The Evolution of SDTM
|
|
|
- Lora McDaniel
- 6 years ago
- Views:
Transcription
1 The Evolution of SDTM What s new? Tina Apers CRO Manager Mobile tina.apers@businessdecision.com Business & Decision Life Sciences Tel Fax Sint-Lambertusstraat 141 Rue Saint- Lambert 1200 Brussels
2 Agenda 1 FDA Submission Landscape 2 Evolution of CDISC Models 3 Development of Standards 4 CDISC SHARE 5 SDTM Highlights
3 Agenda 1 FDA Submission Landscape 2 Evolution of CDISC Models 3 Development of Standards 4 CDISC SHARE 5 SDTM Highlights
4 FDA Announcements HHS Food and Drug Administration (FDA) PROPOSED RULE STAGE 36. ELECTRONIC SUBMISSION OF DATA FROM STUDIES EVALUATING HUMAN DRUGS AND BIOLOGICS Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 355; 21 USC 371; 42 USC 262 CFR Citation: 21 CFR ; 21 CFR ; 21 CFR ; 21 CFR Legal Deadline: None c Abstract: The Food and Drug Administration is proposing to amend the regulations governing the format in which clinical study data and bioequivalence data are required to be submitted for new drug applications (NDAs), biological license applications (BLAs), and abbreviated new drug applications (ANDAs). The proposal would revise our regulations to require that data submitted for NDAs, BLAs, and ANDAs, and their supplements and amendments be provided in an electronic format that FDA can process, review, and archive. The proposal would also require the use of standardized data structure, terminology, and code sets contained in current FDA guidance (the Study Data Tabulation Model (SDTM) developed by the Clinical Data Interchange Standards Consortium) to allow for more efficient and comprehensive data review
5 China s SFDA Announcement February
6 EMA «Clinical Data Transparency Initiative» Project Scope Clinical reports & data from all clinical studies in Europe Timelines Jan 2013 Apr 2013 : Advisory Groups Patient Confidentiality Clinical Data Formats Rules of engagement Good Analysis Practice Legal Aspects June 2013 : Draft Agency Policy Nov 2013 : Final Agency Policy Jan 2014 : Policy comes into force
7 EFSA Announcements
8 Agenda 1 FDA Submission Landscape 2 Evolution of CDISC Models 3 Development of Standards 4 CDISC SHARE 5 SDTM Highlights
9 Overview of CDISC Models Content Standards Semantics Technical Standards Therapeutic Areas SEP 2013 Upcoming
10 Updates over time SEP 2013 Content Standards Technical Standards SDTM v1.1 SDTM IG v3.1.1 Define.xml v1.0 ODM ODM v1.1 v1.2.1 SDTM ODM v1.0 BRIDG v1.3 SDTM IG v1.1 v3.1 ADaM ODM BRIDG / v2.0 v1.2 v1.0 SDTM v1.2 SDTM IG v3.1.2 CDASH v1.0 BRIDG v2.1 BRIDG v2.0 BRIDG v1.1.1 Semantics Therapeutic Areas ADaM v2.1 ADaM IG v1.0 BRIDG v3.0 BRIDG v2.2 BRIDG v3.0.3 ADaM Val. Checks v1.0 BRIDG v3.0.2 ODM v1.3.1 BRIDG v3.0.1 Protocol Model v1.0 SDTM v3.1.2 Am.1 Alzheimer v1.0 SDM.XML v1.0 ADaM Val. Checks v1.1 CDASH v1.1 SEND v3.0 Virology Parkinson s Disease Devices BRIDG v3.2 ADaM Val. Checks v1.2 SDTM v1.3 SDTM IG v3.1.3 Tuberculosis Pain PRM Toolset v1.0 CDASH UG v1.0 BRIDG v3.1 SDTM QS Supplements CDASH E2B SAE IG ADaM MD Guide BRIDG v4.0 BRIDG UG v2 Define.xml v2.0 PKD CDASH v1.2 SDTM v1.4 SDTM IG v3.1.4 SDTM Associated Persons IG v1.0 SEND v3.0.1 Asthma Alzheimer v1.1 ADaM IG v1.1 Protocol Concept Guide Cardiovascular Therapeutic Brain Injury Schizophrenia Oncology Virology- Hepatitis C Diabetes Multiple Sclerosis Define.xml IG Validation CDASH v2.0 SDTM v1.5 SDTM IG v3.1.5 ADaM General Occurrence Model v1.0 ADaM Integration IG v1.0 Extended ODM PRM XML Schema SDTM.xml v1.0 SEND v3.1 SDTM Devices IG v1.1 SDTM Device Submission Pilot
11 The Evolution of SDTM SDTM V1.1 and SDTM IG V3.1.1 Only for studies initiated prior to 13 Jun 2011 Date Support Ends 28 Jan 2015 SDTM V1.2 and SDTM IG V3.1.2 Published Nov 2008 SDTM V1.2 and SDTM IG V3.1.2 Am. 1 Published Dec 2011 SDTM V1.3 and SDTM IG V3.1.3 Published Jul 2012 SDTM V1.4 and SDTM IG V3.1.4 Expected end 2013
12 Data Standards Governance DATA GOVERNANCE PROCESS DEDICATED TEAM
13 Technical Plan Project Schedule Published March
14 CDISC Team Charters CDASH Team SDS Team Device team ADaM Team XML Technologies Team Terminology team BRIDG Team Questionnaire Team Protocol Team
15 CDISC Volunteers
16 Agenda 1 FDA Submission Landscape 2 Evolution of CDISC Models 3 Development of Standards 4 CDISC SHARE 5 SDTM Highlights
17 Published Therapeutic Areas SEP Oncology Domains Included in SDTMIG Alzheimer s Disease V1 - Final 3. Pain V1 - Provisional 4. Parkinson s Disease V1 - Provisional 5. Polycystic Kidney Disease V1 - Provisional 6. Tuberculosis V1 - Provisional 7. Virology V1 Provisional 8. Asthma Open for public review * A CDISC provisional release is defined as a proposed standard that has completed a public review within the CDISC user community and is available for initial use; but subject to modification for some component parts still in process
18 CFAST Therapeutic Area Standards CFAST Coalition for the Advancement of Standards and Therapies Joint initiative of CDISC & C-Path Development of therapeutic area standards along with FDA and TransCelerate Biopharma, Inc.
19
20 Enhanced Standards Development Process
21 CFAST Program Overview July 2013
22 Enhanced Standards Development Process CFAST Deliverables: 1. Mindmap visualization of disease area clinical concepts 2. Essential core data elements of the disease 3. Definitions 4. Data types (simple & ISO 21090) 5. BRIDG and SDTM mappings 6. SDTM domains and examples 7. Minimum value sets (from code lists) with definitions and C-Codes 8. User/Implementation Guide with permissions statement 9. Standard CDASH CRFs with SDTM annotations, as appropriate Source : Cdisc Intrachange July
23 Agenda 1 FDA Submission Landscape 2 Evolution of CDISC Models 3 Development of Standards 4 CDISC SHARE 5 SDTM Highlights
24 What is CDISC SHARE?
25
26 CDISC SHARE R1 Implementation Plan Initial Release of CDISC SHARE is planned early 2014
27 What is the Potential Value of SHARE? Improves data quality based upon better definitions, change control Improves data consistency, encourages data re-use and facilitates aggregation of data and comparisons across organizations Improves data exchange, sharing, workflow and collaboration among multiple parties with clear, unambiguous standardised definitions Supports ability for 2 computers to understand information without direct human interpretation (interoperability) Provides reduction in costs resulting from maintaining individual (and different) dictionaries within research organizations Improves the speed by which we develop new standards among all stakeholders with consistent, reliable governance Maintains version traceability, change control to allow impact analysis Source : Cdisc Intrachange July
28 Agenda 1 FDA Submission Landscape 2 Evolution of CDISC Models 3 Development of Standards 4 CDISC SHARE 5 SDTM Highlights
29 General Releases SEP 2013 Public Review Period ended SDTM IG v3.1.4 Batch 1 SDTM IG v3.1.4 Batch 2 SDTM IG v3.1.4 Batch 3
30 SDTM IG V3.1.4 Batch 1 Specifications for representing exposure data, Immunogenicity and Reproductive data EC - Exposure as Collected IS - Immunogenicity Assessments SR - Skin Response RD - Reproductive Details
31 SDTM IG V3.1.4 Batch 2 Specifications for representing morphology, histopathology and physiology data MO - Morphology MI - Microscopic Findings CV - Cardiovascular Physiology PR - Procedures TD - Trial Disease Assessments DD - Death Details SS - Subject Status
32 SDTM IG V3.1.4 Batch 3 Draft SDTM Domain, SDTM Model Document and SDTMIG for AP SDTM 1.4 SDTMIG for Associated Persons HO - Healthcare Resource Utilization
33 Link TA QS SDTMIG domains Therapeutic Areas Oncology Alzheimer s Disease Pain Parkinson s Disease Polycystic Kidney Disease Tuberculosis Virology Questionnaires Alzheimer s disease Assessment Scale Cognitive (ADAS-Cog) Mini Mental Scale (MMSE) Audio Verbal Learning Test Version A (AVLTvA) Pain Intensity Brief Pain Inventory (BPI) EuroQol (EQ-5D) Karnofsky Performance Status Scale SF-36 Health Survey Hamilton Depression Scale Faces Pain Scale Mini Mental State Examination (MMSE) SDTMIG TU Tumor Identification TR Tumor Results RS Disease Response RELREC Related Records SDTMIG EC - Exposure as Collected IS - Immunogenicity Assessments SR - Skin Response RD - Reproductive Details MO - Morphology MI - Microscopic Findings CV - Cardiovascular Physiology PR - Procedures TD - Trial Disease Assessments DD - Death Details SS - Subject Status SDTM 1.4 SDTMIG for Associated Persons HO - Healthcare Resource Utilization
34 Questions?
35 Thank you for your attention Tina Apers CRO Manager Mobile Business & Decision Life Sciences Tel Fax Sint-Lambertusstraat 141 Rue Saint- Lambert 1200 Brussels
CDISC/TransCelerate Collaboration and TransCelerate work streams. -Clinical Data Standards -Common Protocol Template -esource
CDISC/TransCelerate Collaboration and TransCelerate work streams -Clinical Data Standards -Common Protocol Template -esource July 2016 TransCelerate Clinical Data Standards Project Opportunity
CDISC Data Standards Validation
CDISC Data Standards Validation How can it be done? Peter Van Reusel Business Unit Director Business & Decision Life Sciences Tel +32 2 774 11 00 Fax +32 2 774 11 99 Mobile +32 476 54 59 17 peter.vanreusel@businessdecision.com
The SDTMIG: What s New in 3.2
Accenture Life Sciences Rethink Reshape Restructure for better health outcomes. The SDTMIG: What s New in 3.2 Fred Wood Data Standards Consulting Lead Accenture Life Sciences RTP CDISC User Network March
CDISC Controlled Terminology across the Clinical Trial Continuum. Bay Area Implementation Network 6 March 2008
CDISC Controlled Terminology across the Clinical Trial Continuum Bay Area Implementation Network 6 March 2008 Bron Kisler Co-Founder / Director of Terminology CDISC Terminology Initiative Overview / Background
LOINC in Regulated Clinical Research a Lab LOINC Steeringg Committee Meeting 08 June 2017
LOINC in Regulated Clinical Research a Lab LOINC Steeringg Committee Meeting 08 June 2017 Lauren Becnel, Ph.D. VP, Biomedical Informatics & Alliances, CDISC Asst Prof, Duncan Comprehensive Cancer Center,
CDISC Journal. Current status and future scope of CDISC standards. By Rebecca D. Kush, President and CEO, CDISC. 1. Introduction
CDISC Journal Clinical Data Interchange Standards Consortium oc tober 2012 Current status and future scope of CDISC standards By Rebecca D. Kush, President and CEO, CDISC 1. Introduction In translational
CDISC Standards: Current and Future
CDISC 2010 CDISC Standards: Current and Future CDISC Japan Interchange Tokyo, Japan 20 July 2010 Rebecca D. Kush, PhD President and CEO, CDISC Clinical Research Standards (Content) (Protocol-driven Research;
Evolving Regulatory Guidance on Submission of Standardized Data. James R. Johnson, PhD RTP CDISC User Network
Evolving Regulatory Guidance on Submission of Standardized Data James R. Johnson, PhD RTP CDISC User Network 2014-06-11 Originally Presented at PhUSE Conference 2013 Brussels, Belgium (Paper Number: RG03)
CDASH Clinical Data Acquisition Standards Harmonization
CDISC Italian User Group Meeting 16 November 2007 CDASH Clinical Data Acquisition Standards Harmonization 1 Outline Background Organization Goals Timelinesand Process Review of progress Results Future
HD Regulatory Science Consortium (HD-RSC) A consortium aimed at accelerating treatments for Huntington s disease
HD Regulatory Science Consortium (HD-RSC) A consortium aimed at accelerating treatments for Huntington s disease Critical Path Institute / CHDI Foundation Huntington s Disease Regulatory Science Consortium
CDISC and Clinical Research Standards in the LHS
CDISC and Clinical Research Standards in the LHS Learning Health System in Europe 24 September 2015, Brussels Rebecca D. Kush, PhD, President and CEO, CDISC CDISC 2015 1 CDISC Healthcare Link Goal: Optimize
Consortia-Based Strategies in Neurodegenerative Diseases: Critical Path Institute s Track Record in Collaborative Efforts
Consortia-Based Strategies in Neurodegenerative Diseases: Critical Path Institute s Track Record in Collaborative Efforts Martha A. Brumfield, PhD President & CEO Agenda C-Path Model for Collaboration
Visualising CDISC SDTM for Monitoring and Review. Philip C. M. Bartle Clinical Innovation, PPD
Visualising CDISC SDTM for Monitoring and Review Philip C. M. Bartle Clinical Innovation, PPD Visualising CDISC SDTM for Monitoring and Review 1 2 3 4 5 6 7 Bringing CDISC SDTM Alive with Spotfire and
October, Integration and Implementation of CDISC Standards
Integration and Implementation of CDISC Standards October, 2008 Barbara Lentz, Associate Director, Electronic Data Management Standards, Processes & Training Pat Majcher, Statistical Reporting Services
Industrialized Clinical Data Standards Management Speed of automation, Power of accuracy and Transforming clinical data into business intelligence
Industrialized Clinical Standards Management Speed of automation, Power of accuracy and Transforming clinical data into business intelligence Executive Summary The majority of commercially available legacy
CDISC Tech Webinar Leveraging CDISC Standards to Drive Crosstrial Analytics; Graph Technology and A3 Informatics 26 OCT 2017
CDISC Tech Webinar Leveraging CDISC Standards to Drive Crosstrial Analytics; Graph Technology and A3 Informatics 26 OCT 2017 CDISC 2017 1 Panelists Jim LaPointe Managing Director, Cambridge Semantics Patrick
CDISC UK Network face to face Reading
CDISC UK Network face to face Reading Paul Houston, CDISC Head of European Operations CDISC Update and European Activity 2 CDISC Values and Principals Core value Foster CDISC community is altruistic
CDISC Production Standards Status & Plans
Bay Area User Network CDISC Production Standards Status & Plans Wayne R. Kubick Sr. Vice President, Lincoln Technologies CDISC Technical Director SDS Team Leader Agenda Topics The role and work of the
From Standards that Cost to Standards that Save: Cost Effective Standards Implementation
From Standards that Cost to Standards that Save: Cost Effective Standards Implementation Jeffrey M. Abolafia, Rho, Chapel Hill, NC Frank DiIorio, CodeCrafters Inc., Philadelphia, PA Warning This presentation
Steps and Slides of Implementing Global Standards Producing High Quality Programming Outputs Edition
Steps and Slides of Implementing Global Standards Producing High Quality Programming Outputs Edition David Izard, MS Terek Peterson, MBA Richard Addy, MS CDISC ODM SDTM LAB CDASH ADaM PRM SEND Controlled
Statistical Review and Data Standards: It s Gettin Better All The Time
Statistical Review and Data Standards: It s Gettin Better All The Time Steve Wilson, Dr.P.H., CAPT USPHS Office of Biostatistics FDA/OMPT/CDER 2017 PharmaSUG Baltimore, MD May 17, 2017 Disclaimer This
Implementation and Operation of CDISC ODM-based EDC by UMIN
Implementation and Operation of CDISC ODM-based EDC by UMIN Takahiro Kiuchi, M.D., Ph.D. UMIN Center, The University of Tokyo Hospital, Tokyo, Japan 1 Content 1. CDISC standards and academic research 2.
PharmaSUG 2017 Paper DS14
PharmaSUG 2017 Paper DS14 Considerations in Submitting Standardized Electronic Data Under the Animal Rule: The Use of SDTMIG and SENDIG Domains, and the Need for New Domains and Concepts Fred Wood, Accenture
Biomarker Data Management in Clinical Trials: Addressing the Challenges of the New Regulatory Landscape
Biomarker Data Management in Clinical Trials: Addressing the Challenges of the New Regulatory Landscape Introduction Biomarkers and specialty labs are core to modern clinical trials.the broad and evergrowing
CDASH 2.0. Berlin Éanna Kiely CDISC Engineer
CDASH 2.0 Berlin Éanna Kiely CDISC Engineer 2016-09-13 Agenda CDASH 1.1 & CDASHIG 2.0 CDASH Concepts TAUG Examples Current Regulatory Perspective on CDASH Questions 2 CDASH: CDISC End to End Clinical Data
Putting CDISC Standards to Work How Converting to CDISC Standards Early in the Clinical Trial Process Will Make Your CDISC Investment Pay
How Converting to CDISC Standards Early in the Clinical Trial Process Will Make Your CDISC Investment Pay Jon Roth, Vice President, Data Sciences & Biometrics Authorized Trainer for ADaM, CDISC Mark Vieder,
CFAST Therapeutic Area Program Steering Committee 2013 Meeting Summaries (January-August)
CFAST Therapeutic Area Program Steering Committee 2013 Meeting Summaries (January-August) Participant full names and titles: Wayne: Wayne Kubick, Chief Technology Officer, CDISC (Chair) Becky: Rebecca
PharmaSUG Paper PO12
PharmaSUG 2016 - Paper PO12 CDISC Standards End-to-End: Transitional Hurdles Alyssa Wittle, Chiltern International, King of Prussia, PA Christine McNichol, Chiltern International, King of Prussia, PA Antonio
Roadmap for Managing Multiple CRO Vendors
PharmaSUG 2017 - Paper PO27 Roadmap for Managing Multiple CRO Vendors Veena Nataraj, Shire, Lexington, MA Karin LaPann, Shire, Lexington, MA ABSTRACT When working with CROs, the relationship established
Eileen Navarro MD, FACP Medical Officer, OCS, OTS, CDER, FDA
Eileen Navarro MD, FACP Medical Officer, OCS, OTS, CDER, FDA 1 www.fda.gov WHAT MEDICAL REVIEWERS CAN DO WITH STANDARDIZED DATA AND METADATA RECEIVED IN MODULE 5 Eileen Navarro, MD, FACP OCS/OTS/CDER/FDA
End-to-End Management of Clinical Trials Data
End-to-End Management of Clinical Trials Data A Revolutionary Step Toward Supporting Clinical Trials Analysis Over the Next Decades of Clinical Research WHITE PAPER SAS White Paper Table of Contents Introduction....
Aepodia is a team of experts with more than 15 years
Aepodia is a team of experts with more than 15 years experience in early clinical development and translational science with small startup and large global pharmaceutical companies. Aepodia s team has
Optimizing Your Study Data Submissions to FDA Updates from CDER and CBER
This single PDF file contains the slides for all three presentations in the webinar: Optimizing Your Study Data Submissions to FDA Updates from CDER and CBER Please page down to find the slides for all
CDISC International Interchange Program Embracing a Changing Landscape Standards to Connect Research and Patient Care
CDISC International Interchange Program Embracing a Changing Landscape Standards to Connect Research and Patient Care B e t h e s d a N o r t h M a r r i o t t H o t e l a n d C o n f e r e n c e C e n
Question and Answer Guide Regarding Notification on Practical Operations of Electronic Study Data Submissions
Administrative Notice April 27, 2015 To: Prefectrual Health Department (Bureau) Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare Question
Electronic Health Records and Clinical Data Interchange Standards
Electronic Health Records and Clinical Data Interchange Standards Stephen E. Wilson, Dr.P.H., CAPT USPHS Director Division of Biostatistics III Center for Drug Evaluation and Research US Food and Drug
The use of electronic Health Records in Clinical Research - The value of CDISC Standards
The use of electronic Health Records in Clinical Research - The value of CDISC Standards FH-Prof. Dr. Jozef Aerts University of Applied Sciences FH Joanneum Graz, Austria Who is Jozef Aerts? CDISC volunteer
Availability of Masked and De-identified Non-Summary Safety and Efficacy Data; Request for
This document is scheduled to be published in the Federal Register on 06/04/2013 and available online at http://federalregister.gov/a/2013-13083, and on FDsys.gov 4160-01-P DEPARTMENT OF HEALTH AND HUMAN
Janssens Discovery Data Integrity program (DDI): A journey over the last 7 years Research Integrity: Position yourself for success!
Janssens Discovery Data Integrity program (DDI): A journey over the last 7 years Research Integrity: Position yourself for success! David J. Gallacher, PhD DDI Co-Lead, Global Head of Safety Pharmacology
Clinical Data Standards Governance. Tammy Burns, Expert Clinical Data Manager 11 th January 2013
Clinical Data Standards Governance Tammy Burns, Expert Clinical Data Manager 11 th January 2013 Standards Used and Formal Govenance Standard Types General and Therapeutic Area Data Standards Collection
21 st Century Cures Act: Progress Update
21 st Century Cures Act: Progress Update ShaAvhrée Buckman-Garner, MD, PhD Director, Office of Translational Sciences Center for Drug Evaluation and Research September 25, 2017 Background 21 st Century
Chapter 1. Pharmaceutical Industry Overview
Chapter 1 Pharmaceutical Industry Overview 1.1 Introduction 2 1.2 Regulations 2 1.2.1 Health Insurance Portability and Accountability Act 2 1.2.2 The Code of Federal Regulations 3 1.2.3 Guidance for Industry
FDA > CDRH > CFR Title 21 Database Search
Seite 1 von 7 FDA Home Page CDRH Home Page Search A-Z Index 510 (k) Registration Listing Adverse Events PMA Classification CLIA CFR Title 21 Advisory Committees Assembler Recalls Guidance Standards New
FDA Biomarker Learnings and the Future
FDA Biomarker Learnings and the Future ShaAvhrée Buckman-Garner, M.D., Ph.D., F.A.A.P. Director Office of Translational Sciences Center for Drug Evaluation and Research Food and Drug Administration What
Model-Based Qualification of Biomarkers. Klaus Romero, MD MS FCP Director of Clinical Pharmacology and Quantitative Medicine
Model-Based Qualification of Biomarkers Klaus Romero, MD MS FCP Director of Clinical Pharmacology and Quantitative Medicine Critical Path Initiative (CPI) Critical Path Institute (C-Path) Independent 501(c)3
Specific pathologist responses for Standard for Exchange of Nonclinical Data (SEND)
J Toxicol Pathol 2017; 30: 201 207 Review Specific pathologist responses for Standard for Exchange of Nonclinical Data (SEND) Atsushi Watanabe 1, 2*, Osamu Kusuoka 1, Norihiro Sato 1, Osamu Nakazono 1,
The Anatomy of Clinical Trials Data: A Beginner s Guide
ABSTRACT Paper 1759-2018 The Anatomy of Clinical Trials Data: A Beginner s Guide Venky Chakravarthy, BioPharma Data Services, Ann Arbor, Michigan An audience that wants to learn more about clinical trials
Developing Strong Partnerships to Ensure Success With Global Medical Device Trials. 23-February-2017, OCT Burlingame
Developing Strong Partnerships to Ensure Success With Global Medical Device Trials 23-February-2017, OCT Burlingame www.genae.com With you, for you Agenda 01 02 Identify the core group of stakeholders
Pharmacovigilance and the Generic Industry. Mark Vieder RPh MBA Director, Safety & Medical Writing Biorasi
and the Generic Industry Mark Vieder RPh MBA Director, Safety & Medical Writing Biorasi Disclaimer: This presentation has been prepared by Biorasi, LLC solely for the purpose of sharing information and
Clinical Data Acquisition Standards Harmonization (CDASH)
Clinical Data Acquisition Standards Harmonization () Prepared by: CDISC Team Section Table of Contents Page 1.0 Orientation... 1 1.1 Purpose... 1 1.2 Organization of this Document... 1 1.2.1 General Notes...2
ectd: A Clinical Reviewer s Experience Sarah M. Connelly, MD Medical Officer Division of Antiviral Products FDA
ectd: A Clinical Reviewer s Experience Sarah M. Connelly, MD Medical Officer Division of Antiviral Products FDA Disclaimer The views and opinions expressed in the following PowerPoint slides are those
Global Clinical Trials in Korea
Global Clinical Trials in Korea In-Sook Park Department of Drug Evaluation Korea Food & Drug Administration Contents Regulatory changes relevant to Clinical Trials in Korea Current Status of Clinical Trials
GCP Basics - refresher
p. 01 GCP Basics - refresher Agenda: p. 02 Brief History of GCP GCP Regulations Principles of ICH E6 Sponsor Responsibilities Computer Systems Common Compliance Issues Brief History of GCP 3 Brief History
CDISC Public Webinar Standards Updates and Additions. May
CDISC Public Webinar Standards Updates and Additions May 19 2016 Agenda ADaMIG v1.1 John Troxell, Accenture OCCDS v1.0 Sandra Minjoe, Accenture CDISC Online Education & Event Updates John Ezzell, CDISC
Expanded Access to Investigational Imaging Drugs
Expanded Access to Investigational Imaging Drugs Phillip B. Davis, MD FDA/CDER/ODEIV/DMIP 6/09/2016 1 Overview Expanded Access (EA) Defined Requirements for all EA authorizations Types of EA Individual
Breaking the Silo Mentality Working With Opinion Leaders
CBI s 2 nd Annual KOL Conference Breaking the Silo Mentality Working With Opinion Leaders Kashif Chaudhry Objectives Share a view on the changing environment impacting the pharmaceutical industry and KOL
HTAs and EMA working together: 23 parallel scientific advice procedures later - what have we learned?
HTAs and EMA working together: 23 parallel scientific advice procedures later - what have we learned? DIA 26th Annual EuroMeeting, Vienna 2014 Jan Regnstrom, MD, PhD Senior Scientific Officer An agency
Expanded Access. to Investigational Drugs & Biologics. for Treatment Use
SJMHS Research Compliance Office Guidance Document Expanded Access to Investigational Drugs & Biologics for Treatment Use May 2015 1 Expanded Access to Investigational Drugs & Biologics for Treatment Use
Presentation Outline
IND Application Process: For The New Clinical Investigator John M. Centanni Department of Medicine University of Wisconsin Presentation Outline Journey from basic to clinical research Introduction to FDA
Pre-Competitive Collaboration in Clinical Trials. July 24, 2013 Garry A. Neil, MD Board of Directors, Chairman
Pre-Competitive Collaboration in Clinical Trials July 24, 2013 Garry A. Neil, MD Board of Directors, Chairman Value R&D leaders identified Clinical Trial Execution as a key priority area for industry-wide
Exploration des données d essais cliniques en utilisant le standard CDISC
Exploration des données d essais cliniques en utilisant le standard CDISC Florence Kussener French System Engineer Florence.Kussener@jmp.com SAS Institute AGENDA Outcomes of using CDISC standards Case
The Patient-Reported Outcome (PRO) Consortium:
The Patient-Reported Outcome (PRO) Consortium: A Collaborative Approach to PRO Instrument Development and Qualification Stephen Joel Coons, PhD Executive Director The views and opinions expressed in the
IRB-GCP and Timelines. Andrew Majewski, MSc. 1 st DOLF Meeting Washington University School of Medicine St Louis, Missouri-USA October th, 2010
IRB-GCP and Timelines Andrew Majewski, MSc. 1 st DOLF Meeting Washington University School of Medicine St Louis, Missouri-USA October 11-14 th, 2010 1 Factors that affect Timelines Finalized Protocol Finalized
Connecting the parts Developing an integrated IDMP strategy
Connecting the parts Developing an integrated IDMP strategy Contents The evolving regulatory landscape 1 Developing the right strategy 5 Impact of ISO on the life sciences industry 6 Contacts 7 The evolving
McKinsey Center for Government What's Driving the Recent Surge in New Drug Approvals?
McKinsey Center for Government What's Driving the Recent Surge in New Drug Approvals? Alexia Cesar, Philip Ma, Navjot Singh, Jeff Smith What's Driving the Recent Surge in New Drug Approvals? In 2012, the
CANADA (HEALTH CANADA)
1 GMP GAZETTE TM January 2016 HPFBI CANADA (HEALTH CANADA) NNHPD NHPs Notice to Stakeholders Regarding Site Licensing Update Who s affected? Manufacturers, packagers, labellers, importers, and distributors
Deployment of SAS Programming Contract Staff: Pathway to Sinkhole or Best Strategy for Programming Division? Parag Shiralkar, Eliassen Group, NJ, USA
PharmaSUG 2013 Paper MS04 Deployment of SAS Programming Contract Staff: Pathway to Sinkhole or Best Strategy for Programming Division? Parag Shiralkar, Eliassen Group, NJ, USA Abstract In pharmaceutical
EU perspective: European procedure for Qualification of novel methodologies for medicine development. Elmer Schabel MD
EU perspective: European procedure for Qualification of novel methodologies for medicine development Elmer Schabel MD Nothing to disclose See: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/landing/ex
Non-clinical Assessment Requirements
Non-clinical Assessment Requirements Presented by: Maria Nieto-Gutierrez Safety and Efficacy of Medicines/Human Medicines Development and Evaluation An agency of the European Union Contents: Relevance
Clinical trials from CRA s point of view
Clinical trials from CRA s point of view Dr Jacek S Gregorczyk MPharmS, PhD Clinical Research Associate (CRA) at MDS Pharma Services UK office - a global CRO REGULATION of CLINICAL TRIALS World Medical
Copyright. Jeremiah J. Kelly (2015). All rights reserved. Further dissemination without express written consent strictly prohibited.
Statutory Framework for Biologics Drugs Investigational Use Application IND Pre-Market Approval Applications 505(b)(1) NDA 505(b)(2) NDA 505(j) ANDA Over-the-Counter (OTC) Non- Rx Drugs Monograph Biologics
THE VISUALIZATION AND ANALYSIS OF IMMUNO-ONCOLOGY STUDIES USING JMP CLINICAL
THE VISUALIZATION AND ANALYSIS OF IMMUNO-ONCOLOGY STUDIES USING JMP CLINICAL GEOFFREY MANN, PHD JMP LIFE SCIENCES PRODUCT MANAGER GEOFFREY.MANN@JMP.COM BACKGROUND: IMMUNO- ONCOLOGY Immuno-Oncology studies
GUIDELINE REGARDING COLLECTION, VERIFICATION, AND SUBMISSION OF THE REPORTS OF ADVERSE EVENTS / REACTIONS OCCURRING IN CLINICAL DRUG TRIALS
1. PURPOSE This guideline is about the collection, verification, and submission of the reports of adverse events / reactions occurring in clinical drug trials, and code breaking methods. 2. DEFINITIONS
EAUTIFUL BDATA AGGREGATION EXTRAVAGANZA. Implementing a Clinical Data Repository and Analytics Platform in 90 Days
DATA IS SIMPLY EAUTIFUL BDATA AGGREGATION EXTRAVAGANZA This artful imagery is an abstract representation of data coming from a myriad of sources to create a single, impactful image. Created by data artist,
Chin Koerner Executive Director US Regulatory and Development Policy
Chin Koerner Executive Director US Regulatory and Development Policy Novartis Pharmaceuticals Corporation 1700 Rockville Pike Suite 510 Rockville, MD 20852 Tel 301.468.5607 Fax 301.468.5614 Email: Chin.Koerner@novartis.com
Flexible and Pending Monographs
Flexible and Pending Monographs USP Approaches to Accommodate Multiple Approved Products Doreen McDonald Senior National Account Manager U.S. Pharmacopeial Convention Flexible Monographs: Background From
SWABIK Software Tools for the Exchange of Image Storage Media in Clinical Research (SWABIK)
SWABIK Software Tools for the Exchange of Image Storage Media in Clinical Research (SWABIK) This work is funded by the German federal ministry of research and education (grant 01 EZ 1023) 2 Outline Introduction
Regulatory and ethical requirements in medical devices studies. France
Regulatory and ethical in medical devices studies France SECTIONS A.Type of research SECTIONS A.Type of research We have differentiated 8 types of research: Medical device alone with CE mark use within
Welcome to the American College of Toxicology s Webinar Series. We will begin at 11AM EDT
Welcome to the American College of Toxicology s Webinar Series We will begin at 11AM EDT Preparing for Nonclinical edata Regulatory Submissions to the US FDA SEND and Beyond September 5, 2013, 11:00 AM
Fergus Sweeney, European Medicines Agency
Fergus Sweeney, European Medicines Agency Disclaimer The views presented in this presentation/these slides are those of the author and should not be understood or quoted as being made on behalf of the
Report from the Paediatric Committee on its first anniversary
European Medicines Agency London, 11 July 2008 Doc. Ref. EMEA/PDCO/347884/2008 Report from the Paediatric Committee on its first anniversary The European Medicines Agency s Paediatric Committee (PDCO)
Regulatory and ethical requirements in medical device studies. Finland
Regulatory and ethical in medical device studies Finland SECTIONS A.Type of research SECTIONS A.Type of research We have differentiated 8 types of research: Medical device alone with CE mark use within
Okaloosa RESTORE Advisory Committee (ORAC) October 3, :00 PM 8:00 PM Northwest Florida State College
Okaloosa RESTORE Advisory Committee (ORAC) October 3, 2013 6:00 PM 8:00 PM Northwest Florida State College Agenda Minutes Approval Consultant s Administrative Report Scheduled Presentations - None Regional
Business Practice Manual for The Transmission Planning Process
Business Practice Manual for The Transmission Planning Process Posted: June 2, 2015 Intentionally left blank TABLE OF CONTENTS 1. Introduction... 9 1.1. Purpose of California ISO Business Practice Manuals...
Drug Development: Why Does it Cost so Much? Lewis J. Smith, MD Professor of Medicine Director, Center for Clinical Research Associate VP for Research
Drug Development: Why Does it Cost so Much? Lewis J. Smith, MD Professor of Medicine Director, Center for Clinical Research Associate VP for Research Drug Development Process by which new chemical entities
Copyright. Jeremiah J. Kelly (2015). All rights reserved. Further dissemination without express written consent strictly prohibited.
Statutory Framework for Devices Medical Devices Investigational Use Application IDE (21 CFR 812) Abbreviated IDE Exempt Pre-Market Approval Applications 510(k) Pre-marketing Notification (21 CFR 807(e))
E2B, Safety databases & Eudravigilance
E2B, Safety databases & Eudravigilance Delphine BERTRAM, PharmD Hospices Civils de Lyon France HOT TOPICS IN PV Hod Hasharon 7 May 2014 Dr Irene Fermont- ISOP ISRAEL Dganit Even Sapir -MSD Spontaneous
GOOD CLINICAL PRACTICE (GCP) Series Catalog
GOOD CLINICAL PRACTICE (GCP) Series Catalog CITI Program s GCP series consists of three basic courses and three refresher courses. The basic courses include: GCP for Clinical Trials with Investigational
22 nd February Utilizing big data to enhance patient recruitment
22 nd February 2017 Utilizing big data to enhance patient recruitment Overview Barriers to recruitment success Current solutions to overcome recruitment barriers Outsourcing (3 rd Party Vendors, CROs)
Sunshine on Europe: impact of recent EFPIA and EU guidelines on publication planners. Susan Scott, PhD, CMPP Director, Scott Pharma Solutions Ltd
Sunshine on Europe: impact of recent EFPIA and EU guidelines on publication planners Susan Scott, PhD, CMPP Director, Scott Pharma Solutions Ltd Disclaimer As an independent consultant, the views expressed
Expanded Access and the Individual Patient IND
Expanded Access and the Individual Patient IND Research Wednesdays April 26, 2017 Erika Segear Johnson, PhD, RAC Associate Director of Regulatory Affairs Office of Regulatory Affairs and Quality Office
Applying SDTM and ADaM to the Construction of Datamarts in Support of Cross-indication Regulatory Requests
Applying SDTM and ADaM to the Construction of Datamarts in Support of Cross-indication Regulatory Requests Data-what? This presentation will discuss some of the complexities involved when integrating study
Standard for Exchange of Nonclinical Data Implementation Guide: Nonclinical Studies
Standard for Exchange of Nonclinical Data Implementation Guide: Nonclinical Studies Prepared by the CDISC Standard for Exchange of Nonclinical Data Team Notes to Readers This is the implementation guide
IBM Clinical Trial Management System for Sites
Service Description IBM Clinical Trial Management System for Sites This Service Description describes the Cloud Service IBM provides to Client. Client means the contracting party and its authorized users
Clinical Trial Transparency UK perspective
Clinical Trial Transparency UK perspective Dr Bina Rawal Medical, Innovation & Research Director Association of the British Pharmaceutical Industry January 2014 1 Outline Transparency timeline Campaign
The Role of Comparative Analyses for Evaluation of Generic Drug-Device Combinations in an ANDA
The Role of Comparative Analyses for Evaluation of Generic Drug-Device Combinations in an ANDA K. Witzmann, MD Inhalation and Drug-Device Combination Products Team Office of Research and Standards, Office
Update on Current FDA Policies and Priorities
Update on Current FDA Policies and Priorities Vernessa Pollard MassMEDIC FDA Update December 12, 2017 Boston Brussels Chicago Dallas Düsseldorf Frankfurt Houston London Los Angeles Miami Milan Munich New
April 13, Background
Pfizer Inc 235 East 42nd Street New York, NY 10017-5755 Tel 212 733 4210 Fax 646 383 9249 Email: marc.wilenzick@pfizer.com April 13, 2009 http://www.regulations.gov Christine Ireland Committee management
Clinical Trials Management for Molecular Diagnostics. April 2016
Clinical Trials Management for Molecular Diagnostics April 2016 Clinical Operations Responsibilities Accrue samples that have proper informed consent for use Retrospective cohorts Remnant samples Prospective