$2,085 – $6,275

4th Clinical Regulatory Medical Writing Forum (EXL)

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Sheraton Philadelphia University City Hotel

3549 Chestnut Street

Philadelphia, PA 19104

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4th Clinical Regulatory Medical Writing Forum

Regulatory medical writers face quite the challenging prospect when preparing applications and documents for submission to global regulatory authorities. They must coordinate with various stakeholders to gather, organize and compile information on new products and processes, interpret the data from clinical trials, and present the findings in a clear and concise way. Their ability to communicate the results and outcomes of a product while maintaining a logical narrative and managing aggressive deadlines helps determine whether a new therapeutic or medical device is approved for commercialization.

The 4th Clinical Regulatory Medical Writing Forum is designed to provide attendees with the strategies and insights needed to efficiently compose clinical regulatory documents, manage in-house and external resources, effectively execute the writing process, and understand the recent developments in regulations.

Conference Chairperson

Bert Wagner
Associate Director, Regulatory Medical Writing
JANSSEN

Featured Speakers


Madhavi Gidh-Jain, Ph.D., Senior Director, Head of Medical Writing, Clinical Documentation (US), SANOFI
Vishal Soni, Head of NTE, Early Development and Clinical Pharmacology Medical Writing, TEVA PHARMACEUTICALS
Barbara Kress, Executive Director, Clinical Data Disclosure and Transparency, MERCK

Deborah Collyar, President, PATIENT ADVOCATES IN RESEARCH (PAIR); Research Summary Manager, HEALTH LITERACY MEDIA (HLM)
Lisa Cloutier, Head, Outsourcing Operations for Regulatory Medical Writing, JANSSEN
Gretchen Griffin, M.S., Director, Regulatory Strategic Writing, ABBVIE

Top Five Reasons to Attend

  1. Discuss innovative ideas for improving collaboration between sponsors and vendors
  2. Review process reengineering and change management strategies for implementing transparency initiatives
  3. Explore the use of cost-effective tools and technologies to help improve the efficiency of document preparation
  4. Leverage best practices for constructing narrative (safety) summaries for study reports
  5. Hear about effective mentoring programs to recruit, train and hire medical writers

Who Should Attend

This conference is of interest to professionals from pharmaceutical, biotechnology and medical device companies who are involved in regulatory medical writing with the following job functions:

  • Medical Writing
  • Regulatory Writing
  • Regulatory Affairs
  • Regulatory Operations
  • Clinical Operations
  • Technical Writing
  • Clinical Research
  • Electronic Submissions
  • Medical Affairs
  • Clinical Documentation
  • Clinical Publishing
  • Submissions and Documentation
  • Global Medical Publishing

This conference is also of interest to:

  • Document Application Suppliers
  • Information Management Consultants
  • Research Informatics
  • Clinical Research Organizations
  • Component Authoring Software Suppliers
  • Publication Service Providers
  • Medical Writing Service Providers
  • Bibliographic Software Suppliers
  • eCTD Suppliers
  • Regulatory Submissions Providers
  • Consultants

Agenda

Day One

Monday, July 10, 2017

8:00AM – 8:45AM

Registration and Continental Breakfast

8:45AM – 9:00AM

Chairperson’s Opening Remarks

Bert Wagner, Associate Director, Regulatory Medical Writing, JANSSEN

9:00AM – 9:45AM

Effective Project Management Tips for Medical Writers

Lynne Munno, M.A., M.S., Associate Director, Medical Writing, DECIPHERA PHARMACEUTICALS

9:45AM – 10:30AM

Review Process Re-Engineering: How to Achieve More Efficient and Valuable Document Review

Barry Drees, Ph.D., Senior Partner, TRILOGY WRITING & CONSULTING

10:30AM – 11:00AM

Networking Break

11:00AM – 11:45AM

Address the Need for Streamlined Processes and Increased Awareness Among Global Regulatory Authorities Regarding eCTD Submissions for Legacy Products

Anil H. Vaidya, Associate Director, Medical Writing, Cardiovascular/Metabolic/Rare Diseases, PFIZER

11:45AM – 12:30PM

Understand the New FDA Guidance for Assessing the Abuse Potential of New Products

Vishal Soni, Head of NTE, Early Development and Clinical Pharmacology Medical Writing, TEVA PHARMACEUTICALS

12:30PM – 1:30PM

Luncheon

1:30PM – 2:15PM

Preparing the Investigator’s Brochures with the Investigator in Mind

Rene A. Alvarez, Director, Medical Writing, SUNESIS PHARMACEUTICALS

2:15PM – 3:00PM

An Overview of Pediatric Plans: Medical Writing for the Evolving Pediatric Landscape

Jennifer Rilstone, Ph.D., Senior Regulatory Documentation Scientist, PD Regulatory Documentation, F. HOFFMANN-LA ROCHE

3:00PM – 3:30PM

Networking Break

3:30PM – 4:15PM

Writing Plain Language Summaries in Accordance with the New EU Guidelines

Carmen E. Aldinger, Ph.D., M.P.H., Program Manager, MULTIREGIONAL CLINICAL TRIALS CENTER OF BRIGHAM AND WOMEN’S HOSPITAL, HARVARD

4:15PM – 5:00PM

PANEL: A Year Into Implementation — Where Does the Industry Stand in Meeting the EU’s Clinical Trial Disclosure and Data Transparency Requirements?

Carmen E. Aldinger, Ph.D., M.P.H., Program Manager, MULTIREGIONAL CLINICAL TRIALS CENTER OF BRIGHAM AND WOMEN’S HOSPITAL, HARVARD
Deborah Collyar, President, PATIENT ADVOCATES IN RESEARCH (PAIR); Research Summary Manager, HEALTH LITERACY MEDIA (HLM)
Behtash Bahador, Senior Manager, Quality and Compliance, Communicating Trial Results, CENTER FOR INFORMATION & STUDY ON CLINICAL RESEARCH PARTICIPATION (CISCRP)
Barbara Kress, Executive Director, Clinical Data Disclosure and Transparency, MERCK

5:00PM –

Day One Concludes

Day Two

Tuesday, July 11, 2017

8:00AM – 8:45AM

Continental Breakfast


8:45AM – 9:00AM

Chairperson’s Recap of Day One


Bert Wagner, Associate Director, Regulatory Medical Writing, JANSSEN

9:00AM – 9:45AM

How to Sustain and Grow a Relationship Between a Sponsor and Vendor


Rumina Sunderji, Outsourcing Manager, Product Development Regulatory Documentation, F. HOFFMANN-LA ROCHE

9:45AM – 10:30AM

PANEL: Innovative Ideas to Improve the Working Relationship Between the Sponsor and Medical Writing Service Providers


Lisa Cloutier, Head, Outsourcing Operations for Regulatory Medical Writing, JANSSEN
Mari Welke, Director of US Operations, TRILOGY WRITING & CONSULTING
Maha Saad, Ph.D., MBA, Associate Director, Global Medical Safety, JANSSEN
Gretchen Griffin, M.S., Director, Regulatory Strategic Writing, ABBVIE

10:30AM – 11:00AM

Networking Break


11:00AM – 11:45AM

Structured Content and Information Design That Maintains Consistency and Turns Content Into “Data”


Mitzi Allred, Ph.D., EE, Director, Clinical Operations, MERCK
Vasu Ranganathan, President, ARBORSYS GROUP

11:45AM – 12:30PM

Creative Artificial Intelligence (AI): Teaching Computers to Be Medical Writers


Madhavi Gidh-Jain, Ph.D., Senior Director, Head of Medical Writing, Clinical Documentation (US), SANOFI

12:30PM – 1:30PM

Luncheon


1:30PM – 2:15PM

Develop a Robust Onboarding and Training Process for New Medical Writers


Bert Wagner, Associate Director, Regulatory Medical Writing, JANSSEN

2:15PM – 3:00PM

Competency Models and Certifications That Can Help Medical Writers Succeed


Darryl Z. L’Heureux, Ph.D., Senior Scientific Writer, BRISTOL-MYERS SQUIBB
Eileen Girten, M.S., Adjunct Assistant Professor of Biomedical Writing, UNIVERSITY OF THE SCIENCES

3:00PM – 3:45PM

PANEL: Effective Mentoring Programs to Recruit, Train and Hire Medical Writers


Bert Wagner, Associate Director, Regulatory Medical Writing, JANSSEN
Darryl Z. L’Heureux, Ph.D., Senior Scientific Writer, BRISTOL-MYERS SQUIBB
Eileen Girten, M.S., Adjunct Assistant Professor of Biomedical Writing, UNIVERSITY OF THE SCIENCES

3:45PM –

Conference Concludes



Faculty


Carmen E. Aldinger, Ph.D.
Program Manager, MULTI-REGIONAL CLINICAL TRIALS CENTER OF BRIGHAM WOMEN’S HOSPITAL AND HARVARD

Mitzi Allred, Ph.D., EE
Director, Clinical Operations, MERCK

Rene A. Alvarez
Director, Medical Writing, SUNESIS PHARMACEUTICALS

Behtash Bahador
Senior Manager, Quality and Compliance, Communicating Trial Results, CENTER FOR INFORMATION & STUDY ON CLINICAL RESEARCH PARTICIPATION (CISCRP)

Behtash Bahador, Senior Manager, Quality and Compliance, Communicating Trial Results, CENTER FOR INFORMATION & STUDY ON CLINICAL RESEARCH PARTICIPATION (CISCRP)

Lisa Cloutier
Head, Outsourcing Operations for Regulatory Medical Writing, JANSSEN

Deborah Collyar
President, PATIENT ADVOCATES IN RESEARCH (PAIR)

Research Summary Manager, HEALTH LITERACY MEDIA (HLM)

Barry Drees, Ph.D.
Senior Partner, TRILOGY WRITING & CONSULTING

Madhavi Gidh-Jain, Ph.D.
Senior Director, Head of Medical Writing, Clinical Documentation (US), SANOFI

Eileen Girten, M.S.
Adjunct Assistant Professor of Biomedical Writing, UNIVERSITY OF THE SCIENCES

Gretchen Griffin, M.S.
Director, Regulatory Strategic Writing, ABBVIE

Barbara Kress
Executive Director, Clinical Data Disclosure and Transparency, MERCK

Darryl Z. L’Heureux, Ph.D.
Senior Scientific Writer, BRISTOL-MYERS SQUIBB

Lynne Munno, M.A., M.S.
Associate Director, Medical Writing, DECIPHERA PHARMACEUTICALS

Vasu Ranganathan
President, ARBORSYS GROUP

Jennifer Rilstone, Ph.D.
Senior Regulatory Documentation Scientist, PD Regulatory Documentation, F. HOFFMANN-LA ROCHE

Maha Saad, Ph.D., MBA
Associate Director, Global Medical Safety, JANSSEN

Maha Saad, Associate Director, Global Regulatory Medical Writing, CNS/Neuropsychiatry, TEVA PHARMACEUTICALS

Vishal Soni
Head of NTE, Early Development and Clinical Pharmacology Medical Writing, TEVA PHARMACEUTICALS

Rumina Sunderji
Outsourcing Manager, Product Development Regulatory Documentation, F. HOFFMANN-LA ROCHE

Anil H. Vaidya
Associate Director, Medical Writing, Cardiovascular/Metabolic/Rare Diseases, PFIZER

Bert Wagner
Associate Director, Regulatory Medical Writing, JANSSEN

Mari Welke
Director of US Operations, TRILOGY WRITING & CONSULTING



Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

NO REFUNDS OR TRANSFER ALLOWED ON REGISTRATIONS
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Sheraton Philadelphia University City Hotel

3549 Chestnut Street

Philadelphia, PA 19104

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