Investigator Initiated-Sponsored Research (IISR)
|
|
|
- Elfrieda Walsh
- 6 years ago
- Views:
Transcription
1 Investigator Initiated-Sponsored Research (IISR) State of the Industry and the Need for Global Standards and Metrics Alexander Kostek and DeeAnn Tinjum
2 Disclaimer The views and opinions expressed by the presenter and set forth in the following PowerPoint slides are those of the individual presenters and should not be attributed to Pfizer Inc., or any of their respective directors, officers, employees, or any organization with which the presenter is affiliated. These PowerPoint slides are the intellectual property of the individual presenters and are protected under the copyright laws of the United States of America and other countries.
3 Objectives Understand the current state of IISR programs globally and the need for minimum standards and comprehensive programs Describe the current regulatory and legal environment for IISR programs and understand current industry led initiatives for IISR standards Explain the mission and vision for IISRA
4 What is IISR? Investigator Initiated Research/Studies/Trials Investigator Sponsored Research/Studies/Trials Physician Initiated Research/Studies/Trials Physician Sponsored Research/Studies/Trials Investigator Initiated Sponsored Research (IISR)
5 Current Global Environment Lack of clear, specific Regulatory Guidelines for IISR Varying global definitions of sponsorship Unfamiliarity with research by Investigators Inconsistencies in Industry policies Inconsistencies in Industry resources & support
6 Regulatory & Legal Considerations Food, Drug and Cosmetic Act International Conference Harmonization (ICH)/Good Clinical Practice (GCP) Guidelines US Department of Health & Human Services Federal Code of Regulations (CFR Section 21) OIG: Compliance Program Guidance Sunshine Act Federal Anti- Kickback Statute
7 Regulatory & Legal Considerations, cont. False Claims Act (FCA) Foreign Corrupt Practices Act (FCPA) European Unions Clinical Trial Directive European Medical Research Council (EMRC) of the European Science Foundation PhRMA and AdvaMed Codes
8 Proposal Submission Identify submission method Ensure transparency & availability to the public Provide templates and clear directions Document receipt Ensure completeness of proposal
9 Proposal Review Committee reviews using well defined criteria: Company Strategy Scientific Merit Patient Safety Fair Market Value (FMV) Expertise of the Investigator Scientific, Legal and Regulatory considerations Committee decision is documented Decision communicated to the submitter
10 Example of Review Process Research interest received Medical Affairs does initial review, application packet sent if warranted Denial Decision communicated to submitter Submitter completes standard IISR application form Team Review Conditionally Approved Submitter updates proposal Approved (and communicated to submitter) Submitter provided IISR Start Up Packet Deferred (IISR to be re-evaluated by team) Finalize Contract / Legal Review IISR authorized and research initiated
11 Proposal Review, cont. Provide a IISR packet Company specific Review Protocol Prior to IRB/EC submission Record comments Communicate to submitter
12 IISR Agreement Develop an IISR agreement template including: Compliance with laws and regulatory requirements Support provided by company & how it is provided IND or IDE submission, if applicable Registration of study Safety reporting Study progress reports from sponsor Publication expectations Intellectual Property Company rights for review prior to submissions Indemnification Term and termination
13 Overall Program Management Communicate with the sponsor-investigator Collect study progress reports Distribute funding and/or product Maintain study documents Ensure Safety Reporting Develop Metrics Obtain deliverables for internal review Perform close out
14 IISRA - Mission Statement IISRA is an independent association of professionals dedicated to promoting excellence in investigator initiated-sponsored research (IISR) programs. Our commitment is to support members through the development and implementation of educational activities, professional knowledge standards, and ethical practices.
15 Approximately 300 professionals Membership Pharma, biotech, device, academia, CROs, technology vendors, consultants Growing European Interest Benefits: Communication forum for consensus building Networking with global IISR professionals Tools and information Access to IISRA Position Statements and Guidelines Stay abreast of new trends/benchmarking Free to join:
16 Standards and Best Practices Guidance Documents Position Statements Implementation of IISRA By-Laws Pulse on Compliance/Ethics Issues Surveys and Benchmarking IISRA Activities Leadership Presence at National Organizations/Conf. Networking Job Postings (Future) 16
17 2011/2012 Strategic Goals Broaden Communication Among Members Advance the Value of the IISRA Org Sustain IISRA s Growth 17
18 Goal: Broaden Communications Increase IISR presence and community dialogue through on-line media Accomplishments IISRA group established on LinkedIn (Jan 2011) Updated website (Feb 2011) Focus IISR presence at industry conferences in the USA Accomplishments (Chair/Speaker/Moderator) Center for Business Intelligence (CBI) Standards/Best Practice Webinar_Sponsor is SteepRock (Jan 2011) Collaborative Group Initiative (Mar 2011, Oct 2011) CBI IIS Conference (June 2011) ExL Pharma IIT Conf in USA (Apr 2011, Sept 2011, Apr 2012) Q1 Productions_Medical Device in USA (Sept 2011) DIA - IIS Trial Master File (TMF) Content Model (Jan 2012) ACRP Abstract and Oral Presentation (April 2012) 18
19 Broaden Communications, Con t Support IISRA values Accomplishments Conduct IISRA annual elections (2011; 2012) IISRA By-Laws (July 2011) Increase exposure to non-industry partners (government, academia) Future Regulatory links and training slides for Investigators Greater interface and input with FDA 19
20 Goal: Advance Value of IISRA Drive the creation / completion of new position statements and guidelines Accomplishments Metrics Guidance Document (Mar 2011) IISRA surveys - future guidance topics (Apr and June 2011) Ongoing committees: Industry collaboration with Cooperative Groups Polaris initiates FMV (interviews in May 2011; draft Jan 2012) Initiating four new documents 20
21 Advance Value of IISRA (Con t) Expand the usages / offerings through IISRA.org Future Job postings Networking Create additional value for the biopharm and device industries, and also for government / academia Future 2012 member survey Links to portals for industry grant applications 21
22 Goal: Sustain IISRA Growth Achieve a target membership of 500 registrations globally Accomplishment: Membership doubled from approx 180 to 300 members Increase presence in Europe, Asia/Pacific & emerging markets Accomplishments: DIA_Europe: Intro of IISRA to EU community (Mar 2011) Q1 Productions (Frankfurt, Germany) Chair/Speaker IISRA Board increased from one to four EU members Plan and execute at least two (2) IISRA general sessions 2012 annual meeting via conference attendance and webinar Build strategic partnerships (FDA, Medical Affairs) 22
23 Initiatives With Other Organizations National Organization s National Cancer Institute (NCI) Clinical Trials Network (CTN) Inter- National Conferences Industry Leaders Technology Vendors Industry_Posting of Grant Applic. Links Committees for Position/Guidance Docs Polaris SteepRock DIA (USA) DIA (Europe) MedNet Solutions ACRP ExL Pharma IIT CBI ISS CBI Coop Groups Q1 Prod (USA) ExL Pharma IIT (Europe) Q1 Prod 23
24 IISRA Board of Directors ( ) Chairperson: Officers: Karen Bartels (AstraZeneca) President: Anton Ehrhardt (Sanofi) Vice President: Ran Frenkel (Clinipace_Europe) Treasurer: Nader Molavi Secretary: Patricia Westergren (MedNet) Executive Committee: Executive Director: Alex Kostek (Pfizer) Members: Dan Bromberg (Polaris) Jocelyn Ulrich (HGSI) Ornah Levine-Dolberg (Lundbeck) Jonathan Chambers (Pierre-Fabre) Ouadah Hadjebi (Editor, IST Journal) 24
25 IISRA Guidance Documents / Position Statements 25
26 Guidance Documents and Position Statements Completed Documents - Currently Available on the IISRA Website ( IISRA Mission Statement Standards and Best Practices Metrics Guidelines Setting Up an IISR Program Statement on Fair Market Value Future Documents - IISRA conducted a survey at the ExL Pharma and CBI Conferences in 2011 to determine topics of interest 26
27 Survey Results: Desired Topics New Committee Initiatives: Fair Market Value (FMV) - Initiated Collaborative Initiative with NCI - Initiated Contract Bottlenecks Publications CTMS System for IISR Programs Sunshine Act 27
28 A thank you for their contributions! Cynthia Barbitsch Karen Bartels Shiferaw Kibriye Michael Montgomery Wendy Moore Matthew Silverman DeeAnn Tinjum Mary Voehl Pat Westergren
Why do we need an addendum to ICH E6?
Addendum to ICH E6 Hideaki Ui, Ph.D. Inspection Director Office of Non-clinical and Clinical Compliance Pharmaceuticals and Medical Devices Agency, Japan Disclaimer The views and opinions expressed in
The Meeting Planner s Challenge: Contending with Ever-Changing Healthcare Regulations
The Meeting Planner s Challenge: Contending with Ever-Changing Healthcare Regulations Rosaelena Bernaducci, CMP Sr. Meeting Professional & Compliance Manager Bernaducci & Assoc Disclaimer The views and
Vertex Investigator-Initiated Studies Program Overview
Vertex Investigator-Initiated Studies Program Overview Our Goal Our Investigator Initiated Study grants support independent, investigator-initiated research designed to advance scientific knowledge of
Training, Site Selection and Human Subject Protection: Factors to Consider When Developing a Monitoring Plan
Training, Site Selection and Human Subject Protection: Factors to Consider When Developing a Monitoring Plan Cynthia F. Kleppinger, M.D. Senior Medical Officer Office of Scientific Investigations Office
PMDA Update: Its current situation
PMDA Update: Its current situation and future direction Tatsuya Kondo, M.D. Ph.D. Chief Executive Pharmaceuticals and Medical Devices Agency (PMDA), Japan 25th Annual EuroMeeting 4-6 March 2013 RAI, Amsterdam
Registration of Clinical Trials: Background and Implementation
Registration of Clinical Trials: Background and Implementation Ida Sim, MD, PhD Project Coordinator Department of Research Policy and Cooperation World Health Organization Geneva, Switzerland; and University
Regional Alignment in Asia Pacific -
Regional Alignment in Asia Pacific - a Perspective from the Chair of the APEC Regulatory Harmonization Steering Committee (RHSC) Mike Ward Chair, APEC RHSC 3 rd Annual DIA Latin American Regulatory Conference
Ferring Investigator-Initiated Trials (IIT) Submission Guidelines
Ferring Investigator-Initiated Trials (IIT) Submission Guidelines WHAT WE SUPPORT The mission and purpose of the Ferring Investigator-Initiated Trial Program is to provide support for investigator-initiated
Physician/Industry Contacts: Updated Focus on CME & Grassley Looks at Possible Research Conflicts
Physician/Industry Contacts: Updated Focus on CME & Grassley Looks at Possible Research Conflicts AdvaMed Webinar // October 28, 2008 R. Michael Scarano, Jr. Heidi A. Sorensen Judith A. Waltz 10/20/2008
Introduction to the United States Food and Drug Administration (FDA) and FDA Inspection Process VOICE
Introduction to the United States Food and Drug Administration (FDA) and FDA Inspection Process VOICE 2011 MTN Annual Meeting March 27, 2011 Lisa Noguchi, MSN Donna Germuga, DAIDS, OCSO, RN, BSN Objectives
CURRICULUM VITAE. 23 December 1968, Varna, Bulgaria
CURRICULUM VITAE NAME: Milen Nikolaev Vrabevski, MD DATE/PLACE OF BIRTH: 23 December 1968, Varna, Bulgaria CONTACT DETAILS: South Side Business Centre 38, Maystor Aleksi Rilets Str., 5th fl. Res. Distr.
STEERING COMMITTEE NOMINEES FOR THREE VACANCIES MARCH 2018
STEERING COMMITTEE NOMINEES FOR THREE VACANCIES MARCH 2018 KRISTEN BRETZIUS PSI Documentation Center Manager CRO Change Control Board Member Artifact Subtype Team Zone 4 SME Team (Team Lead) Zone 5 SME
ectd IV: It s Almost As Fun As Super Bowl XLIX DIA eregulatory and Intelligence Annual Conference Disclaimer
ectd IV: It s Almost As Fun As Super Bowl XLIX DIA eregulatory and Intelligence Annual Conference Mark Gray FDA/CBER Senior Project Manager 1 Disclaimer Views expressed in this presentation are those of
Direct Patient ADR reporting system in Japan. Kazuhiko Mori, Chief Safety Officer Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Direct Patient ADR reporting system in Japan Kazuhiko Mori, Chief Safety Officer Pharmaceuticals and Medical Devices Agency (PMDA), Japan Disclaimer The views and opinions expressed in the following PowerPoint
Commission Guidelines for the implementation of the Clinical Trials Regulation NTA Ethics Oslo
Commission Guidelines for the implementation of the Clinical Trials Regulation NTA Ethics 30.1.2017 Oslo 3.2.2017 O. Konttinen 1 Background Based on directive 2001/20/EC of the clinical trials on medicinal
CQA Consultant of HVCC, Hilversum, the Netherlands. Coaching of auditors on various levels is an on-going activity.
CURRICULUM VITAE Name : Vlaskamp First name : Johanna Maria (Hanny) Title : BSc. Address : Vuurvlindermeent 14 1218 GZ Hilversum The Netherlands Phone : +31 (0)6 54995411 (mobile) Nationality : Dutch EDUCATION
LivaNova Terms and Conditions for Donations and Grants
LivaNova Terms and Conditions for Donations and Grants The following Terms and Conditions apply to all LivaNova Donations and Grants approved by the LivaNova regional Donation and Grant Committees, including;
Solutions for GCP Compliance Challenges. September 23, 2015 Northwestern University IRB Brown Bag Session
Solutions for GCP Compliance Challenges September 23, 2015 Northwestern University IRB Brown Bag Session PAMELA MASON, MPH Vice President, Mason Professional Services, LLC Adjunct Faculty, Northwestern
Solutions for GCP Compliance Challenges
Solutions for GCP Compliance Challenges September 23, 2015 Northwestern University IRB Brown Bag Session PAMELA MASON, MPH Vice President, Mason Professional Services, LLC Adjunct Faculty, Northwestern
Determining and Reporting Adverse Events vs. Product Complaints
Determining and Reporting Adverse Events vs. Product Complaints Pharma Perspective: Jacqueline Grissinger Director, Office of Consumer Medical Safety Johnson & Johnson Medical Device Perspective: Lisa
September 2-3, 2013 Chengdu, China
Root Cause Investigations and Corrective Actions for GCP Compliance September 2-3, 2013 Chengdu, China Good Clinical Practice (GCP) is a compilation of best practices and quality standards to be applied
Standard Operating Procedures
Standard Operating Procedures 5.7 Site Initiation Version V1.0 Author/s Approved B Fazekas, S Kochovska D Currow Effective date 30/09/2017 Review date 30/09/2019 DO NOT USE THIS SOP IN PRINTED FORM WITHOUT
AN OVERVIEW OF CLINICAL STUDY TASKS AND ACTIVITIES
1 AN OVERVIEW OF CLINICAL STUDY TASKS AND ACTIVITIES Key Clinical Study Tasks and Activities 2 Discussion of Key Tasks and Activities 3 Development of the Clinical Protocol and Study Materials 3 Qualification
Dr. R. Sathianathan. Role & Responsibilities of Principal Investigators in Clinical Trials. 18 August 2015
18 August 2015 Role & Responsibilities of Principal Dr. R. Sathianathan Professor of Psychiatry, SRMC, Porur & Former Director, Institute of Mental Health, Chennai Principal Investigators & GOOD CLINICAL
2017 Clinical Trials Data Library
2017 Clinical Trials Data Library Copyright 2017 CenterWatch. Identification to Activation: A One-Year Cycle Median Site Startup vs. Cycle Time by Selected Countries Number of Registered Studies with Posted
FDA Perspective on the Pre- Submission Program: Updates from MDUFA IV
FDA Perspective on the Pre- Submission Program: Updates from MDUFA IV Maureen Dreher, PhD Policy Analyst Clinical Trials Program/ Office of Device Evaluation/ CDRH Agenda Pre-Submission Program background
Novartis Hellas: Vision & Responsibility for the Patients
Novartis Hellas: Vision & Responsibility for the Patients Foteini Bampanara Head of Communications, Leadership Team member 6 th Annual CSR Capital Link Congress June 27 th 2016 Disclaimer 2 OUR MISSION:
European Patients Academy (EUPATI) Update
European Patients Academy (EUPATI) Update EMA meeting with patient/consumer organisations 11 Dec 2013 Maria Mavris EURORDIS // EUPATI WP4 Co-Lead For patient-centric medicines R&D and to contribute to
THANK YOU FOR JOINING ISMPP U TODAY!
THANK YOU FOR JOINING ISMPP U TODAY! The program will begin promptly at 10:30am eastern August 14, 2013 ISMPP WOULD LIKE TO THANK the following Corporate Platinum Sponsors for their ongoing support of
MARKEY CANCER CENTER CLINICAL RESEARCH ORGANIZATION STANDARD OPERATING PROCEDURES SOP No.: MCCCRO-D
Page 1 of 8 MARKEY CANCER CENTER CLINICAL RESEARCH ORGANIZATION STANDARD OPERATING PROCEDURES SOP No.: Title: Data Safety and Monitoring Committee Administrative and Revision: N/A Revision Date: N/A Functional
CORDIS Partners Service Research Participant Portal
CORDIS Partners Service Research Participant Portal 12th July 2012 Formation au montage de projets du 7ème PCRD Paris Karl Ferrand - Head of CORDIS Content section - EU Publications Office Community Research
Regulatory Submissions Trends Survey 2002 Ellen Semple Date received (in revised form): 18th March, 2003
Ellen Semple joined CDC Solutions in July 2002 and is VP of Global Marketing. She oversees the strategic direction of CDC Solutions global marketing teams and works directly with CDC s work headquarters
National Council on Radiation Protection and Measurements Homeland Security Recommendations Related to Nuclear and Radiological Terrorism
National Council on Radiation Protection and Measurements Homeland Security Recommendations Related to Nuclear and Radiological Terrorism DHS Standards Program Review August 29, 2006 Name - DA Schauer
Addendum to ICH E6 (R2)
Addendum to ICH E6 (R2) Stephanie Shapley (US FDA) - Rapporteur Dr. Fergus Sweeney (EMA) - Regulatory Chair Date: December 15, 2015 International Council for Harmonisation of Technical Requirements for
Suggestions for Modification of the Clinical Trials Directive ELN Annual Meeting 01 February 2011
Suggestions for Modification of the Clinical Trials Directive ELN Annual Meeting 01 February 2011 European Medical Research Councils Dr Kirsten Steinhausen 1 ESF Member Organisations ESF is an independent
Patient Survey Data Results: Reminder Preferences in Patient- Reported Outcomes Studies
Patient Survey Data Results: Reminder Preferences in Patient- Reported Outcomes Studies Mark Wade Director, Patient Focused Solutions Almac @AlmacClinTech Disclaimer The views and opinions expressed in
European Freight Forwarding Index
European Freight Forwarding Index Volume development in April 15 Finn Bjarke Petersen finpe@danskebank.dk +45 45 12 36 Philip Levin phle@danskebank.dk +45 45 13 21 85 Important disclosures and certifications
Overview ICH GCP E6(R2) Integrated Addendum
2017 Biomedical Research Alliance of New York LLC CITI Program is a division of BRANY Overview ICH GCP E6(R2) Integrated Addendum Introduction On 15 December 2016, the International Council for Harmonistion
Mitzi Cardenas Sr. VP/Strategy, Business Development and Technology Truman Medical Centers
Mitzi Cardenas Sr. VP/Strategy, Business Development and Technology Truman Medical Centers HIMSS Stage 7: What it Means Heart of America HIMSS and the Missouri Health Information Management Association
EMSCO. The European MDS studies coordination office. Supporting Clinical Research, Education and Consulting in the field of MDS across Europe
EMSCO The European MDS studies coordination office Supporting Clinical Research, Education and Consulting in the field of MDS across Europe FISM Torino, 1. Apr. 2014 MDS Clinical Trials in Europe 2014
AHIA: Mitigating Risk through Auditing and Monitoring. Grants and Educational Activities
AHIA: Mitigating Risk through Auditing and Monitoring Grants and Educational Activities October 18, 2007 Heather J. Stewart Dir., Corporate Compliance Counsel MedImmune Disclaimer My opinions are based
PRESCRIPTION DRUG OVERDOSE PREVENTION PROGRAM RFP QUESTIONS
Academic Detailing RFP #IBEBPDOP-FS-AD-2019 QUESTIONS & ANSWERS September 28, 2018 1. What would be the estimated start date since the contract ends June 30, 2019? Answer: December 1, 2018 as an estimated
TITLE: Reporting Adverse Events SOP #: RCO-204 Page: 1 of 5 Effective Date: 01/31/18
SOP #: RCO-204 Page: 1 of 5 1. POLICY STATEMENT: The research team is responsible for recognizing changes in subject health that may qualify as adverse events, classifying those results as defined in the
Training components for GCP. inspectors in PMDA. Tomonori Tateishi, MD, PhD Office of Conformity Audit, PMDA
Training components for GCP inspectors in PMDA Tomonori Tateishi, MD, PhD Office of Conformity Audit, PMDA Content 1. Conformity inspection in the training program for newcomers to PMDA 2. The training
Audit and Inspection
Audit and Inspection DIPLOMA COURSE on Research & Development of Products for Public Health Needs Thammasat University, Thailand 28 November, 2008 Dr. Allan K. Johansen, Roche Products Pty Limited, Australia
European CRO Federation
European CRO Federation The interface between Industry CRO and Clinical Trials Networks: Defining the Roles EMA, London, 22 March 2012 Dr. Martine Dehlinger-Kremer Vice President Global Regulatory Affairs,
CDISC Standards Webinar Latest Updates and Additions 31 Jan 2013
CDISC Standards Webinar Latest Updates and Additions 31 Jan 2013 CDASH-SAE Domains CDISC CDASH SAE Team Update Rhonda Facile, CDISC Gary Walker, Quintiles CDISC 2013 2 Agenda Background Mapping CDASH to
Physician / Investigator. Over 40% of clinical trial data are entered into health record and EDC 1
EHR4CR AN INNOVATIVE PLATFORM AND BUSINESS MODEL ACDM Annual Conference, 9 Richard Perkins, eclinical Forum Electronic Health Records for Clinical Research 1 Industry-centric growth in ICT 57% of R&D investment
2019 AANS Annual Scientific Meeting Abstract Instructions
Visit MyAANS and login. Login Enter in your user ID and password. If you forgot your user ID and/or password, please use the Login Help link. Do not create another account if you cannot remember your password.
Good Clinical Practice. Lisa de Blieck MPA CCRC Clinical Trials Coordination Center
Good Clinical Practice Lisa de Blieck MPA CCRC Clinical Trials Coordination Center Good Clinical Practice (GCP) An international standard for the design, conduct, performance, monitoring, auditing, recording,
Now We are Getting to the Hard Parts: An Analysis Files Perspective
Now We are Getting to the Hard Parts: An Analysis Files Perspective Steve Wilson Director, CDER/OTS/OB/DBIII 2010 CDISC Interchange Renaissance Hotel, Baltimore, MD November 3-4, 2010 Disclaimer Views
GCP Inspection by PMDA
2012 EU GCP Inspectors Working Group Workshop London, 12-14 November 2012 Practical Experience in GCP inspections, non EU/EEA countries GCP Inspection by PMDA Kazuko Natsui Inspector for GCP Inspection,
Experience report on Marie Skłodowska- Curie Reintegration Grant Dr. Kathrin Buchholz. 8 th GGL Career Day Academia or Industry?
Experience report on Marie Skłodowska- Curie Reintegration Grant Dr. Kathrin Buchholz 8 th GGL Career Day 16.02.2017 Academia or Industry? 1 The basics of my career 09/1998 01/2004, JLU Gießen Studies
GRANTS.GOV Updates Federal Demonstration Partnership Meeting. Presented by Grants.gov September 7, 2017
GRANTS.GOV Updates Federal Demonstration Partnership Meeting Presented by Grants.gov September 7, 2017 RELEASE UPDATE 09/06/2017 GRANTS.GOV Updates Federal Demonstration Partnership JAD Meeting Slide 2
Ghassan Karam Project Manager ICTRP - WHO, Geneva
Beirut, 2 June 2016 Ghassan Karam Project Manager ICTRP - WHO, Geneva 1 Outline Background ICTRP Network of countries Search Portal & Data model Statistics The Lebanese registry of clinical trials 2 What
New European Union Clinical Trial Regulations
New European Union Clinical Trial Regulations Incorporate Monitoring and Safety Reporting Techniques into U.S. and EU Clinical Trial SOPs Anita K. Murthy Deputy Director, Global Regulatory Affairs Bayer
Toward Greater Scientific Rigor
Toward Greater Scientific Rigor Good Clinical Practice (GCP) A NEW REQUIREMENT! The Center for Clinical & Translational Science 205.934.7442 ccts@uab.edu www.uab.edu/ccts @cctsnetwork The requirement:
Pharmacovigilance: The patient s Perspective. Souzi Makri Chairperson AGORA EUPATI Fellow Executive Secretary CYPLAR President ENFA
Pharmacovigilance: The patient s Perspective Souzi Makri Chairperson AGORA EUPATI Fellow Executive Secretary CYPLAR President ENFA Scope of presentation Why is Pharmacovigilance important for patients?
Patient Registries Initiative Background, Achievements, Next steps
Patient Registries Initiative Background, Achievements, Next steps 21 November 2017 ENCePP Plenary meeting Presented by Xavier Kurz, Surveillance & Epidemiology Service, European Medicines Agency An agency
Guidance for Industry ANDA Submissions Prior Approval Supplements Under GDUFA
Guidance for Industry ANDA Submissions Prior Approval Supplements Under GDUFA DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this
STANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number End of Study Report SOP-RES-027 Version Number 2 Issue Date 15 Apr 2016 Effective Date 26 May 2016 Review Date 26 May 2018 Author(s) Reviewer(s) Natalie
EURAXESS Researchers in Motion
EURAXESS Researchers in Motion 1 EURAXESS: Background Europe aims to become the most innovative region in the world (former Lisbon Strategy, Innovation Union flagship initiative of the current Europe 2020
Client Alert. European Commission Proposes Overhaul of EU Clinical Trials Legislation
Number 1374 July 30, 2012 Client Alert Latham & Watkins Corporate Department European Commission Proposes Overhaul of EU Clinical Trials Legislation Only time will tell whether the Commission will achieve
Effective Date: April 2014 Revision: September 29, Executive Chair, Co-Chairs, NSHA REB Members, REB Office Personnel, Researchers.
TITLE: Standard Operating Procedure (SOP) External Inspections or Audits NUMBER: NSHA REB-SOP-9-002 Effective Date: April 2014 Revision: September 29, 2017 Applies To: Executive Chair, Co-Chairs, NSHA
Clinical Research Professionals
Training & Resources for Clinical Research Professionals Course & Publications Catalog January July 2016 In-Person and Web-Based Training Courses, Customized Training, elearning and Publications for Clinical
Research Governance in a public health service. Dr Angela Watt Director Research Governance and Ethics AHRDMA Annual Scientific Meeting 16 June 2017
Research Governance in a public health service Dr Angela Watt Director Research Governance and Ethics AHRDMA Annual Scientific Meeting 16 June 2017 Research Governance Research Governance What & Why? A
Rules and Procedures for IMI Calls for proposals. IMI Webinar 17 July 2017
Rules and Procedures for IMI Calls for proposals IMI Webinar 17 July 2017 Outline 1. Introducing IMI 2. Participation rules 3. Funding rules 4. Intellectual property rules 5. From Call to grant award 6.
DMTF Standards Incubation Process
1 2 3 4 Document Number: DSP4008 Date: 2010-11-19 Version: 1.2.0 5 6 7 8 9 Document Type: Process Document Status: DMTF Informational Document Language: en-us 10 DSP4008 11 12 Copyright Notice Copyright
CAUTION. Introduction
Introduction Most physicians strive to work ethically, render high-quality medical care to their patients, and submit proper claims for payment. Society places enormous trust in physicians, and rightly
Phase 1: Project Orientation and Analysis
Status Date Time Trip Activit Lead Purpose Deliverable Oct. 17 Nov. 9 Nov. 10 2:00 3:30 pm 10:15 am 4:45 pm 6:00 8:00 pm 8:30 am 11:30 am 11:45 am 12:45 Phase 1: Project Orientation and Analsis -- Project
OMeGA Medical Grants Association RESIDENCY/CORE COMPETENCY INNOVATION GRANT RECIPIENT AGREEMENT. Order number* Program applicant name*
OMeGA Medical Grants Association 2015-2016 RESIDENCY/CORE COMPETENCY INNOVATION GRANT RECIPIENT AGREEMENT Order number* Program applicant name* This Grant Recipient Agreement is between OMeGA Medical Grants
SESAR Joint Undertaking (SJU) Project Execution Guidelines for SESAR 2020 Exploratory Research 2016
SESAR Joint Undertaking (SJU) Project Execution Guidelines for SESAR 2020 Exploratory Research 2016 Version 1.00.00 7 December 2016 EDITION [01.00.00] Authoring & Approval Authors of the document Name
Observers Takuya Noro MHLW X X X Hideto Yokoi PMDA Advisor X X X Adriana Gamboa INFARMED X X X
Page 1 of 7 GHTF SG2 Meeting Location: INFARMED, Av. do Brasil, 53, 1749-004, LISBOA, PORTUGAL Date: 27-29 February 2008 Attendance: Name Organization Email 27/2 28/2 29/2 Miguel Antunes (MA) INFARMED
Quality Assurance and Site Monitoring Visits. Introduction. Training Outline
Instructors: 2009 Web Seminar Series Quality Assurance and Site Monitoring Visits Amanda Moore and Scott Provost, M.M., M.S.W. "This training has been funded in whole or in part with Federal funds from
D5.1 Dissemination plan WP5 Dissemination and networking
D5.1 Dissemination plan WP5 Dissemination and networking This project has received funding from the European Union s Horizon 2020 research and innovation programme under grant agreement No 692276. DISCLAIMER
Review of Existing Center for Drug Evaluation and Research Regulatory and Information
This document is scheduled to be published in the Federal Register on 09/08/2017 and available online at https://federalregister.gov/d/2017-19033, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
Registry of Patient Registries (RoPR) Policies and Procedures
Registry of Patient Registries (RoPR) Policies and Procedures Version 4.0 Task Order No. 7 Contract No. HHSA290200500351 Prepared by: DEcIDE Center Draft Submitted September 2, 2011 This information is
Guidance for the Tripartite model Clinical Investigation Agreement for Medical Technology Industry sponsored research in NHS Hospitals managed by
Guidance for the Tripartite model Clinical Investigation Agreement for Medical Technology Industry sponsored research in NHS Hospitals managed by Contract Research Organisations (CRO mcia, 2011 version)
1. Introduction, purpose of this Standard Operating Procedure (SOP)
SOP-CTN-001- Clinical Trial Network - General Organisation and Principles European Society of Anaesthesiology Details Document Type Document name Ref # Version Effective from Review date Owner Prepared
Convention on Nuclear Safety
Convention on Nuclear Safety National Report by Malta for the 7 th Review Meeting Made in connection with Article 5 of the Convention on Nuclear Safety List of Acronyms and Abbreviations... 2 Introduction....
Marie Sklodowska-Curie Actions Introduction
EU-JordanNet II Enhancement of Jordan-European S&T Partnerships Marie Sklodowska-Curie Actions Introduction Ana Martinez OGPI- International Project Management Office University of Alicante (SPAIN) The
Human Research Protection Program Institutional Review Board
Human Research Protection Program Institutional Review Board Policies and Procedures Guidebook TABLE OF CONTENTS Federal, State and University Regulations Related to the IRB... Section 1.0 Definition of
PGY1 - Project Learning Experience Description
PGY1 - Project Learning Experience Description General Learning Experience Description The ASHP PGY-1 Residency Accreditation Standards require that all residents have project experience during the residency
INNOSPEC INC. GIFTS, HOSPITALITY, CHARITABLE CONTRIBUTIONS, AND SPONSORSHIPS POLICY
INNOSPEC INC. GIFTS, HOSPITALITY, CHARITABLE CONTRIBUTIONS, AND SPONSORSHIPS POLICY CONTENTS 1. INTRODUCTION... 1 2. SCOPE... 1 3. GENERAL RULE... 1 4. DEFINITIONS... 2 5. GIFTS... 2 5.1 GIFTS PROCESS
1. Introduction, purpose of this Standard Operating Procedure (SOP)
Details Document Type Document name Ref # Version Effective from Review date Owner Prepared by Reviewed by Approved by Superseded documents Relevant regulations/legislation/guidelines/reference Standard
New federal requirements for posting of clinical trials information
in the news Health Care October 2016 New Clinical Trial Rule Alters Reporting Requirements In this Issue: Introduction... 1 Types of Clinical Trials Subject to the Final Rule... 2 The Responsible Party
ENRICHING THE POLICY-MAKING PROCESS THROUGH MULTISTAKEHOLDER DIALOGUE
ENRICHING THE POLICY-MAKING PROCESS THROUGH MULTISTAKEHOLDER DIALOGUE WHO BI-REGIONAL CONSULTATION ON GOOD GOVERNANCE FOR IMPROVED ACCESS TO MEDICINES 9 Nov 2015 Manila Philippines 1 INTRODUCTION MeTA:
Guideline for Research Programmes Rules for the establishment and implementation of programmes falling under the Programme Area Research
Guideline for Research Programmes Rules for the establishment and implementation of programmes falling under the Programme Area Research EEA Financial Mechanism and Norwegian Financial Mechanisms 2014
Standard Operating Procedures
Clinical Monitoring and Site Verification Procedure Overview To define the standard procedures for preparation and documentation of site visits for clinical monitoring and spoke verification for any NETT
REQUEST FOR GRANT PROPOSALS. RESPONSE DEADLINE: Friday, March 2, 12 PM ET
REQUEST FOR GRANT PROPOSALS RESPONSE DEADLINE: Friday, March 2, 2018 @ 12 PM ET Veterans Coming Home: Finding What Works Community Engagement and Station Support Grants I. PURPOSE The Corporation for Public
Topical Peer Review 2017 Ageing Management of Nuclear Power Plants
HLG_p(2016-33)_348 Topical Peer Review 2017 Ageing Management of Nuclear Power Plants Terms of Reference for Topical Peer Review Process This paper provides the terms of reference for the peer review of
FISMA in Federal Contracts: What to do Who can help. Rachel Rice Ackman MGH Research Compliance Office
FISMA in Federal Contracts: What to do Who can help Rachel Rice Ackman MGH Research Compliance Office What is FISMA? Federal Information Security Management Act Federal law involving specific Information
FDA Medical Device Regulations vs. ISO 14155
Vol. 11, No. 9, September 2015 Happy Trials to You FDA Medical Device Regulations vs. ISO 14155 By Shawn Kennedy Medical device clinical trials must comply with 21 CFR Parts 11 (Electronic Records), 50
Work plan for GCP Inspectors Working Group for 2018
22 March 2018 EMA/87812 /2018 Committees and Inspections Chairperson: Ana Rodriguez The activities outlined in the work plan for 2018 have been agreed in view of preparation for the Agency s relocation
RMI Researched Medicines Industry Association
RMI Researched Medicines Industry Association Submission to: Medsafe On the: Proposed Clinical Trials Guidelines 30 November 2009 Contact Kevin Sheehy, Scientific and Technical Manager RMI, Level 8, 86
BEST PRACTICES FOR DETERMINING FAIR MARKET VALUE FOR ALLIED HEALTH PROFESSIONAL SERVICES
BEST PRACTICES FOR DETERMINING FAIR MARKET VALUE FOR ALLIED HEALTH PROFESSIONAL SERVICES Presented at CBI conference: FMV of HCP and Investigator Payments May 20, 2015 AGENDA Section I Overview of the
NPUAP certainly has a daunting national
INSiDE THE N P U A P NATIONAL PRESSURE ULCER ADVISORY PANEL Volume 18 Fall 2004 In this issue Letter from the President DTI Update Alumni Update Consensus Conference 12100 Sunset Hills Road Suite 130 Reston,
Independent Grants for Learning & Change (IGLC) Track 2 - Call for Grant Applications (CGA)
I. Background Independent Grants for Learning & Change (IGLC) Track 2 - Call for Grant Applications (CGA) Resident and Fellow and Practitioner Training to Optimize Patient Focused Menopause Management
RECORD RETENTION: Imaging Data Longevity
WHITE PAPER RECORD RETENTION: Imaging Data Longevity MDDX Research & Informatics 580 California St, Floor 16 San Francisco, California 94104 T (800) 441-MDDX F (866) 382-4696 info@mddx.com www.mddx.com
Keele Clinical Trials Unit
Keele Clinical Trials Unit Standard Operating Procedure (SOP) Summary Box Title SOP Index Number SOP 21 Version 4.0 Approval Date Effective Date Non-Compliance: Deviations and Serious Breaches of GCP and/or