Biomedical Writing, Special Summer Course Offerings

USciences is offering a summer course series on labeling, labeling and advertising, and compliance and enforcement in the field of promotion of biomedical products.

  • There are no course pre-requisites, but an understanding of the basic drug development process is helpful.
  • Each course is stand-alone; participants can take one, two, or all three in the sequence.
  • The cost is $1,618 per credit (each course is 1 credit.)  Ask about the Kate Mayes Fellowships for incoming MS and for BW Certificate students. Also ask about the discount for taking a course without academic credit.

Apply Now!

For non-matriculated students:
Please complete the Online Course Audit Registration Form and email to graduate [at] usciences [dot] edu (subject: Biomedical%20Writing%2C%20Special%20Summer%20Courses) or fax to 215-895-1185.

For current USciences students:
Please use the current course registration procedures in WebAdvisor.

Course Descriptions

Overview of Pharmaceutical Labeling

BW 780 Section 1, May 9–June 10, 2016

Online meetings will be held on Tuesday nights at 7:30 p.m.

This 5-week course is designed to provide the student with a general familiarity with pharmaceutical labeling, with a focus on prescription drugs and an emphasis on requirements in the U.S. It can be taken as a stand-alone course or as background for understanding the following units on Advertising and Promotion, and Compliance and Enforcement. Those participants who complete the course should be able to:

  • Understand the varied uses of prescription drug labeling and how it is developed to address the needs of all users;
  • Understand the expectations of health authorities and interactions with the sponsor during submission and review of applications;
  • Identify the distinctions between preparing labeling intended for health care professionals (HCP) and patients/caregivers;
  • Appreciate the current challenges and opportunities that relate to dissemination and distribution
  • Importance of labeling in the communication of drug information.

Labeling and Promotion of Biomedical Products: Consumer-directed Advertisements

BW 780 Section 2, June 13–July 15, 2016

Online meetings will be held on Tuesday nights at 7:30 p.m.

This 5-week course explores regulatory topics in the promotion and advertising of biomedical products such as pharmaceuticals and biologics. Sessions will include information on pharmaceutical advertising in general, print ads, and Internet advertising and promotion. Those participants who complete the course should be able to:

  • Identify FDA regulatory issues associated with advertising regulated products
  • Conceptualize, analyze, synthesize and evaluate compliance with several relevant FDA guidances regarding regulated promotion and advertising

Compliance and Enforcement in Biomedical Communication

BW 780 Section 3, July 18–August 19, 2016

Online meetings will be held on Tuesday nights at 7:30 p.m.

This 5-week course examines legal and compliance issues as they affect medical writers and promotional activities. Topics include the effects of laws such as the False Claims Act and Anti-Kickback Law, and the punishments that can be applied for noncompliance. These punishments include corporate integrity agreements, fines in the billions, and other enforcement actions. Those participants who complete the course should be able to:

  • Identify situations that implicate the false claims act and the Anti-Kickback Laws
  • Conceptualize, analyze, synthesize and evaluate several FDA guidances, and other governmental and non-governmental documentation.
  • Understand the REMS process
  • Understand Responses to warning letters regarding promotional compliance