MPTX 518: Writing Regulatory Submissions

Instructors:
Michael Hamrell, PhD, President, Moriah Associates
Mary Ann Foote, PhD, Director of Medical Communications, Amgen
Frances Richmond PhD, School of Pharmacy, USC
Additional speakers to be named

Course weight: 3 credits

Placement: Spring 2003 days and time TBA

Recommended Preparation:

Undergraduate degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience; enrollment in MS (Regulatory Science) or permission of instructor

Introduction and Purposes:

Medical products such as drugs are heavily scrutinized by regulatory agencies because of their potential negative impact on human or animal health. Thus, continuous communication must take place between companies that are developing and marketing drugs and the governmental regulators responsible for their approval and oversight. Typically, these communications include major submissions of scientific, engineering and patient data as a prerequisite for seeking permission to conduct clinical trials, or to market a product. Individuals responsible for creating the dossiers must understand when the evidence that is accumulated is sufficient to make a case for going forward with a new clinical trial or product marketing submission. Failure to do a good job on these submissions is critical for the company; failure to obtain a timely approval can have a disastrous effect on stock prices, sales revenue and development time-lines that can bankrupt a company or deprive society of a much needed therapy. In this course, students with a basic knowledge of biomedical science and regulatory structure will study the rules and methods by which regulatory submissions are governed. Particular attention will be paid to investigational drug applications, abbreviated drug applications and new drug applications in the US, and to the development of a common technical document in the EU. In addition, students will review in depth some of the principles related to scientific writing. Writing assignments will be used to identify individual concerns with grammatical construction, style and format. Students should understand not only the materials that must be compiled in a drug submission, but how to present that information in a convincing and credible way.

- Identify the key parts of different types submissions including IND, NDA, BLA and ANDA submissions
- Differentiate between the requirements of EU and US submissions
- Understand the language requirements of submissions in different countries
- Recognize the scope of evidence needed to develop different subsections of submission dossiers
- Understand the role played by medical writing departments in major companies and how these interact with other departments
- Be able to use the basic tools of electronic submissions, such as XML and be familiar with some of the computer-assisted packages that bridge between various software platforms
- Appreciate the importance of appearance and consistency of presentation in a marketing submission
- Identify some of the most common problems identified by reviewers and the solutions to the problems.

Some parts of the course will be taught in conjunction with a team of experts from the Drug Information Association. An emphasis will be placed on relatively informal lecture formats in which students are encouraged to ask and answer questions throughout the didactic sessions. As befits a course in which writing is important students will be asked to write at least two parts of a submission; the style, format and grammar of these submissions will be examined and the content of the submission will be discussed. As part of a novel strategy to meet the needs of part-time as well as full-time students, the course will be taught in a condensed period of full days totalling 40 face-to-face hours.

Course Requirements and Grades:

Midterm test 20%
Written submission segments 50%
Case study 30%
At the end of the course students should be able to demonstrate a competent knowledge of the subject matter as appraised by formal examination. In addition, students will be assigned to teams. Each team will be assigned a case study in which a product submission is being developed. The research and submission plan will be submitted as a paper and a brief class presentation.

The research paper will be evaluated on the basis of the following criteria:
• Clear introduction of the problem to be solved
• Review of current guidelines and identification of regulatory requirements
• Identification of other issues that affect submission
• Specification of any additional tests or information that might be needed
• Timeline and budget for the plan

Recommended Textbook

Mathieu, M. (2000) New Drug Development: A Regulatory Overview. Parexel: Waltham

Eisenberg, Anne (1992) Effective Technical Communication.2 nd ed McGraw-Hill :

The textbook will be supplemented by a list of readings that will compliment the text. In some cases in which the reading is necessary to cover topics outside of the scope of the text, materials will be available in hand-outs. Additional relevant materials will also be provided as a reader at a modest charge.

Attendance and Conduct:

The Student Handbook, SCampus and University Catalogue provide guidance regarding academic policies and procedures. Students should regard the program as a part of their professional development in which courtesy and responsibility are significant factors in success. Thus, students are expected to communicate absences from class and are expected to attend all examinations and class presentations. Under normal circumstances, papers and exams must be submitted on or before the scheduled deadlines. Failure to make appropriate arrangements in case of justifiable delay will result in a penalty of 10% in the assigned mark for the first two weeks of delay, and further penalties for additional unapproved delays.