1. 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

2. 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?

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

4. 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 , 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

5. 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