Issue link: http://www.e-digitaleditions.com/i/686898
Inhalation JUNE 2016 9 A key objective of the European Phar- maceutical Aerosol Group (EPAG) is to recommend harmonized standards and methodology. To achieve this, meetings with regulatory agencies are held. Successful regulatory meetings with Germany and Sweden During 2014, a successful meeting with German Bundesinstitut für Arzneimittel und Medizinprodukte (BfARM) took place. It was followed by a meeting in 2015 with the Swe- dish Medical Products Agency (MPA). Both meetings focused on Abbreviated Impactor Measurement (AIM) and harmonization of test methods. Agreement was reached for MPA to actively participate in the EPAG nasal sub-team work. Initial discussions with the British Pharmacopoeia Continuing this theme, initial discus- sions have been held with British Pharmacopoeia staff, focusing on the inhalation products monograph that is currently under consideration for comments. Dialogue will continue and a face-to-face meeting has been proposed for summer 2016. Developing opinions on pulmonary and nasal delivery Another of EPAG's objectives is to develop opinions on pharmaceutical topics relevant to pulmonary and nasal delivery products. Conse- quently, topics of interest are regu- larly reviewed and specific areas of interest are selected. The topics iden- tified for further consideration during 2016 are: Tanya Church Chiesi Limited CROSS - I NDUSTRY A brief update from EPAG • E-Health • Quality by Design (QbD) • Human Factors (lab studies vs. clin- ical studies) • Improving products; What is the definition of better? (a 360-degree view) Additional plans for 2016 During 2016, increased interaction with universities is also planned. Spe- cialist speakers will be invited to high- light differing opinions on key topics and produce lively and informed debates. For further information on EPAG activities, please visit www.epag.co. uk where a contact form can also be found. Tanya Church is Deputy Head of Lab- oratory at the Chiesi Chippenham Research Centre, Chippenham, Wilt- shire, UK, Tel.: +44 1249 466937. ORGANIZATIONS