10:00am EDT
10:45am EDT
#131: IDMP Update
Chair VP
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...
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Speakers
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...
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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...
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Monday June 27, 2016 10:45am - 12:00pm EDT
204B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
12:15pm EDT
10:30am EDT
#313: The Future of Clinical Research Data: 2020 and Beyond
Chair
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...
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Speakers
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...
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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...
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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...
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Wednesday June 29, 2016 10:30am - 11:45am EDT
204B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
2:00pm EDT
#341: eTMF: Selection, Implementation, and What's Next?
Chair
Chief Strategy Officer, Phlexglobal
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...
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Speakers MD
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...
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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
- Credit Type CME, IACET, RN
- Audience Intermediate
- Featured Topics Clinical Trial Transparency-Clinical Trial Disclos
- Interest Area Document & Records Management, Clinical Data Management, Regulatory Affairs, Clinical Research
- format json
- Interest Area Document & Records Management,Clinical Data Management,Regulatory Affairs,Clinical Research
- Featured Topics Clinical Trial Transparency/Clinical Trial Disclos
- Credit Type CME, IACET, RN
- Tags Session