Spring 2027

Introduction to Regulatory Practice

Introduction to Regulatory Practice examines key regulatory agencies and practices governing the pharmaceutical industry, highlighting FDA and ICH regulations and guidance for product development.

offering recorded3 credits
Recorded instructors · Spring 2027 Daniel KappPamela SwatkowskiSharon Ayd +3 more

Summary

1 / 3

Recent recorded grades — Spring 2025: 4.00 GPA, 100.0% A/AB (n=13 letter grades); Fall 2025: 3.90 GPA, 94.1% A/AB (n=34 letter grades); Spring 2026: 3.86 GPA, 95.2% A/AB (n=21 letter grades).

What you’ll be able to do

  • Describe the laws and regulations associated with drugs, biologics, and medical devices in the United States.

  • Justify the importance of regulatory affairs in Life Sciences.

  • Develop a meeting and communication strategy for interacting with the FDA and submitting appropriate documentation

  • Analyze the regulations that impact drug and biologics development, dietary supplements, medical devices, and diagnostics.

  • Analyze and compare nonclinical and clinical product development.

Source: UW Guide

Grade history

↗
average GPA
letter grades
A
AB
B
BC
C
D
F

All recorded terms · compare terms & instructors

Prerequisites

Course map

Declared in MS Pharmaceutical Sciences or Capstone Certificate in Applied Drug Development

  • Declared in MS Pharmaceutical Sciences or Capstone Certificate in Applied Drug Development
PHMSCI 751 used by

“Used by” includes alternatives; linked courses may have other requirements. This is a best-effort interpretation; check the catalog requirements above.

Prerequisite text tree
  • Declared in MS Pharmaceutical Sciences or Capstone Certificate in Applied Drug Development

Professors

Spring 2027

Recent recorded grades — Spring 2025: 4.00 GPA, 100.0% A/AB (n=13 letter grades); Fall 2025: 3.90 GPA, 94.1% A/AB (n=34 letter grades); Spring 2026: 3.86 GPA, 95.2% A/AB (n=21 letter grades). Includes jointly taught sections.

Recent recorded grades — Spring 2025: 4.00 GPA, 100.0% A/AB (n=13 letter grades); Fall 2025: 3.90 GPA, 94.1% A/AB (n=34 letter grades); Spring 2026: 3.86 GPA, 95.2% A/AB (n=21 letter grades). Includes jointly taught sections.

Recent recorded grades — Spring 2025: 4.00 GPA, 100.0% A/AB (n=13 letter grades); Fall 2025: 3.90 GPA, 94.1% A/AB (n=34 letter grades); Spring 2026: 3.86 GPA, 95.2% A/AB (n=21 letter grades). Includes jointly taught sections.

Recent recorded grades — Spring 2025: 4.00 GPA, 100.0% A/AB (n=13 letter grades); Fall 2025: 3.90 GPA, 94.1% A/AB (n=34 letter grades); Spring 2026: 3.86 GPA, 95.2% A/AB (n=21 letter grades). Includes jointly taught sections.

Recent recorded grades — Spring 2025: 4.00 GPA, 100.0% A/AB (n=13 letter grades); Fall 2025: 3.90 GPA, 94.1% A/AB (n=34 letter grades); Spring 2026: 3.86 GPA, 95.2% A/AB (n=21 letter grades). Includes jointly taught sections.

Recent recorded grades — Spring 2025: 4.00 GPA, 100.0% A/AB (n=13 letter grades); Fall 2025: 3.90 GPA, 94.1% A/AB (n=34 letter grades); Spring 2026: 3.86 GPA, 95.2% A/AB (n=21 letter grades). Includes jointly taught sections.

Historical instructors & teaching patterns

DANIEL KAPP is recorded teaching in Fall 2020, Fall 2021, Fall 2022, Spring 2023, Fall 2023, Spring 2024, Fall 2024, Spring 2025, Fall 2025, Spring 2026. Recorded history may be incomplete and does not establish a future schedule.

PAMELA SWATKOWSKI is recorded teaching in Fall 2020, Fall 2021, Fall 2022, Spring 2023, Fall 2023, Spring 2024, Fall 2024, Spring 2025, Fall 2025, Spring 2026. Recorded history may be incomplete and does not establish a future schedule.

SHARON AYD is recorded teaching in Fall 2021, Fall 2022, Spring 2023, Fall 2023, Spring 2024, Fall 2024, Spring 2025, Fall 2025, Spring 2026. Recorded history may be incomplete and does not establish a future schedule.

TERRANCE OCHELTREE is recorded teaching in Fall 2021, Fall 2022, Spring 2023, Fall 2023, Spring 2024, Fall 2024, Spring 2025, Fall 2025, Spring 2026. Recorded history may be incomplete and does not establish a future schedule.

THOMAS GUILLIAMS is recorded teaching in Fall 2020, Fall 2021, Fall 2022, Spring 2023, Fall 2023, Spring 2024, Fall 2024, Spring 2025, Fall 2025, Spring 2026. Recorded history may be incomplete and does not establish a future schedule.

WILLIAM PUTNAM is recorded teaching in Fall 2021, Fall 2022, Spring 2023, Fall 2023, Spring 2024, Fall 2024, Spring 2025, Fall 2025, Spring 2026. Recorded history may be incomplete and does not establish a future schedule.

Recorded history may be incomplete and does not establish a future schedule.

Calendar & sections

Spring 2027

Schedule loads here as you scroll.

SectionModeEnrolled / capacityWaitlist
LEC 001Online Only0 / 450
LEC 002Online (some classroom)0 / 300

Times are Central. Select a meeting for details; export includes recorded dates for the selected sections. Enrollment reflects scan time.

Meeting source records
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Student experience

the class

Recent recorded grades — Spring 2025: 4.00 GPA, 100.0% A/AB (n=13 letter grades); Fall 2025: 3.90 GPA, 94.1% A/AB (n=34 letter grades); Spring 2026: 3.86 GPA, 95.2% A/AB (n=21 letter grades).

difficulty & workload

No workload feedback recorded.

Topics

  • Key regulatory agencies and practices in the pharmaceutical industry
  • Current and emerging FDA and ICH regulations and guidance documents
  • Regulations impacting drug, biologics, dietary supplements, medical devices, and diagnostics
  • Nonclinical and clinical product development

Skills

  • Describing US laws and regulations for drugs, biologics, and medical devices
  • Developing strategies for FDA meetings and documentation submission
  • Analyzing regulations impacting pharmaceutical products
  • Comparing nonclinical and clinical product development

Grades

Latest available · Spring 2026— not enough history to project Spring 2027.

average GPA
A / AB grades
letter grades
Instructor

Grade distribution · % of letter grades

A
AB
B
BC
C
D
F

Grades over time

Through Spring 2026

More grade details Grade mix, volume & source data

Not enough comparable courses for Spring 2027 in UW–Madison.

Sources & history

UW–Madison

Catalog & offerings

Descriptions, prerequisites, and recorded course offerings.

Catalog observation history

Observations at scan time; dates do not imply when a catalog change took effect.

Download part 1
Selected offering source records
PHMSCI 751 · Spring 2027

Introduction to Regulatory Practice

Recorded 2026-10-14
Raw records 
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    "run_id": "20261014T203208-0851c9a1",
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    "offering_id": "1274:718:025607",
    "course_id": "PHMSCI 751",
    "course_uid": "course_c0f8183ed6f60b09902fd459",
    "term_id": "1274",
    "source_course_id": "025607",
    "source_subject_id": "718",
    "title": "Introduction to Regulatory Practice",
    "credits_min": 3,
    "credits_max": 3,
    "typically_offered": "Not Applicable"
  }
]
Rate My Professors

Student reviews

Original comments behind the course and instructor summaries.

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No records available.

Madgrades

Grade history

Recorded grade distributions by term, section, and instructor.

Explore recorded grades
Dataset & model

Recorded 2026-10-14

View the dataset on Hugging Face
Model outputs & technical records
Qwen/Qwen3.8-27B
LLM outputs across runs
Download part 1
Full model traces

Recorded model configuration, reasoning, and tool conversations.

Download part 1
Model & dataset provenance 
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  "model": "Qwen/Qwen3.8-27B",
  "model_revision": "1d4bf0f2ff6012fd82039f2fa52739d0dd7c60c0",
  "task_version": "17",
  "output_id": "b455aef5b3c681aa7e26397d47847c61763882f4d53cfcd1cd493a47ca65d8d9",
  "requirements_status": "needs_review",
  "dataset_revision": "fc1811fa52e581ea57a35c0cf3343f8740a8ffbf",
  "observed_at": "2026-10-14 17:50:09.728220+00:00"
}