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Theresa Jeary, BSc (Hons), MSc

Global Head, Medicinal & Biologics Team
BSI Group

Theresa Jeary, Global Head, Medicinal & Biologics Team, BSI.

Theresa has a MSc in Pharmaceutical Science and over 30 years’ experience in the Pharmaceutical and Medical Device sectors.
In addition to product development and regulatory expertise from a industry perspective,

Theresa has 15 years Notified Body experience and was recently appointed the Global Head of the Medicinal & Biologics Team at BSI, leading a multidisciplinary team, of experts with responsibility for the A117 service offering, Conformity assessment processes for devices that utilise human or animal tissue, Rule 21, IVF/ ART, Preservation Solutions for Organ transplantation, Rule 14 Device medicinal consultations and consultations for devices utilising TSE risk species tissues as per 722/2012.

Theresa is a regular presenter on MDR Implementation, Rule 14 and Article 117 and regularly participates in Team-NB working groups, heading the Rule 21 WG, and contributes to various scientific publications and regulatory guidance and has extensive experience of interacting with EU Competent Authorities.

Disclosure information not submitted.

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