4.02 compliance training brian a. dahl senior counsel takeda pharmaceuticals north america, inc....
TRANSCRIPT
![Page 1: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/1.jpg)
4.02 Compliance Training
Brian A. Dahl
Senior Counsel
Takeda Pharmaceuticals North America, Inc.
November 14, 2003
![Page 2: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/2.jpg)
Seven Elements of an Effective Compliance Program
• Implementing written policies and procedures• Compliance officer and compliance committee• CONDUCTING EFFECTIVE TRAINING AND
EDUCATION• Developing effective lines of communication• Conducting internal monitoring and auditing• Enforcing standards through well-publicized
disciplinary guidelines• Responding to problems and undertaking corrective
action
![Page 3: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/3.jpg)
Compliance Training
OIG Guidance
“The proper education and training of officers, directors, employees, contractors, and agents, and periodic retraining of personnel at all levels are critical elements of an effective compliance program.”
![Page 4: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/4.jpg)
Summary of Presentation
• Topics
• Personnel
• Format
• Timing
• Documentation
![Page 5: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/5.jpg)
Topics of Training
• General Sessions
• Specific Sessions
![Page 6: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/6.jpg)
Topics of Training
• General Sessions:
– Your compliance program– Written policies and procedures– Applicable federal requirements
![Page 7: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/7.jpg)
Topics of Training
• Specific Sessions:
– Anti-kickback statute– Calculation and reporting of pricing information– Calculation and reporting of rebate payments
![Page 8: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/8.jpg)
Topics of Training
• How do you know what specific areas to train on?– Government enforcement activities– Past compliance issues– Internal auditing and monitoring activities– Helpline / Hotline calls– Questions from employees
![Page 9: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/9.jpg)
Topics of Training
• Corporate Integrity Agreements– General Training
• CIA requirements• Compliance Program
– Specific Training• Proper methods for promoting, marketing, selling products in
accordance with applicable statutes and regulations• Personal obligation of each individual involved in marketing
and sales to ensure that marketed and sold appropriately• Applicable legal rules• Examples of proper/improper promotion, marketing, and sales
practices
![Page 10: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/10.jpg)
Topics of Training
• Example-centered training
– Relevancy to job function– Engaging content– Keep the training fresh
![Page 11: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/11.jpg)
Personnel to Train
OIG Guidance
“The OIG suggests that all relevant personnel (i.e., employees as well as agents of the pharmaceutical manufacturer) participate in various educational and training programs of the company.”
![Page 12: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/12.jpg)
Personnel to Train
• Positions
• Functions
• Responsibilities
![Page 13: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/13.jpg)
Personnel to Train
• Corporate Integrity Agreement – TAP– Covered Persons
• “officers, directors, employees, contract workers, and agents working at TAP’s facilities”
• “specifically includes all other personnel, apart from those acting under co-promotion agreements, who comprise TAP’s contract sales force, if any.”
![Page 14: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/14.jpg)
Personnel to Train
• Corporate Integrity Agreement – Abbott– Covered Persons
• Directors
• Officers and employees engaging in marketing and sales
• Officers and employees of a particular business unit
– Relevant Covered Persons• Covered Persons engaged in the marketing and sales
of the product at issue
![Page 15: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/15.jpg)
Personnel to Train
• Corporate Integrity Agreement – AstraZeneca– Covered Persons
• All officers, employees, and contractors/agents whose job responsibilities relate to:
– Sales and marketing activities for gov’t reimbursed products
– Calculating and reporting of prices
– Negotiation, implementation, and any reporting related to gov’t contracts
![Page 16: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/16.jpg)
Contractor Training
OIG Guidance
“All employees and, where feasible and appropriate, contractors should receive the general training.”
![Page 17: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/17.jpg)
Contractor Training
• Corporate Integrity Agreements – TAP, Bayer & GSK– Covered Persons
• specifically contract sales force
![Page 18: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/18.jpg)
Contractor Training
• Employment Law Issues– Differential training
• Content
• Detail
– Train select contractors• Sales force – YES
• Others – DEPENDS
![Page 19: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/19.jpg)
Format of Training
OIG Guidance
“The OIG recognizes that the format of the training program will vary depending upon the size and resources of the pharmaceutical manufacturer.”
![Page 20: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/20.jpg)
Format of Training
• Live
• Computer-based training
• Videotape
• Video/audio conferencing
![Page 21: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/21.jpg)
Format of Training
• Live training – who delivers?– Compliance Officer– Legal– Company trainers– Supervisory employees– Outside consultants
![Page 22: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/22.jpg)
Format of Training
• Corporate Integrity Agreement – GSK– “training and education . . . may be provided by
supervisory employees, knowledgeable staff, or GlaxoSmithKline trainers and/or outside consultant trainers”
– Trainers “shall be knowledgeable about the subject areas of their training”
![Page 23: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/23.jpg)
Format of Training
• Live training – multiple messengers?
– Consistency of message– Competency to answer questions
![Page 24: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/24.jpg)
Format of Training
• Computer-based training vendors
– Off-the-shelf training– Semi-custom– Custom
![Page 25: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/25.jpg)
Format of Training
• Other avenues
– Intranet– Newsletters– One-on-one (e-mails / voicemails)
![Page 26: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/26.jpg)
Timing of Training
OIG Guidance
“The pharmaceutical manufacturer should train new employees soon after they have started working.”
![Page 27: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/27.jpg)
Timing of Training
• Corporate Integrity Agreements– Initial training
• Within 30 days after beginning employment– Bayer / GSK / Abbott
• Within 60 days after beginning employment– TAP / AstraZeneca
– Annual training• Specified amount of time
• “reasonable and appropriate”
![Page 28: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/28.jpg)
Documentation of Training
OIG Guidance
“The compliance officer should document any formal training undertaken by the company as part of the compliance program.”
![Page 29: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/29.jpg)
Documentation of Training
• Attendance logs
• Descriptions of the training sessions
• Copies of the materials distributed at the training sessions
![Page 30: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/30.jpg)
Documentation of Training
• Certification– All employees should certify:
• Have received the training
– If based on a policy/procedure, should certify:• Received
• Read
• Understand
• Will comply
![Page 31: 4.02 Compliance Training Brian A. Dahl Senior Counsel Takeda Pharmaceuticals North America, Inc. November 14, 2003](https://reader035.vdocuments.site/reader035/viewer/2022062618/55146ea2550346494e8b5f3c/html5/thumbnails/31.jpg)
Documentation of Training
• Corporate Integrity Agreements– “Each individual who is required to attend
training shall certify, in writing, or in electronic form, that he or she has received the required training. The certification shall specify the type of training received and the date received. The Compliance Officer . . . shall retain the certifications, along with all course materials.”