Overview:
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.
This webinar focusses on best practices for document preparation for a regulatory submission, and combines lessons learned over many decades of experience.
Key topics:
- 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.
Speakers:
Keith Dawes
Keith 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.
Tim Weber, PhD
Tim has more than 25 years of CRO medical writing experience, including over 15 years as a manager of medical writing staff 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.
Audience:
- Project Management
- Regulatory Affairs
- Medical Affairs
- Pharmacovigilance professionals
- Pharmacologists
- Biostatistics
- Data Management
- Data Standards
- Medical Writing