03 January 2017 EMA/624263/2016 Corporate Stakeholders Department
Agenda – EMA-Association of the European SelfMedication Industry (AESGP) annual bilateral meeting 11 January 2017, 14:00 – 17:00, Meeting Room 03-F
Chair: Marie-Helene Pinheiro Item
Topic
Time
1.
Welcome and general update on EMA priorities
14:00 – 14:05
2.
AESGP Self-Care Agenda and priorities
14:05 – 14:30
3.
4. 5.
6.
Centralised procedure & non-prescription medicines: taking stock of the last 10 years and the way forward Linking SPOR implementation and optimisation of regulatory processes Framework for interaction with the industry including AESGP feedback on participation in different EMA platforms AOB
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Oct 23, 2017 - under Article 107i of Directive 2001/83/EC, based on pharmacovigilance data. Action: For adoption of ..... manufacturing process; and 3) removal of the following missing information: special patient groups. Action: For .... analysis of
Jul 31, 2017 - Human Medicines Research and Development Support Division. Agenda ... use of such prior knowledge in regulatory application dossiers, to support manufacturing and control strategies ... of accelerated access schemes.
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Nov 27, 2017 - Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be