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Sanj Raut, PhD

Biologicals Quality / Pharmaceutical Assessor
MHRA
Potters Bar, United Kingdom

Sanj Raut, PhD, Biologicals Quality / Pharmaceutical Assessor, Innovative Medicines, Healthcare Quality and Access, Medicines and Healthcare products Regulatory Agency (MHRA), UK.

Dr Raut is a Pharmacologist by training with his undergraduate and PhD degrees from the University of Liverpool, UK. He has extensive (>30 years) relevant experience (principally gained at NIBSC-MHRA) in measurement of the quality of biological medicines.

This includes the development of World Health Organization (WHO) International, British and European Reference Standards for Blood Products (e.g. Coagulation Factor VIII (FVIII), fibrinogen, factor XIII, FVIII bypassing agents and neutralising antibodies (inhibitors) to FVIII). He has established > 20 WHO International Standards and Secondary (European Pharmacopeial, & National) Working Standards in the field of Haemostasis. As Project Leader, he has developed, calibrated and delivered >20 Product Specific Reference Materials, for Blood products and IVDDs.

He has extensive experience also as a Study Director, performing National/EU Official Control Authority Batch Release (OCABR) & Independent Batch Release Control (IBRC) Testing of high-profile Blood products (such as FVIII, VWF, APCCs) for both UK-GB and non-UK batch release.
This includes experience as a qualified HoD signatory for UK/GB batch release certification for all Blood Products marketed in UK/GB.

As Head of Haemophilia Laboratory (and Group Leader), he has extensive (>30 years’) research experience in the fields of fibrinolysis, coagulation and thrombosis, with >60 peer-reviewed publications (including Chapters in books) covering various aspects of Haemostasis and Haemophilia.

He has served on numerous national and international committees and advisory boards (JPAC-SACBC, ISTH-SSC), relating to medicine safety, immunogenicity and adverse events, international standardisation and the harmonisation of diagnostic tests. He is a registered Expert at the following external Stakeholders: WHO, EDQM, ISTH, EMEA.

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