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
- Discuss innovative ideas for improving collaboration between sponsors and vendors
- Review process reengineering and change management strategies for implementing transparency initiatives
- Explore the use of cost-effective tools and technologies to help improve the efficiency of document preparation
- Leverage best practices for constructing narrative (safety) summaries for study reports
- Hear about effective mentoring programs to recruit, train and hire medical writers
Speakers
- 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)
- 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
- Thuy Anh Le, Associate Director, Medical Writing, TAIHO ONCOLOGY
- 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
- 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 fill in your name and email to receive the conference agenda of this event.
Conference Day One - Monday, July 10, 2017
- Including: Morning & Afternoon Networking Break, Luncheon
Conference Day Two - Tuesday, July 11, 2017
- Including: Morning Networking Break, Luncheon
The agenda is available as PDF under downloads at the right side of the page.
Venue
Sheraton Philadelphia University City Hotel
3549 Chestnut St, 19104
Philadelphia, PA, USA
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
Venue
Sheraton Philadelphia University City Hotel3549 Chestnut Street
Philadelphia, PA 19104
Sheraton Philadelphia University City is a dynamic lifestyle hotel with a contemporary urban design and lifestyle amenities for business and leisure travelers. Our beautifully renovated hotel offers cutting-edge technology, warm hospitality and beautiful social spaces where you are free to relax, meet, work, dine and do your thing. Our hotel is immersed in the culture and history of Philadelphia, from museums that trace world civilizations to ethnic eateries and elite universities.
To make reservations attendees can call 1-888-627-7070 and request the negotiated rate for ExL’s July Meetings.
To make reservations online
Click HereThe group rate is available until June 23, 2017. Please book your room early as rooms available at this rate are limited.
