| DIA European Meeting, Lisbon, Portugal From April 7th - 10th, 2005 |
|---|
| presentation |
FDA and EMEA Guidances: Which Impact on the Industry?
|
| Dominique Dubois, MD, MBCPM Johnson & Johnson Pharmaceutical Services, Beerse, Belgium |
Use of Patient Reported Outcomes to Support FDA Approval Decisions
|
| Jane A. Scott, Ph.D. SEALD Endpoint Reviewer Center for Drug Evaluation Office of New Drugs US Food and Drug Administration |
| ISPOR Annual Meeting, Arlington, VA, USA - 2004 From June 15th - 18th, 2004 |
|---|
| poster |
Training regulatory agencies in PRO evaluation: the Workmats experience
|
| Catherine Acquadro, MD, Leticia Lobo-Luppi, PhD, Mapi Research Institute, Lyon, France; Olivier Chassany, MD, PhD, Délégation Régionale à la Recherche Clinique, Hôpital Saint-Louis, Paris, France |
| DIA Special Workshop, Paris, France From June 10th - 11st, 2004 |
|---|
| presentation |
Assessing Treatment Impact Using PROs: Challenges in Study Design, Conduct and Analysis
|
| None |
Session 1: PRO, when do they add Value? Examples in Oncology
|
| Pierre-Philippe Sagnier, Bayer Health Care, UK |
Session 1: PRO, when do they add value? Examples in Respiratory Diseases
|
| Thys van der Molen, University of Groningen, Department of General Practice, The Netherlands |
Session 1: PRO, when do they add value? Overview: Examples of When PROs Add Value
|
| Asha Hareendran, Pfizer Global Pharmaceuticals, UK |
Session 2: Regulatory Issues - Importance of Guidance in PRO's: Pros and Cons
|
| Dominique Dubois, Johnson & Johnson Pharmaceutical Services LLC, Belgium |
Session 2: Regulatory Issues - Practical Experience from a Reviewer: Reviewers - What Do They Expect?
|
| Giovanni Apolone, Mario Negri Institute, Italy |
Session 3: Methodological Issues - Clinical Trial Design and Cross-cultural Issues for PROs
|
| Linda Abetz, MAPI Values Ltd., UK |
Session 3: Methodological Issues - Interpretation: Clinical Significance: What Does It Mean?
|
| Patrick Marquis, MAPI Values, US |
Session 3: Methodological Issues - Statistical Issues: Missing Data, Multiplicity
|
| Peter Fayers, University of Aberdeen, Medical School, UK |
Session 4: European and FDA approval decision - QoL from a Regulatory Perspective
|
| Andre J.A. Elferink, Medicines Evaluation Board, The Netherlands |
Session 4: European and FDA approval decision - Use of PRO's to Support European and FDA Approval Decisions: An Introduction on QOL
|
| Eric Abadie, French Medicines Agency (AFSSAPS), France |
Session 4: European and FDA approval decisions - The Role of Patient Reported Outcomes in US Drug Approval and Labeling Decisions
|
| Laurie B. Burke, FDA, USA |
Parallel session 1: Gastrointestinal disorders - Added-value of PROs in Gastrointestinal Disorders: Perspective from a Clinician
|
| Karsten Lauritsen, Odense University Hospital, Denmark |
Parallel session 1: Gastrointestinal disorders - Added-value of PROs in Gastrointestinal Disorders:Perspective from a Pharmaceutical Representative
|
| Ingela Wiklund, AstraZeneca, Sweden |
| Parallel session 1: Gastrointestinal disorders - The Patient's Perspective in Gastrointestinal Disorders: From Top to Bottom |
| Olivier Chassany, Saint-Louis University Hospital, Paris, France |
Parallel session 2: Experience of PROs in Respiratory Disease - What Can We Learn?
|
| Michael Spencer, GlaxoSmithKline, UK |
Parallel session 2: Respiratory diseases - PROs in Respiratory Medicine: A Neglected Friend?
|
| David Lyons, Irish Medicines Board, Ireland |
Parallel session 2: Respiratory diseases - QoL in Chronic Bronchial Diseases
|
| Pascal Chanez, Hospital Arnaud de Villeneuve, France |
Parallel session 3: Oncology - A Clinician's View of HRQL in Oncology: Is it Worth it? Does it Matter?
|
| Kerry Cheong, Guys and St. Thomas's Hospitals, UK |
Parallel session 3: Oncology - Do PROs Have Incremental Value in Oncology? The Case of Quality of Life Measures in Breast Cancer
|
| Giovanni Apolone, Mario Negri Institute, Italy |
Parallel session 3: Oncology - Health Related Quality of Life Assesment in Clinical Oncology Research and Practice: Current Status and Future Challenges
|
| Neil Aaronson, The Netherlands Cancer Institute, The Netherlands |
| Introduction to Patient Reported Outcomes (PRO's), Sigtuna, Sweden From April 2th - 4th, 2004 |
|---|
| presentation |
EMEA and the Regulatory Environment: A Review of the EMEA Notes for Guidance
|
| Catherine Acquadro, MD, Mapi Research Institute, Lyon, France |
EMEA and the Regulatory Environment: Labels in Europe?
|
| Catherine Acquadro, MD, Mapi Research Institute, Lyon, France |
Patient Reported Outcomes in Phase III Regulatory Requirements: Regulatory issues and Best Practice
|
| Olivier Chassany, MD, Clinical Research Delegation, Assistance Publique - Hôpitaux de Paris (AP-HP), Medical University, Paris, France |
Regulatory Issue: What does a regulator look for in the submission files with regard to PROs?
|
| Olivier Chassany, MD, Clinical Research Delegation, Assistance Publique Hôpitaux de Paris (AP-HP), Medical University, Paris, France |
Translation Requirements: The Experience of Mapi Research Institute
|
| Catherine Acquadro, MD, Mapi Research Institute, Lyon, France |
Why Use PROs? The Relation to Clinical Outcomes
|
| Olivier Chassany, MD, Clinical Research Delegation, Assistance Publique Hôpitaux de Paris (AP-HP), Medical University, Paris, France |
| 2nd Annual Outcomes Research Meeting, Washington DC, USA March 24th, 2004 |
|---|
| presentation |
EMEA Recommendations on PRO's: A Review of the EMEA Notes for Guidance
|
| Catherine Acquadro, MD, Mapi Research Institute, Lyon, France |
| 5th DIA Meeting on Medical/Technical Writing, Paris, France From March 12th - 13th, 2004 |
|---|
| presentation |
General Introduction to Health Related Quality of Life
|
| Catherine Acquadro, MD, Mapi Research Institute, Lyon, France |
Health Related Quality of Life from the Authorities
|
| Olivier Chassany, MD, Clinical Research Delegation, Assistance Publique Hôpitaux de Paris (AP-HP), Medical University, Paris, France |
| ISPOR 6th Annual European Congress, Barcelona, Spain From December 9th - 11st, 2003 |
|---|
| poster |
Recommendations to the European Regulators for the Cultural Adaptation of Health-Related Quality of Life Measures
|
| Conway K, Mear I, Acquadro C, Mapi Research Institute, Lyon, France |
| presentation |
An Industry Perspective on Guidelines for Translation and Cultural Adaptation
|
| Maria Kubin MD, MSc Global Health Outcomes, Bayer, Germany |
ERIQA recommendations for translation and cultural adaptation of HRQL Measures
|
| Catherine Acquadro, MD, Mapi Research Institute, Lyon, France |
ISPOR Group Good Practices For Translation and Linguistic Validation
|
| Diana Wild MSc, Oxford Outcomes Ltd |
Why are Guidelines Important to the Pharmaceutical Industry?
|
| Sandra L Ford, Outcomes Research Specialist Pfizer Pharmaceuticals USA |
| Swedish Medical Products Agency (MPA), Uppsala, Sweden October 11st, 2003 |
|---|
| presentation |
Patient Reported Outcomes(PROs) Workmats
|
| Catherine Acquadro, MD, Mapi Research Institute, Lyon, France Ingela Wiklund, Astra Hässle, Sweden |
Scientific Criteria in studies assessing Patient Reported Outcomes (PROs)
|
| Olivier Chassany, MD, Clinical Research Delegation,Assistance Publique - Hôpitaux de Paris (AP-HP), Medical University, Paris, France |
Value of Patient Reported Outcomes: An Industry Perspective
|
| Ingela Wiklund, PhD, Professor, Senior Principal Scientist Global Outcomes Research, AstraZeneca, Sweden |
| DIA Euro Meeting, Rome, Italy From April 5th - 7th, 2003 |
|---|
| presentation |
Do EMEA guidelines recommend the assessment of Quality of Life in clinical trials?
|
| Catherine Acquadro, MD, Mapi Research Institute, Lyon, France |
European Guidance for the Improved Integration of Quality of Life in Drug Regulation Process (ERIQA)
|
| Olivier Chassany, MD, Clinical Research Delegation, Assistance Publique Hôpitaux de Paris (AP-HP), Medical University, Paris, France |
How to Increase the Credibility of Patient Reported Outcomes in the Drug Development Process
|
| Pierre-Philippe Sagnier, MD, MPH Global Health Economics & Outcomes Research Bayer |
| ISPOR Annual Meeting - 2002 From December 5th - 8th, 2002 |
|---|
| poster |
A Literature Review for Cross-Cultural Adaptation of HRQL Measures
|
| Katrin Conway, Isabelle Mear, Catherine Acquadro, Mapi Research Institute – in collaboration with the ERIQA Group |
| ISPOR 5th Annual European Congress, Rotterdam, The Netherlands From December 3th - 5th, 2002 |
|---|
| presentation |
Literature Review of Guidelines For Cross-Cultural Adaptation of HRQL Measures
|
| Catherine Acquadro, MD; Katrin Conway, Isabelle Méar, Mapi Research Institute, Lyon, France |
| ISOQOL Annual Meeting 2002 From November 30th - December 2th, 2002 |
|---|
| poster |
Pre-selection of EMEA Efficacy Working Party Documents for Review and Comments
|
| Léticia Lobo-Luppi PhD, Catherine Acquadro, MD, Mapi Research Institute, Lyon, France – in collaboration with the ERIQA Group |
| 4th Journée of Lariboisière, Paris, France November 25th, 2002 |
|---|
| presentation |
Health-Related Quality of Life & Patient-Reported Outcomes : Scientific and useful outcome criteria ?
|
| Proceedings Published by Springer Vertag France (Bilingual Edition) |
| DIA, Hilton Head, NC, USA April 10th, 2002 |
|---|
| poster |
Literature Review for Cross-Cultural Adaptation of HRQL Measures
|
| Katrin Conway, Isabelle Mear, Catherine Acquadro, Mapi Research Institute, Lyon, France - in collaboration with the ERIQA Group |
| 2nd National QOL Symposium, Shenzhen, China From February 10th - 13th, 2002 |
|---|
| presentation |
A Review of Major Quality of Life (QOL) Activities in Europe and The United States of America
|
| Bernard Jambon, Mapi Research Institute, Lyon, France |
| ISPOR 4th Annual European Congress, Cannes, France From December 11st - 13st, 2001 |
|---|
| presentation |
Health Related Quality of Life and Patient Reported Outcomes: A European Perspective
|
| Olivier Chassany, MD,.Clinical Research Delegation, AP-HP, & Medical University, Paris, France |
| ISOQOL Annual Meeting - 2001 From November 31st - December 2st, 2001 |
|---|
| poster |
A decisive step towards the recognition of Patient Reported Outcomes (PROs) in clinical trials: report of a meeting held at the FDA on February 16, 2001
|
| Catherine Acquadro, MD, Mapi Research Institute, Lyon, France for the ERIQA Group and the PRO Harmonization Group |
Proposed Guidelines for the 1st Step of Cross Cultural Adaptation of Patient Reported Outcomes (PROs) Measures: A Literature Review Focusing on Health Related Quality of Life Assessment
|
| Katrin Conway, Isabelle Mear, Catherine Acquadro for the ERIQA Group, Mapi Research Institute, Lyon, France |
| DIA Workshop: ''Pharmacoeconomic and Quality of Life Labeling and Marketing Claims A Global Update, Philadelphia, PA, USA From November 29th - 30th, 2001 |
|---|
| presentation |
Role of Health Related Quality of Life (HRQL) Outcomes in the European Drug Regulatory Process: Review of the EMEA Documents
|
| Catherine Acquadro, MD, Mapi Research Institute, Lyon, France, Patrick Maquis, MD, MBA. MAPI Values For the ERIQA group |
| ISOQOL Pan-Pacific, Tokyo, Japan From May 13th - 15th, 2001 |
|---|
| presentation |
Guidance for the improved integration of HRQL in the drug regulatory process. The ERIQA Working Group experience
|
| Olivier Chassany, MD, Clinical Research Delegation, Assistance Publique-Hôpitaux de Paris (AP-HP), Medical University, Paris, France |
| DIA, Hilton Head, NC, USA - 2001 From April 12th - 15th, 2001 |
|---|
| poster |
Role of Health-Related Quality of Life (HRQL) outcomes in the European Drug Regulatory Process: A review of the EMEA documents
|
| Véronique Staniek, Ph.D., Catherine Acquadro, M.D. Mapi Research Institute, Lyon, France, for the ERIQA Group |
| ISOQOL From November 30th - December 1st, 2000 |
|---|
| poster |
Results of The Spring 2000 HRQL Harmonization Meeting
|
| Catherine Acquadro, MD , Mapi Research Institute, Lyon, France; Patrick Marquis, MD , Mapi Values, Lyon, France For the ERIQA Group |
| ISPOR Annual Meeting, Arlington, VA, USA - 2000 From June 12th - 16th, 2000 |
|---|
| poster |
HRQL Regulatory issues: Comparison of US and European Initiatives
|
| Marquis P , Mapi Values, Lyon, France; Evans C , Mapi Values, Boston, Massachusetts, USA; Abetz L , Mapi Values, Bollington, UK; Acquadro C , Mapi Research Institute, Lyon, France; for the ERIQA group. |
Role of HRQL evaluation in the drug Regulatory process: results from a European Regulatory Survey
|
| Catherine Acquadro, M.D., Mapi Research Institute,Lyon, France, for the European Regulatory Issues on Quality of Life Assessment (ERIQA) Group |
| ISPOR, Edinburgh, UK From December 11st - 13st, 1999 |
|---|
| presentation |
European guidance document for the improvement of the integration of HRQL assessment in the drug regulatory process
|
| Olivier Chassany, MD, Agence Française du Médicament, Senior Lecturer in Therapeutics, UniversityLariboisière Hospital, France, for the ERIQA Group |
The ERIQA Project
|
| Catherine Acquadro, MD, Mapi Research Institute, Lyon, France |
| European ISPOR Meeting - 1999 From December 5th - 8th, 1999 |
|---|
| poster |
European Guidance Document for the Improvement of the integration of HRQL assessment in the drug regulatory process
|
| Chassany O, Hopital Lariboisiere, France; Fullerton S, UCLA Department of Medicine, USA; Sagnier P, Bayer, Medical Affairs, United Kingdom; Aaronson N, The Netherlands Cancer Institute; Marquis P, Mapi Research Institute, France for the ERIQA Group |
| ISOQOL, Barcelona, Spain December 3th, 1999 |
|---|
| presentation |
HRQL & Regulatory Issues in Europe: The ERIQA Reference Document
|
| Olivier Chassany, MD, Agence Française du Médicament, Senior Lecturer in Therapeutics, University Lariboisière Hospital, France, advisor for the ERIQA Group |
HRQL and REGULATORY ISSUES: Status Comparison of US and European Initiatives: similarities and differences
|
| Dr. Kunle Adesina, MAPI Values, UK; Dr Patrick Marquis, MAPI Values, France |
The ERIQA Project: Overview
|
| Catherine Acquadro, MD, Mapi Research Institute, Lyon, France |
| ISOQOL Annual Meeting - 1999 From November 30th - December 2th, 1999 |
|---|
| poster |
A comparison of the EMEA and FDA draft guidelines in congestive heart failure (CHF) with particular reference to QOL outcomes
|
| Wiklund I , Astra Hassle Research Laboratories, Sweden, Apolone G , Mario Negri Institute, Italy, Chassany O , Hopital Lariboisiere, France, Fullerton S , UCLA Dept of Medicine, USA, Acquadro C , Jambon B , Mapi Research Institute, France for ERIQA |
Recommendations for minimal quality of life validation criteria in clinical trials
|
| Fullerton S, UCLA Department of Medicine, Los Angeles, USA Chassany O, Hopital Lariboisiere, Paris, France Wiklund I, Astra Hassle Research Laboratories, Molndal, Sweden; Apolone G, Mario Negri Institute, Milan, Italy Acquadro C, Jambon B, Mapi Institute |
Recommendations for minimal quality of life validation criteria in clinical trials
|
| Fullerton S , UCLA Department of Medicine, USA Chassany O , Hopital Lariboisiere, France Wiklund I , Astra Hassle Research Laboratories, Sweden; Apolone G , Mario Negri Institute, Italy Acquadro C, Jambon B, Mapi Institute for the ERIQA Group |
| Health Ouctomes Conference, Canberra, Australia August 21st, 1999 |
|---|
| presentation |
The European Regulatory Issues on Quality of Life Assessment (ERIQA) Project
|
| Katrin Conway, Mapi Research Institute, Lyon, France |
| Tokyo, Japan August 16th, 1999 |
|---|
| presentation |
HRQL and Regulatory Issues The ERIQA Project and other initiatives
|
| Katrin Conway, Mapi Research Institute, Lyon, France |
| ISPOR Annual Meeting, Washington DC, USA June 26th, 1999 |
|---|
| presentation |
Quality of Life & Regulatory Issues
|
| Olivier Chassany, MD, Senior Lecturer in Therapeutics, Hôpital Lariboisière - University Paris, France, for the ERIQA Group |
| ISPOR Annual Meeting - 1999 From June 19th - 23th, 1999 |
|---|
| poster |
A comparison of the EMEA and FDA draft guidelines in congestive heart failure (CHF) with particular reference to QOL outcomes
|
| Wiklund I, Astra Hassle Research Laboratories, Sweden, Apolone G, Mario Negri Institute, Italy, Chassany O, Hopital Lariboisiere, France, Fullerton S, UCLA Dept of Medicine, USA, Acquadro C, Jambon B, Mapi Research Institute, France for ERIQA |
A review and evaluation of the EMEA Documents with reference to quality of life (QOL) assessment
|
| Apolone G, Brunetti M, Mario Negri Institute, Milano, Italy De Carli G, GlaxoWellcome, Verona, Italy Acquadro C. Mapi Research Institute, Lyon, France for the European Regulatory Issues on QoL Assessment (ERIQA) Group |
| PHRMA Conference on HRQL and Regulatory Issues, Washington DC, USA From April 24th - 25th, 1999 |
|---|
| presentation |
The European Regulatory Issues on Quality of Life Assessment (ERIQA) Project
|
| Ingela Wiklund, Astra Hässle, Sweden;Bernard Jambon, Mapi Research Institute, Lyon, France |