EFA Meet and Greet the EU training
The European Medicines Agency
14th June 2021, 13h:00 CEST
Online
The EFA Meet & Greet the EU training is part of the EFA capacity building programme for 2020
Objective: INFORM - Provide meaningful input, skills and competences to EFA Members and expert patients from other respiratory diseases interested in participating in regulatory processes for medicines development.
Target audience: Staff, volunteers and members of the Board of EFA members. Open also to patients non-attached to an EFA member, provided they belong to patient groups active in the field of respiratory disease.
Time |
Topic |
Presenter |
Online Materials |
13h00-13h15 |
Welcome
|
Isabel Proaño, Director of Policy and Communications (EFA) |
|
13h15-14h15 |
Authorisation of medicines in Europe and patient involvement
Regulatory pathway of medicines in Europe:
Case study of EFA patients involved in the past Discussion |
Maria Mavris, Patient Relations, Public and Stakeholder Engagement department (EMA) |
The European Medicines Agency (video)
The EMA centralised procedure (video)
How the EMA interacts with patients and consumers (video)
EMA-PCWP patients and consumers working party (video) |
14h15-14h25 |
Comfort break |
||
14h25-15h30 |
Information and patient involvement in practice
Assessment of patient participation in the processes for respiratory medicines:
Practical exercise: reviewing a document Feedback, Questions and Answers |
Maria Mavris (EMA) |
How are patients involved in the review of documents? (video)
What is scientific advice? (video) |
15h30-15h40 |
Comfort break |
||
15h40-16h00 |
Red tape How to fill in the administrative forms at EMA and support available:
Questions and answers |
Susanna Palkonen, Director (EFA) Erna Botjes, EFA representative at EMA (EFA) |
Declarations of interest: a practical guide (video) |
16h00-16h45 |
Safety: pharmacovigilance and safety monitoring of medicines for allergy and respiratory disease
Feedback, questions and answers |
Sabine Straus, Chair of the Pharmacovigilance Risk Assessment Committee (PRAC) of EMA |
Pharmacovigilance (video)
What is a European safety referral (video) |
17h00-17h15 |
EFA network pool of expert patients Wrap up and closing |
Isabel Proaño (EFA)
|
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