Regulatory Submission Writing for NDA Success

Life Sciences, Pharmaceutical Regulation,
  • Tuesday, September 10, 2024 | 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central)
  • 60 min

Discover an informative webinar that focuses on best practices for document preparation for a regulatory submission and combines lessons learned over many decades of experience.

Regulatory submissions are essential as they serve as the primary mechanism for regulatory agencies to evaluate the safety and efficacy of new drugs and to approve a drug for marketing and patient use. The preparation of written documentation associated with a submission is fundamental for its eventual success and Medical Writers play a pivotal role in this process.

In this webinar, the expert speakers will delve into the submission process, highlighting the various types of submissions and the role of medical writing at each stage. They will cover the common requirements for technical documents and outline the differences in application requirements across major regions such as the US, EU, UK, China and Japan.


The importance of leadership, precise timing and strategic planning in the submission process will be discussed, emphasizing the need for assembling a key team, setting clear expectations and establishing effective working rules. The webinar will also explore how to consistently incorporate standards across documents, clarify key messages and seamlessly integrate pivotal clinical trial documents.

Moreover, they will examine how individual components of an application contribute to the broader submission strategy, focusing on maintaining quality, the necessity of tracking and documentation, resolving conflicts efficiently and preparing for multiple submissions or follow-up requests.

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Register for this webinar today to learn about the specific requirements for regulatory submissions across major global regions, the importance of strategic planning and how to enhance the coherence and quality of technical documentation.


Keith Dawes, ICON

Keith Dawes, Senior Director, Medical Writing, ICON

Keith Dawes has over 20 years of medical writing experience in CROs, pharma and medical communications. He has extensive experience in writing and managing regulatory submissions. Since 2017, Keith has also managed ICON’s writing team in Europe, India and China.

Message Presenter
Tim Weber, ICON

Tim Weber, PhD, Senior Director, Medical Writing, ICON

Tim Weber has more than 25 years of CRO-related medical writing experience, including over 15 years as a Manager of Medical Writing in North America. Before moving into management, his primary areas of focus included GI disorders, oncology, immunology and respiratory. He has written and managed regulatory submissions in all of these therapeutic areas.

Message Presenter

Who Should Attend?

This webinar will appeal to senior professionals from biotech and large pharma companies involved in:

  • Project management
  • Regulatory affairs
  • Medical affairs
  • Pharmacovigilance
  • Pharmacologists
  • Biostatistics
  • Data management
  • Data standards
  • Medical writing

What You Will Learn

Attendees will learn about:

  • The submission process, the various types of submissions and how medical writing contributes to each stage
  • Common requirements for technical documents and the differences in the application requirements across key regions: US, EU, UK, China and Japan
  • The importance of leadership, timing and planning in the submission process and how establishing a team of key individuals and setting clear expectations and working rules are vital
  • How to effectively incorporate standards across documents, understand key messages and integrate pivotal clinical trial documents effectively
  • How the individual components of an application fit into the wider submission, with a focus on quality, the importance of tracking and documentation, effectively addressing conflicts and planning for multiple submissions or follow-up requests

Xtalks Partner


ICON is the world’s leading clinical research organisation, powered by healthcare intelligence. From molecule to medicine, we advance clinical research providing a comprehensive suite of outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. Our outsourcing models can be adapted to suit small local trials to large global programs, including full service, standalone services, FSP and full asset development.

With headquarters in Dublin, Ireland, ICON employs approximately 41,150 employees in 113 locations in 53 countries.

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