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.
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
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 Head, Outsourcing Operations for Regulatory Medical Writing, JANSSEN, Kelly DiGian Director, Data TRansparenct and Disclosure, TEVA PHARAMCEUTICALS, Monica Eiland, Ph.D. Lead Medical Writer, SHIRE, Douglas Fiebig Senior Partner, TRILOGY WRITING And 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, 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, Maha Saad, Ph.D., MBA Americas Local Operating Companies Team Lead, Bioresearch Quality and Compliance, JANSSEN, Mari Welke Director of US Operations, TRILOGY WRITING AND CONSULTING, Peter Zhang, Ph.D. Head of Biostatistics, OTSUKA PHARMACEUTICALS
Time: 9:00 am to 5:00 pm
Early Bird: USD 1895.0,
Standard: USD 2095.0,
Onsite: USD 2295.0
6th Clinical Regulatory Medical Writing Forum
Reviews are public and modifiable.
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