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Agenda

Best Practices for Preparing and Disseminating Regulatory and Medical Communications

September 10-12, 2019
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

DAY ONE Wednesday, September 11, 2019

7:15

Registration and Continental Breakfast

8:15

Day One Chair’s Welcome and Opening Remarks

Debra Guerreiro
Plain Language Summary Program Lead
Janssen Data Transparency

Discover Best Practices in the
Medical Writing Landscape

8:30

Steering the Ship —
Strategies for Successful Medical Writing Project Management

Lynne Munno, MA, MS
Director of Medical Writing, Oncology Submissions
Pfizer Inc

9:15

What’s Next for Automation and AI in the Medical Writing Landscape

Julia Forjanic Klapproth
President and Senior Partner
Trilogy Writing & Consulting

Sian Ratcliffe
Vice President, Head of Medical Writing
Pfizer

10:00

Networking and Refreshment Break

10:30

Tactics for Improving Document Quality

Laura Sheppard, MBA, MA
Director of Medical Writing, Clinical Operations
Endo Pharmaceuticals

11:15

Extending the Application of Plain Language and Lay Summaries
Across New Functions and Audiences: Benefits and Challenges

Richard White MA PhD
Chief Operating Officer
Oxford PharmaGenesis

Brian Falcone PhD
Executive Vice President
Oxford PharmaGenesis

12:00

Networking Luncheon

1:15

CHOOSE BETWEEN TWO EDUCATIONAL WORKSTREAMS (I-II)

I Regulatory & Medical Communications Writing

1:15

Cultivating Presence While
Working Remotely

Gretchen Griffin
Director, Regulatory Strategic Writing
AbbVie

Robert Storella
Senior Principal Medical Writer
EMD Serono, Inc.

2:15

Navigate Data Redaction and Disclosure Requirements for
Company Confidential Information and Protected Personal Information

Sanjay Bagani
Director, Clinical Trials Transparency
Xogene

3:00

Networking and Refreshment Break

3:30

Case Study — Strategies for Improving the Medical Writing Process

Meredith Murray, RN
Principal Scientist, Clinical Content Standards
Merck

4:15

Writing Strategically for the Digital Era 2.0

Becky Nuttall
Submission Medical Writer
Pfizer Inc

 
II Plain Language Summaries

1:15

Identify and Incorporate the
Patient Perspective

Deborah Collyar
President
Patient Advocates In Research (PAIR)

2:15

Discussion on the Dissemination of Plain Language Summaries

Thomas Wicks
Chief Strategy Officer
TrialScope

3:00

Networking and Refreshment Break

3:30

Evaluate Translation Processes and Navigate Cultural Norms

Laura Maria Pigozzi, PhD
Visiting Assistant Professor,
Cook Family Writing Program
Northwestern University

4:15

Determine Best Practices for Providing Lay Summaries to Pediatric Participants and their Caregivers

Julia Vail, PMP
Clinical Research Communications Specialist III
Duke Clinical Research Institute

5:00

Close of Day One and Networking Reception

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

DAY TWO Thursday, September 12, 2019

7:30

Continental Breakfast

8:15

Day Two Chair’s Review of Day One

Gretchen Griffin
Director, Regulatory Strategic Writing
AbbVie

8:30

Strategies for Tailoring Your Message for a Target Audience

Eileen Girten
Director, Medical Writing
Pfizer Inc

9:15

Writing for Patients —
The Importance of Health Literacy and Numeracy in Clinical Research

Lisa Chamberlain James
Senior Partner
Trilogy Writing & Consulting

10:00

Networking and Refreshment Break

10:30

CHOOSE BETWEEN TWO EDUCATIONAL WORKSTREAMS (III-IV)

III Regulatory & Medical Communications Writing

10:30

Maximize Medical Communications through Lean Writing

Diane Petrovich
Medical Writing, Clinical Operations
Merck

Sarah Eichenberg
Director, Medical Writing and Transparency
Jazz Pharmaceuticals

11:15

Roadmap to Writing Successful CSRs

Darryl L’Heureux
Senior Scientific Writer
Bristol-Myers Squibb

12:00

Networking Luncheon

1:00

CSRs — It’s Just a Phase

John Redue
Associate Director, Medical Writing
Seattle Genetics, Inc.

1:45

Clinical Trial Transparency and
Public Disclosure

Oladayo Oyelola, PhD
Director, Clinical Trial Information Disclosure
Daiichi Sankyo, Inc.

 
IV Plain Language Summaries

10:30

How to Approach Writing Plain Language Summaries for
Different Stages of Research and Complex Clinical Trials

Vidhi Vashisht
Associate Director,
Clinical Trial Disclosure
Kinapse, a Syneos Health Company

11:15

Health Literacy in Clinical Research Communications —
Tools and Techniques

Sylvia Baedorf Kassis, MPH
CYT Program Manager
Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard

12:00

Networking Luncheon

1:00

Top Tips for Developing Child-Friendly Consent / Assent / Plain Language Materials

Jennifer Preston
Senior Patient and Public Involvement Manager
University of Liverpool

1:45

Apply Plain Language in Other Patient and Public Communications

Behtash Bahador, MS
Senior Manager, Quality and Compliance, Communicating Trial Results
Center for Information & Study on Clinical Research Participation (CISCRP)

2:30

Co-Chair’s Closing Remarks and Key Takeaways

Gretchen Griffin
Director, Regulatory Strategic Writing
AbbVie

Debra Guerreiro
Plain Language Summary Program Lead
Janssen Data Transparency

Agenda

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

DAY ONE Wednesday, September 11, 2019

7:15

Registration and Continental Breakfast

8:15

Day One Chair’s Welcome and Opening Remarks

Debra Guerreiro
Plain Language Summary Program Lead
Janssen Data Transparency

Discover Best Practices in the
Medical Writing Landscape

8:30

Steering the Ship —
Strategies for Successful Medical Writing Project Management

Lynne Munno, MA, MS
Director of Medical Writing, Oncology Submissions
Pfizer Inc

9:15

What’s Next for Automation and AI in the Medical Writing Landscape

Julia Forjanic Klapproth
President and Senior Partner
Trilogy Writing & Consulting

Sian Ratcliffe
Vice President, Head of Medical Writing
Pfizer

10:00

Networking and Refreshment Break

10:30

Tactics for Improving Document Quality

Laura Sheppard, MBA, MA
Director of Medical Writing, Clinical Operations
Endo Pharmaceuticals

11:15

Extending the Application of Plain Language and Lay Summaries
Across New Functions and Audiences: Benefits and Challenges

Richard White MA PhD
Chief Operating Officer
Oxford PharmaGenesis

Brian Falcone PhD
Executive Vice President
Oxford PharmaGenesis

12:00

Networking Luncheon

1:15

CHOOSE BETWEEN TWO EDUCATIONAL WORKSTREAMS (I-II)

I Regulatory & Medical Communications Writing

1:15

Cultivating Presence While
Working Remotely

Gretchen Griffin
Director, Regulatory Strategic Writing
AbbVie

Robert Storella
Senior Principal Medical Writer
EMD Serono, Inc.

2:15

Navigate Data Redaction and Disclosure Requirements for
Company Confidential Information and Protected Personal Information

Sanjay Bagani
Director, Clinical Trials Transparency
Xogene

3:00

Networking and Refreshment Break

3:30

Case Study — Strategies for Improving the Medical Writing Process

Meredith Murray, RN
Principal Scientist, Clinical Content Standards
Merck

4:15

Writing Strategically for the Digital Era 2.0

Becky Nuttall
Submission Medical Writer
Pfizer Inc

 
II Plain Language Summaries

1:15

Identify and Incorporate the
Patient Perspective

Deborah Collyar
President
Patient Advocates In Research (PAIR)

2:15

Discussion on the Dissemination of Plain Language Summaries

Thomas Wicks
Chief Strategy Officer
TrialScope

3:00

Networking and Refreshment Break

3:30

Evaluate Translation Processes and Navigate Cultural Norms

Laura Maria Pigozzi, PhD
Visiting Assistant Professor,
Cook Family Writing Program
Northwestern University

4:15

Determine Best Practices for Providing Lay Summaries to Pediatric Participants and their Caregivers

Julia Vail, PMP
Clinical Research Communications Specialist III
Duke Clinical Research Institute

5:00

Close of Day One and Networking Reception

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

DAY TWO Thursday, September 12, 2019

7:30

Continental Breakfast

8:15

Day Two Chair’s Review of Day One

Gretchen Griffin
Director, Regulatory Strategic Writing
AbbVie

8:30

Strategies for Tailoring Your Message for a Target Audience

Eileen Girten
Director, Medical Writing
Pfizer Inc

9:15

Writing for Patients —
The Importance of Health Literacy and Numeracy in Clinical Research

Lisa Chamberlain James
Senior Partner
Trilogy Writing & Consulting

10:00

Networking and Refreshment Break

10:30

CHOOSE BETWEEN TWO EDUCATIONAL WORKSTREAMS (III-IV)

III Regulatory & Medical Communications Writing

10:30

Maximize Medical Communications through Lean Writing

Diane Petrovich
Medical Writing, Clinical Operations
Merck

Sarah Eichenberg
Director, Medical Writing and Transparency
Jazz Pharmaceuticals

11:15

Roadmap to Writing Successful CSRs

Darryl L’Heureux
Senior Scientific Writer
Bristol-Myers Squibb

12:00

Networking Luncheon

1:00

CSRs — It’s Just a Phase

John Redue
Associate Director, Medical Writing
Seattle Genetics, Inc.

1:45

Clinical Trial Transparency and
Public Disclosure

Oladayo Oyelola, PhD
Director, Clinical Trial Information Disclosure
Daiichi Sankyo, Inc.

 
IV Plain Language Summaries

10:30

How to Approach Writing Plain Language Summaries for
Different Stages of Research and Complex Clinical Trials

Vidhi Vashisht
Associate Director,
Clinical Trial Disclosure
Kinapse, a Syneos Health Company

11:15

Health Literacy in Clinical Research Communications —
Tools and Techniques

Sylvia Baedorf Kassis, MPH
CYT Program Manager
Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard

12:00

Networking Luncheon

1:00

Top Tips for Developing Child-Friendly Consent / Assent / Plain Language Materials

Jennifer Preston
Senior Patient and Public Involvement Manager
University of Liverpool

1:45

Apply Plain Language in Other Patient and Public Communications

Behtash Bahador, MS
Senior Manager, Quality and Compliance, Communicating Trial Results
Center for Information & Study on Clinical Research Participation (CISCRP)

2:30

Co-Chair’s Closing Remarks and Key Takeaways

Gretchen Griffin
Director, Regulatory Strategic Writing
AbbVie

Debra Guerreiro
Plain Language Summary Program Lead
Janssen Data Transparency