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Clinical Data Standards and Submission Compliant Deliverables Webinar Series.
Receive a 10% Discount when you register ONLINE for Parts 1 and 2 in ONE transaction.
SEPTEMBER 14
PART 1: HISTORY, BENEFITS, AND IMPLEMENTATION OF DATA STANDARDS (CDISC, SHARE, CDASH, and SDTM)
This webinar will provide a historical overview of emerging standards such as CDISC SHARE, CDASH, and SDTM. Presenters will explain the benefits of these standards as well as how to implement them from an EDC/DM perspective.
SEPTEMBER 21
PART 2 - DATA STANDARDS FOR REGULATORY SUBMISSION DELIVERABLES: CONNECTING THE CLINICAL DATA AND SUBMISSION LIFECYCLES
Presenters will discuss the ODM and ADaM standards, how and where they fit into the process, and the time and cost benefits of producing submission compliant deliverables. Presenters will also discuss the new 1.5.1 Study Data Specifications and its impact on preparing a compliant data package for eCTD submissions to the FDA.
SEPTEMBER 23
CRITICAL CHAIN IN THE PHARMACEUTICAL INDUSTRY
This highly interactive webinar will provide you with an opportunity to fully explore how Critical Chain improves the execution of projects in the pharmaceutical industry, particularly in the areas of project management, R&D functions, and executive sponsorship.
FEATURED TOPICS
- Critical chain at the team level
- Executive sponsorship
- Sustainability
- Scalability
- Change management
SEPTEMBER 29
OPIOID CLASS REMS: WHAT'S NEXT?
This webinar will explore the considerations that went into the proposed
REMS, why it was rejected, and what is likely to happen going forward.
OCTOBER 5
THE EMERGENCE OF DIGITAL SIGNATURES IN CLINICAL OPERATIONS
This webinar will address business benefits, technical challenges, and deployment considerations from CRO, sponsor, and Software-as-a-Service (SaaS)/CSO perspectives based on real-world use of digital signatures in the clinical market today.
FEATURED TOPICS
- Case studies of actual digital signature deployments within quality, audit, and compliance operations; Site monitoring and field operations; and investigator portals
- Case studies presented on live installations at large pharma, medical device, and SaaS-based clinical services
- Applications discussed range from quality and compliance documentation, investigator site monitor reporting, clinical trial management (CTMS) and investigator portal for Trial Master File forms
CONTACT
To suggest a topic or volunteer to organize a webinar, contact Colleen.Braun@diahome.org. |