Regulatory

Articles

• 2017. Maier WC et al. – Post-approval studies for rare disease treatments and orphan drugs
• 2016. Fournie X et al. – Interventional vs. non-interventional study classication in the EU: Considerations on the impact of Direct-To-Patient contacts
• 2011. Marquis P et al. – The role of health-related quality of life data in the drug approval processes in the US and Europe: A review of guidance documents and authorizations of medicinal products from 2006 to 2010
• 2008. Acquadro C et al. – Literature review of methods to translate health-related quality of life questionnaires for use in multinational clinical trials
• 2003. Acquadro C et al. – Incorporating the patient’s perspective into drug development and communication: An ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001

Posters & Presentations

• 2017. RARE Meeting – Are patient-reported outcome measures (PROM) used in the evaluation of orphan drugs?
• 2017. ISPOR European Congress – A review of clinical outcome assessments labeling in Europe and in the United States (2013-2016)
• 2017. ISPOR European Congress – PRO labeling for products approved by the European Medicines Agency (EMA) for narcolepsy
• 2017. ISPOR European Congress – Analysis of recent approvals of immuno-oncology drugs across England, Scotland, Germany and France
• 2017. ISOQOL Annual Conference – Are clinical outcome assessment (COA) data important in the evaluation of medicines for the treatment of Alzheimer’s disease approved by the FDA and the EMA?
• 2017. RAPS Regulatory Convergence – EU MDR and IVDR: Overview
• 2017. RAPS Regulatory Convergence – Regulation of laboratory developed tests
• 2017. EAN Congress – The role of clinical outcome assessment (COA) data in the drug approval process of medicines for the treatment of restless legs syndrome (RLS): A review of the labels of medicines approved by the FDA and the EMA
• 2017. ISPOR Annual International Meeting – Importance of clinical outcome assessment (COA) data in the evaluation of medicines for the treatment of Alzheimer’s Disease (AD): A review of the labels of medicines approved by the FDA and the EMA
• 2017. ISPOR Annual International Meeting – Importance of clinical outcome assessment (COA) data in the evaluation of medicines for the treatment of restless legs syndrome (RLS): A review of the labels of medicines approved by the FDA and the EMA
• 2016. ISPOR European Congress – Patient Information and Consent Form in Europe: Requirements from Regulatory Authorities for Pharmaco-Epidemiological Studies
• 2016. ISOQOL Annual Conference – Patient-Reported Outcomes (PROs) Used to Support Claims in Myeloproliferative Neoplasms (MPNs): A Review of the Labels of Products Approved by the EMA
• 2016. ISCTM Autumn Conference – Clinical Outcome Assessments Used/Recommended by the EMA and FDA for the Evaluation of Products to Treat Autism Spectrum Disorder
• 2016. DIA Annual Canadian Meeting – Health Policy Initiatives: Ideas Becoming Official Policy and Beyond. In Session 6 Track A: Policy Development and Direction
• 2016. DIA Annual Meeting – Priority Review Vouchers: A New Paradigm for Funding Research?
• 2016. ASCP Annual Meeting – The Role of Clinical Outcome Assessment (COA) Data in the Drug Approval Process of Products for the Treatment of Autism Spectrum Disorder in the USA and Europe: A Review of Guidance Documents and Authorizations of Medicinal Products
• 2016. ISPOR Annual International Meeting – Patient-Reported Outcomes (PRO) Claims in Acromegaly: A Review of the Labels of Products Approved by the FDA and the EMA
• 2016. ISPOR Annual International Meeting – The Role of Clinical Outcome Assessment (COA) Data in the Drug Approval Process of Products for the Treatment of Duchenne Muscular Dystrophy in the USA and Europe: A Review of Guidance Documents and Authorizations of Medicinal Products
• 2016. AAN Annual Meeting – Is Health-Related Quality of Life an Important Evaluation Criterion in Drug Development of Multiple Sclerosis (MS) Products? A Review of Labels of MS Products Approved the FDA and the EMA
• 2015. ISPOR European Congress – PRO Claims in Fibromyalgia: A Review of the Labels of Products Approved by the FDA and the EMA
• 2015. ISPOR Annual European Congress – Does Health-Related Quality of Life Evaluation in Psoriasis Matter? A Review of Labels of Psoriasis Products Approved by the FDA and the EMA
• 2015. ISPOR Annual International Meeting – Does Health-Related Quality of Life Evaluation in Multiple Sclerosis (MS) Matter? A Review of Labels of MS Products Approved by the FDA and EMA
• 2015. ISPOR Annual International Meeting – A Review of Health-Related Quality of Life (HRQL) Claims in Labels of Asthma Products – Can We Consider the Asthma Quality of Life Questionnaire (AQLQ) as a Potentially Acceptable Measure for Qualification?
• 2015. ISPOR European Congress – Development of a Database of Published Regulatory Recommendations Concerning the Use of Clinical Outcome Assessment (COAs) in Drug Development: Outcomes Insite
• 2014. ISPOR European Congress – Regulatory Issues in PRO Advertising: A Review of the DDMAC/OPDP Letters from 1998 to 2013 to Identify PRO Claims Violations and Examine their Evolution Over Time
• 2014. ISPOR European Congress – PRO Claims in Orphan Medicines Approved by the European Medicines Agency (EMA) for the Treatment of Lymphoproliferative Disorders
• 2014. ISPOR European Congress – An Examination of the Regulatory and Reimbursement Processes for Biobetters and Comparison with Biosimilars
• 2014. ISOQOL Annual Conference – Update of the Patient-Reported Outcome and Quality of Life Instruments Database (PROQOLID): Integration of the New COA Taxonomy-The ClinRO Example
• 2014. ISPOR Annual International Meeting – Patient-Reported Outcome (PRO) Claims in Products Indicated for the Treatment of Rare Diseases and Approved by the European Medicines Agency (EMA)
• 2014. ISPOR Annual International Meeting – The Role of PRO Data in the Drug Approval Process of Products for the Treatment of Cystic Fibrosis in the USA and Europe: A Review of Guidance Documents and Authorizations of Medicinal Products
• 2014. ISPOR Annual International Meeting – Descriptive Review of the Pharmacovigilance and Risk Assessment Committee (PRAC) Activities Since its Establishment
• 2014. ECRD Conference – Patient-reported outcomes (PRO) claims in products indicated for the treatment of rare diseases and approved by the European Medicines Agency (EMA)
• 2013. ISPOR European Congress – Reasons Given by the European Medicines Agency for Revising Disease- Specific Scientific Guidelines
• 2013. ISPOR European Congress – Patient-Reported Outcome (PRO) Claims in Products Approved for Chronic Obstructive Pulmonary Diseases (COPD) in Europe and in the USA
• 2013. ISPOR European Congress – Do EMA and FDA Have Different Opinions/Requirements in Terms of Pediatric Studies for Sitagliptin (Alone or in Combination)?
• 2013. ISPOR Annual International Meeting – Patient-Reported Outcomes (PROs) in Anti-Diabetic Product Approvals in Europe and in the USA.
• 2013. ISPOR Annual International Meeting – Patient-Reported Outcomes (PROs) Claims in Products Indicated for Treatment of Non-Small Cell Lung Carcinoma and Approved in Europe and in the United States
• 2012. ISPOR European Congress – Review of all Products Authorized by the European Medicines Agency from 1995 to 2011 in Regards to Pediatric Investigation Plan Applications
• 2012. ISPOR European Congress – Development of a Post-Marketing Requirements (PMR) Database
• 2012. ISPOR European Congress – Development of a Translation Evidence Tracking Tool to Comply with the FDA Review Requirements for the Translation of PRO Instruments
• 2012. ISPOR European Congress – Patient-Reported (PROs) in Antineoplastic Product Approvals in Europe and in the USA
• 2012. ISOQOL Annual Conference – Development of a Checklist to Comply with the FDA Review Requirements for the Translation of PRO Instruments
• 2012. ISPOR Annual International Meeting – Development of a Regulatory Post-Marketing Studies Database
• 2012. ISPOR Annual International Meeting – What is the Influence on Clinical Research of the EMA Guideline on Medicinal Products for the Treatment of Alzheimer’s Diseases?
• 2011. ISPOR European Congress – Update of the Patient-Reported Outcome and Quality Of Life Instruments Database (PROQOLID) Using the FDA Guidance on PRO Measures
• 2011. ISPOR European Congress – The Impact of Regulatory (FDA and EMA) and EUNETHTA Guidelines on Patient-Reported Outcomes and Health-Related Quality of Life on Market Authorisation and Pricing
• 2011. ISOQOL Annual Conference – The Role of Health-Related Quality of Life Data in the Drug Approval Processes in the USA and Europe: A Review of Guidance Documents and Authorizations of Medicinal Products from 2006 to 2010
• 2011. ISOQOL Annual Conference – Update of the Patient-Reported Outcome and Quality of Life Instruments Database (PROQOLID) Using the FDA Guidance on PRO Measures
• 2011. ISPOR Annual International Meeting – The Role of Health-Related Quality of Life Data in the Drug Approval Processes in the USA and Europe: A Review of Guidance Documents and Authorizations of Medicinal Products from 2006 to 2010
• 2010. ISPOR European Congress – Recommendations about Translations in the Final FDA Guidance on PRO Measures: What Has Changed and What Has Remained
• 2010. ISOQOL Annual Conference – Recommendations about Translations in the Final FDA Guidance on PRO Measures: What Has Changed and What Has Remained
• 2010. ISPOR Annual International Meeting – Comparison of the PRO Endpoints found in Labeling Claims of Products for the Treatment of Psoriasis with Those Recommended by the Corresponding EMA Guidance
• 2010. ISPOR Annual International Meeting – Patient-Reported Outcomes in Clinical Research: Present Status and Look at the Future
• 2010. ISPOR Annual International Meeting – PRO Labelling Claims in Antineoplastic Agents
• 2010. ISPOR Annual International Meeting – Patient-Reported Outcomes Supporting Oncology Product Labeling Claims: Trends and Challenges
• 2009. ISOQOL Annual Conference – Documenting Content Validity of Patient-Reported Outcomes (PRO) to Support Labeling and Promotional Claims for FDA-Regulated Medical Products
• 2009. ISPOR European Congress – Oncology Patient-Reported Claims: Maximising the Chance for Success
• 2009. ISPOR Annual International Meeting – Patient-Reported Outcome (PRO) Labeling Claims in Pain Treatment: Overview of US and European Drug Approvals
• 2009. ISPOR Annual International Meeting – Development of a Regulatory Post-Marketing Studies Database
• 2008. ISPOR European Congress – Update of Trends in the inclusion of Patient-Reported Outcome (PRO) Data in Approved Drugs Labeling by FDA and EMEA
• 2008. ISPOR European Congress – Access to Health-Related Quality of Life Instruments (HRQL) and their Translations in the Light of EMA Recommendations
• 2008. ISPOR European Congress – Label Claims Based on Patient Reported Outcomes in EMEA and FDA Approvals since 2000
• 2008. ISPOR Annual International Meeting – Access to Patient-Reported Outcome (PRO) Instruments and their Translations in the Light of FDA Recommendations
• 2008. ISPOR Annual International Meeting – Recent Trends in the Inclusion of Patient-Reported Outcome (PRO) Data in Approved Drugs Labeling by FDA and EMEA
• 2006. ISPOR European Congress – Comparison of the PRO Endpoints Found in Labeling Claims of Urinary Incontinence Drugs with Those Recommended by the Corresponding EMEA Note for Guidance
• 2005. ISPOR European Congress – Issue Panel 3: Submission of Patient-Reported Outcomes to the EMEA and the FDA: Areas of Convergence or Divergence
• 2003. ISPOR European Congress – Recommendations to the European Regulators for the Cultural Adaptation of Health-Related Quality of Life Measures
• 1999. ISPOR Annual International Meeting – Minimal Standards for the Validation of Quality of Life Instruments Used in Clinical Trials
• 1999. ISPOR Annual International Meeting – A Comparison of the EMEA and FDA Draft Guidelines in Congestive Heart Failure (CHF) with Particular Reference to Quality of Life (QOL) Outcomes
• 1999. ISPOR Annual International Meeting – ISPOR HEALTH POLICY SESSION. Oral Presentation: European Regulatory Issues on QOL Assessment (ERIQA) Project
• 1999. ISPOR Annual International Meeting – A Review and Evaluation of the EMEA Documents with Reference to Quality of Life (QOL) Assessment