DIA 2016 Annual Meeting

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Electronic Submissions Gateway (ESG) is an FDA solution for accepting electronic regulatory submissions. It has been in production since 2006. This session will provide an update and Q&A on its status and the technology and process enhancements.

Learning Objectives

Discuss the Electronic Submissions Gateway (ESG) process and solutions for submission of regulatory; Describe the technology and process enhancements planned for ESG._x000D_


Chair

Ron D. Fitzmartin, PhD, MBA

Speaker

FDA eCTD v4.0 Two-Way Communication
Mark A. Gray

Panelist
Virginia Hussong

Panelist
La Misha Fields

Component Type: Workshop
Level: Basic

Typically content is created and managed and delivered as large static documents. Content is created multiple times by multiple authors and content is siloed between content creators and product lines. Multiple inconsistent versions of content exist.

Submission-related standards such as eCTD and SPL require structured content; however, these standards only provide the capability to submit content, they do not support the need to more effectively create and manage content. Structured content is today’s best practice for the creation, management, and delivery of content for clinical, labeling, and promotional materials. We will introduce you to the concepts of structured content in a fun, interactive way, then take you through real-world examples so you can understand the inner workings of structure. You will leave with 10 Steps to Structure guidelines.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Discuss the concepts and benefits of structured content.

Chair

Ann Rockley, MLIS

Component Type: Session
Level: Intermediate

Hear results from the third annual Veeva Paperless TMF Survey, which analyzes the observations of trial master file (TMF) owners from around the globe to identify the barriers, business drivers, and benefits of moving to fully paperless TMFs. Learn how much has changed over the last three years as organizations move along the TMF maturity continuum from passive to active eTMF.

Chair

Veeva Systems

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-538-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will include information on required data standards in regulatory submission and FDA's efforts to develop, test, and support therapeutic area data standards. Discussion will include FDA's participation in and status of international data standards initiatives such as IDMP.

Learning Objectives

Discuss required data standards in NDAs, BLAs, INDs and ANDAs 2; Summarize FDA's efforts to develop, test and support therapeutic area data standards; Describe FDA's participation in and status of international data standards initiatives, such as IDMP.

Chair

Mary Ann Slack

Speaker

OCP Update
Eileen E. Navarro Almario

CDER Perspective
Colleen Ratliffe, MS, PMP

FDA Update
Stephen E. Wilson, DrPH

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

The session will address the nonclinical regulatory development of robust human tissue (HT) technologies/models, validation, applications and the possible future switch from in vivo animal models to HT technologies.

Learning Objectives

Discuss the acceptability of human tissue (HT) technologies data in support of clinical trials and MAA submissions; Identify nonclinical requirements for the use of data generated with HT technologies; Describe validation of models; Identify GLP requirements.

Chair

Michelle Cathian Beharry, MS

Speaker

Overcoming Barriers to Human Tissue Use for Safety Assessment
Anthony Holmes, PhD

The Use of Human Tissue Technologies in Support of Clinical Trials and Marketing Authorization Regulatory Submissions
Michelle Cathian Beharry, MS

Component Type: Session
Level: Basic
CE: CME 1.00; IACET 1.00; RN 1.00

This session covers the current role of global SAFE-BioPharma standard for identity and access management trust and EngageZone, Merck's initiative enhancing collaboration between it and hundreds of partner organizations. _x000D_


Learning Objectives

Evaluate risk associated with Internet-based collaboration; Discuss approaches to develop secure, trust-based information sharing; Define critical terminology such as multi-factor authentication, federation, and identity and access management.

Chair

Mollie Shields-Uehling

Speaker

Industry Perspective
Andrew Porter

Component Type: Session
Level: Advanced
CE: CME 1.25; IACET 1.25; RN 1.25

The current trend in the industry involves multiple stakeholders working toward a similar goal, whether that be creation of a clinical study report (CSR), an entire marketing application, or any other medical writing deliverable. Such work could include collaborations between pharma companies, CROs, independent contractors, or any combination thereof. The speakers will present successful case studies involving codevelopment of products between two pharmaceutical companies as well as a specialized strategic medical writing partnership between pharma and a CRO, focused on writing and primary publishing of the sponsor’s CSRs. You will leave this session with a strategy for creating high-quality deliverables on time and within budget across a product’s life cycle, regardless of the type of partnership utilized in your organization. Come with questions!

Learning Objectives

Assess challenges associated with different types of partnerships and proactively implement solutions; Evaluate and establish an outsourced strategic medical writing partnership; Identify and incorporate best practices for successful partnerships and submissions in your organization.

Chair

Tammy Franklin, MSc

Speaker

Sponsor Companies as Partners: Tips for Creating a Successful Partnership for Medical Writing
Tammy Franklin, MSc

A Specialized Strategic Medical Writing Partnership: A Case Study
Timothy D. Garver, PhD

Partnerships in Action: Learning from Real-Life Submissions Involving Multiple Stakeholders
Angela Campbell, PhD