2017 Medical Writers Summit (CBI) by medical writing

R E G I S T E R B Y O C T O B E R 6 , 2 0 1 7 A N D S AV E $ 3 0 0 !

MWC and RAC Credits Available! Pending Approval

THE MEDICAL WRITERS SUMMIT

FOR REGULATORY AND MEDICAL COMMUNICATIONS WRITERS DECEMBER 6-7, 2017 • DOUBLETREE BY HILTON PHILADELPHIA CENTER CITY • PHILADELPHIA, PA

DISTINGUISHED SPEAKING FACULTY INCLUDES: CONFERENCE CHAIRPERSON: Kathy Spiegel, Global Regulatory Writing Senior Manager, Amgen; President Elect, American Medical Writers Association (AMWA)

Alberta Davis, Ph.D., Franchise Liaison Ophthalmology, Novartis Pharmaceuticals

Art Gertel, Principal, MedSciCom, LLC; Past President, American Medical Writers Association (AMWA)

Angela Johnson, Senior Manager Clinical Affairs Operations, GE Healthcare

Becky Nuttall, Medical Writing Lead, EMD Serono

Jennifer O’Donnell, Contract Senior Medical Writer, Jazz Pharmaceuticals

Sean Patterson, Senior Medical Writer, Mallinckrodt Pharmaceuticals

John Redue, Senior Manager, Medical Writing, Sunovion Pharmaceutical, Inc.

Annette Ruff, Senior Scientific Medical Writer, Smith & Nephew

UNPARALLELED CONTENT FOR MEDICAL WRITERS, BY MEDICAL WRITERS • Gain insight on the changing medical writing landscape and enhance strategies for highlighting key messages in the digital era • Cultivate core project management strategies to improve medical writing efficiencies • Share techniques for successful collaboration with partners for outsourced medical writing

• Dive into emerging career growth opportunities in the field • Take part in a statistical analysis refresher course • Focus on building cross-functional excellence through the evaluation of successful teamwork strategies

B E N E F I T F R O M T W O TA I L O R E D W O R K S T R E A M S : R E GU L ATO RY • SKILLS LAB — Cultivate Proven Clinical Writing Best Practices • Analyze the New Clinical Protocol Templates from FDA and TransCelerate Biopharma ASSOCIATION PARTNER:

M ED ICAL COM M UN ICAT ION S • SKILLS LAB — Achieve Team-Reviewed Perfection in Writing Deliverables • Cross Continents and Perspectives — An Insightful Comparison of Ghost Writing and Publications Standards PREMIER MEDIA PARTNERS:

SUPPORTING MEDIA PARTNERS:

A division of UBM Americas

REGISTER AT WWW.CBINET.COM/MEDICALWRITING • 800-817-8601 CBI’s Medical Writers Summit is the go-to event to connect with fellow medical writers and industry thought-leaders in an unmatched educational setting. Driven by medical writers, this conference dives into the high-level and niche challenges and features educational workstreams including a special skills lab tailored for both regulatory and medical communications writers. ABOUT OUR ASSOCIATION PARTNER:

The American Medical Writers Association (AMWA) is the resource for professional medical communicators, promoting excellence in medical communication and providing educational resources in support of that goal. Visit www.amwa.org for information about online education, conferences, corporate training programs, certification, membership and other career resources. Earn MWC recertification points at this conference.

WHO SHOULD ATTEND: You will benefit from attending this event if you are a professional from the pharmaceutical, biotech or medical device industries with responsibilities or involvement in the following areas: • • • • • • • • •

Medical Writing Regulatory Writing Publications Writing Scientific Writing Clinical Communications Medical Communications Scientific Information Clinical Affairs Operations Project Management

This conference also benefits medical writing consultants and service providers.

A GREAT PLACE TO MEET YOUR MARKET! Take advantage of the best opportunity to meet potential clients face-to-face. Build relationships while demonstrating thought leadership and sharing expertise. For more information on how to position your company as a sponsor or exhibitor, contact Karen Hanover at 339-298-2184 or email karen.hanover@cbinet.com.

DAY ONE

3:15

WEDNESDAY, DECEMBER 6, 2017 12:00

Main Conference Registration

1:00

Chairperson’s Opening Remarks

When writing a deliverable, be it a protocol, CSR, CTD, investigator’s brochure, poster, peer-reviewed manuscript or otherwise, developing a document that focuses on the key message is imperative. In this session, learn how to get out of the way of the data and implement various techniques for focusing on the story in your writing. • Set up your story succinctly and efficiently • Concentrate on the data that supports the story, in particular the primary endpoints • Integrate effective organizational elements to enhance the deliverable and ensure your reader stays engaged Elizabeth Brown, Managing Medical Writer, Merck & Co.

Kathy Spiegel, Global Regulatory Writing Senior Manager, Amgen; President Elect, American Medical

Writers Association (AMWA)

Embrace the Changing Medical Writing Landscape and Develop Enhanced Project Management Strategies 1:15

How do you get the most important points across when your document is read with only half the attention it deserves? In this kick-off keynote, open your eyes to strategic writing practices that align with the new electronic age of document reading. • Use documents as a tool to guide the readers to the information they need • Weave key messages throughout the deliverable and ensure the takeaway is clear • Discuss the effects of digital documentation and how they continue to change the deliverable format Becky Nuttall, Medical Writing Lead, EMD Serono 2:00

4:00

Jazz Pharmaceuticals

Networking and Refreshment Break

Collaborate and Communicate to Successfully Manage Outsourced Medical Writing

Connect with internal and external partners to navigate the management of a successful outsourcing relationship. • Define and comply with internal and external standards and SOPs CASE • Discuss possible solutions to common STUDIES roadblocks for successful collaboration • Review successful case studies in the coordination of multiple external vendors in a regulatory filing John Redue, Senior Manager, Medical Writing,

Sunovion Pharmaceutical, Inc.

4:45

Explore the Global Medical Writing Movement and Emerging Career Growth Opportunities Dive into how the global medical writing landscape is shifting and the new challenges and opportunities arising in the field. • Discuss the impact of global medical and regulatory changes • Experience how digital technologies are reshaping medicine and medical writing • Adopt a global mindset with key strategies for tomorrow’s global medical and regulatory communications world • Explore changes in global topics such as translations and editing • Establish personal development goals for career growth in the medical writing field Angela Johnson, Senior Manager Clinical Affairs Operations,

Establish Core Medical Writing Strategies through Effective Project Management How can efficiencies be built into the medical writing process? Discuss with peers the top roadblocks that commonly delay deliverables and strategize efforts to hit deadlines. • Determine what you need from other teams to meet the deadline • Share best practices to identify and combat common roadblocks • Implement pre-specified milestones for the team to encourage achieving goals • Understand how to incorporate key project management practices into deliverable planning Jennifer O’Donnell, Contract Senior Medical Writer,

2:45

Kimberly Jochman, Principal Medical Writer, Merck & Co.

KEYNOTE ADDRESS

Examine the Paradigm Change — How to Write Strategically to Highlight Key Messages in the Digital Era

Use a Focused Authoring Strategy to Create a Message-Driven Deliverable

GE Healthcare

5:30

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY T WO 8:00

THURSDAY, DECEMBER 7, 2017

Continental Breakfast

CHOOSE FROM T WO TAILORED WORKSTRE A MS (A- B): A . RE GU L AT O RY 8:30

SKILLS LAB

Cultivate Proven Clinical Writing Best Practices

B. M E DIC A L C O M M U NIC AT IO NS 8:30

Achieve Team-Reviewed Perfection in Writing Deliverables

Learn the value, skills and discipline needed to be successful as a clinical regulatory writer. • Enhance skills to write scientifically accurate, concise and to the point messages in clinical documents • Establish effective time management plans for writing and review cycles • Timeline management — Best practices to maintain a reasonable yet aggressive timeline 9:15

Analyze the New Clinical Protocol Templates from FDA and TransCelerate Biopharma The protocol template is a roadmap for conducting clinical trials. Recently, the FDA and NIH released a new model document providing both instructional and sample text, which has been harmonized with a separate protocol template for industry-sponsored research. • Overview of new model documents • Discuss the strengths of a consistent, well-organized protocol template and downstream effects • Identify problematic areas in protocols and propose solutions Darryl L’Heureux, Ph.D., Senior Scientific Writer,

Bristol-Myers Squibb

10:00

10:30

SKILLS LAB

Collaborate internally to establish effective team-review strategies. • What is the medical writer’s responsibility in team-reviewing? • How do you ensure the team’s work has been properly team-reviewed? • Implement team-review strategies early on in the process • Evaluate examples of team-reviewed documents for FDA submission Sean Patterson, Senior Medical Writer,

Mallinckrodt Pharmaceuticals 9:15

Shackleton’s Ghost Writer — Are Authorship Standards Always Important? While we are accustomed to formalized authorship conventions, these are seldom applied outside of the realm of peer-reviewed scientific and medical publications. Should “authors” outside of this context be held to the same standards?

CASE STUDY

• Case study of authorship outside of medical/ scientific literature • Authorship standards juxtaposed • Assessment of meaningful universal standards Art Gertel, Principal, MedSciCom, LLC; Past President,

American Medical Writers Association (AMWA)

Networking and Refreshment Break

Chairperson’s Review of Day One Kathy Spiegel, Global Regulatory Writing Senior Manager, Amgen; President Elect, American Medical Writers Association (AMWA)

REGISTER AT WWW.CBINET.COM/MEDICALWRITING • 800-817-8601 • Overcome the disadvantages of not having a scientific background and embrace the value of a fresh perspective • Garner reasoning from the documents provided in order to feel fully confident in understanding the subject matter for the reports you write • Work with internal teams to ensure appropriate knowledge for writing the deliverable • Be able to defend your work if necessary and ask questions when required Alberta Davis, Ph.D., Franchise Liaison Ophthalmology,

Develop Essential Skills for the Success of the Medical Writing Department 10:45

Navigate Basic Statistical Analysis and Understand the Results through a Medical Writing Lens Embark on a ‘statistics for the non-statistician’ course like no other — Learn the ins and outs of statistical analysis as it applies to medical writers’ work. • Ensure you are getting what is needed from the statistical tables

Novartis Pharmaceuticals

2:00

• Translate the statistical language into valuable information for the deliverable

Strengthen Cohesive Cross-Functional Team Building Practices In order to navigate the tangled web of internal communications, a working cross-functional relationship is the key to success. In this session, engage with participants from across the medical writing field to discuss the challenges and strategies for establishing a successful cross-functional working environment. • Infuse best practices and compliant processes throughout the entire team • Enhance communication skills to make internal communications more efficient • Analyze successful teamwork strategies MODERATOR: Kathy Spiegel, Global Regulatory Writing Senior Manager, Amgen; President Elect, American Medical Writers

• Be quick to define the information provided in the statistical table Carl Di Casoli, Principal Statistician, Celgene 11:30

PANEL DISCUSSION

A How-To Guide — Using the CORE Reference to Navigate the ICH E3 Guideline for CSR Writing Learn how to use the CORE reference tool, context of its origin and the opportunity to participate in a live demonstration of how the tool works. • Explore how CORE applies Policy 0070 requirements

Association (AMWA)

• Understand the ICH E3 structure and how it relates to the CORE reference

PANELISTS: Kelly Kilibarda, Ph.D., Medical Writer and Consultant,

• Develop best practices for using the CORE reference to develop ICH-compliant CSRs Art Gertel, Principal, MedSciCom, LLC; Past President,

Whitsell Innovations, Inc.

John Redue, Senior Manager, Medical Writing,

Sunovion Pharmaceutical, Inc.

American Medical Writers Association (AMWA)

Annette Ruff, Senior Scientific Medical Writer, Smith & Nephew

Aaron Bernstein, Ph.D., Principal Medical Writer,

Aaron Bernstein Consulting, LLC 12:15

Networking Luncheon

1:15

Maintain Confident Accountability in Your Work When responsible for content that is sometimes beyond the scope of your academic training, how do you maintain confident accountability in the work? In this session, discover teamoriented strategies for assuring accountability on all deliverables.

2:45

Knowledge Exchange and Wrap-Up In conclusion, participants highlight the important knowledge and strategies gained throughout the conference and discuss how the information can be taken back to the office and implemented to achieve more successful and efficient medical writing skills, timelines and programs. Kathy Spiegel, Global Regulatory Writing Senior Manager, Amgen; President Elect, American Medical Writers

Association (AMWA)

3:15

Close of Conference

R E G I S T E R B Y O C T O B E R 6 , 2 0 1 7 A N D S AV E $ 3 0 0 !

MWC and RAC Credits Available! Pending Approval

THE MEDICAL WRITERS SUMMIT

SCAN HERE

FOR REGULATORY AND MEDICAL COMMUNICATIONS WRITERS DECEMBER 6-7, 2017 • DOUBLETREE BY HILTON PHILADELPHIA CENTER CITY • PHILADELPHIA, PA

CBI 70 Blanchard Road Burlington, MA 01803

WAYS TO REGISTER NOW!

A division of UBM Americas

WEB

www.cbinet.com/ medicalwriting

ANY QUESTIONS OR TO REGISTER CONTACT:

cbireg@cbinet.com

PHONE

800-817-8601 339-298-2100 outside the U.S.

LIVE CHAT

Christian Alongi phone 339-298-2131 email christian.alongi@cbinet.com

www.cbinet.com/ medicalwriting

THE MEDICAL WRITERS SUMMIT

REGISTRATION FEE:

Pharma/Biotech/Medical Device Companies Academics/Freelancers

PC17418

VENUE: ADVANTAGE PRICING $1599 $899

Standard $1899 $1199

Onsite $1999 $1299

Register by October 6, 2017 and SAVE $300. Fee includes continental breakfast, lunch, wine and cheese reception, refreshments and conference documentation. Credit Card (Visa, MC, AMEX, Discover) or checks accepted. Please make checks (in U.S. funds drawn on a U.S. bank) payable to: CBI. (No personal checks accepted.) PLEASE NOTE: All advertised discounts are taken from the full, Standard Rate.

GROUP RATE: Looking to bring your team? Contact Information Services to learn about potential group savings. Call 800-817-8601 or email cbireg@cbinet.com. * Advantage pricing rates do apply when applicable. Offer may not be combined with any other special pricing promotions. Offer may be used at CBI co-located events.

SATISFACTION GUARANTEED: CBI stands behind the quality of its conferences. If you are not satisfied with the quality of the conference, a credit will be awarded towards a comparable CBI conference of your choice. Please contact 800-817-8601 for further information. Advanced preparation for CBI conferences is not required.

DoubleTree by Hilton Philadelphia Center City 237 South Broad Street Philadelphia, PA 19107 Phone Reservations: (800) 222-8733 Hotel Direct Line: (215) 893-1600

ACCOMMODATIONS: To receive CBI’s special discounted hotel rate online or by phone, please go to: • Online:

www.cbinet.com/medicalwriting

• Phone reservations: (800) 222-8733 and mention CBI’s Medical Writers Summit Book Now! The DoubleTree by Hilton Philadelphia Center City is accepting reservations on a space and rate availability basis. Rooms are limited, so please book early. All travel arrangements subject to availability. PLEASE NOTE: All hotel reservations for this conference should be booked directly with the hotel. CBI does not use Housing Bureaus and none are authorized to call on our behalf.

SUBSTITUTION AND CANCELLATION: Your registration may be transferred to a member of your organization up to 24 hours in advance of the conference. All cancellations received in writing on or before 14 days prior to the start date of the event will be refunded, less a $399 administrative charge. No refunds will be made after this date; however, the registration fee less the $399 administrative charge can be credited to another CBI conference if you register within 30 days from the date of this conference to an alternative CBI conference scheduled within the next six months. In case of conference cancellation, CBI’s liability is limited to refund of the conference registration fee only. Cancellation of a conference due to events beyond our control* are subject to a $399 administrative charge should you or a colleague be unable to attend the rescheduled date. CBI reserves the right to alter this program without prior notice. Please Note: Speakers and agenda are subject to change. In the event of a speaker cancellation, every effort to find a suitable replacement will be made. The opinions of the conference faculty do not necessarily reflect those of the companies they represent or CBI. *Events beyond our control include: severe weather conditions, natural and man-made disasters and any other similar events.