Parastoo Karoon

Parastoo Karoon

Parastoo Karoon

Principal Consultant

Parastoo is a Small Molecule Clinical and Scientific expert with extensive experience in the review and approval of drug product and clinical sections of MAA dossiers including benefit risk determination, labelling negotiations and product information. Parastoo focusses on the EU and has a special interest in cardiovascular products.

Parastoo provides advice on drug development and submission strategies, interactions with Regulatory Authorities and regulatory affairs issues. She also performs gap analysis of Clinical section of dossiers, drafts and reviews scientific advice, MAA and variation documents. Parastoo provides excellent advice based on a unique combination of broad knowledge of the EU regulatory landscape, an indepth understanding of Module 5 requirements and a drive to fully understand client needs.

Work Experience

Parastoo joined Parexel in September 2017. Prior to joining Parexel, she spent over 5 years in Scientific/ Clinical Assessment at the MHRA and additional 7 years in Pediatric Policy and different aspects of drug regulation in MHRA. She was an accredited assessor for Paediatric procedures and interacted directly with PDCO. Parastoo was previously employed as European Regulatory Lead for Amgen Inc London, UK.

Education

Parastoo has a degree in Pharmacology (B.Sc.) from King’s College London, a Masters and a Ph.D. in Pharmacology/Neuroscience from University College London. She is a member of the Organisation for Professionals in Regulatory Affairs (Topra) and Drug Information Association.

We are always available for a conversation.

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