ENCePP Plenary Meeting Reports

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• ENCePP Plenary Meeting, 30 November 2022

 

• Meeting report
• Agenda

 

Presentations

• Catherine Cohet, Susana Perez-Gutthann - Welcome and introduction
• Marco Cavaleri - Update on COVID-19 vaccines and therapeutics
• Dani Prieto-Alhambra - DARWIN EU®
• Catherine Cohet, Susana Perez-Gutthann - Update from the Steering Group
• Alejandro Arana - Update from WG1
• Rosa Gini - Update from WG2
• Gianluca Trifiro - Update from WG3
• Andrej Segec - ENCePP website update
• Katerina-Christina Deli - Update on the RWD sources and RWD studies catalogues
• Arnold Chan - Collaboration between ENCePP and learned societies - guidance initiatives (ISPE)
• Gianluca Trifiro - Collaboration between ENCePP and ISOP
• Susana Perez-Gutthann - HARmonized Protocol to Enhance Reproducibility (HARPER) - An ISPE-ISPOR Joint Task Force of the RWE Initiative
• Catherine Cohet - GVP Module VIII & ICH M14
• Helga Gardasdottir, Xavier Kurz - Directions for ENCePP and impact on the work plan development
• Pierre Engel - Safety and effectiveness of MVA-BN vaccination against MPox infection in at-risk individuals in Germany & US
• Shirley V Wang, Sebastian Schneeweiss - Generating reliable insights from RWE for decision-making highlights from RCT-DUPLICATE
• Xabier Garcia de Albeniz - Target Trial Emulation With and Without Cloning
• Iryna Vlasenko - Patient views on use of their data in pharmacoepidemiological studies

 

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• ENCePP Plenary Webinar, 18 November 2021

 

• Meeting report
• Agenda

 

  Presentations

• Gianmario Candore, Susana Perez-Gutthann - Welcome and introduction
• Marco Cavaleri - Update on therapeutics and vaccines for COVID-19
• Kelly Plueschke- CHMP Guideline on registry-based studies
• Xavier Kurz - Metadata, Data Quality framework and Catalogues Project
• Ana Cochino - Rebuild of catalogues survey – EU PAS Register
• Francois Domergue - HMA-EMA Big Data workplan and update on DARWIN EU_FINAL for website
• Stefania Simou - Training Curriculum on Big Data for regulators
• Luis Pinheiro - Artificial Intelligence in Medicine Regulation
• Gianmario Candore - ENCePP Steering Group and Working Groups
• Ana Cochino - Survey results on the Data source catalogue
• Miriam Sturkenboom - Timely real world evidence to monitor COVID-19 vaccine
• Dani Prieto-Alhambra - Update on TTS and vaccine studies
• Deborah Layton - E-CORE - European COVID-19 Observational Research Exchange

 

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• ENCePP Plenary Webinar, 20 November 2020

 

• Meeting report
• Agenda

 

       Presentations

• Xavier Kurz - Welcome and introduction
• Olaf Klungel - Key considerations for observational studies on COVID-19
• Marco Cavaleri - Development and authorisation status of Covid-19 vaccines
• Georgy Genov - EU network vaccine monitoring strategy
• Miriam Sturkenboom - ACCESS - vACCine covid-19 monitoring readinESS
• Miriam Sturkenboom - CONSIGN - Covid-19 infectiON and medicineS In preGNancy
• Marta Valenciano - I-MOVE-COVID-19 Network
• Javier Díez-Domingo - DRIVE - COVID Vaccine Effectiveness
• Tom MacDonald - Achievements of the current ENCePP Steering Group, 2016-2020
• Julianna Fogd - New ENCePP Steering Group 2021-2023
• Gianluca Trifirò - Review of post-authorisation studies registered in the EU PAS register
• Xavier Kurz - Draft proposal for new ENCePP mandate
• Nikolai Brun - HMA-EMA Big Data Task Forc - Recommendations and workplan
• Francois Domergue and Gianmario Candore - The Data Analysis and Real-World Interrogation Network in the European Union (DARWIN EU)
• Katerina-Christina Deli - Meta-data - data discoverability and data quality

 

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• ENCePP Webinar, 19 March 2019 (organised by Agenzia Regionale di sanità Toscana)

 

• Meeting report
• List of participants

 

       Presentations

• Report from the Steering Group
• Report from Working Group 1: research standards and guidances
• Report from Working Group 2: Independence and Transparency
• Report from Working Group 3: Inventory of EU data sources and methodological approaches for multisource studies
• Report from Special Interest Group (SIG): Measuring impact of pharmacovigilance activities

 

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• ENCePP Plenary Meeting, 21 November 2017

 

• Meeting report
• List of participants

 

       Presentations

• ENCePP anniversary 2007-2017
• Report from the Steering Group
• Framework of collaboration between EMA and academia
• Models for multi-database studies
• ENCePP Code of Conduct - Revision 4
  • Perspective from academia
  • Perspective from industry
  • Perspective from CROs
• Promoting ENCePP at national level - Introduction to the Italian model
• Table of effects in benefit-risk assessments
• EMA patient registries initiative

 

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• ENCePP Plenary Meeting, 22 November 2016

 

• Meeting report
• List of participants

 

       Presentations

• Report from the Steering Group
• Report from WG1 'Research Standards and Guidances'
• Report from SIG 'Measuring impact of pharmacovigilance activities'
• Election of the ENCePP Steering Group
• 50 years of pharmacovigilance: unfinished job
• Identifying opportunities for 'Big Data' in medicines development and regulatory science
• Meta-analysis of safety - thoughts from CIOMS X
• EURO-SALT - a study of drug exposed acute liver injury in European transplant centres
• Pragmatic Trials - The Salford Lung Study
• EMA draft framework of collaboration with academia
• Scientific guidance on post-authorisation efficacy studies
• The General Data Protection Regulation and use of health data: challenges for pharmaceutical regulation
• ENCePP Seal studies and imposed PASS: new compliance and disclosure measures

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• ENCePP Plenary Meeting, 24 November 2015

 

• Meeting report
• List of participants

 

       Presentations

• Report from the Steering Group
• Session introduction: Brainstorming on funding mechanisms for PAS
• Scenario 1: Central mechanism for industry-funded studies
• Scenario 2: Medication safety in pregnancy
• Scenario 3: Collaborative studies on vaccines
• OFSEP - The French Registry of Multiple Sclerosis
• Lessons learned from PROTECT on common protocols for multi-database studies
• Why do we need methods to measure impact?
• A pilot experience on disseminating EMA alerts - Impact on medical prescribing at the Catalan Institute of Health
• Monitoring and evaluating the effect of regulatory action: some recent case studies
• Estimation of renal function: implications for drug dosing in the elderly

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• ENCePP Plenary Meeting, 25 November 2014

• Meeting report
• List of participants

       Presentations

• Reporting requirements PAS
• Report from the ENCePP Steering Group
• Use of routinely collected electronic healthcare data (IMS Health)
• Use of routinely collected electronic healthcare data (CSD Medical Research)
• Progress update - ENCePP guidance for conducting systematic reviews and meta-analysis of PhEpi studies
• Impact assessment of regulatory sciences - application to PROTECT outputs
• CODEMISUSED project
• Lessons learned on post-authorisation safety studies (PASS)
• ENCePP and research that supports HTA
• Report on EMA pilot on adaptive pathways
• ENCePP partner survey on registering studies and the ENCePP Study Seal

 

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• ENCePP Plenary Meeting, 12 November 2013

• Meeting Report
• List of Participants

        Presentations

• Report from the ENCePP Steering Group
• Report from Working Group 1
• Report from Working Group 2
• Report from Working Group on HTA
• Report from Working Group Data Integration
• Election of the ENCePP Steering Group
• Request for collaboration / India
• Pharmacogenomics - Introductory remarks

• Pharmacogenomics – A Clinical Perspective

• Pharmacogenomic methods – An Epidemiological Perspective

• Pharmacogenomics, an important step in the quest for biomarkers of drug response

• IMI - current status and future calls

 

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• ENCePP Plenary Meeting, 18 June 2013

• Meeting Report
• List of Participants

       Presentations

• Report from the ENCePP Steering Group
• European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)
• Global Research in Paediatrics (GRiP)
• PHARMacovigilance for Adverse effects in Childhood arthritis focussing on Immune modulatory Drugs (PHARMACHILD)
• Case-population strategy in pharmacovigilance
• ENCePP best evidence - Experience so far
• Results of ENCePP survey of industry

 

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• ENCePP Plenary Meeting, 11 October 2012

• Meeting Report
• List of Participants

       Presentations

• Report from the ENCePP Steering Group
• Report from Working Group 1
• Report from Working Group 3
• Post-authorisation safety studies and the EU PAS Register
• New PV Legislation: Reporting
• Boosting Drug Development through Public-Private Partnership: The IMI Model
• Maternal medication and pregnancy outcomes
• Different study designs for signal detection and signal evaluations in pregnancy
• EUROmediCAT: First results from an FP7 programme to evaluate medicines in pregnancy

 

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• ENCePP Plenary Meeting, 3 May 2012

• Meeting Report
• List of Participants

        Presentations

• Report from ENCePP Steering Group
• Astro-lab project
• The Psonet collaboration
• Suggestions for Optimising ENCePP
• Proposed new legislation on data protection
• Good Vigilance Practice: post-authorisation studies
• Adverse drug reaction research in FP7
• HTA & ENCePP
• EHR4CR project

 

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• ENCePP Plenary Meeting, 23 November 2011

• Meeting Report
• List of Participants

       Presentations

• Reflections of outgoing ENCePP Steering Group
• Report from ENCePP WG2
• Feedback from PML Workshop
• Feedback from Rare Diseases Workshop
• ENCePP Steering Group Elections
• Meta-analysis and pooling of data
• Highlights from informal PhVWP
• EMA Geriatric Medicines Strategy
• PROTECT-EU2P Training Platform

 

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• ENCePP Plenary Meeting, 30 June 2011

• Meeting Report
• List of Participants

           Presentations

• Feedback from Task Force "Access to data"
• Results of the ENCePP partners survey
• Barriers to entering data sources into the database
• Specialist networks and ENCePP
• Plenary Survey: funding topics
• Feedback from Task Force "non-interventional trials"
• EC consultation on revision of Clinical Trials Directive
• Focus on Drugs in the Elderly: Assessment of renal function by various techniques
• Synergies between ENCePP and Health Technology Assessment
• The US FDA Sentinel Initiative
• Motivation for an ENCePP study & Impact of regulatory action
• An ENCePP study: Impact of risk minimisation among users of rosiglitazone-containing products

 

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• ENCePP Plenary Meeting, 18th November 2010

• Meeting Report
• List of Participants

Presentations

• Report from the ENCePP Steering Group
• Presentation from investigators of first ENCePP study awarded
• EMA-funded study: Award of first tender
• Lessons learned from first ENcePP studies
• Highlights of new PhV Legislation relevant to ENCePP
• Database of studies
• ENCePP Guide on Methodological Standards in PhEpi
• Implementing rules for Code of Conduct: Access to data
• ENCePP Work Plan 2011-12

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• ENCePP Plenary Meeting, 8th June 2010

• Meeting Report

Presentations

• Report from the ENCePP Steering Group
• ENCePP Code of Conduct
• Register of Studies Progress Report
• e-Register of Studies: an interim solution
• ENCePP Database of Research Resources – Release 2.0 (demonstration)
• ENCePP Partner Forum
• WG 2: Progress Report & Mandate Revision
• WG 3: 2010 Progress Report
• Lessons learnt from Influenza A(H1N1) vaccines benefit-risk monitoring
• Networking in drug and vaccine safety research: challenges, added value
• Data Collection on Adverse Events of Anti-HIV Drugs: The D:A:D Study
• The European Group for Blood & Marrow Transplantation (EBMT)
• ENCePP Infoday London – 26th November 2010

Fliers

• ENCePP study
• European Medicines Agency scientific debate

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• ENCePP Plenary Meeting, 11th December 2009

• Meeting Report
• List of Participants

Presentations
ENCePP Milestones
Election of the ENCePP Steering Group
Public Consultation
Guide on MRS_WG1
ENCePP e-Inventories
H1N1 Strategy EU level
EuroSIDA and flu
DAD study
Co-opted members for PhVWP
Call for Expressions of interest

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• ENCePP Plenary Meeting, 18th September 2009

• Meeting Report
• List of Participants

Presentations
ENCePP Overview
ENCePP Study Seal
ENCePP Checklist of Operational Research Standards
ENCePP Code of Conduct
ENCePP Steering Group
ENCePP Plenary Mandate
ENCePP Database Mock-up
ENCePP Database of Research Resources Data sets
ENCePP Database of Research Resource Centres
ENCePP Registry of PASS
FP7 4th Call in the field of Drug Safety Research
European Strategy for influenza H1N1
ENCePP Outlook and Highlights

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• ENCePP Scientific Convention, 25th November 2008

• Report of the ENCePP Scientific Convention: EU Health Care Databases for Pan-EU Pharmacoepidemiological Research - 25 November 2008
  

• List of Participants
  
  Presentations:
  Pharmacovigilance needs and opportunities for ENCePP
  One Databases - two answers, ten databases - million answers
  Biologics in inflammatory disease
  Using a primary care database to evaluate drug safety in pregnancy: possibilities and limitations
  How modified PEM supports risk management: a selected brief overview
  European database networking models
  NorPEN - The Nordic Pharmacoepidemiological Network for knowledge exchange, research and research training

 

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