Newsletter – May 2018

Greetings, North Central Members!


Welcome to the May 2018 chapter newsletter. Let us know what you think, and remember, you can always read it on the chapter website. You can find previous newsletters on the website as well. And we always welcome suggestions for newsletter topics.



In this issue:










AMWA North Central Chapter Spring Event:

CER Writing and EU MDR

Speaker: Karen Bannick, MA, RAC, FRAPS

Date: May 16

Location: Fulton Brewery, 414 6th Avenue North, Minneapolis

Networking: 5:30 to 6:30 p.m. Program: 6:30 to 7:30 p.m.

Our AMWA North Central spring program will feature Karen Bannick of Bannick Consulting, whose work includes manuscripts, medical device regulatory submissions, and clinical documents. An experienced independent consultant, Karen will speak about the new European Union Medical Device Regulation (EU MDR) and its impact on the writing of clinical evaluation reports (CERs). Discussion related to CERs and the new requirements is timely, because companies have only a limited period to update their reports. The topic is also especially relevant given that our North Central region includes the “Medical Alley” of medical device companies.

Appetizers and drinks will be served.

Please RSVP to president (at) amwanorthcentral (dot) org.



SE Minnesota Writers and Editors Discussion Group

May 11, noon to 1 p.m.

Details: These quarterly gatherings are informal, and lunch is provided by the chapter. All AMWA members and guests are welcome. To have an accurate head count for the lunch order, RSVP one week before the meeting (email June Oshiro at oshiro (dot) june (at) mayo (dot) edu).

We have no formal discussion topic for this meeting—let’s talk about whatever’s on your mind! If it’s been a while since you’ve attended, come on back, don’t be shy! If you’ve never joined us before, please consider coming by and introducing yourself. Nonmembers are welcome, too.

Directions to our meeting are at Hope to see you there!



Book Club: Monday, September 24, 2108, at 6 p.m.

A World without “Whom”: The Essential Guide to Language in the Buzzfeed Age

Details: This fall, we’ll discuss A World without “Whom”: The Essential Guide to Language in the Buzzfeed Age by Emmy J. Favilla. We’ll meet at Boca Chica Restaurant on the West Side of St. Paul, a few minutes south of downtown St. Paul: 11 César Chávez [Wabasha] St., just west of Robert St.. The parking lot is ample, as are the baskets of chips. If you plan to attend, please let Mary Knatterud know by 2 p.m. on September 24: knatt001 (at) umn (dot) edu or 651-645-3858.

Even if you haven’t started or finished the book by then, feel free to come and chime in anyway. Our small group varies: new and/or returning AMWA Book Club fans are always welcome.

For those of you who like to read ahead, we have chosen our books for 2019:

  • January 28, 2019: The Written World: The Power of Stories to Shape People, History, Civilization by Martin Puchner
  • April 29, 2019: Blood: An Epic History of Medicine and Commerce by Douglas Starr
  • September 30, 2019: Better: A Surgeon’s Notes on Performance by Atul Gawande



New Programming Committee Chair

Welcome our new Programming Committee Chair: Messac Che Neba!

Messac will lead the Programming Committee in developing chapter events for professional development and for networking, including the quarterly happy hour gatherings. Thank you, Messac, for your willingness to contribute to the North Central chapter by helping us learn and connect.



Other Volunteers Are Still Needed

AMWA North Central is a volunteer-based organization. If members don’t take an active role, the chapter will cease to function, and members will lose access to programming, news, and networking opportunities. Consider taking your turn to lead (or join) a committee. These committee chair positions are open:


Membership Committee Chair: AMWA is only as strong as its members, and our chapter is in need of a Membership Committee Chair to be a point of contact for our current members, keep our email lists up to date, and facilitate outreach to potential, new, and former members.

Finance Committee Chair: The Finance Committee Chair coordinates the annual audit of the chapter’s financial records at the close of the fiscal year (July) and reports the findings to the Chapter Treasurer.

Publications Committee Chair: As our Publications Committee Chair, you can use your editorial and organizational skills to keep chapter members informed by writing and asking others to write for our monthly e-newsletter (e.g., profiles of members, “What We Do” articles, and news items).


Not ready or able to serve as a Committee Chair? All our committees welcome members to share ideas and keep the workload light.

In addition to keeping our group viable, volunteering with AMWA is a great way to network with your fellow members. It’s also a good way to fortify your C.V. with an extra line showing how you give back to your profession! If you can volunteer a few hours a month to help, contact our Executive Committee: EC (at) amwanorthcentral (dot) com. Thank you!



AMWA National Conference

Medical Writing & Communication Conference

November 1–3, 2018 (with preconference events on October 31)

Renaissance Washington DC Downtown Hotel

Registration is now open for AMWA’s 2018 national conference, with early bird rates in effect through June 15.

Visit the AMWA website to register and plan your trip. Remember, earlier registration gets you into more of the workshops, roundtables, or other sessions you want to attend and gives you more time to complete the homework for any workshops that require it. A preliminary schedule and listings of workshops, education sessions, and discussion roundtables are posted online.




What We Do: Medical Affairs

by Kelly K. Haagenson, PhD


Perhaps like me before I started working in the field, you have never heard of medical affairs. Or maybe you have and immediately think, “Oh yeah, the off-label people.” Although it is true that Medical Affairs teams are in the unique position to provide information on non-FDA-approved uses of commercially available drugs and devices, in reality medical affairs teams provide scientific support for a broad variety of activities.

The primary purpose of medical affairs is to respond to unsolicited requests for off-label medical information. These questions might be related to treatment of an unapproved indication, a surgical technique for device implantation that differs from labeling, or a use in a patient population that has not been studied, such as pediatric patients or pregnant women. The FDA requires the responses to these questions to be truthful, accurate, and not misleading. Responses must also be tailored to the questions being asked.

In addition to fielding off-label questions, medical affairs teams can provide clinical evidence for the safety and efficacy of on-label indications, and they can answer technical questions related to device management and the cost-effectiveness or complications of a therapy. All conclusions must be those of the publication authors.

One thing medical affairs personnel cannot do is provide medical advice or recommendations. The clinician receiving the information must ultimately use his or her expertise to decide whether a therapy or procedure is right for the patient.

In addition to providing medical information, medical affairs personnel engage in scientific exchange activities, such as providing conference support, meeting with clinicians to discuss recently published literature, or facilitating medical education events.

Medical affairs teams also collaborate with other internal colleagues. Typical activities may include reviewing publications that the marketing department uses to support product claims, creating publication summaries to train field personnel, working with clinical teams on evidence dissemination strategies, participating in manuscript development, providing a scientific perspective to business leadership, and training field staff on how to interact with customers.

The structure of medical affairs teams varies greatly between industries and between companies. Some teams are their own department, some report to regulatory affairs, and some are part of marketing or clinical departments.  Some groups are set up as call centers and others follow a medical science liaison model; members of those types of teams respond to questions verbally the majority of the time.

Others, like my team, primarily respond in writing. We provide relevant labeling information and a comprehensive summary of journal articles identified through a literature search. For commonly asked questions, we are able to leverage previously developed content, but we must make sure that all included information is specific to the question being asked and that we are not introducing off-label content that was not requested.

When pursuing a career in medical affairs, it is helpful to have a scientific background. Members of my team have advanced degrees in biology, neuroscience, oncology, public health, and pharmacy. Good communication skills are also a must.  Each member of my department completes the AMWA Essential Skills certificate as part of our onboarding.

One of the things I love most about my job is that it allows me to combine my passions for science, writing, and helping others. It’s extremely rewarding to know that the information my team provides helps clinicians make informed decisions about how they treat their patients.

The variety of activities we engage in also means that no day is ever boring! I’m always learning something new. I enjoy collaborating with colleagues across many departments. A career in medical affairs might not be an obvious path for a medical writer, but now that I’ve found it I can’t imagine doing anything else.



High level overview of Medical Affairs responsibilities:

FDA Draft Guidance for responding to unsolicited requests for medical information:



Read a Good Book?

Whether you’ve read a professional/technical, biomedical/science nonfiction, or fiction book that you think other chapter members may enjoy, share a short review with us. Write a paragraph or a few about what you liked about the book, how it might be good for medical writers to read, or how it might fill a need. Send your submissions to jean (at) imagesmythe (dot) com.