New York Professional Events List


4th Clinical Regulatory Medical Writing Forum


Date
Jul 10, 2017 - 08:00 AM - Jul 11, 05:00 PM
Organizer
exlevents
Location
Sheraton Philadelphia University City Hotel 3549 Chestnut Street Philadelphia, PA 19104,

Philadelphia,
PA,
US,
ZIP: 19104
Phone: +1 929 900 1853

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.

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
  • Structured Content Software Suppliers

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Please contact the event manager Marilyn below for the following:
 
- For Tickets/Registrations,
- Discounts for registering  5 or more participants.
- If you company requires a price quotation.
 
Event Manager Contact:


marilyn.b.turner(at)nyeventslist.com or Contact:  +1 929 900 1853
 
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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This Event Listing is Promoted by  New York Media Technologies LLC in association
with EXL Events Inc.

 
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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
 
 


Speaker Details



Event Categories
BUSINESS & MANAGEMENT CONFERENCES
,
HEALTH AND MEDICINE CONFERENCES
,
Healthcare
,
Life Sciences, Biotechnology
,
Technology
Keywords: fun, applications, Clinical , conference , design , development , Engineering , Fun , functions, implemen




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