Transform Your Regulatory Submissions: Strategies for Consistency & Efficiency

開催日: 2025年11月20日 (木曜日)

開催時間: 11:00 EST - 12:00 EST

薬事規制

Planning and Preparing Regulatory Submissions Using Top-down Messaging

Ready to transform your regulatory submission process?

Developing consistent, data-driven messages is a critical step in preparing regulatory submissions, yet it’s often overlooked. This can lead to inefficiencies, inconsistencies, and late-stage surprises that derail your timeline.

Join Certara experts for an exclusive session where we’ll share strategies proven across dozens of successful marketing applications. Discover how a modern, top-down approach can streamline your workflow and accelerate approvals.

Key Learning Objectives:

In this webinar, you will learn how to:

Embrace a visionary, top-down approach over conventional bottom-up methods to drive efficiency.
Build and align key messages early using the Target Product Profile (TPP), U.S. Annotated Label, and Module 2 summaries.
Ensure seamless consistency across the CTD, from labeling to clinical and non-clinical study reports.
Master best practices and sidestep common pitfalls by knowing when to start planning and how to avoid critical gaps.

Who is this webinar intended for?:

Leave with practical tools and real-world insights to achieve smoother, faster, and more effective submissions.

Who should attend this webinar?
This session is essential for professionals in regulatory strategy, writing, and submission planning, including:

Regulatory Affairs Leaders and Associates
Medical and Regulatory Writers
Clinical Development and Program Managers
CMC, Non-clinical, and Clinical Scientists
Quality and Submission Leads

講演者

Steve Sibley

Vice President of Global Submissions | サターラ

Steve Sibleyは、製薬業界で30年以上の経験を持ち、Certara Drug Development Solutions（CDDS）において薬事文書作成のコンサルティングを提供するとともに、グローバル申請サービス部門の責任者を務めています。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 | サターラ

Brenda Taylor is a Director of Global Submissions at Certara. She 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 Bowlby

Senior Director Global Submissions | サターラ

Dr. Bowlbyは臨床研究および医薬品開発業界において25年余の経験を有しています。直近の10年間は、米国食品医薬品局および欧州医薬品庁への数多くの新薬申請、生物製剤承認申請、治験薬（IND）申請をリードしてきました。また、治験薬概要書（IB）、治験総括報告書（CSR）、臨床試験の要約および概要、対面説明資料（briefing package）、およびその他の規制文書のオーサリングも指揮してきました。それ以前の職務では、ハーバード・メディカル・スクールにおける自身の科学的研究と博士課程修了後の研究に関して、多数の生物医学的な原稿、ポスター、スライドを計画・執筆しました。彼の専門の治療領域には、眼科、神経内科、精神科、慢性疼痛管理分野が含まれます。最新の生物医薬品環境で使用されている創薬および医薬品開発アプローチについての専門的知識を有しています。

Don’t let an outdated process slow you down. Reserve your spot today and learn how top-down planning can ensure consistency and accelerate approvals for your next submission.

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