3. HEALTH, SAFETY AND ENVIRONMENTAL PROTECTION

Transcription

1 1. PURPOSE It is the goal of UCB, Inc. (UCB) to ensure that its marketing and promotional activities comply with all applicable state and federal laws. In addition, UCB Inc. endeavors to conform to pertinent industry guidance, the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals, the U.S. Department of Health and Human Services Office of the Inspector General (OIG) Guidance to the pharmaceutical industry, and the Accreditation Council for Continuing Medical Education (ACCME) standards for industry support of continuing medical education. This SOP describes the policies and procedures to be followed in initiating, documenting, and operating UCB Inc. speaker training programs. 2. SCOPE This SOP applies to all speaker training programs run by any UCB business unit or copromotion partner, including third party vendors and applies to health care professionals (HCPs) who provide speaker program services in the United States, in accordance with the Promotional Peer-to-Peer Programs SOP. 3. HEALTH, SAFETY AND ENVIRONMENTAL PROTECTION There are no significant hazards or special instructions relating to the arrangements described that need to be detailed in this SOP. 4. RESPONSIBILITIES Business Unit Product Manager Obtaining review and approvals for all speaker training activities and revisions from the Business Unit Management team (with corresponding Legal support), Professional Education and Compliance. Selecting and coordinating third party vendors for speaker training programs. Ensuring that all speaker training program materials are appropriately reviewed and approved by UCB Review Committee. Ensures all training activities align with UCB Compliance policy and procedures. Compliance Reviewing and approving training plans. Providing and/or delivering compliance related materials for training. Monitoring speaker training activities to ensure compliance with this procedure. Page 1 of 9

2 Review Committee Reviewing and approving training content. Medical Affairs Reviewing and approving all CVs for nominated speakers. Legal Reviews and approves speaker contract templates and modifications. Professional Education (working in partnership with any third party vendors) Obtaining nominated speaker CV approvals from Medical Affairs. Ensuring that documentation of training attendance, records of attendance compensation and expense reimbursement, and signed contracts are maintained in a central repository. 5. PROCEDURE 5.1 Key Points In addition to following the procedures set forth in this SOP, speaker training programs must also comply with all UCB policies and procedures governing the engagement of HCPs. Please see SOPs: U.S. Compliance - Engaging HCPs/HCIs in Fees for Service Arrangements; Fair Market Value. The purpose of speaker training is to train medical professionals to speak for UCB, not as a mechanism to establish or maintain a relationship with or gain access to the participants. Speaker training may not be used as a promotional tool, an opportunity to discuss offlabel uses of UCB products, or as a reward or inducement for the prescription, use or recommendation of UCB products. Accordingly, it is never appropriate to conduct a return on investment ( ROI ) analysis or analyze the impact of attending speaker training on the prescribing habits of participants. Speakers must be selected based on their clinical expertise, public speaking skills, and experience. Only the number of speakers reasonably needed to fulfill UCB s speaking program needs will be selected and trained. Prior to being trained as a speaker, each HCP must have a fully executed contract in place and a completed W-9 form on file with Professional Education. Prior to making presentations on behalf of UCB, all HCPs making such presentations must complete training on content of promotional presentation and UCB Compliance Page 2 of 9

3 requirements for promotional programs. Speaker training must be renewed at least annually, unless UCB Compliance grants an exception, and more often if there are significant changes to the approved speaking materials (e.g., promotional slide deck) or product labeling. Speaker training is appropriate if there is a genuine intention to utilize the speaker in the twelve-month period following the training for the minimum number of programs set forth in the annual program plans. Information and materials disseminated at speaker training programs must be limited to those that will facilitate the training and preparation of speakers to make presentations on UCB s behalf. This information must be approved by the Review Committee prior to speaker training programs. 5.2 Types of Speaker Training Programs Formal group speaker training should generally be conducted no more than once a year. In certain circumstances, such as a substantial or material change to the prescribing information, speaker training may occur more frequently. Documented prior approval of the training plan by Compliance is required before conducting such training. Live Speaker Training Programs - Speakers receive training through live, in-person programs. Electronic training resources - Web-based training that is provided as primary or supplemental training. One-on-one speaker training - In exceptional circumstances when a speaker is unable to attend the speaker training program, a Medical Science Liaison, after advance approval by their respective Medical Director and UCB Compliance, may jointly with the Business Unit Product Manager train the HCP on scientific and clinical information related to the promotional presentation. Business Unit Product Manager must complete a training plan prior to the activity and post training provide documentation validating training occurred. 5.3 Approval of Training Plan As specific training activities are planned, training activities where HCP s will be providing and/or presenting to other nominated Speakers must be reviewed and approved by Compliance using an Activity Notification Form. The details of the specific activity will be compared against the annual program plans (as described in the Promotional Speaker Programs SOP) to ensure consistency. The Business Unit Program Manager should provide details for: Training agenda and dates Training delivery method (including any required independent study) Page 3 of 9

4 Location/venue for training and rationale Total number of speakers to be invited for training Speaker compensation for training (as applicable) Trainers for event and proposed fees (as applicable) The agenda, venue, selection of participants and other details for all speaker training programs must be designed to meet the purpose of training speakers on UCB s products and compliance policies. The number of participants invited to speaker training should reflect the number of speakers UCB reasonably expects to use within the coming year based on the Product Team s annual speaker program plan. Prior to engaging the services of a potential speaker, all internal UCB requirements must be met (e.g. CV approved, W9 completed, confirmation that the speaker has not been excluded or disqualified, contract executed). 5.4 Content of Speaker Training Meeting All speaker training sessions must include subject matter training, training on the compliance requirements of the FDA with respect to promotion of pharmaceutical products, and UCB compliance guidelines including the following: Requirements relating to the appropriate use of UCB-approved slides Requirement that presentations be consistent with the product s approved prescribing information Requirements related to appropriately balancing efficacy claims with related important safety information Requirement to present objective, balanced, and non-misleading information Appropriate manner of handling unsolicited questions about off-label use of UCB products Requirement to disclose to presentation attendees that the speaker is presenting on behalf of UCB and that UCB is sponsoring the presentation. Information provided at speaker training sessions should be directly related to the topics on which the individuals will be presenting, including the slides which will be used as the basis of the speakers presentations. All training materials (e.g., slide kits, instructions) should be submitted to the appropriate Review Committee for approval in advance of their use. Page 4 of 9

5 5.4.1 UCB Personnel Involvement in Training Programs UCB employee attendance at speaker training meetings will be limited to individuals who are directly involved in delivery of the training material content and individuals necessary to facilitate the training session and learn about conducting future programs. In general, sales specialists and their direct managers are prohibited from attending speaker training sessions, unless Compliance approval is provided in advance. No employee, regardless of role, is permitted to engage in product details or sales activities during a speaker training activity. 5.5 Compensation, Expenses and Venue Compensation Compensation for participating in speaker training should be reasonable and represent fair market value for the time commitment of the trainee. All speakers will be paid according to a pre-set rate structure determined by UCB. Speakers may not receive any type of compensation for one-on-one training Reimbursement for Travel, Meals and Other Expenses UCB may pay for the reasonable travel, lodging, meals and other reasonable expenses of speakers attending a UCB speaker training session. The number of nights of lodging paid by UCB may not exceed the number necessary for the speaker training. If a meeting ends after 3 p.m. or there are no reasonable flights available after the ending time of the meeting, UCB may pay for the lodging for that night. UCB s policy requires that meal expenses in connection with speaker training programs adhere to the following limits, including food, beverage, tax and tip: Breakfast: $25 per person Lunch: $50 per person Dinner: $125 per person UCB may not pay for the travel, incremental lodging, meals, or other expenses of anyone accompanying a HCP speaker trainee. Additional information regarding venue and meals is set forth in the policy U.S. Meals and Educational Materials for Healthcare Professionals and Customers Venue/Entertainment for Live Speaker Training Meetings Live speaker training meetings must be held in locations that are conducive to the business purpose of the meeting. The venue should not be selected based on the existence or quality of amenities, but rather upon proximity to attendees or Page 5 of 9

6 transportation, quality and cost of meeting rooms and business support, and other business related factors. Resorts or luxury hotels are not appropriate venues. Recreation and entertainment is strictly prohibited in connection with speaker training sessions. Speakers may not bring guests to speaker training sessions or Company organized meals and UCB will not pay for any expenses associated with a guest of a speaker. Additional information regarding venue and meals is set forth in the policy U.S. Meals and Educational Materials for Healthcare Professionals and Customers. 5.6 Documentation, Record Maintenance and Retention 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. Records related to this procedure will be maintained by the activity owner unless otherwise specifically directed by the Legal Department. For GxP records retention refer to Corporate SOP Global Archive Procedure for Critical Records. All trainees must sign a UCB speaker contract. Copies of the contracts must be submitted to Professional Education and will be maintained on file in a central repository. Documentation will be maintained for each speaker training session, including the agenda, training materials, faculty list, and list of trainees. Each contracted HCP must certify to training completion and such certifications will be archived by Professional Education. Such certification may be included in the training completion documentation and shall include a statement that the speaker attended and received all required training, that he/she understood such training and had opportunity to ask questions regarding the training and information contained therein, and that he/she agrees to abide by Company policies and procedures. Compensation for participation in speaker training will be disclosed as required by federal and/or applicable state law. HCPs may not condition their agreement to attend speaker training on the nondisclosure of this information. Professional Education, with support from any third party vendors, will maintain a system to document and track: Identification and selection of speaker trainees Verification of each individual s attendance at training, the date, and the topic for all training mediums HCP trainee certifications regarding completion of training (which may be included in the training documentation) Page 6 of 9

7 Signed contracts for trainees, approved CVs and W9 forms Compensation and expense reimbursement paid to each trainee 6. ABBREVIATIONS AND DEFINITIONS Abbreviations and definitions, used in this document, are in accordance with the UCB 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. 6.1 Abbreviations FDA Food and Drug Administration FMV Fair Market Value CV Curriculum vitae HCP Health Care Professional 6.2 Definitions Fair Market Value Healthcare Professional The price, expressed in terms of cash equivalents, at which property would change hands between a hypothetical willing and able buyer and a hypothetical willing and able seller, acting at arm s length in an open and unrestricted market, whether neither is under compulsion to buy or sell and when both have reasonable knowledge of the relevant facts 1. 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. Page 7 of 9

8 7. RELATED DOCUMENTS 7.1 Associated Documents N/A 7.2 References sop , Retention Periods for GxP Records sop , U.S. Compliance - Engaging HCPs/ HCIs/Patients/Caregivers in Fees for Service Arrangements sop , Promotional Peer-to-Peer Programs gov , Fair Market Value gov , U.S. Meals and Educational Materials for Healthcare Professionals and Customers 1 American Society of Appraisers Business Valuation Standards Glossary ; Approved June 2005 Copyright 2005, American Society of Appraisers. 8. LIST OF APPENDICES N/A 9. SOP HISTORY Supersedes SOP(s) (SOP number and version) UCBCOM-SOP-005 Migration into MIKADO CD Changes sop v1.0 sop v2.0 sop v3.0 sop v4.0 sop v5.0 Periodic revision, format change Updated due to changing business requirements Revised section 6.3 to provide clarity around need for activity notification (needs assessment) approvals. Section 5.2 improving clarity of process for MSL one:one training. Section 5.2 One-on-one speaker training rules for engagement of MSLs in the activity. Section 6.2 definition for HCP Page 8 of 9

9 DOCUMENT APPROVAL ELECTRONIC SIGNATURES Signed by Meaning of Signature Server Date (dd-mmm-yyyy HH:mm:ss TZ) GRAVES Mark Subject Matter Expert Approval 10-Sep :00:25 CEST JEFFORDS SCHENCK Jan Author Approval 10-Sep :15:39 CEST DAVIS Clive Management Approval 13-Sep :37:08 CEST HELLING Douglas Legal Approval 15-Sep :05:54 CEST DHALLA Anisa Compliance Approval 29-Sep :04:17 CEST Page 9 of 9