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Monday, June 27
 

10:00am EDT

#122: DBMS Consulting/Clinical Ink Innovation Theater: Accelerating Clinical Trial Innovation: Technology Case Studies for Improving Data Collection, Monitoring, and Medical Coding Processes
Limited Capacity seats available
Component Type: Session
Level: Intermediate

Standardization supports efficiency but usually with a lack of flexibility. Make the introduction of new technologies less challenging by limiting the scope of change. Learn how one top 5 pharmaceutical company is replacing EDC with eSource by mapping data into their existing processes and clinical database. Learn solutions for expiring dsNavigator support and how a centralized medical coding model can eliminate coding discrepancies by integrating safety systems with RDC, Rave and InForm via Oracle's TMS.

Chair

DBMS Consulting

Chair
DC

DBMS Consulting

NA

Monday June 27, 2016 10:00am - 10:30am EDT
Exhibit Hall B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 20: Innov Theater, Session

10:45am EDT

#131: IDMP Update
Limited Capacity seats available
Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

CBER provided critical leadership and technical expertise to the development of IDMP standards and currently continues leading international efforts to delineate a common approach for their implementation and to consider their future application. This session will provide an update on this initiative.

Learning Objectives

Discuss the status of IDMP implementation.

Chair

Vada A. Perkins

Speaker

ISO IDMP: Benefits Beyond Compliance
Niels Gronning, MSc

Interoperability and Standardization Within the Life Sciences: Justification, Mechanisms, and Opportunities
Tom Macfarlane, RAC


Chair
VP

Vada Perkins

Senior Advisor for Regulatory Science, IDMP Topic Lead, CBER, FDA
Capt. Vada A. Perkins, MSc, BSN, RN, is the Deputy Associate Director for Review Management (acting) with the FDA's Center for Biologics Evaluation and Research, Office of the Director. He received his MSc. in Bioscience Regulatory Affairs from The Johns Hopkins University and his... Read More →

Speakers
avatar for Niels Gronning

Niels Gronning

Principal Consultant, NNIT A/S
With a professional and academic bacground within the pharmaceutical industry Niels Grønning possesses extensive knowledge within the area of IT & Life Sciences. His area of expertise is predominantly found within regulatory affairs, IT (strategy, architecture & compliance) and more... Read More →
avatar for Tom Macfarlane

Tom Macfarlane

Director, Life Sciences, Accenture Accelerated R&D Services
A Neuroscientist by training, Tom has worked in most therapeutic areas during time at Ipsen, Parexel and as a freelance consultant. Now at Accenture, he continues to represent clients to EMA and to facilitate drug development strategies; but also works with emergent technologies/concepts... Read More →

Monday June 27, 2016 10:45am - 12:00pm EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech/Data/ Records/Subs, Session

12:15pm EDT

#146: Tata Consultancy Services Innovation Theater: Data Transparency Initiative: An Innovative Solution
Limited Capacity seats available
Component Type: Session
Level: Intermediate

With a growing commitment in the pharma world to data transparency, we require an innovative technology-driven solution using newly developed digital tools to make data and document sharing solutions achievable, scalable, and cost-effective. Metadata analytical algorithms will be used for de-identification and anonymization of data. This will ensure a greater control of the quality and reduction in overall process time.

* Presented by: Helle-Mai Gawrylewski, Sr. Director Regulatory Medical Writing, Janssen R&D. Titusville, NJ, USA
* Supported by: Arghya Chattopadhyay, Vice President, Biostatistics and Statistical Programming, Tata Consultancy Services

Chair

Tata Consultancy Services

Chair
avatar for Tata Consultancy Services

Tata Consultancy Services

NA

Monday June 27, 2016 12:15pm - 12:45pm EDT
Exhibit Hall B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 20: Innov Theater, Session
 
Wednesday, June 29
 

10:30am EDT

#313: The Future of Clinical Research Data: 2020 and Beyond
Limited Capacity seats available
Component Type: Forum
Level: Advanced
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will engage a panel of experts who will discuss current and emerging opportunities and trends in the representation and use of research data and describe a future vision for capitalizing on these to improve the future research process.

Learning Objectives

Describe current state, trends and opportunities such as data transparency, electronic health records, interoperability, wearable technologies, regulatory science, data standards and analytics; Describe a vision for future clinical research data systems and processes that can logically evolve from the current state to meet these requirements including opportunities to improve the research process.

Chair

Wayne R. Kubick, MBA

Speaker

Panelist
Dave Evans, MS

Panelist
Armando Oliva, MD

Panelist
Kenneth A. Getz, MBA


Chair
avatar for Wayne Kubick

Wayne Kubick

Chief Technology Officer, HL7
Mr. Kubick is CTO for Health Level Seven International, intent on improving clinical research through technology and data standards. He was formerly CTO and a Board member for CDISC, and has 2+ decades in a variety of leadership roles in clinical R&D with BBN, Parexel International... Read More →

Speakers
avatar for Dave Evans

Dave Evans

Managing Director, Accenture
Dave Evans is a senior technology and clinical research executive with over 35 years of experience in the clinical research, regulatory and healthcare industries. He is recognized industry-wide as a leading technology visionary for developing and implementing complex process and... Read More →
avatar for Kenneth Getz

Kenneth Getz

Director, Research Professor, Tufts Center For the Study of Drug Development
Kenneth A. Getz, MBA, is the Deputy Director and Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he directs research programs on drug development management strategy and practice. He is also the Founding Chair of the Center... Read More →
avatar for Armando Oliva

Armando Oliva

President and Chief Medical Officer, Semantica LLC
His expertise includes clinical data standards, regulated study data submissions, and regulatory submission and review policy. A former Associate Director for Informatics in OCS, he focused on developing, adopting, and implementing clinical data standards to support premarketing assessment... Read More →

Wednesday June 29, 2016 10:30am - 11:45am EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech-Data- Records-Subs, Forum

2:00pm EDT

#341: eTMF: Selection, Implementation, and What's Next?
Limited Capacity seats available
Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

This session will walk through the steps from vendor selection to global implementation of an eTMF software and associated services - both as a general approach and a case study for a top ten pharmaceutical company. It will elaborate on the various workstreams established to ensure success.

Learning Objectives

Describe the hurdles to successful global implementation of an eTMF; Discuss the importance of a robust TMF structure; Recognize that an eTMF is not about the software, its about the processes and workflows.

Chair

Karen Jane Roy, MPharm

Speaker

eTMF: Challenges and Possible Solutions
Laxman Kumar Jakkala, SR, PhD

Global Implementation of a Full Service Provision eTMF Software and Services: A Case Study
Martina M Duevel, DrSc


Chair
avatar for Karen Roy

Karen Roy

Chief Strategy Officer, Phlexglobal, United Kingdom
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as... Read More →

Speakers
MD

Martina Duevel

Senior GCPM ONC, eTMF Process Owner Representative, Bayer Pharma AG
Dr. Martina Duevel eTMF Process Owner Representative, Bayer In the pharmaceutical industry for 16 years with roles in QA and Clinical Project Management. Project Lead for eTMF implementation and maturation, and Process Owner Representative for internal oversight and vendor govern... Read More →
LJ

Laxman Jakkala

Director, Global Quality Assurance, MakroCare

Wednesday June 29, 2016 2:00pm - 3:00pm EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech-Data- Records-Subs, Session