As biotech and pharmaceutical companies advance innovative therapies toward commercialization, preparing for a successful marketing application submission has never been more critical. Regulatory expectations continue to evolve across regions, and even minor gaps in submission readiness can lead to costly delays or a refuse-to-file outcome. Early assessment and proactive planning are essential to de-risk the submission process and streamline approval pathways.
In this webinar, experts in regulatory strategy and operations will discuss how sponsors can assess marketing application readiness throughout pivotal trial planning, execution and submission preparation. Attendees will gain insights into identifying and addressing potential gaps in critical data across chemistry, manufacturing and controls (CMC), nonclinical, clinical and geography-specific regulatory requirements. The session will also highlight key interactions with regulatory agencies and operational strategies to streamline submission execution.
Register for this webinar to learn practical approaches for building submission confidence, reducing regulatory risk and positioning programs for a smoother path to market approval.
Speakers
Cathy Gatza, PhD, Vice President, Regulatory Strategy, Premier Research
Catherine Gatza, PhD, is an experienced Regulatory Strategist with over 11 years of experience across both CROs and Sponsor companies in the pharmaceutical industry. Dr. Gatza is skilled in the development of strategic and streamlined drug development programs across multiple therapeutic areas, with a specialization in 505(b)(2) applications. She has led the development of regulatory strategy for small, mid- and large pharmaceutical companies, from early-stage proof-of-concept to NDA submissions and approvals, as well as post-approval support for small molecules, biologics, fixed-dose combination and drug-device combination products. She has extensive experience in leading multidisciplinary teams to support drug development programs.
Dr. Gatza has worked across multiple therapeutic areas, including oncology, cardiovascular disease, gastroenterology, metabolic diseases, neurology, dermatology, reproductive health and infectious diseases, including rare diseases. Dr. Gatza has participated in over 45 FDA meetings and been involved in submissions across 13 FDA Divisions, as well as the Office of Generic Drugs and the Office of Orphan Product Development.
Dr. Gatza has a PhD in Cell and Molecular Biology from Baylor College of Medicine and completed a postdoctoral fellowship in breast and colon cancer at Duke University Medical Center.
Message Presenter
Elizabeth Narciso, Vice President, Regulatory Operations, Premier Research
Elizabeth Narciso leads a team of regulatory operations professionals in preparing and submitting regulatory documentation on behalf of clients to the Food and Drug Administration and other health authorities. She has spent her career in regulatory operations and has integrated regulatory affairs in a variety of roles, including Research Associate, Regulatory Associate, Documentation Specialist and Publisher. Additionally, she has experience developing and maintaining systems and procedures. Prior to joining Premier, Ms. Narciso held roles at Genitope, PDL Biopharma, CV Therapeutics, Matrix Pharmaceutical and Theravance. She holds a Bachelor’s Degree in Biology with an emphasis in Microbiology from San Francisco State University.
Message PresenterWho Should Attend?
This webinar will benefit Managers and above at biotech and specialty pharma companies with job functions including, but not limited, to:
- Drug Development
- Clinical Operations
- Medical Affairs
- Regulatory Affairs
- Project Management
What You Will Learn
Attendees will gain insights into:
- Assessing marketing application approval readiness
- Identifying gaps and developing remediation plans to reduce delays
- Navigating regional regulatory differences, including eCTD updates
Xtalks Partner
Premier Research
Premier Research International LLC (Premier) is a global leader in clinical research and consulting services with expertise in driving an efficient and effective path to market for the life sciences industry.
Premier is built with the needs of biotech in mind, turning breakthrough science into life-changing drugs, devices, and diagnostics by addressing trial complexity, overcoming development hurdles, and demonstrating product value.
Leveraging deep therapeutic expertise, innovative technology, and product development operational proficiency—from preclinical planning to clinical trial execution and commercialization—our integrated approach offers personalized, end-to-end solutions to identify the pertinent data and insight necessary to make informed decisions earlier and deliver accelerated development timelines for a smarter, faster path to approval. To learn more visit premier-research.com.
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