In order for a new drug or therapy to gain marketing authorization, writers must coordinate with various stakeholders to gather, organize and compile information on new products or processes; interpret data from clinical trials; and find efficient ways to present trial findings. These documents are then submitted to the FDA, EMA and other regulatory authorities for their approval, with very little time to respond to inquiries or provide additional information.
Given the constant evolution of US and international regulations, it is vital that medical writers stay up to date with the ever-changing regulatory landscape and find innovative approaches to managing the writing process to meet deadlines.
The 6th
Clinical Regulatory Medical Writing Forum will address recent regulatory changes and feature industry leaders as they discuss process improvement strategies. Return to work armed with the necessary tools and techniques to contend with aggressive deadlines.
Top Five Reasons to Attend
- Establish patient anonymization and de-identification processes that satisfy transparency requirements while preserving the integrity of the clinical research
- Increase the quality and speed of protocol writing by leveraging various templates, and minimize uncertainty in the interpretation of clinical data
- Analyze the benefits of having a medical writer as a strategic partner in document preparation and submission planning
- Create models for working with vendors/contractors that can be adapted for changing program and document needs
- Develop effective onboarding and mentoring programs that will allow you to recruit millennials and train the next generation of 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
Speakers
- Jo Blyskal, Senior Director and Head of Global Regulatory Medical Writing and Data Disclosure, TEVA PHARM
- Mamta Chawla, M.Sc., Ph.D., Director Program Delivery, Development Operations, KINAPSE
- Lisa Cloutier, Associate Director, Regulatory Medical Writing Business Operations, JANSSEN
- Monica Eiland, Ph.D., Lead Medical Writer, SHIRE
- Douglas Fiebig, Senior Partner, TRILOGY WRITING & CONSULTING
- Madhavi Gidh-Jain, Ph.D., Head, Medical Writing and Site Coordinator for Clinical Documentation (U.S.), SANOFI
- Lawrence Giraudi, Manager, Regulatory Documentation, F. HOFFMAN-LA ROCHE
- Jerry Hattrup, President, AUDUBON PM ASSOCIATES
- Kelley L. Hill, Senior Director, Global Medical Writing, ALEXION PHARMACEUTICALS
- Darryl Z. L'Heureux, Ph.D., Global Development and Medical Affairs, Medical Data Operations, MW Manager, BRISTOL-MYERS SQUIBB
- Lakshmi Ramkumar, Medical Writing Department Head, BOSTON BIOMEDICAL
- Maha Saad, Ph.D., MBA, Americas Local Operating Companies Team Lead, Bioresearch Quality and Compliance, JANSSEN
- Mari Welke, Director of US Operations, TRILOGY WRITING & CONSULTING
- Peter Zhang, Ph.D., Head of Biostatistics, OTSUKA PHARMACEUTICALS
Please fill in your name and email to receive the Agenda of this event.
Venue
Sonesta Philadelphia Downtown Rittenhouse Square
1800 Market St, 19103
Philadelphia, PA, USA
Venue
Sonesta Philadelphia Downtown Rittenhouse Square1800 Market St.
Philadelphia, PA 19103
Explore the comfort and fresh, contemporary vibe at the all-new Sonesta Philadelphia. A premier choice among hotels in Philadelphia enjoys spacious, modern accommodations and luxurious amenities while staying in the heart of downtown and only steps away from Rittenhouse Square.
To make reservations, please call 1.800. SONESTA and request the negotiated rate for ExL's July Meetings. To make reservations online
Click HereThe group rate is available until June 17, 2019. Please book your room early, as rooms available at this rate are limited.
