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Agenda

December 6-7, 2017
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

DAY ONE WEDNESDAY, DECEMBER 6, 2017

12:00

Registration and Welcome Refreshments

1:00

Chairperson’s Welcome and Opening Remarks

Kathy Spiegel, PhD, MWC
Global Regulatory Writing Senior Manager, Amgen;
President, American Medical Writers Association (AMWA)

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

1:15

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

Becky Nuttall
Medical Writing Lead
EMD Serono

2:00

Establish Core Medical Writing Strategies Through Effective Project Management

Jennifer O’Donnell
Contract Senior Medical Writer
Jazz Pharmaceuticals

2:45

Networking and Refreshment Break

3:15

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

Elizabeth Brown
Managing Medical Writer
Merck & Co.

Kimberly Jochman
Principal Medical Writer
Merck & Co.

4:00

CASE STUDIES
Collaborate and Communicate to Successfully Manage Outsourced Medical Writing

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

4:45

Explore the Global Medical Writing Movement and Emerging Career Growth Opportunities

Angela Johnson
Associate Director, Regulatory and Scientific Affairs
CTI Clinical Trials and Consulting

5:30

Close of Day One

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

DAY TWO THURSDAY, DECEMBER 7, 2017

8:00

Continental Breakfast

CHOOSE FROM TWO TAILORED WORKSTREAMS (A-B):

A. REGULATORY

8:30

SKILLS LAB Cultivate Proven Clinical Writing Best Practices

Learn the value, skills and discipline needed to be successful as a clinical regulatory writer.

Kelly Kilibarda, PhD
Medical Writer and Consultant
Whitsell Innovations, Inc.

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.

Darryl L’Heureux, PhD
Senior Scientific Writer
Bristol-Myers Squibb

 
B. MEDICAL COMMUNICATIONS

8:30

SKILLS LAB Achieve Team-Reviewed Perfection in Writing Deliverables

Collaborate internally to establish effective team-review strategies.

Sean Patterson, PhD
Senior Medical Writer
Mallinckrodt Pharmaceuticals

9:15

CASE STUDY
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?

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

10:00

Networking and Refreshment Break

10:30

Chairperson’s Review of Day One

Kathy Spiegel, PhD, MWC
Global Regulatory Writing Senior Manager, Amgen;
President, American Medical Writers Association (AMWA)

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

Carl Di Casoli
Principal Statistician
Celgene

11:30

A How-To Guide — Using the CORE Reference to Navigate the ICH E3 Guideline for CSR Writing

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

Aaron Bernstein, PhD
Principal Medical Writer
Aaron Bernstein Consulting, LLC

12:15

Networking Luncheon

1:15

Maintain Confident Accountability in Your Work

Alberta Davis, PhD
Franchise Liaison Ophthalmology
Novartis Pharmaceuticals

2:00

PANEL DISCUSSION Strengthen Cohesive Cross-Functional Team Building Practices

MODERATOR:

Kathy Spiegel, PhD, MWC
Global Regulatory Writing Senior Manager, Amgen;
President, American Medical Writers Association (AMWA)

PANELISTS:

Kelly Kilibarda, PhD
Medical Writer and Consultant
Whitsell Innovations, Inc.

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

Annette Ruff
Medical Writer, Senior Manager
Pfizer

2:45

Knowledge Exchange and Wrap-Up

Kathy Spiegel, PhD, MWC
Global Regulatory Writing Senior Manager, Amgen;
President, American Medical Writers Association (AMWA)

3:15

Close of Conference

Agenda

Want more agenda details? Download the brochure.
Want more agenda details? Download the brochure.

DAY ONE WEDNESDAY, DECEMBER 6, 2017

12:00

Registration and Welcome Refreshments

1:00

Chairperson’s Welcome and Opening Remarks

Kathy Spiegel, PhD, MWC
Global Regulatory Writing Senior Manager, Amgen;
President, American Medical Writers Association (AMWA)

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

1:15

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

Becky Nuttall
Medical Writing Lead
EMD Serono

2:00

Establish Core Medical Writing Strategies Through Effective Project Management

Jennifer O’Donnell
Contract Senior Medical Writer
Jazz Pharmaceuticals

2:45

Networking and Refreshment Break

3:15

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

Elizabeth Brown
Managing Medical Writer
Merck & Co.

Kimberly Jochman
Principal Medical Writer
Merck & Co.

4:00

CASE STUDIES
Collaborate and Communicate to Successfully Manage Outsourced Medical Writing

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

4:45

Explore the Global Medical Writing Movement and Emerging Career Growth Opportunities

Angela Johnson
Associate Director, Regulatory and Scientific Affairs
CTI Clinical Trials and Consulting

5:30

Close of Day One

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

DAY TWO THURSDAY, DECEMBER 7, 2017

8:00

Continental Breakfast

CHOOSE FROM TWO TAILORED WORKSTREAMS (A-B):

A. REGULATORY

8:30

SKILLS LAB Cultivate Proven Clinical Writing Best Practices

Learn the value, skills and discipline needed to be successful as a clinical regulatory writer.

Kelly Kilibarda, PhD
Medical Writer and Consultant
Whitsell Innovations, Inc.

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.

Darryl L’Heureux, PhD
Senior Scientific Writer
Bristol-Myers Squibb

 
B. MEDICAL COMMUNICATIONS

8:30

SKILLS LAB Achieve Team-Reviewed Perfection in Writing Deliverables

Collaborate internally to establish effective team-review strategies.

Sean Patterson, PhD
Senior Medical Writer
Mallinckrodt Pharmaceuticals

9:15

CASE STUDY
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?

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

10:00

Networking and Refreshment Break

10:30

Chairperson’s Review of Day One

Kathy Spiegel, PhD, MWC
Global Regulatory Writing Senior Manager, Amgen;
President, American Medical Writers Association (AMWA)

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

Carl Di Casoli
Principal Statistician
Celgene

11:30

A How-To Guide — Using the CORE Reference to Navigate the ICH E3 Guideline for CSR Writing

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

Aaron Bernstein, PhD
Principal Medical Writer
Aaron Bernstein Consulting, LLC

12:15

Networking Luncheon

1:15

Maintain Confident Accountability in Your Work

Alberta Davis, PhD
Franchise Liaison Ophthalmology
Novartis Pharmaceuticals

2:00

PANEL DISCUSSION Strengthen Cohesive Cross-Functional Team Building Practices

MODERATOR:

Kathy Spiegel, PhD, MWC
Global Regulatory Writing Senior Manager, Amgen;
President, American Medical Writers Association (AMWA)

PANELISTS:

Kelly Kilibarda, PhD
Medical Writer and Consultant
Whitsell Innovations, Inc.

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

Annette Ruff
Medical Writer, Senior Manager
Pfizer

2:45

Knowledge Exchange and Wrap-Up

Kathy Spiegel, PhD, MWC
Global Regulatory Writing Senior Manager, Amgen;
President, American Medical Writers Association (AMWA)

3:15

Close of Conference