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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

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

Rated 4.7 / 5
(3 reviews)

Program/Course ID:SAM04
Enrollment Period:12 months.
Average Learning Time:~60 minutes.
Additional Resources:Supplemental materials/activities.
Accredited Program:1 CPD Credits.
Method of Training:
Online, asynchronous, self-paced eLearning.
Accessibility:24/7 access to all program materials.
Catalog:Pharmaceutical Sales and Marketing.
Demonstration:Four (4) free trial courses are available.
Group/Employee Training:Click here to request a quote.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with validation QR barcode.
  Price: $185.00 USD  
CPD Accredited Training

Document your dedication to quality, compliance, safety, and job performance by earning a certification of training.

Training Program: Pharmaceutical Sales & Marketing: Marketing of Prescription Drugs in the USA- Interactions with Healthcare Professionals
Training Provided By: Biopharma Institute

Schedule: Self-paced. Immediate access to training materials 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 course and successfully pass an online, multiple-choice final assessment within a 12-month period. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.

Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is promptly launched and made available to the student upon course completion. Certificates are issued in an encrypted PDF format, and include a watermark, unique validation code, and QR verification barcode.

Once all training requirements have been satisfied the achievement can be verified from our website using the unique certificate ID or QR barcode located on the certificate. For professional certification programs, a digital badge is additionally issued to verify training and document the achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.

Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance.


  • 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


Who will benefit from this module?
Sales representatives and marketing personnel need to understand Good Promotional Practices (GPP) and 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

This Course is Included in the Following Professional Certification Program(s):

Professional Certification Program:

Pharmaceutical Sales & Marketing Compliance Professional Certification

Program ID: SAMPRO
Price: $645.00 (USD)

Benefits of Being Certified from Biopharma Institute: Throughout our training students will be engaging in active learning using interactive eLearning modules validated by 3rd party organizations for relevancy, compliance, and regulatory content. Courses are developed by subject matter experts (SMEs) and instructional design professionals with the goal to promote the students' retaining of key knowledge. The programs further offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 300 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity. We supply our training to clinical research, pharmaceutical, and medical device industries.

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 and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.

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Benefits of Training with Biopharma Institute

Immediate access to courses:Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning:24/7 access to all course materials and assessments for 12 months.
Open enrollment:No prior course prerequisites or work experience required.
Expertise:Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated:Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.
Optimized for learning:Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
Secure and safe access:Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training:Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs.
Training manager access:A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:Courses can be delivered directly to most corporate Learning Management Systems (LMS).
Purchase orders (POs):POs are accepted from all companies. Request an invoice when starting the procurement process.
Reimbursement:Some employers may reimburse their employees for training expenses. Check your company's policy.
Financial assistance:Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
Career advancement:Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.

Have Questions? Contact Us:

Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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For quotes or invoices please provide the course(s) and number of students.