Sponsored Webcast: Best Practices for Simultaneous Submissions to EMA/FDA (On Demand)

Sponsor companies are now expected to submit globally as quickly as possible.  Successful achievement of this combination of speed and complexity requires extensive regulatory knowledge and planning.  The first half of this webcast will cover how to plan for simultaneous global submissions, including aspects the team can control and aspects that are out of the team’s control.  The second half of this webcast will cover the strategic planning and practices necessary for efficiently publishing and assembling the thousands of documents and data files required for submission.

Registration Fees & Deadlines

Learning Objectives

• Factors to be addressed to achieve simultaneous global submissions.
• What factors are typically within a team’s control, which are not, and how to mitigate the potential impacts of those factors not in the team’s control.
• Which activities can be aligned across application types to expedite the publishing of simultaneous submissions and prevent unnecessary re-work.
• How to leverage re-usability and commonality for efficiency in eCTD publishing.

Who Should Attend?

• All regulatory affairs professionals
• Product and submission team leads
• Regulatory Operations
• Project Managers
• Regulatory and Medical Writers

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 Regulatory Strategy, 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 (CDDS). 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.

Rachel Bombara
Sr. Regulatory Services Manager, Certara

Rachel Bombara has more than 13 years of experience in regulatory operations and helping sponsors achieve their eCTD submission goals. She has led the eCTD submission publishing of a variety of application types for different regions, from small amendments to large-scale original marketing applications, as well as mentored and trained others in eCTD publishing and submission management. She has also spoken at industry conferences on topics pertinent to investigational and marketing related submissions and produced a variety of blogs, presentations, and other materials to share valuable industry insights.