Presenter: Satish Tadikonda, Ph.D., President, Virtify, Inc.
Use of Structured Product Labeling Four (SPL R4) is now mandated and changes the submissions process for all Human Health, Animal Health and Biologics and Vaccines organizations. Organizations are modifying in-house systems to meet the new SPL R4 requirements and are evaluating new technologies and solutions to help with this process.
The mandated move to e-submissions forces Life Sciences organizations to make changes in business process and technology. Registrants will replace Forms 2656, 2657 and 2658 with an electronic submission using the SPL R4 format. Understanding how to keep current with SPL R4, while optimizing the e-submissions process offers organizations the opportunity for cost savings and more consistent and reliable submissions.
However, to make the transition to SPL R4 and deploy a best practice implementation presents a challenge. The impact of SPL R4 has profound organizational impact in authoring, packaging and delivery of information.
During this webinar, Dr. Tadikonda will address:
- how an optimized e-submissions process will enable more efficient and effective compliance with SPL R4
- specific tips and techniques for accelerating the process of moving from SPL R3 submissions to SPL R4
- how to manage the entire content lifecycle to assure that changes for SPL R4 compliance fit into an enterprise-wide e-submissions strategy
- what impact the move to SPL R4 compliance will have on existing processes, infrastructure investments and legacy systems
At the conclusion of the presentation you will understand:
- Best practices for complying with SPL R4
- How to accelerate the conversion process from SPL R3 submissions to SPL R4 submissions
- How to automate the information transfer to SPL XML structure
- How to manage change with SPL R4 and streamline submissions planning, preparation and tracking
- How to perform in-depth validation and QC for SPL R4 information
Your Speaker: Satish Tadikonda is President of Virtify, Inc, a global Life Sciences software company headquartered in Cambridge , MA . During his 20+ years of experience in the drug and medical device industries, he has worked on a number of long-term strategic initiatives and quick win solutions in the Life Sciences and Information technology sectors. With a deep understanding of drug discovery and development processes, Dr. Tadikonda has significant experience with global clinical and regulatory submission standards and has been actively involved in leading, or participating in, the development of electronic standards for the industry. Prior to Virtify, Dr.Tadikonda founded companies focused on electronic data capture and R&D systems integration and held senior management positions with leading companies in the pharmaceutical and medical device.