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Tuesday, June 28
 

10:30am EDT

#217: Electronic Submissions Gateway: Next Generation
Limited Capacity seats available

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



Chair
avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Informatics Advisor, Office of the Director, CBER, FDA, United States
Ron Fitzmartin is Senior Informatics Advisor, Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions... Read More →

Speakers
avatar for La Misha Fields

La Misha Fields

IT Program Manager, Electronic Submissions Gateway, OIMT, OC, FDA
La Misha Fields is the Program Manager of the FDA’s Electronic Submissions Gateway (ESG) under the Office of Information Management and Technology located in Rockville, MD. She is an informatics and technology professional with over 6 years of FDA experience, including 5+ years... Read More →
avatar for Mark Gray

Mark Gray

Senior Project Manager, BSS, CBER, FDA
Mark has over 30 years experience in Information Management including; software developer/project manager in CBER; Director of Applications Development & Services in CDER; and PDUFA IT Program Director. Mark currently work’s for CBER’s Bioinformatics Support Staff. His responsibilities... Read More →
avatar for Virginia Hussong

Virginia Hussong

Director, Div. of Data Management Services & Solutions, OBI, OSP, CDER, FDA
Ginny Hussong has over 20 years of experience in the pharmaceutical industry, of which the past 10 have been in CDER. As Acting Director of the Division of Data Management Services and Solutions, she supports the receipt, processing and archive of electronic regulatory submissions... Read More →
avatar for Virginia Hussong

Virginia Hussong

Chief, Data Standards Program, CBER, FDA
Ginny Hussong is Chief of CBER’s Data Standards Program, and has been with FDA for 14 years. She was previously Director of Data Management Services and Solutions within CDER. As Chair of CBER’s Data Standards Committee, Ginny’s recent projects include creating a new joint data... Read More →


Tuesday June 28, 2016 10:30am - 11:45am EDT
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

12:00pm EDT

#231: Introduction to Structured Content
Limited Capacity seats available

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


Chair
avatar for Ann Rockley

Ann Rockley

Chief Executive Officer, The Rockley Group Inc.
Ann Rockley has helped pharmaceutical, medical devices, and healthcare providers create intelligent content strategies and adopt structured content management for more than 15 years. She has helped clinical, labeling, and marketing content teams meet the increasing demands of regulatory... Read More →

Tuesday June 28, 2016 12:00pm - 1:00pm EDT
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

3:25pm EDT

#256: Veeva Innovation Theater: 2016 Paperless TMF Survey: Trends and Insights
Limited Capacity seats available

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


Chair
VS

Veeva Systems, Inc.

NA
Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. From compliant promotional content management to best-in-class multichannel marketing, Veeva provides innovative marketing solutions to more than 200 pharmaceutical and biotech companies... Read More →

Tuesday June 28, 2016 3:25pm - 3:55pm EDT
Exhibit Hall B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm EDT

#264: FDA Update on Data Standards
Limited Capacity seats available

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



Chair
avatar for Mary Ann Slack

Mary Ann Slack

Director, Office of Strategic Programs, CDER, FDA, United States
Ms. Slack has 30+ years extensive leadership and management experience in both the public and private sectors, developing informatics strategy and implementing business solutions. She currently serves as Director of FDA CDER Office of Strategic Programs, which plays a lead role in... Read More →

Speakers
avatar for Eileen Navarro Almario

Eileen Navarro Almario

Lead Medical Officer, OCS, OTS, CDER, FDA
Eileen Navarro is Associate Director for Clinical Affairs in the Office of Computational Science, OTS, CDER, where she leads a team of analysts in providing regulatory review and training support to medical officers, statisticians, and safety evaluators. She is a Fellow of the American... Read More →
avatar for Colleen Ratliffe

Colleen Ratliffe

Project Management Officer, Office of Strategic Programs, CDER, FDA
Colleen Ratliffe is a project management officer on the Data Standards team within the Office of Strategic Programs, CDER. The data standards team’s core functions include coordinating and leading projects that support and promote the development of data standards and policy and... Read More →
avatar for Stephen Wilson

Stephen Wilson

Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER, FDA
Dr. Wilson has worked as a Statistical Reviewer and Supervisory Mathematical Statistician in FDA/CDER for 28 years and is currently the Director of the Division of Biometrics III and a Captain in the USPHS. He received his doctorate in Biostatistics from UNC/Chapel Hill in 1984.


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech/Data/ Records/Subs, Session
 
Wednesday, June 29
 

10:30am EDT

#312: Human Tissue Models: A Look into the Future of Safety Pharmacology Studies
Limited Capacity seats available

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



Chair
avatar for Michelle Beharry

Michelle Beharry

Senior Non-Clinical Assessor, Medicines and Healthcare products Regulatory Agency (MHRA)
Michelle spent 4 years in the pharmaceutical Industry as a regulatory/investigative toxicologist, then joined the MHRA and is now a Senior Pharmaco-Toxicologist. Principally, this involves the assessment of nonclinical data for Clinical Trials and Marketing Authorisation applications... Read More →

Speakers
AH

Anthony Holmes

Head, Technology Development, NC3Rs
Anthony Holmes is Head of Technology Development at the NC3Rs. He oversees a programme of work focusing on the interface between academia and industry and the acceleration of technologies out of the science base and in to application to reduce animal use and address scientific and... Read More →


Wednesday June 29, 2016 10:30am - 11:30am EDT
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Thursday, June 30
 

10:45am EDT

#408: Securing Internet-Driven Collaboration in Drug Development
Limited Capacity seats available

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



Chair
avatar for Mollie Shields-Uehling

Mollie Shields-Uehling

President and Chief Executive Officer, Safe-BioPharma Association
The SAFE-BioPharma standard assures the identity trust inherent in implementation of the TransCelerate Shared Investigator Portal, in Merck’s EngageZone portal, and in other industry collaboration portals. Digital signature applications certified compliant with the SAFE-BioPharma... Read More →

Speakers
avatar for Andrew Porter

Andrew Porter

Director of Enterprise Architecture, IT Planning & Innovation, Applied Tech, Merck & Co., Inc.
His expertise includes creating the architectures for Identity and Access Management (IAM) and Enterprise Knowledge Management (EKM) solutions that support Merck's External Partner Program (EPP) and clinical trials initiatives. Mr. Porter has also provided architectural alignment... Read More →


Thursday June 30, 2016 10:45am - 11:45am EDT
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am EDT

#406: Navigating Partnerships and Submissions: Best Practices for Successful Medical Writing Deliverables Involving Multiple Stakeholders
Limited Capacity seats available

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



Chair
avatar for Tammy Franklin

Tammy Franklin

Head of Global Medical Writing, UCB
Tammy Franklin is the Senior Director of Global Medical Writing at UCB and is responsible for the leadership and management of a medical writing organization. She has over 15 years of experience in regulatory writing, including extensive knowledge of submission planning and content... Read More →

Speakers
avatar for Angela Campbell

Angela Campbell

Principal Medical Writer/AD, Shire Pharmaceuticals
I have been a medical writer for over 14 years, with experience at all phases of drug development, from pre-clinical to post-marketing. I have prepared a variety of regulatory documents in support across many therapeutic areas. I have also worked on suport documents such as manuscripts... Read More →
TG

Timothy Garver

Chief Operating Officer and Executive Vice President, Impact Pharmaceutical Services
Tim Garver, PhD, is the Executive VP and COO of Impact Pharmaceutical Services, Inc., a consulting and contract research organization. Tim has over 20 years of medical writing experience for both drugs and biologics, during which time he has played a key role in over 25 marketing... Read More →


Thursday June 30, 2016 10:45am - 12:00pm EDT
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA