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Home » Pharmaceutical Sales & Marketing: Marketing of Prescription Drugs in the USA- Interactions with Healthcare Professionals

Pharmaceutical Sales & Marketing: Marketing of Prescription Drugs in the USA- Interactions with Healthcare Professionals

Certification TrainingProgram/Course ID: SAM04
Enrollment Period: 6 months.
Average Learning Time: ~60 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 1 CPD Credits.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
CPD Accredited TrainingCatalog: Pharmaceutical Sales and Marketing.
Demonstration: Five (5) free trial courses are available.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
  Price: $185.00 USD  

Document your dedication to compliance, safety, and job performance by earning a training certification from Biopharma Institute

Training Program: Pharmaceutical Sales & Marketing: Marketing of Prescription Drugs in the USA- Interactions with Healthcare Professionals
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

The heaviest legal penalties imposed on drug companies concern interactions with healthcare professionals in the context of prescription drug marketing, notably for violations of the Anti-Kickback Statute and the False Claims Act. Monetary penalties have amounted to billions of dollars in some cases.

Payments or other transfers of value made to certain healthcare professionals or teaching hospitals must be reported to the government. In addition, company-sponsored speaking programs and detailing by sales representatives must comply with provisions of the Federal Food, Drug, and Cosmetic Act on advertising and promotion. Industry guidance urges drug companies to follow the highest ethical standards as well as all legal requirements. In this course we identify the laws and guidance that apply, and we provide information that will help companies to market their products without incurring penalties.

In companion courses on marketing of prescription drugs in the USA, we deal with the legal and regulatory framework for advertising and promotion of drugs, with general regulatory compliance in that context, and with considerations that are particular to consumer-directed advertising and online promotion.

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying requirements.

Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to verify training, and can be displayed on social networking sites, such as LinkedIn.


Outline:


  • Statutes and regulations
  • Regulatory and industry guidance
  • Anti-Kickback Statute
  • False Claims Act
  • Major settlements under FCA/AKS
  • Physician Payments Sunshine Act
  • Drug samples
  • Distribution of reprints and other publications
  • Detailing by sales representatives
  • Speaker programs
  • Third-party scientific and educational events
  • Medical advisory boards
  • Responding to unsolicited requests for off-label information
  • Gifts of educational or non-educational items
  • Assessment

Objectives:


Who will benefit from this module?
Sales representatives and marketing personnel need to understand the legal and regulatory requirements that must be met, and the industry guidance that applies, when interacting with healthcare professionals in the context of marketing of prescription drugs in the USA. In addition, this module will be of benefit to regulatory affairs and legal personnel involved with aspects of marketing.

Learning objectives
  • Identify the principal US legal statutes and regulations on interactions between drug companies and healthcare professionals (HCPs)
  • Identify Important sources of guidance from the Office of Inspector General (OIG) of the Department of Health and Human Services, the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Food and Drug Administration (FDA)
  • Outline the provisions of the Anti-Kickback Statute, and access regulations on its ?safe harbors? provisions
  • Outline the provisions of the False Claims Act, including the use of qui tam ?whistleblower? lawsuits, and understand the risk of heavy penalties for violations
  • Comply with reporting requirements under the Physician Payments Sunshine Act
  • Comply with the requirements of the Prescription Drug Marketing Act and the Affordable Care Act as regards the provision of drug samples to HCPs
  • Follow guidance from the FDA on distribution of reprints and other publications to HCPs
  • Comply with limitations on detailing by sales representatives
  • Comply with legal requirements, and OIG, PhRMA and FDA guidance, on company speaker programs and third-party scientific and educational events
  • Outline the role of medical advisory boards and comply with PhRMA guidance on bona fide consulting services
  • Respond appropriately to unsolicited requests for off-label information

Information and Guidance:
  • Advertising and Promotional Labeling Branch of the FDA's Center for Biologics Evaluation and Research (CBER)
  • Anti-Kickback Statute
  • False Claims Act
  • FDA 21 CFR Part 202.1, US Code of Federal Regulations on prescription drug advertising
  • PhRMA Code - Pharmaceutical Research and Manufacturers of America Codes
  • REMS - Risk Evaluation and Mitigation Strategy
  • PHS Act - Public Health Service Act

Pharmaceutical Sales & Marketing: Marketing of Prescription Drugs in the USA- Interactions with Healthcare Professionals is included in the following professional certification programs:



Professional Certification Program:

Pharmaceutical Sales & Marketing Compliance Professional Certification

Course ID: SAMPRO
Price: $645.00 (USD) | Learn more

Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules which have been developed to promote the retaining of key knowledge, access to references, case studies, and other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and corporations with their training requirements. Biopharma Institute certifications are recognized by a wide spectrum of industries and companies, and our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing, regulatory affairs, validation systems, pharmacovigilance, good clinical laboratory practice (GCLP), data integrity, and medical devices.

Employee / Corporate Training: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale (1-100 students) and large-scale (100+ students) training requests.


Online Training: The Benefits of Remote Learning & eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
  • Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.


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