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EMA announced a workshop it will be conducting on “ICH Q3D from a quality perspective,” on April 5-6, 2016, at its headquarters in London. Participants will include EU regulators, the European Pharmacopoeia and the pharmaceutical industry. The workshop will focus “mainly on the quality aspects of the guideline and its implementation in the European regulatory system,” the announcement notes. The training modules developed and endorsed by the Q3D Implementation Working Group (IWG) will be used as a basis for the material presented at the workshop. According to the agenda, the meeting will be divided into three “blocks” – safety, quality, and regulatory/pharmacopeia – and will include EU regulatory agency, pharmacopeia, and industry presenters with discussion periods after each session. Attendance at the workshop is by invitation only.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
