Join us at a location near youFor an exclusive, complimentary, life sciences seminar
Reuse, Reduce, Recycle: Use Structured Authoring to Save Time & Improve Compliance
Many life sciences organizations have considered using a structured authoring approach to meet their regulatory needs, but few have been able to achieve solid success in doing so. Structured authoring enables organizations to develop documentation that is consistent and repeatable while saving time and money in the process. The promise is great so, why hasn’t adoption been higher?
It has been a widely accepted concept that organizing – or structuring – your content can be beneficial. But when concept meets with reality, the true struggle begins: what is the best approach? How can I follow this structure and still have the flexibility I often need? How can I balance granularity and complexity? How much time needs to be invested – and how much time can be gained – in authoring, review and approval? How can structured authoring facilitate consistency and compliance?
DitaExchange has teamed with eCTDConsultancy in Europe and Powell Regulatory Services in the US to host a series of half-day seminars for life sciences organizations to share how adding structure to your content will help your organization create, manage, deliver and re-use critical information. Our goal is to help you better understand how structured content management enables organizations to standardize their information across their business while increasing document quality and decreasing costs and time to market. In this complimentary, half-day seminar, you will:
- Learn how a proactive approach to structuring your content can lead to both re-usability and consistency
- Uncover new techniques for collaborative authoring
- Discover how your regulatory documents (including clinical study reports, product information and Module 3 documents) and regulatory submissions can become faster to prepare
- 8-9 AM Registration & Breakfast
- 9-10 AM Repetition of content across regulatory documents
- 30- Minute Break
- 10:30-11:30 AM Free Your Content Realizing Reusability – Jim Nichols, Dita Exchange
- 11:30-11:45 Wrap-Up
Meet the Speakers
Hans van Bruggen
Hans is a visionary concerning regulatory information management, considering the right-first-time creation of information and documentation (content) and the ability to see the scientific content in context of use. Content concerns regulatory-, chemical/pharmaceutical-, nonclinical- and clinical information justifying the consistently produced high quality drugs with a favourable benefit-risk ratio for a clearly defined patient population when used in accordance with the prescribing information. Hans is a director and regulatory affairs scientist with eCTDConsultancy.
Sarah Powell is the founder of Powell Regulatory Services. Sarah has over 28 years of experience in pharmaceutical and related regulated industries. Sarah has been a consultant for the last 8 years and has worked on assisting clients with projects related to process improvements, standards development, defining filing strategies and writing and review of submission content. Prior to that, Sarah worked on a variety of projects related to implementation of regulatory solutions and has contributed to defining product strategies for industry leading software solutions. While in industry, Sarah performed a variety of roles within the Clinical, Quality, Regulatory Affairs and Regulatory Operations groups. Sarah has extensive experience with preparing regulatory submission for biologic products for submission in the US and EU. She also has detailed knowledge on the requirements for the electronic submissions.
Jim is vice president of U.S. Operations and Life Sciences for Dita Exchange, Jim Nichols is responsible for driving the company’s efforts in North America as well as its global strategy for the Life Sciences market. His responsibilities also include leading the company’s marketing, client services, professional services and product management.
Prior to joining DitaExchange, Jim held several executive level positions with technology companies including over 10 years at Liquent (now part of Parexel), Thomson Reuters, ePharmaSolutions and Liaison Technologies. Nichols graduated with a bachelor’s degree in Mathematics from Penn State University and lives in Delaware with his partner.