arivis will discuss the different types of promotional material submissions and the documents needed.
We will discuss the different document types permitted by FDA standards and how Promotional and Consumer materials will be presented separately. Additionally, we will discuss best practices for what to do with materials that are produced in a format not permitted for eCTD.
arivis likes to give the attendees a better understanding of OPDP submissions and how to prepare them for a compliant eCTD submission. The Attendees should be able to feel confident when putting together an OPDP submission and get a better understanding on which document types are accepted in eCTD format and what steps to take to ensure their files are compliant.
Wednesday Feb 12 from 10:30-11:45 am EST
Senior Manager, Regulatory Operations, arivis Inc.
Heather Fisher is a Senior Regulatory Operations Manager at arivis, where she serves as a collaborative extension of pharmaceutical clients’ regulatory teams. She is proud to support clients throughout the life of their regulatory applications to ensure life-changing medications are brought to market while meeting internal and agency driven goals. Heather has worked with Accenture for ten years prior to joining Arivis and has completed multiple NDA, IND, CTA and MAA applications in her tenure. She enjoys working with clients and helping them to learn eCTD and advance their knowledge to better meet the needs of their company.
About the conference
DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) Forum provides the elements needed to meet the challenges of optimizing the efficient use of regulatory information: the RIM principles, effective processes and tools, benefits to data applications across the product lifecycle, and examination of real-life results. DIA will present four tracks and daily health authority plenary sessions to provide a comprehensive view of content and regulatory information management and submissions. All tracks are supported with daily plenary sessions providing regulatory intelligence updates by health authority representatives from FDA, Health Canada, and other regions of interest.
This Forum provides multiple opportunities for networking, knowledge sharing, and education for both business- and technology-focused attendees.
Venue: Bethesda North Marriott Hotel and Conference Center 5701 Marinelli Road, North Bethesda, MD 20852, USA