Agenda – 5th Clinical Regulatory Medical Writing Forum

  • Day One
  • Day Two

Day One

 Thursday, July 12

8:45AM – 9:00AM

Chairperson’s Opening Remarks
Lawrence Giraudi, Manager, PD Regulatory Documentation, F. HOFFMAN-LA ROCHE

9:00AM – 9:45AM

Build a Medical Writing Group and Drive Communications Excellence Through the Use of a Strategic Communication Plan
Janet Stoltenborg, Head, Global Medical Communication Science, ASTRAZENECA
Cat Baj-Lindsey, Principal Medical Communication Science, ASTRAZENECA

9:45AM – 10:30AM

Examine a Fully Outsourced Model for the Preparation and Execution of Quality Control and Medical Writing
Cindy Seip, M.S., MPH, Director, Medical Writing, OTSUKA

10:30AM – 11:00AM

Networking Break

11:00AM – 11:45AM

Discuss How to Sustain and Grow a Relationship Between Sponsor, CRO and Medical Writing Service Providers
Debbie Nassif, Associate Director and Head of Medical Writing Operations, BIOGEN
Michelle Grimaud, Associate Data Science Business and Operations Management Director, ASTELLAS
Mari Welke, Director of US Operations, TRILOGY WRITING & CONSULTING

11:45AM – 12:30PM

Master the Logistics of Medical Writing: How to Tame the Complexity of Preparing CTD Submission Dossiers
Douglas Fiebig, Senior Partner, TRILOGY WRITING & CONSULTING

12:30PM – 1:30PM

Luncheon

1:30PM – 2:15PM

Medical Writing Support of Regulatory Briefing Books
Dylan Harris, Director, Medical Writing Group Lead, SHIRE

2:15PM – 3:00PM

Beyond Lean and Automation — Integrating Medical Writing and Trial Transparency
Mamta Chawla, M.Sc., Ph.D., Director Program Delivery, Development Operations, KINAPSE

3:00PM – 3:30PM

Networking Break

3:30PM – 4:15PM

Examine the Role of the Medical Writer in Preparing PIPs and PSPs
Jennie Pullen, Associate Director and Head of Medical Writing, IMMUNOGEN

4:15PM – 5:00PM

Interactive Group Discussion
Lawrence Giraudi, Manager, PD Regulatory Documentation, F. HOFFMAN-LA ROCHE


Day Two

 Friday, July 13

8:00AM – 8:45AM

Continental Breakfast

8:45AM – 9:00AM

Chairpersons’ Recap of Day One
Lawrence Giraudi, Manager, PD Regulatory Documentation, F. HOFFMAN-LA ROCHE

9:00AM – 9:45AM

Technology-Driven Approaches to Supporting the Creation/Production of Different Clinical and/or Regulatory Documents
Madhavi Gidh-Jain, Ph.D., Senior Director, Head Medical Writing (U.S.), SANOFI

9:45AM – 10:30AM

Writing for the Future: Reduce, Reuse, Recycle
Lawrence Giraudi, Manager, PD Regulatory Documentation, F. HOFFMAN-LA ROCHE

10:30AM – 11:00AM

Networking Break

11:00AM – 11:45AM

Medical Writing Best Practices for Combination Therapies
If you are interested in leading this session, please contact Andrew Sinetar at asinetar@exlevents.com.

11:45AM – 12:30PM

Effective Preparations of Briefing Documents for FDA Advisory Committee Meetings
Kelley L. Hill, Senior Director, Global Medical Writing, ALEXION PHARMACEUTICALS

12:30PM – 1:30PM

Luncheon

1:30PM – 2:15PM

Protocols: Built to Succeed
Monica Eiland, Ph.D., Lead Medical Writer, Clinical Scientific Writing, SHIRE

2:15PM – 3:00PM

The Secret to Success — Efficient and Effective Document Reviews
Paula Wun, Senior Director, Medical Writing, SAGE THERAPEUTICS

3:00PM – 3:15PM

Chairperson’s Closing Remarks
Lawrence Giraudi, Manager, PD Regulatory Documentation, F. HOFFMAN-LA ROCHE