Meet our Subject Matter Experts

Adam Kopel

Assistant Interventionalist

Interventional & Surgical Research, Preclinical

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Adam Saltman, PhD, MD

Chief Medical Officer

Clinical, FDA, Product Development, Regulatory

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Adrian Keene

Associate VP, Global Biological Safety & Validation and EMEA Consulting Services

Biological Safety, Clinical, EU IVDR, EU MDR, Regulatory

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Áine Mary Duffy, BSc (Hons), PhD

Clinical & Regulatory Operations Manager

Clinical, EU MDR, FDA, Medical Writing, Regulatory

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Alexander Hermann, PhD

Supervisor, Study Director Group

Biological Safety, Chemical Characterization, FDA

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Alfred Dibao-Dina, PhD, DABT

Biological Safety Scientist

Biocompatibility, Biological Safety

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Andrea Perciaccante

Analysis Leader

Market Research, Quality, Regulatory

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Andy J. Wyen, MS, DABT, LAT

Principal Toxicologist

Biocompatibility, Biological Safety, Chemical Characterization, EU MDR, FDA, Toxicology

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Angela Sanchez

Associate Scientific Director, Analytical Services

Chemical Characterization, EU MDR, FDA

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Ariadna Navarro, PhD

Senior Strategy Consultant

Clinical, EU IVDR, EU MDR, IVD, Medical Writing, Quality, Regulatory

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Aurélie San Juan, MSc, PhD

Principal Medical Writer, Regulatory

EU MDR, Medical Writing, Regulatory

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Barb Mercier

Associate Manager, Clinical Research Associates

Clinical

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Beatriz Rodriguez Grande, PhD

Regulatory Consultant and Consulting Manager

EU IVDR, EU MDR, Medical Writing, Regulatory

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Brandon Woll, MBA

Principal Strategy Consultant

Director, FDA, Preclinical, Product Development, Quality, Regulatory, Validation

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Brian Kaufman, PMP, CCDM

Manager, Global Clinical Data Management

Clinical, Data Management

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