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Wednesday, October 20, 2021
Home » Pharmaceutical Sales & Marketing: Regulatory Requirements and Guidance on Advertising and Promotion of Prescription Drugs in the USA

Pharmaceutical Sales & Marketing: Regulatory Requirements and Guidance on Advertising and Promotion of Prescription Drugs in the USA

Certification TrainingProgram/Course ID: SAM02
Enrollment Period: 3 months.
Average Learning Time: ~90 minutes.
Additional Resources: Supplemental materials/activities.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
Credit Hours: 2 credits.
Catalog: Pharmaceutical Sales and Marketing.
Demonstration: See free trial enrollment courses.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).

PRICE: USD $185.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Training Program: Pharmaceutical Sales & Marketing: Regulatory Requirements and Guidance on Advertising and Promotion of Prescription Drugs in the USA
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

Advertisements and promotional labeling of prescription drugs in the USA must comply with statutory and regulatory requirements. Advertising and promotion are also subject to guidance from the Food and Drug Administration (FDA) and from industry and professional codes of practice. By identifying the requirements and summarizing the extensive guidance that applies, this course and its companions will help you to advertise and promote your products without incurring legal or regulatory sanctions.

In this course we explain how to advertise and promote prescription drugs in various media, whether to healthcare professionals or consumers, in compliance with legal requirements and guidance from the FDA.

In companion courses, we set out the legal framework for regulation, and we deal with considerations that are particular to consumer-directed advertising and online promotion and to interactions with healthcare professionals.

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:


  • Common drug advertising and promotion issues
  • Relate brand and established names
  • Frequency of presentation of established name
  • Be consistent with the prescribing information (PI)
  • Information possibly consistent with the PI
  • Information not consistent with the PI
  • Include only substantiated information
  • Be truthful and not misleading, reveal material facts, and provide fair balance
  • Include information on risks
  • Balance risks and effectiveness
  • Reveal other material information
  • Avoid selective presentation of favorable information
  • Endorsements and testimonials
  • Avoid broadening or inadequate representation of indications
  • Use up-to-date information
  • Use statistics carefully
  • Avoid misleading juxtaposition of information
  • Avoid misbranding of an investigational drug
  • Brief summary and adequate information for use in print media
  • Major statement in broadcast ads
  • Make adequate provision for access to product labeling
  • Treat comparative claims with care
  • Comparisons of price, dosing, and indications
  • FDA examples of violative and non-violative ads
  • Assessment

Objectives:


Who will benefit from this module?
Sales and marketing personnel need to understand the legal and regulatory requirements that must be met when advertising and promoting 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 common issues with drug advertising and promotion
  • Specify regulatory requirements for the presentation of brand and non-proprietary names of drugs
  • Emphasize the importance of consistency with prescribing information, and give examples of types of information that are, and types that are not, consistent
  • Describe how to support claims for products in promotional communications
  • Be truthful and not misleading, reveal material facts, and provide fair balance between effectiveness and risks in promotional communications
  • Avoid the pitfalls of: selective presentation of favorable information, broadening or inadequate representation of indications, use of out-of-date information, misuse of statistics, misleading juxtaposition of information, and misbranding of an investigational drug
  • Deal appropriately with endorsements and testimonials
  • Outline the role of the brief summary and adequate information for use in print advertisements and promotional labeling
  • Outline the role of the major statement, and make adequate provision for access to product labeling, in broadcast advertisements
  • Treat comparative claims with care
  • Make comparative promotional claims regarding price, dosing, and indications

Information and Guidance:
  • Advertising and Promotional Labeling Branch of the FDA's Center for Biologics Evaluation and Research (CBER)
  • 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: Regulatory Requirements and Guidance on Advertising and Promotion of Prescription Drugs in the USA is Included in the Following Professional Certification Program(s):



Professional Certification Program:

Pharmaceutical Sales & Marketing Professional Certification
Course ID: SAMPRO
Price: $495.00 (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.
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  • 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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