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Home » Pharmaceutical Sales & Marketing: Legal and Regulatory Framework for Advertising and Promotion of Prescription Drugs in the USA

Pharmaceutical Sales & Marketing: Legal and Regulatory Framework for Advertising and Promotion of Prescription Drugs in the USA

Certification Training
 
Rated 4.67/5
3 reviews
Program/Course ID: SAM01
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 quality, compliance, safety, and job performance by earning a training certification.

Training Program: Pharmaceutical Sales & Marketing: Legal and Regulatory Framework for 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 enrollment.

Description:
Biopharma Institute Reviews

Advertisements and promotional labeling of prescription drugs in the USA must comply with statutory and regulatory requirements, as per FDA 21 CFR Part 202. 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 set out the legal framework for the regulation of advertising and promotion of prescription drugs in the USA. We identify the regulatory authorities and sources of guidance. We summarize basic requirements that advertisements and promotional labeling must meet, and we identify consequences that may follow failure to comply.

In companion courses, we deal with regulatory compliance in general, with considerations that are particular to consumer-directed advertising and online promotion, and with certain interactions with healthcare professionals.

Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 6-month period, or a 12-month period for professional certification programs. 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 instantaneously launched and made available to the student in a PDF format upon completion.

Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.


Outline:


  • Regulation of advertising and promotion of drugs
  • Classifying promotional communications
  • Advertisements and promotional labeling
  • Statutory and regulatory requirements
  • Types of advertisement
  • Misbranding and distribution of an unapproved drug
  • FDA offices
  • FDA advisory and enforcement actions
  • Civil litigation by competitor
  • Submission of communication materials to FDA
  • FDA's Bad Ad Program
  • Compliance programs and OIG enforcement
  • Provision of samples
  • 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 particular benefit to regulatory affairs and legal personnel involved with aspects of marketing.

Learning objectives:
  • Identify the federal laws and regulatory authorities that govern advertising and promotion of prescription drugs in the USA
  • Identify sources of guidance on such advertising and promotion
  • Distinguish various types of promotional communication
  • Discuss the distinction between advertisement and promotional labeling
  • Specify statutory and regulatory requirements that must be met by promotional communications that make product claims
  • Distinguish various types of advertisement
  • Outline the activities of the offices of the Food and Drug Administration (FDA) that oversee compliance with requirements on advertising and promotion
  • Identify advisory and enforcement actions by the FDA, and other consequences of violations of federal law
  • Specify requirements for submission of promotional materials to the FDA
  • Outline the role of the Office of Inspector General and its compliance program guidance
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: Legal and Regulatory Framework for Advertising and Promotion of Prescription Drugs in the USA 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 validated by 3rd party organizations for relavancy and regulatory content. The courses are developed by subject matter experts (SMEs) to promote the retaining of key knowledge. They 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 200 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device industries.

Group Training for Employees: 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.


Benefits of Training with Biopharma Institute

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Self-paced courses: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
  • Optimized for learning: Courses include voice-overs, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for malware to deliver optimal level of security and performance.
  • Purchase orders (POs): If a PO is required by your company, request an invoice to start the procurement process. we accept all purchase orders.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Tuition reimbursement: Some employers may reimburse for training expenses. Check your company's training reimbursement policy.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to different positions within their organization.
  • 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.
  • 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 requirements have been fulfilled.


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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