PharmiWeb.com - Global Pharma News & Resources
09-Jul-2019 - 10-Jul-2019

6th Clinical Regulatory Medical Writing Forum

  • Location:
    • Sonesta Philadelphia Downtown Rittenhouse Square
    • Market Street
    • Philadelphia County
    • 19103
    • United States
  • View on a map

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