10:30am EDT
#217: Electronic Submissions Gateway: Next Generation
Chair
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...
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Speakers
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...
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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...
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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...
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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...
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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
Chair
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...
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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
4:00pm EDT
#264: FDA Update on Data Standards
Chair
Director, Office of Strategic Programs, CDER, FDA
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...
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Speakers
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...
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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...
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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
- Credit Type ACPE, CME, IACET, RN
- Audience Intermediate
- Featured Topics Agency Participation
- Interest Area Submissions, Clinical Data Management, Information Technology, Regulatory Affairs, eClinical
- format json
- Interest Area Submissions,Clinical Data Management,Information Technology,Regulatory Affairs,eClinical
- Featured Topics Agency Participation
- Credit Type ACPE, CME, IACET, RN
- Tags Session
10:30am EDT
#312: Human Tissue Models: A Look into the Future of Safety Pharmacology Studies
Chair
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...
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Speakers AH
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...
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Wednesday June 29, 2016 10:30am - 11:30am EDT
113C
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
10:45am EDT
#408: Securing Internet-Driven Collaboration in Drug Development
Chair
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...
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Speakers
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...
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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
Chair
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...
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Speakers
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...
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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...
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Thursday June 30, 2016 10:45am - 12:00pm EDT
113A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA