.Section 6.4.1, Standard Reviews: changed 9 days to 7 days. Removed: ‘Sixteen (16) days prior to target approval date for Sequential workflow’.Section 6.4.1, Expedited Reviews, removed: ‘process is intended for review of time-sensitive business critical materials with the potential to impact the business, patient safety, or are’.Section 6.8, removed the following:‘The RCS identifies a date and time for a meeting for reviewers and line management as soon as possible.

If resolution is reached prior to the line manager discussion, then the scheduled meeting is cancelled.

All line managers or a designee must participate in the meeting or provide input prior to the escalation discussion or meeting.’


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Supersedes SOP(s)(SOP number and version)

Changes

sop-009880 v4.0 Section 4.0, Responsibilities: provided improved clarity for the responsibilities of the Originator, Regulatory Affairs, Legal and Medical.Section 5.6, Approval/Non-Approval Process: Replaced outcome status “Not Approved” with “Requires Review”, and “Withdrawn” with “Rejected”.

sop-009880 v5.0 Updated to include definitions to align with Global terminology.

sop-009880 v6.0 This version never made effective. Additional changes made to align with the new electronic review platform.


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DOCUMENT APPROVAL ELECTRONIC SIGNATURES

Signed by Meaning of Signature Server Date (dd-MMM-yyyy HH:mm:ss TZ)

SANFORD Kristi Subject Matter Expert Approval 18-Nov-2014 16:23:13 CET

JEFFORDS SCHENCK Jan Author Approval 18-Nov-2014 17:14:42 CET

DHALLA Anisa Compliance Approval 19-Nov-2014 02:30:59 CET

HELLING Douglas Legal Approval 01-Dec-2014 19:48:03 CET


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