3rd Clinical Regulatory Medical Writing Forum – 3rd Clinical Regulatory Medical Writing Forum
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 and guidances, 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 3rd 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.
**ExL Events certifies that this conference has been approved for 12 Regulatory Affairs Credits (RAC) by the Regulatory Affairs Professional Society (RAPS)**
Discuss the new EU clinical trials regulation, the challenges of preparing lay summaries and how to stay ahead of the curve
Learn how your peers manage data sharing, redactions and the anonymization of patient data
Determine how to prepare a risk management plan and safety documents for the different regional regulatory authorities
Explore the challenges of preparing pediatric documentation
Discover which tools and technologies can help expedite the medical writing process
Who Should Attend
This conference is designed for representatives from pharmaceutical and biotechnology companies with responsibilities in the following areas: