€800

ICH Q12 and Life-Cycle Management of Pharmaceutical Products Workshop

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DCU All Hallows Campus

All Hallows Campus

Dublin College University

D09 N920 Dublin

Ireland

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Event description
A mix of talks and workshop sessions on the new ICH Q12 guideline which is expected to be finalised in the latter half of 2019.

About this Event

Organised by the CMC Regulatory Science Forum, in partnership with Dublin City University

With the new ICH Q12 guideline expected to reach step 4 of the ICH process during the latter half of 2019, the CMC Regulatory Science Forum have brought together key EU members of the ICH Q12 Expert Working Group, as well as senior regulators, industry experts and academics to discuss this new harmonised approach to management of post-approval changes in a more predictable and efficient manner across the product lifecycle.

This two day workshop will provide an overview of the principles, regulatory tools and enablers described in the guideline, as well as practical examples of how ICH Q12 can provide solutions to challenging areas of life-cycle management of CMC.

For Academia and Government organisations, special discounts may be available.

Please contact us at info@cmcregulatoryscienceforum.ie

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Date and Time

Location

DCU All Hallows Campus

All Hallows Campus

Dublin College University

D09 N920 Dublin

Ireland

View Map

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