Following the success of the PAT Track at our ISPE Singapore Conference in August, the PAT CoP invites you to...
Our Last PAT CoP Session of 2017
Regulatory Aspects of QbD and PAT
- A Dialogue Session -
Date: 3 Nov 2017
Codon Meeting Room, Matrix Building Level 5
30 Biopolis Street
The session will provide an introduction to QbD and PAT as well as an overview of ICH and EMA guidelines. Case studies in dialogue format will cover both qualitative and quantitative applications such as the identification of API and content/blend uniformity with participants having opportunities to interact and discuss on challenges faced during implementation or routine operations. This session hopes to provide a greater understanding, promote knowledge sharing and foster networks in the field of QbD and PAT.
Dr. Oh Ching Mien graduated with a bachelor degree in Pharmacy and Ph.D. in Pharmaceutical Sciences. Previously, he was a regulatory specialist with Health Sciences Authority, where his responsibilities involve critically evaluating and assessing dossiers of therapeutic products, providing recommendations for regulatory decisions and reviewing regulatory policies, processes, and strategies. His previous experiences also include being a process expert with Novartis and a pharmacist in the retail and hospital setting. Currently, he is a deputy manager in business development with ST Healthcare.
Dr. Chew Wee graduated from NUS with a Ph.D. in chemical engineering. He is the founding chairperson of the local Process Analytical Technology (PAT) Community of Practice (CoP) under the ISPE Singapore Affiliate. Wee is a research scientist with A*STAR, holding joint appointments at BioTrans and ICES, where he leads PAT endeavors ranging chemical synthesis, crystallisation, fermentation, with inline analytics and novel chemometrics algorithms. He is currently teaching PAT at the Singapore Institute of Technology (SIT) as an Associate Faculty staff.
Registrations are now open!
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ISPE Singapore Affiliate