Common facilitating practices in facilitated regulatory pathways*

Slides:



Advertisements
Similar presentations
GEO-5 in Ottawa 1 29 November 2004 Draft GEOSS 10-Year Implementation Plan and Status Report on Reference Document Ivan B. DeLoatch, Toshio Koike, Robert.
Advertisements

Effective Supervision
WMO WIGOS in support of DRR 2013 Coordination Meeting of DRR FP October 2013, Geneva Dr S. Barrell, Chair, ICG-WIGOS Dr I. Zahumensky, WIGOS-PO.
WMO WIGOS in support of DRR 2013 Coordination Meeting of DRR FP October 2013, Geneva Dr S. Barrell, Chair, ICG-WIGOS Dr I. Zahumensky, WIGOS-PO.
Developing Culturally Competent Evaluation Tools with Client Organizations Jeanette Treiber, Ph.D. Project Director Tobacco Control Evaluation Center Department.
National Public Health Performance Standards Local Assessment Instrument Essential Service:5 Develop Policies and Plans that Support Individual and Community.
© 2014 The Regents of the University of Michigan. This work is licensed under the Creative Commons Attribution 4.0 Unported License. To view a copy of.
1 CULTURAL AND LINGUISTIC COMPETENTCY ON THE US/MEXICO BORDER Esteban Zubia.
Laboratory Biorisk Management Standard CWA 15793:2008
1 Situational Analysis as a Process Tool in Human Services Programming Presented By Gary Bess, PhD Jim Myers, MSW Gary Bess Associates School of Social.
Student Support Team (SST) Training A Humanware Strategic Plan Activity Cleveland Metropolitan School District 1.
Implementing Shared Inspection Management Systems Insights from recent WBG research John R. Wille WBG Investment Climate Advisory Services Amman, Jordan.
Risk Management, Assessment and Planning Committee III-4.
Elizabeth Kinnucan Bethany Perry Jessica Way.  Practice based on research findings “Evidence based practice provides opportunities for nursing care to.
Third OIE Global Conference on Animal Welfare Kuala Lumpur, Malaysia The OIE PVS Pathway Dr. Mariela Varas OIE International Trade Department.
Result of gap analysis and framework of action required in coming five months August rd Meeting of National Influenza Centres in the Western.
WHO Prequalification Programme of Medicines: Experience Working with Manufacturers and Regulators in the WHO Eastern Mediterranean Region Mohamed Abdelhakim.
Business Continuity Program Orientation (insert presentation date) (This presentation is a template that requires adjustments to meet your needs)
IAEA International Atomic Energy Agency Summary and Overview of TECDOC Russel Edge Decommissioning and Remediation Unit Division of Radiation,Transport.
Steve Hodgins Imperial Royale Hotel, Kampala 26 June 2013.
Understanding the EHS Management System Development Process David Downs President EHS Management Partners,Inc.
Taking Stock: Office of Early Childhood Development (OECD) Accomplishments and Opportunities: Results in Brief Diane Schilder, Ed.D. BUILD Consultant.
Exploring issues of data quality in household surveys: Searching for explanations behind discrepant results for vaccination coverage across surveys of.
A WORK IN PROGRESS Kansas Department of Health and Environment Kansas State Department of Education Kansas Department of Social and Rehabilitation Services.
Delivering on Data Revolution in Africa: Country Compacts as the Next Step Alex Ezeh, PhD Executive Director African Population and Health Research Center.
What are the important causes of food- related ill health which need tackling? Is the burden of food-related ill health increasing or decreasing, and for.
Bledsoe et al., Essentials of Paramedic Care: Division 1 © 2007 by Pearson Education, Inc. Upper Saddle River, NJ Division 1 Introduction to Advanced Prehospital.
The Behaviour Change Wheel: a cross-disciplinary model Susan Michie Professor of Health Psychology, UCL UCL Grand Challenges Town meeting May 2013.
IA-DMM Additional Evaluation Efforts. Evaluation questions focused on areas not addressed by FSU Evaluation Plan Evaluation Measures Evaluation Results.
Pharmacy in Public Health: Community Health Course, date, etc. info.
Cochrane Agenda and Priority Setting Methods Group (CAPSMG)
Role of Advisory Groups David Markwell Head of Education E-Learning Advisory Group meeting
HCS 457 MART Experience Tradition /hcs457mart.com FOR MORE CLASSES VISIT
Variability in mortality following caesarean delivery, appendectomy, and groin hernia repair in low-income and middle-income countries: a systematic review.
World Health Organization
Designing Effective Accommodation Plans in Clinical Placement & Internship Settings
IAEA E-learning Program
Russell Glasgow Marina McCreight Borsika Rabin
The FDA Early Feasibility Study Pilot and the Innovation Pathway
PeArLS (Personally Arranged Learning Session)
A Path of Learning and Improvement
Overview of vaccines prequalification
Comparing the registration to reimbursement pathway for new active substances in Europe Germany Poland To help provide a better understanding of the European.
New economies: Scenarios with a likelihood >50% and impact
Effective Support for Children & Families in Essex
World Health Organization
Median Box : 25th and 75th percentiles
Presentation to the EPREV Lessons Learned Workshop
Orphaned Children Morrison and Ellwood (2000):
Presentation title Enhancing the roles of the NAMA registry Asia Pacific and Eastern Europe Regional Workshop on Nationally Appropriate Mitigation Actions.
Comparing the registration to reimbursement pathway for new active substances in Europe Germany Poland To help provide a better understanding of the European.
“Metro Map” analysis of FDA facilitated regulatory pathways and their influence on median approval times  The US Food and Drug Administration (FDA) has.
Jun M, et al. Lancet 2010 Epub May 10
Chicago Public Schools
OPTIONS 2018 HIV R4P Conference Neeraja Bhavaraju, FSG October 2018
Annual Title I Meeting and Benefits of Parent and Family Engagement
Science: Learning Experience 9. wested
Variability in mortality following caesarean delivery, appendectomy, and groin hernia repair in low-income and middle-income countries: a systematic review.
Regional regulatory initiatives use different approaches
Paper Presentation - Ultra Portable Devices
Patient Involvement in the Development and Use of Safe Medicines Introductory Section – Concepts to Consider CIOMS XI WG Second Meeting October 23-24,
АВЛИГАТАЙ ТЭМЦЭХ ҮНДЭСНИЙ ХӨТӨЛБӨР /танилцуулга/
BioCapital Europe 2019, Amsterdam
Utilizing Peer Supports in the Community
Meeting of PAP/RAC Focal Points, Split, Croatia, 8-9 May 2019
Are agencies interested in adaptive licensing?
Title I Document Training, Revision, Input Meeting
Patient Care Coordinators Role in Diabetic Populations
Regulatory review process: What are enablers?
Early Regulatory Agency Involvement and Health Care Facility Performance Success State of Wisconsin Department of Health Services Division of Quality Assurance.
Presentation transcript:

Common facilitating practices in facilitated regulatory pathways* Facilitated regulatory pathways (FRPs) can accelerate access to important new medicines and sponsors of products that may fulfil unmet, serious public health challenges should interact early with national regulatory authorities (NRAs) to address current requirements. While the characteristics of FRPs used by stringent regulatory authorities have been well characterised, no systematic assessment has been conducted of these characteristics for emerging. This study assessed 33FRPs in emerging NRAs from 29 countries to understand their diversity and similarities, noting how often FRPs addressed a characteristic, the most common assessment for each characteristic and the number and distribution of characteristics. This slide provides a summary of the most frequently observed characteristics. Agencies from the Middle East/North Africa and Eastern Europe addressed the most (median, 17) characteristics of FRPs in their public documentation. All FRPs addressed at least twice as many procedural characteristics. A majority of FRPs provided opportunities for frequent interactions between sponsor and agency review teams. Observed diversity in regional FRP characteristics suggests a role for further engagement with emerging NRAs in their design and implementation. These results and further research and experience may suggest FRP characteristics that could be successfully implemented by emerging NRAs. From Liberti L et al. J Pub Health Pol. 2016 Mar 10. doi: 10.1057/jphp.2016.8. From Liberti L et al. J Pub Health Pol. 2016 Mar 10. doi: 10.1057/jphp.2016.8.