Regulatory Affairs – PACMP Poster Presentation.
The RAPS Euro Convergence is the most comprehensive regulatory affairs conference in Europe, focusing on the latest developments in healthcare products in Europe and beyond – pharmaceuticals, medical devices, IVDs, and combination products.
Meet Arriello’s Senior Regulatory Affairs Specialist, Valeria Grigoriev, who presented a poster on the “Traditional approach versus PACMP: Finished Product Manufacturing Site Transfer Variations”.
Valeria has over four years of experience and expertise, with a master’s degree from the State University of Medicine and Pharmacy in Moldova, and an MBA from the Moldovan Academy of Economic Studies.
Her experience covers Research and Development, Project Management of different types of submissions, Due Diligence and Approval, across Europe and the CIS. Typical areas have included MAAs, Variations (National, DCP and MRP), Renewals, and a wide range of other regulatory administrative procedures from Marketing Authorization Transfers to MA Withdrawals.
She has many pieces of research on biosimilars, and technological transfer related projects published in various scientific publications and has participated in many international academic events.
Specific experience: Regulatory Submissions, Due Diligence Reviews, Regulatory Strategy, Project Management, Local Pharmacovigilance, SME application, eCTD guidance and publishing.
Accompanying this poster is an Arriello guide:
“Making Lighter Work of Finished Product Manufacturing Site Transfer Variations in Life Sciences.”
Arriello is at the forefront of ICH Q12/PACMP-based finished product manufacturing site transfer variations management.
Over the two years to March 2023, we catered for up to 50 finished product manufacturing site transfer variations, both national and MRP applications, with submissions successfully performed across the EU and Eastern Europe deriving from our own experience the features of both the traditional and PACMP approaches.
Here we had the opportunity to work with a range of pharmaceutical forms, and generic products, well-established use medications, as well as standalone applications.
Specific new measures under International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use guideline Q12 include the Post-Approval Change Management Protocol (PACMP).
The following guide looks more closely at the benefits of the new protocol, and what’s involved in using the new framework for post-approvals change management linked to finished product manufacturing sites.
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