Sponsored Webcast: eCTD v4.0: The Future of Regulatory Submissions
Virtual Programs 
Industry is currently seeing rapid changes and improvements to existing electronic Common Technical Document (eCTD) formats, requirements and suggested uses from the US Food and Drug Administration (FDA).
These and other changes affect regulatory operations as a whole. The experts at LexisNexis Reed Tech want to be sure that industry are not only up-to-date with, but understand, these new developments.
To support this knowledge share, their in-house team of eCTD experts will present a webinar that provides a comprehensive overview of the upcoming eCTD v4.0 update, a significant shift from the current v3.2.2 standard.
There will be time allotted for live Q+A with the LexisNexis Reed Tech team of experts. Register for this webinar to gain insights into eCTD v4.0 and ensure your organization is prepared for the future of regulatory submissions.
Learning Objectives
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The key changes introduced in eCTD v4.0, including: a single, global XML message format for regulatory submissions, a structure that better reflects the submission process, enhanced life-cycle management capabilities, and bi-directional communication between submitters and regulatory authorities
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The benefits of adopting eCTD v4.0, such as: streamlined submission process, improved data quality and reuse, and enhanced collaboration between sponsors and regulators
Who Should Attend?
- Reg Operations
- Quality Assurance
- Regulatory Scientists
- Drug Development
- Manager level and higher
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
Gary Saner
Senior Regulatory Principal, Information Solutions, LexisNexis Reed Tech
Gary Saner is a subject matter expert on drug labeling, medical device UDI, and other structured content reporting to regulatory agencies and commercial organizations. He has over 40 years of experience in software development, process management and data administration, with the last 19 years focused on the life sciences industry. With a deep understanding of regulations, business requirements, and systems, he has helped shape and implement successful solutions at Reed Tech for data management, validation, processing and submission of drug labeling content, cosmetic information, and medical device UDI data. He serves as chair of the industry’s Structured Product Labeling (SPL) Technical Team.
Robin Schilling
Head of Regulatory Compliance Services, LexisNexis Reed Tech
Robin Schilling leads Reed Tech’s regulatory compliance services, driving a high-performance, passionate team to help our clients efficiently achieve regulatory compliance and support their drug and medical device development needs. An accomplished and innovative technology, regulatory and business leader with significant experience developing vision and driving strategy, Robin brings with her valuable cross-domain experience to our clients, having worked in consulting, product development and government roles in the life sciences and defense industry. Throughout her career, she has worked with a wide-range of internal and external partners to develop strategic programs, streamline operations and empower teams to deliver high-quality products on-time. She also enjoys liaising with the International Standards Organization to help develop the next set of IDMP standards.
Jim Hilferty
Head of Business Transformation, LexisNexis Reed Tech
Jim has been an innovator and disrupter in the regulated life sciences industry for over 20 years. His extensive depth of experience across product, services, support, quality and commercial functions fundamentally underpin his ability to align cross-functional teams across Reed Tech and our customers to solve complex business problems. Jim currently serves as head of business transformation for the life sciences division of LexisNexis Reed Tech, leading the product management team, driving innovative transformation and operational excellence in support of global regulatory compliance within the life sciences industry.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
