Patrick Ruddock

Director, Regulatory and Clinical at Atomvie Global Radiopharma Inc

Based in Toronto, Canada

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Seniority

Director

Department

Science

Location

Toronto

Industry

Pharmaceutical Manufacturing

Company size

146

Contact information

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Email

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p•••••••@atomvie.com

Phone

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Background

About Patrick Ruddock

Regulatory Affairs (RA) Professional with 15+ years' experience in the following areas:* Pre-/post-marketing filings for radiopharmaceuticals, biologics, and Class II - IV devices (Canada and US)* CMC, clinical, administrative and publishing aspects of regulatory submissions * DEL applications and maintenance * Drug development/clinical trial project management including process/method development & validation, non-clinical, regulatory and REB/clinical tasks * Clinical trial activities including reviews and strategic advice for REB filings, protocol deviations, monitoring visit reports, trial data, SAPs, Clinical Study Reports, etc.* Labelling and promotional review & approval * Change control assessment & approval * Working collaboratively with local/global RA, Quality, Product Development, Manufacturing & Marketing colleagues/clients * Regulatory surveillance

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