Sponsored Webcast: Regulatory Writing and Operations to Accelerate Submissions (On Demand)
Accelerating drug approvals in a dynamic regulatory landscape requires precision, efficiency, and adherence to safety standards. Join us for an insightful webinar as we explore the critical role of regulatory writing and operations in advancing drug development timelines while maintaining compliance and patient safety.
This session will provide a comprehensive look at how high-quality regulatory writing ensures clarity and structure in essential documents such as clinical study reports (CSRs), common technical document (CTD) modules, and risk management plans (RMPs). Learn how transparent patient narratives and clear lay summaries foster public trust and meet evolving regulatory demands. On the operations front, discover how industry-leading solutions like electronic CTD (eCTD) submissions, automation, and structured content management streamline global workflows.
We will also discuss strategies such as simultaneous multi-agency submissions and compliance with policies like EMA Policy 0070 to reduce delays while enabling timely access to life-saving therapies.
Registration Fees & Deadlines
Free
Learning Objectives
- Understand the essential role of regulatory writing in drug development.
- Learn how operational strategies, such as eCTD submissions and automation, streamline workflows.
- Explore synergy between writing excellence and operational optimization for faster approvals.
- Gain insights into fostering trust and transparency through patient-focused communication.
Who Should Attend?
Clinical operations, C-Suite, Clinical Development, Clinical Regulatory, Global Submissions, Regulatory affairs, outsourcing, vendor management, medical affairs, medical information officer, Scientific communications, patient safety, pharmacovigilance, pharmacology, Regulatory Operations, Regulatory and Medical Writing?
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Speakers
Evan Richardson
Senior Director, Regulatory Operations and Clinical Disclosure, Certara
A seasoned pharmaceutical industry veteran, Evans Richardson brings nearly 20 years of experience spanning drugs, biologics, and medical devices. He's worked with organizations of all sizes, both within industry and at service providers, developing a broad skillset encompassing regulatory affairs and operations, clinical disclosure, quality management, and project management. Currently, he leads a global team of subject matter experts at Certara, helping clients navigate electronic regulatory submissions and clinical data disclosure requirements.
