EMA Patients and Consumers’ Annual Training Overview: 2007-2016 Presented by Maria Mavris on 20 September 2017 Public Engagement Department, Stakeholders and Communication Division An agency of the European Union
Analysis performed Annual training day began in 2007 • Content description and evolution • Participants per year • Participants per organisation • Outcome of training • Continued training • Questions for discussion Analysis of EMA Training Day 1
Content of annual training day (2007-2011) Year Core m aterial Additional content Material 2007 • Overview of EMA activities • Training book (CD- • EPAR summary – practical ROM) exercises • Package leaflet – practical exercises 2008 • Overview of EMA activities • General overview of experience • Questionnaire • Review of documents • Reviewers’ feedback • EPAR • Eudralink • PL 2009 • Overview of EMA activities • Review ers’ experience • Questionnaire • Review of documents • Patient’s perspective on EMA • EPAR training • PL • Evaluation of review of EMA’s documents 2010 • Overview of EMA activities • Safety Com m unications • Training book (CD- • Review of documents • Background ROM) • EPAR • Patient feedback • PL • Practical exercises and examples Analysis of EMA Training Day 2
Content of annual training day (2011-2013) Year Core m aterial Additional content Material 2011 • Overview of EMA activities • Patient and consumer perspectives on • Training book • Review of documents review of product inform ation and (CD-ROM) • EPAR training for scientific advice • PL • Safety communications 2012 • Overview of new Pharm acovigilance legislation • Introduction of PRAC • Risk Management Plans/ Post Authorisation Safety Studies • Adverse Drug Reaction reporting and Signal Detection • Periodic Safety Update Reports) 2013 • Overview of EMA activities • Scientific advice – what is it and how • Review of documents are patients involved • EPAR • Scientific Advisory Groups – what • PL are they and how are patients involved • Safety communications • Pharmacovigilance – impact for patients Analysis of EMA Training Day 3
Content of annual training day (2014-2016) Year Core m aterial Additional content Material 2014 • Overview of EMA activities • Practical aspects: EMA website/ • Review of documents Declarations of Interest • EPAR • PL • Safety communications • Scientific Advice/ Scientific Advisory Groups • Eudralink/ Declarations of Interest 2015 Short presentations on core topics + use • Hands-on breakout sessions on Documents sent of short videos for key topics document review - with debriefs in advance for preparation for breakout sessions 2016 Short presentations on core topics • Hands-on breakout sessions on As above and document review quiz 4 Analysis of EMA Training Day
Total number of participants: per year 60 53 50 43 41 40 37 Num ber of 29 28 30 25 25 participants 23 22 20 10 0 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Year 5 Analysis of EMA Training Day
Overall attendance per organisation 40 organisations (including 1 HCP) 45 326 attendees in total 41 40 35 30 24 25 22 20 17 16 14 14 13 15 12 10 9 10 8 7 6 7 8 7 7 7 7 6 5 6 6 6 6 5 5 5 5 3 3 3 2 1 2 2 1 1 1 1 0 AE AGE APCDG BEUC DEBRA EATG ECPC EFA EFIM EFNA EGA EGAN EHC EHN ELF ELPA EMSP ENFA EPDA EPF EPHA EURORDIS FIN IAPO IBE ICCCPO IDDT IDF MPE PAE SMA TIF EIWH EuropaUomo GAMIAN Rett Syndrome UPPMD EFCNI HAI IPOPI 6 Analysis of EMA Training Day
Individual attendance per organisation 40 organisations (including 1 HCP) 30 243 different individuals 26 25 23 20 14 15 11 12 12 9 9 10 8 8 7 7 6 6 6 6 5 4 5 5 5 4 4 3 4 4 4 3 5 3 3 3 3 2 1 2 2 1 1 1 1 0 AE AGE APCDG BEUC EATG ECPC EHC ELF EMSP EPF IBE IDF MPE PAE TIF DEBRA EFA EFIM EFNA EGA EGAN EHN EIWH ELPA ENFA EPDA EPHA EuropaUomo EURORDIS FIN GAMIAN IAPO ICCCPO IDDT Rett Syndrome SMA UPPMD EFCNI HAI IPOPI 7 Analysis of EMA Training Day
Outcome of trained participants Many participants trained in the EMA annual training day have subsequently been involved as: Review of documents Members of: Experts in: Management Board Scientific advice Written consultations Scientific committees Scientific advisory groups Working parties Analysis of EMA Training Day 8
Other training resources at EMA Dedicated pages on EMA website for Resources and Training for patients and HCP Links to: • Training documents • Recent relevant workshops • Videos of training days • Short explanatory videos (EMABasics) • External training initiatives (links) Analysis of EMA Training Day 9
'EMA Basics' videos Related docum ents The European Medicines Agency Presentation - The European Medicines Agency The centralised procedure Presentation - The centralised procedure Involvement of patients Presentation - Involvement of patients The Patients’ and Consumers’ Working Party Presentation - The Patients' and Consumers' Working Party EMA video for patient representatives Involvement of patient representatives in scientific advice procedures at EMA Involvement of patient representatives in scientific advisory groups at EMA Pharmacovigilance Presentation - Pharmacovigilance How EMA works with healthcare Presentation - How EMA works with healthcare professionals professionals Scientific advice: what to expect and how to Presentation - Scientific advice: what to expect and how to prepare prepare Declarations of interests: a practical guide Presentation - Declarations of interests: a practical guide How patients are involved in the review of Presentation - How patients are involved in the review of documents documents What is a European safety referral Presentation - What is a European safety referral Analysis of EMA Training Day 10
Future ideas for continued training • Create more one page ‘info sheets’ on EMA activities • Record more EMABasics • Organise webinars on selected topics • Investigate tools for creating on-line quizzes • Create training for young people • Explore adapted regulatory training for healthcare professionals Analysis of EMA Training Day 11
Contact EMA Patients and Consum ers and Healthcare professionals w ebpages EMA basics EMA w ebsite: w w w .em a.europa.eu Contact: m aria.m avris@em a.europa.eu European Medicines Agency 30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone + 44 (0)20 3660 8452 Facsim ile + 44 (0)20 3660 5550 Send a question via our w ebsite www.ema.europa.eu/ contact Follow us on @EMA_ New s Analysis of EMA Training Day 13
Recommend
More recommend
