LIBRARY GUIDE: Pharmaceutical Sales & Marketing

Transcription

1 LIBRARY GUIDE: Pharmaceutical Sales & Marketing

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3 Pharmaceutical Sales and Marketing Course Library Table of Contents: Courses Listed by Functional Area... 4 Basics of the PhRMA Code (PHSM01)...5 Bloodborne Pathogens Health Care Workers (EHS09)...5 Contracting with Health Care Professionals (PHSM02)...5 Ethhical Third party Sales & Marketing Intermediary (SMI) Relationships (MDSM06)...6 HIPAA and Privacy Guidelines for Pharmaceutical Sales Representatives (PRIVACY02)...6 Interactions with Health Care Professionals (HCPs) [Field] (PHSM07)...6 Interactions with Health Care Professionals (HCPs) [In-house] (PHSM06)...7 Introduction to Pharmaceutical Compliance (PHSM09)...7 Introduction to the Regulation of Prescription Drug and Biologic Promotion (PHSM10).. 8 Medical Education for Health Care Professionals (PHSM03)...8 Physician Payment Sunshine Act (PHSM11)... 8 Post-Market Reporting of Adverse Drug Reactions (PHSM08)...9 Promotion of Pharmaceutical Products [Field] (PHSM05) Promotion of Pharmaceutical Products [In-house] (PHSM04)...10 Self-Motivation (EHS94)...10 Page 2

4 Overview: UL EduNeering s Pharmaceutical Sales and Marketing Library is specifically designed for compliance, regulatory, legal, sales and marketing professionals who must understand regulations governing interactions with Health Care Professionals (HCPs) and the Accreditation Council for Continuing Medical Education (ACCME) Guidelines. This Library can be delivered via the web-based UL Platform. Our Learning Services team routinely customizes these courses or develops company-specific courses, policies, reports or exams for our customers. Because our Platform is available in 30+ languages, training can be readily distributed to global learners in their preferred language. Third Party Oversight Risk Assessment Audit Inquiries UL HEALTH CARE COMPLIANCE LEARNING SOLUTION Conduct Code of The courses in this Library address the following topics: Overview of the FDA Regulation on Advertising Promotion of Prescription Drugs in the United States Privacy Guidelines for Pharmaceutical Sales Representatives FDA Regulation of Medical Meetings/Commercial Exhibit Hall Activities Interactions with HCPs Regulation of Advertising and Promotion of Prescription Drugs Promotional Regulatory Considerations for Sales Representatives Policy Tracking Employee Training and Content This Library is part of the Health Care Compliance Suite (HCCS), which helps Life Science companies strip the complexity from compliance learning programs. Our solution shifts compliance learning from a reactive to a proactive process, as it enables you to automate learner risk profiling, establish well-defined certification roles, streamline delivery of training to employees and third parties and generate real-time audit reports that answer detailed compliance questions. As regulatory requirements grow more complex, your training content must be crafted in a way that ensures proper retention and improves employee and contractor performance. Our highly engaging Compliance Course Libraries, when aligned with organization-specific training content, form the backbone of our customers ethics and compliance programs. Our courses are designed by experts in adult learning and employ proven instructional design methodology and mastery, fostering deep processing and understanding of the material and actually resulting in behavior change the goal of effective training. UL works with leading subject matter experts to update our courses as regulations and guidelines change. FDA Partnership UL s Cooperative Research and Development Agreement (CRADA) with the FDA has enabled the FDA to meet its significant training and documentation challenge and also resulted in course content provided or reviewed, and used by the FDA itself, and available to FDA-regulated Life Science companies. All delivered in a valid and 21 CFR Part 11-compliant environment. The CRADA solution, which is available exclusively to UL s Life Science customers, provides the same level of preparedness and learning on which the FDA relies. The CRADA was recently extended through 2019 and expanded to include new technologies. Page 3

5 Pharmaceutical Sales and Marketing Course Library Courses Listed by Functional Area: All Employee Training Basics of the PhRMA Code... PHSM01 Contracting with Health Care Professionals PHSM02 Introduction to Pharmaceutical Compliance... PHSM09 Introduction to the Regulation of Prescription Drug and Biologic Promotions.. PHSM10 Medical Education for Health Care Professionals... PHSM03 Physician Payment Sunshine Act... PHSM11 Post-Market Reporting of Adverse Drug Reactions...PHSM08 Self-Motivation... EHS94 Field Sales Representative Training Bloodborne Pathogens Health Care Workers EHS09 Interactions with Health Care Professionals [Field]... PHSM07 HIPAA and Privacy Guidelines for Pharmaceutical Sales Representatives..... PRIVACY02 Promotion of Pharmaceutical Products [Field]... PHSM05 In-House Employee Training Interactions with Health Care Professionals [In-house]... PHSM06 Promotion of Pharmaceutical Products [In-house]... PHSM04 LEGEND: symbol indicates that the content for this course was provided by the US FDA as a result of a CRADA between the FDA and UL. Learners have the option to take this course via a mobile device, such as an ipad. Page 4

6 Course Descriptions: Listed Alphabetically Basics of the PhRMA Code (PHSM01) This course reflects the updated PhRMA Code on Interactions with Health Care Professionals (HCPs), released by the Pharmaceutical Research and Manufacturers of America (PhRMA), effective as of January This course is designed for Pharmaceutical and Biotech companies to reaffirm their commitment to following the highest ethical standards as well as all legal requirements while promoting products to the medical community. The course provides guidance on a range of issues impacting the interactions with HCPs, including meals, prohibition on entertainment and recreation, guidance on company support for Continuing Medical Education, third party education or professional meetings, use of consultants and speakers, scholarships and educational programs, distribution of educational items, prescriber data and training. After completing this course you will understand how the PhRMA Code impacts your interactions with HCPs as it relates to the marketing of pharmaceutical products. Note: MOB version is available for this course. Bloodborne Pathogens Health Care Workers (EHS09) Health care workers face the risk of exposure to bloodborne pathogens every day. These pathogens include hepatitis, AIDS and other infectious diseases. In this course, participants will learn the sources of bio-hazardous substances and the routes of transmission and symptoms of bloodborne diseases. This course also covers the proper techniques and equipment for personal protection, the actions to be taken following a possible exposure and the components of an effective Exposure Control Plan (ECP). Contracting with Health Care Professionals (PHSM02) Pharmaceutical companies contract with Health Care Professionals (HCPs) to assist them in conducting market research, perform clinical trials or endorse a product. The Pharmaceutical industry has set forth certain guidelines that must be followed when engaging HCPs. After completing this course, you will be able to identify the various types of consulting arrangements that exist between a Pharmaceutical company and HCPs. You should also be able to recognize the key guidelines that regulate the engagement of HCPs, as well as identify some of the dos and don ts of the engagements. Page 5

7 Pharmaceutical Sales and Marketing Course Library Ethhical Third party Sales & Marketing Intermediary (SMI) Relationships (MDSM06) After completing this course, you will be able to identify the key regulatory risks associated with sales and marketing individuals and entities acting on behalf of a medical device, pharmaceutical, or other life science company in a foreign jurisdiction. You will also be able to describe how an effective compliance program can assist a company in mitigating such regulatory risks. Finally, you will be able to recognize the essential elements of an effective compliance program and how it can assist a company in detecting and preventing violations. HIPAA and Privacy Guidelines for Pharmaceutical Sales Representatives (PRIVACY02) This brief course provides a short summary of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and describes how the regulations affect the detailing and customer support activities of pharmaceutical sales representatives. Salespeople in direct contact with physicians and other Health Care Professionals (HPCs) should take this course to prepare for changes in customer relationships and business practices directly related to the Health Care industry s HIPAA compliance efforts. After completing this course, learners will be familiar with the basic provisions of the HIPAA Privacy Rule and recognize how HIPAA affects normal sales and customer support activities. Learners will also be able to correct some common customer misunderstandings about HIPAA while helping customers ensure that patient privacy is not compromised. Topics include: HIPAA basics Interactions with physicians Incidental disclosures Business associate agreements Handling restrictions from treatment areas Sampling and preserving access to storage areas Installing software and demonstrations Patient issues Regulations: Health Insurance Portability and Accountability Act (HIPAA) 45 CFR Parts 160, 164 Target Audience: Salespeople in direct contact with physicians and other HCPs Interactions with Health Care Professionals (HCPs) [Field] (PHSM07) Pharmaceutical companies must ensure that any interactions with Health Care Professionals (HCPs) are in compliance with internal and external guidelines, policies, rules and regulations. This course covers the topics which govern interactions with HCPs, as well as the appropriate manner in which to conduct such interactions. Topics include: Regulations and other factors governing interactions with HCPs Office of Inspector General (OIG) guidance Data integrity Use of drug samples Heightened restrictions on meals The prohibition on entertainment and recreation Page 6

8 Interactions with Health Care Professionals (HCPs) [In-house] (PHSM06) This course covers the guidelines, rules and regulations that govern interactions with Health Care Professionals (HCPs), as well as the appropriate manner in which to conduct such interactions. Key topics include regulations and other factors that govern interactions with HCPs, Office of Inspector General (OIG) guidance, data integrity, use of drug samples, heightened restrictions on meals and the prohibition on entertainment and recreation. Written for in-house sales and marketing professionals, the course provides examples of personal services that HCPs often provide to Pharmaceutical companies as well as the special considerations for engaging government employees, formulary members and speakers. Topics include: Regulations and other factors governing interactions with HCPs Office of Inspector General (OIG) guidance Data integrity Use of drug samples Heightened restrictions on meals The prohibition on entertainment and recreation Discussion on the acceptable use of consultants as well as the engagement of HCPs to obtain information or advice on the marketplace, products, therapeutic areas, or patient needs is provided. Introduction to Pharmaceutical Compliance (PHSM09) The Pharmaceutical industry is under a great deal of scrutiny and change. The past few years have seen an increase in government regulation as well as modifications to industry and other codes, such as the Pharmaceutical Research and Manufacturers of America (PhRMA) Code, on interactions with Health Care Professionals (HCPs) and the Accreditation Council for Continuing Medical Education (ACCME) guidelines. Specific areas covered in this course include FDA guidance on acceptable promotional guidelines, off-label promotion, Office of the Inspector General (OIG) guidance and ACCME guidelines for medical education. After completing this course you will have an overview of the various agencies that govern standards of behavior in the Pharmaceutical industry as well as the key requirements for compliant behavior. Topics include: Overview FDA OIG Additional Laws ACCME guidelines Note: MOB version is available for this course. Page 7

9 Pharmaceutical Sales and Marketing Course Library Introduction to the Regulation of Prescription Drug and Biologic Promotion (PHSM10) Promotional messages for prescription drugs are different from most commercial campaigns because the drugs, and the claims Pharmaceutical companies make regarding their benefits, directly affect public health. The federal government regulates prescription drug and biologic promotions through organizations within the U.S. Food and Drug Administration (FDA). Medical Education for Health Care Professionals (PHSM03) Pharmaceutical companies recognize the importance of educating Health Care Professionals (HCPs) on the latest scientific advances as well as the benefits and risks of prescribing certain products. HCPs receive this education in several ways including through promotional programs organized by Pharmaceutical companies or via independent medical education developed and delivered by third parties. There has been increasing scrutiny on the appropriate use of medical education. As a Pharmaceutical company employee, you need to understand the purpose of medical education and the correct manner in which to support it. After completing this course, you will be able to identify the difference between company-sponsored promotional programs and independent medical education as well as the rules and guidelines that impact these activities. Topics include: Accredited versus non-accredited medical education How Pharmaceutical companies can support medical education The FDA s guidance on medical education Guidelines for patient education and company-controlled education programs. Physician Payment Sunshine Act (PHSM11) This course provides the basics of the Physician Payment Sunshine Act ( Sunshine Law ), which was passed in 2010 as part of comprehensive health reform legislation. The law requires certain businesses to comply with specific transparency requirements. Specifically, those businesses must report payments to physicians and teaching hospitals as well as ownership interests by those physicians. The main purpose of the law is to provide patients with enhanced transparency into the relationships their Health Care Providers have with Life Science and Medical Technology manufacturers. Topics include: Companies Required to Report Payment and Other Transfer of Value Information Required on the Transparency Report Physician Ownership Reporting Exclusions Penalties After taking this course, learners will understand which companies are required to report, what is a covered recipient, and what types of payments need to be reported. Page 8

10 Post-Market Reporting of Adverse Drug Reactions (PHSM08) Food, Drug and Cosmetic (FD&C) Act regulations (21 CFR , and ) frame the requirements for post-marketing Adverse Drug Experiences (ADE). In addition to these laws, you should always follow your company s standards and processes for filing ADE reports. Congress has required that ADE information relating to all prescription drugs be made available to the FDA so that the Agency can take the appropriate action to protect public health when necessary. This course explores the process that prescription drug manufacturers must follow for reporting post-market adverse drug experiences to the FDA. Promotion of Pharmaceutical Products [Field] (PHSM05) Pharmaceutical companies employ a variety of methods to promote their products to Health Care Professionals (HCPs) as well as consumers. These methods include detailing by sales representatives, informational presentations, patient education programs, press releases, communications over the internet and samples. The practice of promoting prescription drugs is highly regulated and it is important for Pharmaceutical companies to ensure they follow all applicable rules and regulations. This course addresses the regulations and acceptable practices for field sales staff, addressing acceptable product promotion, dissemination of information, use of samples for promotional purposes and approved materials for sales visits. Page 9

11 Pharmaceutical Sales and Marketing Course Library Promotion of Pharmaceutical Products [In-house] (PHSM04) Pharmaceutical companies employ a variety of methods to promote their products to Health Care Professionals (HCPs) as well as consumers. These methods include detailing by sales representatives, informational presentations, patient education programs, press releases, communications over the internet and samples. The practice of promoting prescription drugs is highly regulated and it is important for Pharmaceutical companies to ensure they follow all applicable rules and regulations. After completing this course, you will be able to identify the guidelines, rules and regulations that govern the promotion of prescription drugs and how they impact certain routine activities undertaken by Pharmaceutical companies when promoting their products. Developed for in-house pharmaceutical sales and marketing professionals, in-depth compliance guidance is provided on directto-consumer advertising and other promotional programs. Self-Motivation (EHS94) Successful people are good at self-motivation. They don t need external rewards or social approval to pursue the things that are important to them. Participants in this course will learn the five characteristics of self-motivated people and the five skills that are necessary to develop these characteristics. They will learn how to apply these skills at work, at home and in the community. Topics Include: Defining self-motivation Defining the skills necessary for self-motivation Developing a personal mission statement Developing skills to achieve goal Defining and developing creative thinking Developing self-discipline skills Positive self-talk Using self-motivation to improve performance at work Page 10

12 About UL EduNeering UL EduNeering is a business line within UL Life & Health s Business Unit. UL is a premier global independent safety science company that has championed progress for 120 years. Its more than 10,000 professionals are guided by the UL mission to promote safe working and living environments for all people. UL EduNeering develops technology-driven solutions to help organizations mitigate risks, improve business performance and establish qualification and training programs through a proprietary, cloud-based platform, ComplianceWire. For more than 30 years, UL has served corporate and government customers in the Life Science, Health Care, Energy and Industrial sectors. Our global quality and compliance management approach integrates ComplianceWire, training content and advisory services, enabling clients to align learning strategies with their quality and compliance objectives. Since 1999, under a unique partnership with the FDA s Office of Regulatory Affairs (ORA), UL has provided the online training, documentation tracking and 21 CFR Part 11-validated platform for ORA-U, the FDA s virtual university. Additionally, UL maintains exclusive partnerships with leading regulatory and industry trade organizations, including AdvaMed, the Drug Information Association, the Personal Care Products Council and the Duke Clinical Research Institute. 202 Carnegie Center Suite 301 Princeton, NJ UL and the UL logo are trademarks of UL LLC uleduneering.com LG/111914/PH