EURORDIS-SCOPE pharmacovigilance training 22nd March 2017, 8.30 to 13.30 Holiday Inn London Regents Park, Carburton Street, W1W 5EE: Trinity room François Houÿez 22nd March, London

I’ve started a new treatment, I don’t feel well, my doctor doesn’t answer the phone. Can you help? I’ve taken two capsules of long-release paracetamol and not the flash ones. What should I do? I knew I could have diarrhoea with my treatment, but do you know how long this will last for? My pharmacist advised to report any side effect I would have with my new medicine, but how can I do that? There is a black triangle in the leaflet. Does this mean the medicine is dangerous?

Eurordis Survey “Acting on the treatment information you have” 15 February- 31 May 2016. 1,453 responses Allo?

European Network of Rare Diseases Help Lines Caller Profile Analysis October 2016 16 help lines in 12 countries October 2016: 1,633 enquiries 58% by phone, 38% by email, 4% others 52 trained respondents, 777 hours of reply Average duration: 29 minutes 3,405 responses given 16% on disease and care 15% orientation to expert 7% on treatment and regulatory affairs

Agenda of the day An introduction to Pharmacovigilance Time Topic By Style 8.30 Registration   9.00 Welcome François Houÿez, EURORDIS Lecture 9.10 An introduction to Pharmacovigilance Kendal Harrison, MHRA 9.55 Responding to challenging calls Rachael Wyartt, Helplines partnership Workshop 11.10 Tea break 11.35 Responding to challenging calls: continued Rachael Wyartt Helplines partnership 12.05 Patient Engagement: a regulatory perspective Mitul Jadeja, MHRA 13.00 European patient activities Jan MacDonald, MHRA 13.25 Close of meeting 13.30 Lunch