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MWI2: Regulatory Documentation

1. Course number:

MWI2

2. Course title:

Regulatory documentation

4. Dates offered:

Rolling admission

5. Semester hours of credit:

n/a

6. Course description

One of 3 required courses for students in the Medical Writing Institute Certificate Program.

This course explains clinical and non-clinical study design and regulatory reporting of drugs, devices and biologics. Designing and preparing documents for federal approval to market these products requires a basic understanding of:

1. Biomedical clinical research: study design, entry criteria, randomization, controls, blinding, monitoring, statistical analysis and data interpretation, reporting of analysis results.

2. Standardized regulatory document formats: national and international guidelines, company templates

3. Basic submission components: Chemistry, manufacturing and controls (CMC) documents, protocols, investigator brochures, statistical analysis plans, study reports, summary/overview documents, supporting data, IND and NDA safety updates.

4. Publication requirements: international and electronic formats

5. Agency requirements: FDA, EMEA

6. Ethics of clinical trials and pharmaceutical marketing

7. Preparation of clinical study protocols and NDA documents
   

7. Prerequisites:                          

Track 1: PhD earned in the laboratory, MS, MJ, PharmD, MD with graduate training

Track 2: Graduate of undergraduate medical, nursing, pharmacy school, undergraduate degree in sciences or journalism with courses in the sciences.

8. Applicable student population:

Every professional in life sciences needs to know how to present themselves and their data and needs to know how to analyze data and present it to general and professional audiences. Students may be interested in transitioning into careers in medical writing, but they need not be; they may be interested in managing medical writers, creating for-profit and not-for-profit companies or other careers in the US and international pharmaceutical and health industries.

9. Objectives:                               

After completing this course, students will be able to:

1.      Present an overview of the development processes of drugs and devices and the resulting required documents

2.      Describe clinical and non-clinical studies involved in regulatory submissions of drugs, devices or biologics

3.      Differentiate between legal definitions and clinical opinions regarding adverse events

4.      Prepare a narrative description of a serious adverse event by taking and translating into clear and concise language key information from a short hand clinical report

5.     Describe the life cycle of a drug from development to marketing to patent expiration

6.      Describe regulation of drugs, devices and biologics after a drug has been marketed

7.      Define acronyms in the field of regulatory writing

8.   Identify the critical components of drug and device submissions to regulatory authorities

9.      Understand ICH E3 guidelines for the creation of a clinical study report and be able to apply them as done by sponsors and contract research organizations

10.  Understand the process, timelines, and team members involved in the creation of clinical regulatory reports

11.  Be able to concisely write and assemble all sections of a clinical study report including appendices

12.  Understand key statistical concepts related to clinical studies and how they are applied in the creation of a clinical study report

13.  Understand the format and purpose of other regulatory documents, including clinical trial registry summaries, informed consent documents, protocols, and the Common Technical Document and how they fit into the clinical study report and in submission documents

14. Have prepared at least one clinical protocol

15. Have prepared at least one clinical study report template

16. Have prepared at least one clinical study report shell

10. Syllabus:

Topic 1: Regulatory agencies

Topic 2: Drug development processes

Topic 3: Clinical trials

Topic 4: Informed consent and ethics

Topic 5: Adverse events, reporting safety

Topic 6: Package Inserts

Topic 7: Clinical Study Reports

Topic 8: Marketing Applications (NDAs and MAAs)

Topic 9: The Common Technical Document

Topic 10: Electronic Submissions and Overview of International Regulatory Authorities

Topic 11: Dietary supplements.

Topic 12: In vitro tests

Topic 13: Medical devicesTopic 14: Biologics

11. Texts:                                                                             

1.      AMA Style Guide Edition 10.

2.      Thomas A Lang, MA, M Secic, How to Report Statistics in Medicine

3.      Thomas A Lang MA. How to Write, Publish, and Present in the Health Sciences: A Guide for Physicians and Laboratory Researchers

4.      Robert J. Bonk, Ph.D. Medical writing in drug development :a practical guide for pharmaceutical research. The Haworth Press, New York, 1998

5.      Karen E. Woodlin, Ph.D. and John C. Schneider. The CRA's Guide to Monitoring Clinical Research, Thomson Centerwatch, Boston, 2003

6.      Linda Fossati Wood, MaryAnn Foote, (Eds.) Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics

7.      Jane E. Miller. The Chicago Guide to Writing about Numbers;  Univ Chicago Press, 2004.

12. Grading:       Pass or fail according to oral questions, prepared assignments, final certificate examination                                     

13. Teaching aids: File sharing software and chat room software for online posting. Facebook. Twitter. Linkedin.

14. Institutional resources:   Office set up for onsite instruction.

15. Problem-solving and critical thinking: Students determine what contract or job they need and work towards getting it.

16. Evaluation: Students are evaluated from written documents and oral quizzes.

17. Individualization:  Individual consultation with students, by e-mail, phone, Facebook, Linkedin

18. Time described:   2017-2018

19. Faculty:   Susanna J Dodgson PhD                                            

21. Prepared by:  Susanna J Dodgson PhD

22. Date prepared: 

July 2017

23. Date Medical Writing Institute approval: 

Jan 2010; Apr 2013; July 2017