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An agency of the European Union Brainstorm ing on training strategy Current training Training m anual (info on EMA, review of EPAR summaries, package leaflets and safety communications) Once yearly in-house training (info on EMA,


  1. An agency of the European Union Brainstorm ing on training strategy

  2. Current ‘training’ • Training m anual (info on EMA, review of EPAR summaries, package leaflets and safety communications) • Once yearly in-house training (info on EMA, review of EPAR summaries, package leaflets and safety communications) • EMA w ebsite (information on general agency activities and on patients and consumers organisations (PCOs) involvement • Patient leaflet (information on PCO involvement in EMA) • Telephone (individual provision of information for, e.g. Scientific Advisory Group (SAG) meeting, ad-hoc expert meeting or product consultation) 2

  3. What do we want to achieve? • Is the current training adequate? (personal experiences?) • Is there something missing? If so, what? • Does the training provide enough support for patients when engaging in EMA activities? • Does training cover the newer activities such as SAGs, Scientific Advice (SA), etc, adequately 3

  4. Brainstorming 3 groups: • Training material for the website • Increase visibility of patient involvement / dissemination of information • In-house training 4

  5. Brainstorming Training m aterial for the w ebsite • General info on Agency and procedures • Tutorials • Glossary • Info pack for PCOs 5

  6. Brainstorming I ncrease visibility of patient involvem ent/ dissem ination of inform ation • Training activities by PCOs on regulatory activities • Info on EMA interaction with civil society • Methods of dissemination of EMA info • Info pack promotion • The national dimension 6

  7. Brainstorming I n-house training • Identification of topics • Format/ definition • Frequency • Invitees • Training material 7

  8. Feedback following break-out sessions General discussion • Info-pack structure • Implementation and next steps • Priorities/ timelines • Monitoring 8

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