American Medical Writers Association Curriculum Program

American Medical Writers Association Curriculum Program Carolinas Chapter

Friday, May 4, 2007, 8:30 AM to 4:00 PM, The Friday Center

The Friday Center is located off Route 54 in Chapel Hill, North Carolina. (See www.fridaycenter.unc.edu for a map and more details about the venue.)

REGISTRATION FORM Total Enclosed $ ______Registration is limited to the first 30 paid applicants for each Core Curriculum workshop and to the first 16 paid applicants Refunds: There will be a $25 nonrefundable charge for each Core for the Advanced Curriculum workshop. Open sessions are Curriculum class. Advanced Curriculum class fees are nonrefundable. No refunds after April 16, 2007, for the Core limited to 23 registrants. Early registration is advised. Curriculum classes or after April 21, 2007, for the registration fee.

Name______Three concurrent morning and afternoon sessions will be held: Address______Understanding Sample Size and Study Power (ADV) City/State/Zip______[Course #729] Advanced Curriculum Daytime Phone______Approximate homework time: 3 hours Bart Harvey, MD, MEd, PhD E-mail______8:30-11:30 AM

Registration Deadlines: Basics of Human Anatomy and Physiology (EW/PH) Advanced Curriculum: March 29, 2007 [Course #227] Core Curriculum: April 12, 2007 Approximate homework time: 2 hours MaryAnn Foote, PhD Homework Due Dates: 8:30-11:30 AM Advanced Curriculum homework is due April 6, 2007. Core Curriculum homework is due April 20, 2007. Evidence-based Medicine [Open Session] Please fill in applicable prices for member/nonmember: Howard Smith, MA 8:30-11:30 AM Registration (including lunch, open sessions) $60/$120______Writing the Final Report of a Clinical Trial (PH) Morning Class (choose only one) Understanding Sample Size and [Course #414] Study Power (ADV) [#729] $125/$210 ______Approximate homework time: 4 hours Basics of Human Anatomy/Physiology (EW) [#227]$95/$185_____ Howard Smith, MA Evidence-based Medicine (OS) $0/$0______1-4 PM

Afternoon Class (choose only one) Statistics for Medical Writers and Editors (C) Writing the Final Report of [Course #110] a Clinical Trial (PH) [#414] $95/$185 ______Approximate homework time: 3 hours Statistics for Medical Writers/Editors (C) [#110] $95/$185 ______Bart Harvey, MD, MEd, PhD Understanding PK/Pharmacogenomics (OS) $0/$0______1-4 PM

Other fees (optional) Understanding Pharmacokinetics and AMWA annual membership dues $135 ______Pharmacogenomics One-time matriculation fee for Core Curriculum credit (good for 6 years) $125/$235 ______[Open Session] One-time matriculation fee for Advanced Edward K. Lobenhofer, PhD, and Dana L. Randall, MS, PharmD Curriculum credit (good for 8 years) $150/$260 ______1-4 PM Hotel information: Courtyard Marriott of Chapel Hill 100 Marriott Way Chapel Hill, North Carolina 27517 (across the street from the Friday Center) Phone: (919) 883-0700 www.marriott.com/rduch For questions about the workshops contact: AMWA—Carolinas Chapter (credit cards are not Tara Hun-Dorris, President AMWA Carolinas accepted) to: (919) 562-1194; [email protected] Carol Bader, MS 136 Springfork Dr. Mail your registration form and check payable to Cary, NC 27513

American Medical Writers Association—Carolinas Chapter Core Curriculum and Advanced Curriculum Workshops

Biographical Sketches Dr. Randall completed a clinical clerkship in pharmacokinetics at Pfizer. Her medical writing experience spans a number of MaryAnn Foote therapeutic areas, including psychiatry, infectious diseases, MaryAnn Foote, PhD, is a freelance writer/editor/teacher. Her endocrinology, oncology, cardiovascular diseases, and women’s academic appointments include University of Chicago and the health. She is currently Senior Medical Writer at JK Associates, Inc. University of Southern California. She received her doctorate degree from the Ecology Program, Rutgers University (New Howard Smith Brunswick, NJ). Dr Foote started the Medical Writing Department Howard Smith, MA, is the Principal Regulatory Scientist for INC at Amgen (Thousand Oaks, CA) in 1991 and retired as Director, Research, Inc., a full-service contract research organization in Global Regulatory Writing, in 2005; and was Vice President, Charlottesville, Virginia. He has been in the pharmaceutical Scientific Communications, Abraxis BioScience (Los Angeles, CA) industry for over 30 years as a medical writer, a manager of medical in 2006. She helped establish medical writing as a profession in writers, and a regulatory affairs professional. He holds a bachelor’s Japan. She is a Fellow of the American Medical Writers degree in biology and English from Thiel College and a master’s Association (AMWA) and a recipient of the Swanberg degree in biology from the University of Virginia. He studied the Distinguished Service Award. She has edited or written more than history of science for 3 years at Johns Hopkins University, and the 20 books and written more than 200 scientific articles. Currently, majority of his publications are in this field. He is a Fellow and past she is an editor of the third edition of Principles of Molecular president of the American Medical Writers Association. In 1987, Oncology. She is on the editorial board for DIA Journal, is an he received the Outstanding Workshop Leader award from that acquisition editor for Biotechnology Annual Review, and is science organization, and, in 1999, he was the recipient of the Harold editor for AMWA Journal. Swanberg Distinguished Service Award for outstanding contributions to the field of medical writing. Bart Harvey Bart Harvey, MD, PhD, MEd, is an associate professor with the Department of Public Health Sciences and the Graduate Department of Community Health at the University of Toronto, where he currently serves as the director of research in the Department of Family and Community Medicine and the director of the Community Medicine Residency Program. He is also one of the City of Toronto's investigating coroners. He was AMWA’s 2006 Golden Apple award recipient.

Edward Lobenhofer Edward K. Lobenhofer, PhD, has been engaged in genomic research for over a decade, both through his current position as the Senior Manager of Data Analysis at Cogenics and while doing his post-doctoral research at the National Institute of Environmental Health Science. He received his doctoral degree in Cell and Molecular Biology from Duke University. While focused on the application of genomic technologies to answer biological questions in the fields of pharmacology and toxicology, he still enjoys using the teaching skills that he developed while obtaining his BS in Biology Education from Millikin University.

Dana Randall Dana Randall, MS, PharmD, received her BS in Biology, MS in Nutrition, and PharmD from the University of Michigan, Ann Arbor. She was a clinical nutritionist before returning to pharmacy school, and began her medical writing career upon graduation. In addition to pharmacokinetic coursework in the PharmD curriculum, The AMWA Educational Program Understanding Sample Size and Study Power (ADV) [Course #729] The AMWA Curriculum programs are extensive continuing education This workshop is intended for writers and editors who are familiar programs for professional communicators in the medical and allied with basic biostatistics and research methods and who want to scientific fields. The Core Curriculum program offers an opportunity to improve their understanding of and ability to communicate about improve communication skills in five disciplines: editing and writing sample size and study power. We will explore how various factors, (EW); educators (ED); freelance (FL); pharmaceutical (PH); and public particularly sample size, influence a study’s “power”—the ability to relations/advertising/marketing (PRAM). The Advanced Curriculum detect a measured and statistically significant effect. We will also program is designed for those who have earned Core Curriculum examine the role that precision and confidence intervals play in certificates, have taken certain qualifying Core workshops, or have a minimum of 5 years’ experience as biomedical communicators. interpreting and reporting a study’s power. These concepts will be Completion of the requirements for the Core Curriculum program or the addressed from the vantage points of planning studies and of Advanced Curriculum program is recognized with a certificate. interpreting and assessing completed studies. Throughout, we will Registrants must be enrolled in a curriculum program in order to emphasize how to effectively communicate the related concepts to receive credit for workshops. Registrants may enroll in the curriculum lay and professional audiences. APPROXIMATE HOMEWORK programs by paying a one-time enrollment fee. The Core TIME: 3 HOURS. Curriculum enrollment fee (good for 6 years) is $125 for AMWA members and $235 for nonmembers. The Advanced Curriculum enrollment fee (good for 8 years) is $150 for AMWA members and $260 for nonmembers. Registrants taking workshops for Core Open Session Descriptions Curriculum credit must complete the homework and submit it to the workshop leader on time and must attend the entire workshop. Understanding Pharmacokinetics and Pharmacogenomics Registrants taking workshops for Advanced Curriculum credit must We all hear the terms “pharmacokinetics” and complete and submit the homework to the workshop leader on time “pharmacogenomics,” but how many of us really understand these or the workshop is forfeited and no refund will be issued. Workshops terms and their importance in the biomedical industry? In this open- begin promptly. There is a 10-minute grace period for entering the workshop. After that, no one will be admitted. session, a leader from each of the respective fields will discuss these topics in detail. Time will also be provided for a Q&A session. Workshop Descriptions Evidence-based Medicine Evidence-based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. Much of the evidence comes from a Writing the Final Report of a Clinical Trial (PH) [Course #414] critical appraisal of the key articles from the medical literature. This workshop for novices and moderately experienced medical Many of these articles will be concerned with reporting the results writers will offer approaches to generating a clinical study report. of studies of new drugs. Critical appraisal of them involves several The components of the report, issues of quality control, and steps, and the most important of these are: (1) deciding what the common problems and situations will be reviewed. Within this paper is about, (2) assessing the quality of the methods section of framework, ideal and real-world experiences will be discussed. The the paper, (3) analyzing the results and conclusions of the paper. impact of guidelines from the International Conference on This analytical skill is vital, not only to the practicing physician, but Harmonisation and their effect on the standard report structure will also to anyone who works in the broad field of health care, as well be covered in detail. APPROXIMATE HOMEWORK TIME: 4 as to writers and editors of reports and manuscripts dealing with HOURS. medical topics. As the redoubtable Festus on the television series Gunsmoke once pondered, “If ya’can’t read the writin’, how do ya’ The Basics of Human Anatomy and Physiology (EW/PH) [Course know the one who done the writin’ wrote the readin’ right?” This #227] course will be concerned with how to read the “writin’” of a Formerly known as Anatomy and Physiology for Poets (NC), the medical paper to make the assessments on which evidence based workshop is suitable for the beginning and moderately experienced medicine depends. writer or editor and will offer basic knowledge of human anatomy and physiology through lecture and discussion. Organization of the human body, from molecular to system levels, will be covered. APPROXIMATE HOMEWORK TIME: 2 HOURS.

Statistics for Medical Writers and Editors [Course #110] This workshop is designed for participants who have little or no background in statistics. Elementary statistical concepts needed for understanding medical and scientific articles to be covered will include types of variables, levels of measurement, summary statistics, estimation and confidence intervals, and Student’s t test. Emphasis will be placed on understanding statistical presentations and on reporting statistical information—not on calculations or mathematical explanations. APPROXIMATE HOMEWORK TIME: 3 HOURS.