'Regulatory submissions' presentation slideshows

GLOBAL REGULATORY STRATEGY CONSIDERATIONS

1.35k views • 30 slides

Federal Medication Terminologies (FMT) Enabling Health IT Interoperability

Federal Medication Terminologies (FMT) Enabling Health IT Interoperability. Topics. Goal Background Components Accessibility Collaboration Summary. Advancing Excellence in Health Care. U.S. Department of Health and Human Services. Goal.

281 views • 27 slides

CBER Data Standards Management

CBER Data Standards Management. Presented to : DC CDISC Group April 25, 2014. Agenda. CBER Data Standards Management CBER Data Standards Project Portfolio Focus for Addressing Mandates and Processing Gaps for CDISC Data Standards. 2. Role of Data Standards.

382 views • 20 slides

HCC-MUSC Phase I Program Development

HCC-MUSC Phase I Program Development. Melanie B. Thomas, M.D. Associate Director of Clinical Investigations Hollings Cancer Center Associate Professor of Medicine Division of Hematology-Oncology. Clinicians Perspective: Why do we need BIOMARKERS in Clinical Trials?.

384 views • 19 slides

Amanda B. Parrish, PhD, RAC Director, Regulatory Affairs and Quality Erika Segear, PhD, RAC

Office of Regulatory Affairs and Quality. Updates from the Office of Regulatory Affairs and Quality (ORAQ): Regulatory Review Requirements Changes in ORAQ Costs Submission Processes. Amanda B. Parrish, PhD, RAC Director, Regulatory Affairs and Quality Erika Segear, PhD, RAC

203 views • 18 slides

Clinical Evaluation and the Latest 2016 Guideline

228 views • 16 slides

SAFE-BioPharma Association

SAFE-BioPharma Association. SAFE is a member-governed, not-for-profit enterprise that: Manages and promotes the SAFE standard Provides a legal and contractual framework Provides technical infrastructure to bridge different credentialing systems

115 views • 10 slides

How to Design a Custom SDTM Domain for Nonclinical Data Standards Roadmap Team

How to Design a Custom SDTM Domain for Nonclinical Data Standards Roadmap Team. Abstract. 3. Color-Coded Domain Table*. Project: How to Design a Custom SDTM Domain for Nonclinical Data

227 views • 1 slides