Registration Fees & Deadlines

Learning Objectives

• Understand the benefits of a top-down approach to regulatory submissions and how it compares with conventional bottom-up methods
• Learn how to build and align key messages early using tools such as the Target Product Profile (TPP), US Annotated Label, and Module 2 summaries
• Gain strategies to ensure consistency across the CTD, from high-level labeling language to detailed clinical and non-clinical study reports
• Identify best practices and common pitfalls in planning and preparing submissions, including when to start and how to avoid data and messaging gaps

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

Steve Sibley
Vice president of Global Submissions, Certara

With a career spanning more than 30 years in the pharmaceutical industry, Steve Sibley provides regulatory writing consulting services and leads the global submissions service line within Certara Drug Development Solutions. He has led global submission teams and authored critical documentation on more than 45 marketing applications and more than 30 investigational drug applications. Sibley has particular expertise in briefing documents, regulatory defense, and submission planning. Sibley’s work has covered the full range of therapeutic areas and program types, with a particularly strong background in oncology, cardiology, and rare diseases, including participation in health authority meetings and advisory committee meetings. His experience is truly global, having worked in project teams encompassing the United States, the European Union, Australia, and Asia. Sibley draws on his substantial industry knowledge and leadership skills to mentor and train other submission leads.

Brenda Taylor
Director of Global Submissions, Certara

Brenda Taylor has over 20 years of experience in the biotechnology and pharmaceutical industry. She has led regulatory strategy and submission management activities to support pharmaceutical development and manufacturing, with an emphasis on Initial New Drug (IND) applications and marketing applications. Brenda’s research background in microbiology and immunology includes design and performance of nonclinical studies. Her therapeutic areas of expertise include oncology, cardiovascular, and anti-infective agents, spanning both small-molecule drugs and biologics.

Mark Bolby
Senior Director Global Submissions,Certara

Mark Bowlby has over 25 years of experience in the clinical research and drug development industry. During the last 10 years, he has led many New Drug Applications (NDA), Biologics License Applications (BLA), and Investigational New Drug (IND) submissions to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). Bowlby has led the authoring of Investigator’s Brochures (IBs), clinical study reports (CSRs), clinical summaries and overviews, briefing packages, and other regulatory documents. Earlier in his career, Je planned and wrote numerous biomedical manuscripts, posters, and slides regarding his scientific research and postdoctoral work at Harvard Medical School. His therapeutic areas of expertise include ophthalmology, neurology, psychiatry, and chronic pain. He has an expert understanding of drug discovery and development approaches used in the current biopharmaceutical environment.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions