OTC Readers Group May 15: The Night Climbers - CANCELLED

The next meeting of the OTC Readers Group will be May 15, at 6:30 pm, at Panera Bread at 3601 Witherspoon Rd., Durham (map), off U.S. 15-501 between Durham and Chapel Hill. (Panera is behind Kroger.) Vivian McGee will lead us in a discussion of The Night Climbers by Ivo Stourton.

Here's what Publishers Weekly had to say about the book: "British author Stourton's ambitious debut paints a complex, if often predictable, portrait of collegiate hedonism and friends bound by a terrible secret. As an awkward first-year at Cambridge's Tudor College, James fears he'll never join the ranks of his privileged classmates. But when a chance encounter introduces him to a close-knit group of friends devoted to scaling the college's buildings in the dead of night, James finds himself drawn into a world of excess and adventure. Francis, the group's charismatic leader, is adored by the beautiful but aloof Jessica, on whom James harbors a secret crush. The group is rounded out by Lisa, with her eye for shady business deals, and Michael, the blustery jock. After Francis's father, Lord Soulford, cuts off his son's monthly allowance, the friends hatch a plan to maintain their lavish lifestyle that will have disastrous consequences for years to come. With undeniable echoes of Donna Tartt's The Secret History, the novel juggles too many story lines to sustain the suspense needed for such a complicated tale. Still, Stourton is a name to watch."

See you all on May 15!

June Bimonthly Discussion Dinner: "What FDA Wants From You, and Why They Want It - or, A Brief History of Drugs in America"

Maria Oyaski is an Associate Staff Regulatory Affairs Specialist at bioMérieux Inc. (a medical diagnostics firm with US headquarters in Durham) and is also the immediate past president of  the North Carolina Regulatory Affairs Forum. Her industry background includes work in regulatory affairs, clinical research, and pharmacovigilance. Her discussion will aim to demystify NDAs, INDs, IRBs, 1572s, PMAs, 510(k)'s and their ilk by providing a historical perspective on the development of FDA's regulatory submission requirements for various medical products. The discussion will highlight the differences between submissions for investigational use versus marketed products, and drugs vs. devices. Yes, there will be side trips to China, Germany, and the Caribbean, at a minimum.

Registration Now Open for Annual Chapter Conference, BELS Exam

Registration has begun for the AMWA Carolinas Annual Conference, which will be held on Friday, May 2, from 8:30 am to 4:30 pm at the Friday Center in Chapel Hill. This year's conference continues to reflect our commitment to providing quality educational options for chapter members, with a total 4 courses and 3 open sessions being offered. Click here to download the conference registration form, course descriptions, and faculty biosketches (PDF file).

In addition, the Board of Editors in the Life Sciences (BELS) certification exam will be offered from 9 am to noon during the Conference. Visit the BELS Web site for more information about registration and test policies.

Next OTC Readers Group Mar 20: Cold Comfort Farm

The next book for the OTC Readers Group is Cold Comfort Farm, by Stella Gibbons (1932). Ellen Stoltzfus will lead the discussion. The meeting will be held March 20 at 6:30 pm at B. Christopher's Restaurant, 100 Meadowmont Village Circle, Chapel Hill (www.bchristophers.com; 932-1918). Please RSVP to jenny.walker at duke.edu by March 18. Each participant will be responsible for his or her own dinner bill.

From Amazon.com: "Book Description—A hilarious parody of D. H. Lawrence and Thomas Hardy’s earthy, melodramatic novels, the deliriously entertaining Cold Comfort Farm is “very probably the funniest book ever written” (The Sunday Times). About the Author—Stella Gibbons (1902–1989), novelist, poet, and short-story writer, was born in London. Cold Comfort Farm, her first novel, won the Femina Vie Heureuse Prize. Her other novels include Nightingale Wood, Westwood, and Beside the Pearly Waters.

The following OTC Readers Group meeting will be held May 15, and the book will be The Night Climbers, by Ivo Stourton (2007). Venue to be announced.

Dr. Oliver Smithies, Nobel Laureate, to Speak on Mar 6

The Carolinas Chapter of the American Medical Writers Association is very proud to host a lecture by Oliver Smithies, cowinner of the Nobel Prize in Physiology or Medicine for 2007. You are cordially invited to attend this free event.

Dr. Smithies and his colleagues Mario R. Capecchi and Martin J. Evans were awarded the prize for their discoveries concerning embryonic stem cells and DNA recombination in mammals, which led to the ability to target genes in mice. Gene targeting allows scientists to produce almost any type of DNA modification in the mouse genome, making it possible to establish the role of individual genes in health and disease. The work of Drs. Capecchi, Evans, and Smithies will help us to understand gene function in human development, affecting all fields of biomedicine and ultimately benefitting mankind. In particular, Dr. Smithies has used gene targeting to develop mouse models for diseases such as cystic fibrosis, thalassemia, hypertension, and atherosclerosis.

Please join us for this exciting event, to be held March 6, 2007, in the Redbud Room at the Friday Center for Continuing Education, located at 100 Friday Center Drive, just off Highway 54 East, in Chapel Hill. There will be a reception at 6 pm, and Dr. Smithies’ talk will begin promptly at 6:30 pm.

There is no charge for this event, but it is important that you register in advance by contacting the event organizer, Jenny Walker, at jenny.walker@duke.edu or 919-668-5929, by February 22.

For further information, contact Jenny. For directions to the Friday Center, go to www.fridaycenter.unc.edu.

February Discussion Dinner: "Christmas Music in July and Other Useful Tips for Producing Error-free Writing"

John Prosseda of "Hey, look what I found" will join us for our February dinner discussion on the topic of "Christmas Music in July and Other Useful Tips for Producing Error-free Writing," to be held at NeoChina in Cary at 6:30 pm on Thursday, 7 Feb 2008.  The discussion will focus on insights, strategies, and specific techniques to help you find the mistakes in your documents - instead of having your client find them for you! John also promises that we will learn the story behind "Christmas Music in July."

Short Bio: John has been a consultant doing QC-related work for the past 15 years. He has a background in nutrition and has worked with several pharmaceutical companies in the US and abroad. Through his freelance business, he performs quality reviews of regulatory documents, audits clinical and safety databases, and designs process improvement systems to help companies save money and reduce turnaround times.

In the time before our dinner discussion, please consider the following questions:
1. What are the biggest challenges you face as a writer?
2. What things really slow you down during the writing process?
3. What keeps you from doing error-free work?
4. What is the part(s) of the job you wish you didn’t have to do?
5. In what ways could a quality reviewer be of greatest help to you?

2007–2008 Officers Announced

Dear Members:

I am pleased to announce our slate of officers for AMWA Carolinas for 2007–2008. The new roles took effect on October 13, 2007, at the close of the national conference.

The officers are:

• President: Carol Bader
• President-elect: Ellen Stoltzfus
• Secretary: Susan D’Alessandro
• Treasurer: Tracey Fine

Other members serving the Chapter will be--

• Listserv Manager: Diane Feldman
• Newsletter Editor: Deana Betterton-Lewis
• Web Boss: Pat French (note: seeking replacement for this position)
• OTC Readers Group Coordinators: Tracey Fine and Jenny Walker (nonelected position)

Thanks to these volunteers for their service to AMWA’s Carolinas chapter!

Tara Hun-Dorris
President, AMWA Carolinas

Last updated: May 4, 2008