Regulatory Environment Application Presentation Example Outline Below is a sample outline of the Week 5 assessment. You are not required to submit an outline with your Week 5 summative assessment

Regulatory Environment Application
Presentation Example Outline
Below is a sample outline of the Week 5 assessment. You are not required to submit an outline with your
Week 5 summative assessment, but you may wish to create one to help collect and organize the
information you will include in your 12- to 15-slide presentation. While only Sections 1, 2, and 4 are
included in this example, be sure to include all five sections in your submitted presentation. As you
prepare, keep in mind strategies for effectively formatting your slides and speaker notes.
Section 1: Pfizer Pharmaceutical
 Global pharmaceutical company with a global presence
 Founded by Charles Pfizer
 CEO, Albert Bourla, DVM, PhD. 
 Hundreds of products tailored for individual markets; average of 12 years to develop
 Research & development and clinic trials
 Patient assistance programs
Section 2: Consumer Information Pfizer RxPathways
 Pfizer RxPathways is the patient assistance website.
 Includes testimonials from other patients
 Separate pages for health professionals, caregivers, and patients
 Offers resources for patients outside of Pfizer as well as Pfizer programs
 Online enrollment as well as 1-800 numbers
Section 4: Regulatory Impact
 Pfizer is primarily subject to Food & Drug Administration (FDA) regulations.
 The FDA approves requests for new drug patents as well as monitoring of manufacturing
practices.
 The FDA allowed more aggressive direct-to-consumer advertising by pharmaceutical companies
starting in 1999 (Ventola, 2011). 
 Most recently, the FDA approved Pfizer’s development of a COVID-19 vaccine with partner
BioNTech. 
Reference
Ventola, C. L. (2011). Direct-to-consumer pharmaceutical advertising: Therapeutic or toxic? Pharmacy
and Therapeutics, 36(10), 681–684.