EFA Meet and Greet the EU training: The European Medicines Agency

 Registration is closed for this event

 

EFA Meet and Greet the EU training

The European Medicines Agency

14th June 2021, 13h:00 CEST 

Online

FINAL AGENDA

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

  • Importance of allergy and respiratory patient involvement in decisions that affect them 
  • Objectives of the meeting

Isabel Proaño,

Director of Policy and Communications (EFA) 

 

13h15-14h15

Authorisation of medicines in Europe and patient involvement

 

Regulatory pathway of medicines in Europe:

  • Introduction to EMA and the review of its mandate
  • Methodologies for patient organisations and patient engagement and support 
  • Patient involvement in EMA and its impact  

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:  

  • Patient review of medicinal product information and safety information 
  • Scientific Advice Procedures
  • Participation in Scientific Advisory Groups (SAGs) 

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: 

  • Conflict of interest 
  • e-CV 

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

  • Product lifecycle 
  • Monitoring adverse reactions 

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)

 

 

 

14th June, 2021 1:00 PM   through   5:15 PM
Virtual event on Zoom
Brussels,
Belgium
Phone: +3222272712
Email:

Dear Visitor,

for regularly updated information on Covid-19 for allergy and respiratory patients, please consult our Covid-19 resource and information hub.
Stay safe!
The EFA Team